Patient Educator Consultation Checklist (Document 1) Patient Concerns Additional Questions for Dr. [Surgeon Name] Have you had any type of Plastic Surgery before? o Are you happy with your results? o My role in your care o Our commitment to patient education o What we’ll talk about today o Have you read the information we provided you? o Clinical evaluation sheet medical history and patient preferences o Brief history of augmentation o Alternatives versus a single approach o Do implants cause disease? The research and sources o Breast implants and breast cancer o Breast implants and mammography All implants interfere with mammograms o Breast implant technology o Constantly changing alternatives- current alternatives o Limitations of implants- no implant is without tradeoffs o Summarizing the alternatives o Incision alternatives- inframammary, axillary, periareolar, axillary o Implant pocket locations- retromammary, retropectoral, dual plane, totally submuscular o Current implant choices (all saline)- Smooth round, textured round, textured shaped or anatomictypes and manufacturers o Fitting the procedure and implant to your tissues to minimize long-term risks and compromises o Determining the best size o If you could just pick a size, what would it be? o Which is more important, size or problems longterm? o Common misconceptions o How implant size affects your tissues- now and later o Bra cup sizing-we can't guarantee cup size o Balancing your breast with your figure o Measuring your breast, understanding your tissues o Concentrating on shape, fill, dimensions o Photos and planning the operation o The operation- what’s it like o Day surgery routine o The facility and facility personnel o Anesthesia Safety of anesthesia, misconceptions, risks Local versus general anesthesia Our anesthesia personnel o During surgery o What will occur, expected time frame o After surgery o Waking in recovery, then to stepdown with caregiver o Detailed instructions will be given to you Tells you and your caregiver what to expect and do What we do simplifies your instructions o Recovery and activity o Importance of resuming normal activity o What we do and what we need you to do o No bandages, bras, straps, drains or special devices o Nothing aerobic for 2 weeks o Risks of augmentation o This is a totally elective operation with risks and uncontrollable factors o Bleeding o Infection o Sensation compromise o Capsular contracture o Unsatisfactory aesthetic results or scarring o Interference with cancer detection o Complications may require additional surgery, longer recovery, additional costs o Reviewed risks on consent forms & documents o Capsular contracture and breast firmness o What is it? o How a capsule forms o Controlling the capsule o How often does it occur? o Correcting the hard breast o Factors that the surgeon cannot predict or control o Capsular contracture oDifferent degrees, if severe, requires reoperation oSurgeon alone makes final decisions re: reoperation oAll costs are patient's responsibility, no insurance o Tissue stretch problems- increase with implant size o Stretch allowing implant shift downward or outward o Stretch allowing implant rotation o Traction rippling o Your request for a different size implant after surgery o All costs for any surgery relating to factors the surgeon cannot predict or control are the patient's responsibility (surgeon fees, facility fees, anesthesia, lab, time off work)- includes capsular contracture, stretch deformities, implant size changes. o Importance of communicating with us We want to do what you want You must be honest with us at all times The surgeon cannot read your mind o What you can expect from Dr. [Surgeon's Name] Type of care. Written materials. Photos. The operation. Your care. o Dr. [Surgeon's Name] Qualifications Surgical training, board certification, professional affiliations, scientific publications, other. o Patient has read all information material provided (Yes/No) _____Pt. Initial. o Discussed any significant other's involvement, gave patient copy of Will There Be Anyone Else Involved. o Written information provided patient was discussed in detail with patient, answered patient's questions to patient's satisfaction. o All informed consent documents discussed in detail with patient, answered patient's questions. _______Pt. Initial _______Pt. Educator Initial My Preferences and Information that I Fully Understand and Accept: (Document 2) I (please print and sign)__________________________________________ have have not read the following materials [list]sent to me by Dr. [Surgeon’s Name] about breast augmentation by in their entirety. Before visiting with Dr. [Surgeon’s Name], the following are my preferences and choices. I understand that if Dr. [Surgeon’s Name] feels that my choices might have negative short-term or long-term effects on my tissues or my chances for the best result with the least risk of complications, he will discuss these issues with me during our consultation. ______ I understand that Dr. [Surgeon’s Name] can achieve virtually any size breast that I choose, but Dr. [Surgeon’s Name] is limited by the characteristics of my tissues that we can’t change. I also understand that the choices I make, particularly with respect to implant size, can affect the appearance of my breasts as I get older and can affect my risks of having complications or needing additional operations in the future. Please initial one of the following with regard to the BREAST SIZE YOU DESIRE: ______ I want a MINIMAL amount of enlargement. ______ I want to be AS FULL AS I CAN BE AND ACHIEVE A NATURAL APPEARING BREAST THAT IS SAFEST FOR MY TISSUES LONG-TERM. I leave the choice of implant size under these circumstances entirely to Dr. [Surgeon’s Name], and will accept the size of breast that he feels is safest for my tissues long-term. ______ I want a SPECIFIC SIZE BREAST—at least a _____ cup size AND at least a ____cc implant. (Please fill in ALL blanks) Please initial one of the following with respect to CHOICE OF BREAST SIZE AND RISK OF FUTURE PROBLEMS: ______ I WANT A BREAST SIZE THAT WILL HAVE THE LEAST CHANCE OF CAUSING FUTURE SAGGING, COMPLICAITONS, OR NEED FOR ADDITIONAL PROCEDURES SUCY AS A BREAST LIFT. I understand that Dr. [Surgeon’s Name] will choose an implant that will produce the fullest breast possible that is safest long-term, unless I specify a smaller or larger breast. I leave the choice of implant size entirely to Dr. [Surgeon’s Name] based on his evaluation of my tissues and body proportions. I understand and accept that Dr. [Surgeon’s Name] cannot guarantee a cup size of my result, and I will not request a larger implant following my augmentation. ______ I WANT A SPECIFIC BREAST SIZE, EVEN IF IT MIGHT BE LARGER THAN IDEAL FOR MY TISSUES. If I want a larger implant than Dr. [Surgeon’s Name] feels is optimal for my tissues, I understand that I may not have a natural appearing breast. I am willing to accept all responsibility for appearance and increased risks of reoperations, complications, deformities, and additional costs and time off work and normal activities in the future that may result from my selecting an implant that is larger than ideal for my tissues. Please initial one of the following with respect to HOW YOU WOULD LIKE YOUR BREASTS TO LOOK: Three to six months after my augmentation (after my tissues relax), I want the upper portion of my breast to appear: ______ Inwardly curved, NOT FILLED IN THE UPPER PORTION OF THE BREAST. ______ FULL IN THE UPPER BREAST, with a straight or slightly outwardly curved profile in side view. ______ EXTREMELY FULL, WITH A VERY BULGING UPPER BREAST. I understand and accept that this choice produces a breast that does not appear natural and may have excessive bulging with an unnatural appearing transition from the upper chest to the breast. I also understand that an excessively large implant can cause damage to my tissues long-term that could cause me to need additional operations or have permanent deformities, but I want the large implant regardless of those possible consequences. Choices and Preferences for Breast Augmentation (cont’d) for:__________________ IMPLANT SHAPE I prefer: ____ Shaped or Anatomic IMPLANT SHELL TYPE I prefer: ____ Textured ____ Round ____ Smooth IMPLANT MANUFACTURER I prefer: ____ McGhan Medical ____ Mentor ____ Other: _________ ____ I want Dr. [Surgeon’s Name] to choose and will abide by his choice IMPLANT SIZE I prefer: ____ I want an implant that contains at least _______cc of saline (if you have an opinion). If I do not specify a number of cc’s that I want in my implant, I am leaving the decision entirely up to Dr. [Surgeon’s Name], and I will accept his judgement regardless of my breast size following surgery. ____ I have absolutely no specific preference for the number of cc’s in my breast implant, and I want Dr. [Surgeon’s Name] to choose based on his evaluation of my tissues and proportions. If I ask Dr. [Surgeon’s Name] to choose the appropriate size implant that is best for me, I will abide by his choice, understanding that he will fill my breast as much as he feels it can be filled safely, without producing additional risks or tradeoffs. ____ If, after surgery, for any reason I desire a different size implant, I understand and accept that I must specify the exact type and size of implant in cc’s, and that I am totally responsible for all costs associated with changing my implants, including surgeon fees, anesthesia fees, laboratory costs, and surgical facility fees. Further, I will not expect Dr. [Surgeon’s Name] to reoperate to correct any problems that may occur as a result of my requests for a larger or different implant. IMPLANT POCKET LOCATION I prefer: ____ I prefer my implant be placed UNDER muscle. I have read and fully understand and accept the tradeoffs of placing an implant under muscle. ____ I prefer my implant be placed ABOVE muscle. I have read and fully understand and accept the tradeoffs of placing an implant above muscle, and I understand and accept that I may see visible implant edges or other irregularities if the implant is placed above the muscle. ____ I do not have a preference for over or under muscle, and I want Dr. [Surgeon’s Name] to choose according to my tissue requirements. I have read and fully understand the tradeoffs of placing an implant either over or under muscle. INCISION LOCATION I prefer: ____ Under the breast ____ Around the areola ____ In the armpit ____ In the belly button ____ I would like Dr. [Surgeon’s Name] to choose my incision location based on his assessment of my needs and optimal control during the operation, and I will abide by his decision. ______ I have read all of Dr. [Surgeon’s Name]’ informational materials and have had an opportunity to visit with Dr. [Surgeon’s Name]’ patient educator __________________________________. I have had an opportunity to ask questions and have had all of my questions answered to my satisfaction. I will have an additional opportunity to ask Dr. [Surgeon’s Name] questions during our consultation. I feel fully informed, and have had an opportunity to have all of my questions answered to my satisfaction. Signed this _____day of the month of ________, 200___. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) ______ I have been given a copy of this document for my personal records. Factors Following My Augmentation that Dr. Tebbetts Cannot Control I (please print and sign)__________________________________________ have read Dr. Tebbetts’ informational materials and his entire book entitled The Best Breast and have had an opportunity to visit with Dr. Tebbetts’ patient educator _________________________________. The following is essential information that I must understand and accept before having Dr. Tebbetts perform my breast augmentation. I have discussed each of these items with my patient educator and fully understand and accept the tradeoffs, risks, costs, and outcomes associated with each item. _____ From my reading of Dr. Tebbetts’ book The Best Breast, and after my patient educator consultation, I understand and accept that there are several factors related to my individual tissue characteristics, how I heal, and how my tissues respond to my breast implants that Dr. Tebbetts cannot predict by tests before surgery, and cannot control after surgery. INFECTION ______ I fully understand and accept that if I develop an infection following my augmentation, Dr. Tebbetts will remove both of my breast implants, and will never replace either implant to minimize further reoperations, risks, and costs to me. I further understand and accept that, if implant removal is ever required for any reason, that deformities may result that may not be totally correctable. _____ I understand and accept that Dr. Tebbetts must work with what I bring him to work with, and that he cannot change the qualities of the tissues of my breasts that affect stretch following surgery or how I will heal. I also understand and accept that Dr. Tebbetts cannot perform tests before surgery, or in any other way predict 1) how my skin will stretch following my augmentation, and 2) how my body will heal or not heal following my augmentation. TISSUE STRETCH My tissue characteristics and stretch of tissues following my augmentation: How they can affect my results, need for additional surgery, and costs _____ If my tissues stretch excessively in any area following my augmentation, deformities can result over which Dr. Tebbetts has no control. These deformities include the following: 1) excessive sagging or “bottoming out” of the breast with the implant too low and the nipple pointing excessively upwards, 2) shift of the implants to the sides with widening of the gap between the breasts, 3) thinning of tissues over the implant allowing the implant to become visible or palpable (able to be felt) in any area, and 4) visible rippling in any area that can result when the implant pulls on the overlying tissues. _____ I understand and accept that any or all of these deformities can occur in one or both breasts, and do not occur equally on the two sides. I also understand and accept that the larger breast implant I choose or my breasts require for optimal aesthetic results, the greater the risk of these deformities occurring. Although breasts never match exactly on the two sides, if any of these deformities occur, differences in the two breasts may be more noticeable and may not be correctable. _____ I understand and accept that if any or all of the deformities caused by tissue stretch listed above should occur, even though the deformity may be visible, that Dr. Tebbetts alone will determine whether additional surgery is needed. Dr. Tebbetts will base this decision on whether he feels the potential benefits outweigh the potential risks of additional surgery and whether he feels I will get predictable improvement from additional surgery. I agree to abide by Dr. Tebbetts’ decisions in all matters pertaining to whether or not additional surgery is performed. _____ I understand and accept that if my tissues stretch excessively for any reason following my augmentation, that additional surgery will not change the qualities of my tissues that allowed them to stretch in the first place. As a result, additional surgery to correct stretch deformities is unpredictable at best due to the limitations my tissues impose, and that surgery for any of the stretch deformities listed above may not successfully correct the deformity, and that any or all of these deformities can occur again if my tissues stretch again. HEALING CHARACTERISTICS My healing characteristics following my augmentation: How they can affect my results, need for additional surgery, and costs _____ I understand and accept that Dr. Tebbetts has absolutely no control over how my body heals following my breast augmentation, and that he cannot predict (by tests prior to surgery) or control my individual healing characteristics. _____ I understand and accept that my body will form a lining (capsule) around my breast implant following my augmentation, and that the capsule around the implant may contract (tighten) excessively, causing a variety of deformities that may require additional surgery and despite additional surgery, may be uncorrectable and require implant removal. The capsules that form and the amount that they tighten are never equal on both sides, so the effects of the capsule on each breast are usually different. _____ I understand and accept that there are no tests or medical information that can accurately predict whether my capsules will tighten excessively, and that following my augmentation, Dr. Tebbetts has no control over how my body forms the capsule or how much the capsule will tighten or cause deformity. _____ I understand and accept that any or all of the following deformities can result from how the capsule forms and tightens, and that Dr. Tebbetts cannot predict, prevent, or control the occurrence of any of these deformities: 5) Closing of a portion of the lower implant pocket (can be mild or severe), causing slight or significant upward displacement of the implant, and raising the fold under the breast leaving the incision scar below the fold (if the incision was made under the breast) 6) Closing of a portion of the outside of the implant pocket, causing flattening of areas of the outside contour of the breast and inward displacement of the implant. 7) Excessive firmness of the implant or breast 8) Visible edges or bulging deformities in any area of the breast 9) The quality of the scar that I will form wherever my incision is located. 10) The effects of my body healing and scarring in the area of the incision, adjacent areas to the incision or breast, or any area of the breast. 11) Discomfort or pain in areas of the breast 12) Change in sensation or loss of sensation in any area of the breast or adjacent areas. 13) Occurrence of lymph node enlargement or small bands near the incision caused by incision or obstruction of small lymph vessels (both of which usually subside without treatment in 3-6 weeks). _____ I understand and accept that any or all of these deformities can occur in one or both breasts, and do not occur equally on the two sides. Although breasts never match exactly on the two sides, if any of these deformities occur, differences in the two breasts may be more noticeable and may not be correctable. _____ I understand and accept that if any or all of the deformities caused by my healing characteristics or the characteristics of the capsule (lining) around my implants occur, even though the deformity may be visible, that Dr. Tebbetts alone will determine whether additional surgery is needed. Dr. Tebbetts will base this decision on whether he feels the potential benefits outweigh the potential risks of additional surgery and whether he feels I will get predictable improvement from additional surgery. I agree to abide by Dr. Tebbetts’ decisions in all matters pertaining to whether or not additional surgery is performed. _____ I understand and accept that if any of the deformities listed above occur following my augmentation, that additional surgery will not change the qualities of my tissues and healing characteristics that caused the deformity in the first place. As a result, additional surgery to correct these deformities a) is unpredictable at best due to the limitations of my tissues and healing characteristics, b) that surgery for any of the deformities listed above may not successfully correct the deformity, and c) that any or all of these deformities can occur again after additional surgery because of my healing characteristics. RESPONSIBILITY FOR COSTS ASSOCIATED WITH ADDITIONAL SURGERIES _____ Since Dr. Tebbetts cannot predict or control my tissue characteristics or healing characteristics and how they will affect my chances of developing any of the deformities listed above related to tissue stretch and thinning or capsule or scar tissue formation following my augmentation, I understand and accept that should any of the any of the deformites listed above (1-13) occur, if surgery is necessary to try to improve any of the following conditions, that I will be personally responsible for all costs associated with any surgery that is performed (please initial beside each number indicating your complete understanding and acceptance of all costs associated with surgery for each deformity): 1) excessive sagging or “bottoming out” of the breast with the implant too low and the nipple pointing excessively upwards, 2) shift of the implants to the sides with widening of the gap between the breasts, 3) thinning of tissues over the implant allowing the implant to become visible or palpable (able to be felt) in any area, and 4) visible rippling in any area that can result when the implant pulls on the overlying tissues. 5) Closing of a portion of the lower implant pocket (can be mild or severe), causing slight or significant upward displacement of the implant, and raising the fold under the breast leaving the incision scar below the fold (if the incision was made under the breast) 6) Closing of a portion of the outside of the implant pocket, causing flattening of areas of the outside contour of the breast and inward displacement of the implant. 7) Excessive firmness of the implant or breast 8) Visible edges or bulging deformities in any area of the breast 9) Discomfort or pain in areas of the breast 10) The effects of my body healing and scarring in the area of the incision, adjacent areas to the incision or breast, or any area of the breast. 11) Discomfort or pain in areas of the breast 12) Change in sensation or loss of sensation in any area of the breast or adjacent areas. 13) Occurrence of lymph node enlargement or small bands near the incision caused by incision or obstruction of small lymph vessels (both of which usually subside without treatment in 3-6 weeks). _____ I understand and accept that Dr. Tebbetts does not accept insurance or any third party reimbursement for any type of additional surgery that may be necessary following my augmentation, and that I will be personally responsible for prepaying all costs of any additional surgery at least two weeks prior to the scheduled surgery. If I choose to pay by credit card, I understand and accept that I agree to sign additional documents authorizing full payment by my credit card company. Dr. Tebbetts will provide me with copies of my operative note from my surgery, but I assume all responsibility for any filing of insurance and understand that Dr. Tebbetts and his staff will not pursue payments from any third party. _____ I understand and accept that costs of any additional surgery following my augmentation will likely exceed the costs of my original augmentation surgery, and that costs are determined by the complexity and length (time) of the surgery required. Fees for additional surgery will include laboratory fees, electrocardiogram fees if I am over 40 or have any heart condition, possible mammogram or MRI imaging fees, Dr. Tebbetts’ surgeon fees, anesthesia fees, surgical facility fees, and costs of take home medications. I accept personal responsibility for all of these fees, and in addition, I understand and accept that I may have additional costs associated with time off work or normal activities. _____ I understand and accept that Dr. Tebbetts alone sets his fees for all surgeries he performs, that these fees are not negotiable for any reason by any party, and must be prepayed at least two weeks prior to surgery. _____ If following my breast augmentation, any additional surgery for the reasons listed above becomes necessary, and I later choose to dispute any of the items above for which I have indicated my full understanding and acceptance, I agree to pay any and all of Dr. Tebbetts’ costs, including any attorney’s fees, court costs, or any other costs associated with resolving the dispute. ______ I have read all of Dr. [Surgeon’s Name]’ informational materials and have had an opportunity to visit with Dr. [Surgeon’s Name]’ patient educator __________________________________. I have had an opportunity to ask questions and have had all of my questions answered to my satisfaction. I will have an additional opportunity to ask Dr. [Surgeon’s Name] questions during our consultation. I feel fully informed, and have had an opportunity to have all of my questions answered to my satisfaction. Signed this _____day of the month of ________, 200___. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) ______ I have been given a copy of this document for my personal records. To Help with Your Augmentation Choices An Outline of Decisions for: (Document 3) Which breast “look” would you like to achieve from breast augmentation surgery? A “BAYWATCH” appearing breast, A FULL, but NATURAL appearing breast, full in the upper breast, but with a more natural appearing transition from the chest to the breast Initial here ______ OR less natural, ROUND in appearance with a BULGING upper breast and a VISIBLE STEPOFF from the chest in the upper breast Initial here ______ Please choose ONE of the following alternative methods of producing a FULL but NATURAL APPEARING BREAST: Please proceed to Page 2 An ANATOMIC SHAPED IMPLANT, Filled Within Manufacturer’s Recommended Fill Range Initial here ______ Potential Benefits 1. Adequate fill to prevent upper shell collapse while preserving manufacturer’s warranty 2. Provides natural appearance while allowing adequate fill to prevent upper shell collapse 3. Maintains upper breast fill better because upper pole does not collapse 4. Implant shape more like a natural breast shape when filled adequately to prevent upper shell collapse 5. Filled adequately to minimize risks of underfill rippling or wrinkling Potential Tradeoffs & Risks 1. More expensive 2. Requires more technical expertise by surgeon to avoid excessively large pocket for implant 3. Shell slightly thicker (by a few ten-thousandths of an inch) compared to non-textured, smooth implants. Thicker shell may increase durability, but may be easier to feel under thin tissues 4. May feel slightly firmer than an underfilled implant OR A ROUND SHAPED IMPLANT, Filled Within Manufacturer’s Recommended Fill Range Initial here ______ Potential Benefits 1. Can achieve same natural look as anatomic, BUT see tradeoff number 1 at right 2. Cheaper than anatomic 3. May feel the shell slightly less if smooth round, because smooth shell is slightly thinner than textured shell 4. Easier for some surgeons to use, no special requirements in surgical technique Potential Tradeoffs & Risks 1. Achieves natural upper pole appearance, but only if upper pole shell collapses to some degree 2. Upper shell collapse may shorten life of implant shell, may require replacement sooner 3. Shell collapse may increase risks of visible rippling or wrinkling in various areas of the breast 4. Fill amount inadequate to prevent upper shell collapse may increase risks of audible “sloshing” Cont’d from Page 1 A “BAYWATCH” appearing breast, From page 1, you requested: less natural, ROUND in appearance with a BULGING upper breast and a VISIBLE STEPOFF from the chest in the upper breast Initial here ______ Please choose ONE of the following alternative methods of producing a “BAYWATCH” APPEARING BREAST: (less natural, ROUND in appearance with a BULGING upper breast and a VISIBLE STEPOFF from the chest in the upper breast) A ROUND SHAPED IMPLANT, OVERFILLED Past Manufacturer’s Recommended Fill Range Initial here ______ Potential Benefits 1. Less risk of shell collapse, folding, failure if adequate filler is added to prevent upper implant shell collapse 2. Additional filler to prevent upper shell collapse also decreases risks of visible wrinkling or rippling in the breast 3. Less expensive than anatomically shaped implants Potential Tradeoffs & Risks 1. Slightly firmer than an underfilled implant 2. If filled past manufacturer’s recommended fill, may void manufacturer’s warranty 3. When a round implant is filled adequately to prevent upper shell collapse, the upper pole of the implant bulges more than a similar anatomically shaped implant 4. If round, smooth shell, shell may be slightly thinner and harder to feel in the breast OR An EXCESSIVELY LARGE ROUND IMPLANT Filled within Manufacturer’s Recommended Fill Range (It is possible to select an excessively large implant and fill it within manufacturer’s recommended range to produce the desired excessive, unnatural bulging of the upper breast) Initial here ______ Potential Benefits 1. Achieves the desired excess upper fullness and stepoff as the overfilled round, but increases risks of shell folding 2. Preserves the manufacturer’s warranty Potential Tradeoffs & Risks 1. If filled within manufacturer’s recommended range and compressed into a tight pocket, shell folding is very likely to occur. Shell folding may shorten shell life and require implant replacement sooner 2. An implant that is excessively large for your tissues to support may cause any or all of the following: excessive skin stretch, excessive sagging of the breast, excessive thinning of the skin, implant edges that you may feel or see, visible rippling or wrinkling from traction on the tissues, necessity of earlier reoperation for sagging or other problem listed above ______I have been informed, and I understand that NO IMPLANT, REGARDLESS OF SIZE OR SHAPE, can guarantee upper breast fullness long-term, and the larger the implant I select, the more likely stretch of the lower breast envelope will allow loss of upper fullness. Patient Name: (please print) Patient Signature Witness Name: (please print) Witness Signature Date: Date: How Did We Do Informing You? (Document 4) for: __________________ I (please print and sign)__________________________________________ have read Dr. [Surgeon’s Name]’ informational materials and his entire book entitled The Best Breast and have had an opportunity to visit with Dr. [Surgeon’s Name]’ patient educator ___________________. I have had an opportunity to ask questions and have had all of my questions answered to my satisfaction. I will have an additional opportunity to ask Dr. [Surgeon’s Name] questions during our consultation. To assure that I thoroughly understand and accept the essential information about risks and tradeoffs, I am asked to answer the following questions and initial my answers. Please initial the following ONLY IF YOU FULLY UNDERSTAND AND ACCEPT THE INFORMATION WE HAVE GIVEN YOU: ______ I fully understand and accept that perfection is not an option, improvement with tradeoffs is the best we can hope for. No choice we can make is without tradeoffs and risks. ______ I fully understand and accept that no woman has two breasts that match, and that no surgeon can produce two breasts that exactly match. I understand and accept that Dr. [Surgeon’s Name] will try his best to equalize my breasts as much as visually possible given my tissues and their limitations, but my breasts will not match after surgery. ______ I fully understand and accept that the larger we make my breasts, the worse they will look as I get older, the greater the risks of tissue thinning and/or visible rippling, and the greater the risk of my needing additional surgeries with additional risks and costs. ______ I fully understand and accept that Dr. [Surgeon’s Name] cannot and will not guarantee me a specific cup size breast, because cup size is not a consistent or predictable clinical measurement, cup size varies among bra manufacturers, and I may choose to wear a bra that is larger or smaller to produce a certain look in my breasts or for comfort or style reasons. ______ I fully understand and accept that if I have thin tissues in any area, that I will likely feel the edge or the shell of my implant. If I can feel my ribs with my finger beneath my breast, I may feel the edge of my implants. If my tissues are extremely thin, I may even see a portion of the implant shell or an implant edge. Dr. [Surgeon’s Name] will make every effort to provide as much tissue coverage as my tissues will allow to minimize these risks, but he is limited by the quality and thickness of my tissues. ______ I fully understand and accept that Dr. [Surgeon’s Name] cannot predict or control the amount that my tissues may stretch following augmentation. The larger the implant we choose, the more the tissues will stretch, but even with an implant that seems appropriate for my tissues, it is possible for my tissues to stretch excessively or unevenly in one breast or the other. If this occurs, breast shape or position may be different on the two sides, nipple tilt or position may be different, and additional surgery may be required to attempt to correct excess stretching deformities. Because this problem cannot be predicted or prevented, costs of additional surgery are totally my responsibility, including surgeon fees, anesthesia fees, and surgical facility fees. Additional surgical procedures carry additional risks, and do not guarantee correction of stretch deformities. ______ I fully understand and accept that if I develop infection in either breast at any time, that Dr. [Surgeon’s Name] will remove BOTH implants, and will recommend not ever replacing either implant due to risks of reinfection and/or capsular contracture, either of which could necessitate multiple reoperations and/or permanent deformities. ______ I fully understand and accept that capsular contracture (contraction of the lining that forms around every breast implant), although not a medical complication, may cause me to need additional surgery. There are no tests or facts in my medical history that will allow Dr. [Surgeon’s Name] to predict whether I will develop a capsular contracture in one or both breasts, and there are no implant or surgical techniques that can assure that I won’t develop capsular contracture. If I develop capsular contracture, I fully understand and accept that Dr. [Surgeon’s Name] will reoperate on my breasts ONLY ONCE to remove or correct the capular contracture. If I develop another capsular contracture after the first reoperation, Dr. [Surgeon’s Name] will recommend REMOVAL OF BOTH IMPLANTS WITHOUT IMPLANT REPLACEMENT as the safest and best option to prevent an excessive number of reoperations. Additional reoperations could result in greater risks of tissue thinning and/or visible rippling, greater risks of my needing additional surgeries with additional risks and costs, and could result in permanent deformities. I accept full responsibility for all costs associated with correction of capsular contracture, including surgeon fees, anesthesia fees, implant costs, laboratory and drug costs, and surgery center or hospital costs. ______ I fully understand and accept that if my implants ever need to be removed for any reason, the appearance of my breasts will be compromised. The larger the implant that I choose, the worse the appearance of my breasts will be, and the greater the risks of my needing additional surgery with additional costs and risks. ______ I fully understand and accept that if I choose a round shaped implant, that I will then have to choose between filling the implant to manufacturer’s recommendations and risking implant shell rippling, folding, or premature failure, OR request that Dr. [Surgeon’s Name] overfill my implant past manufacturer’s recommendations and possibly void the manufacturer’s warranty. If I choose a prefilled, round saline implant, I accept that the implant may be underfilled and accept the risks of shell rippling, folding, or premature failure. ______ I fully understand and accept that I will be totally responsible for additional surgical fees, surgery facility fees, and anesthesia fees, as well as possible additional lost time off work or normal activities for three specific conditions: 1) Capsular contracture (excessive firmness or pocket closure in any area that causes implant displacement or deformity), 2) any deformity caused by excessive stretching of the breast skin in any area, producing excessive “bottoming” or implant displacement, excessive sagging, or other stretch deformity, and 3) any exchange of breast implants for any reason, including a change in breast implant size or shape. If other complications occur, Dr. [Surgeon’s Name] will not charge any surgical fee for my treatment, but I am responsible for surgery facility fees, lab test fees, and anesthesia fees as well as additional time off work and travel costs. _____ I understand and accept that I am fully responsible for all additional charges for Dr. [Surgeon’s Name]’ surgical fees, implant costs, surgery center fees, anesthesia fees, lab and drug fees, and costs of time off work for recovery for the following conditions: 1) treatment of any capsular contracture or pocket closure problem that could result in breast deformity or malposition of my implants, 2) treatment of any problem that may result from excessive stretch of my tissues, causing malposition of my implants or excessive tissue thinning, or 3) any exchange of breast implants for any reason, including a change in breast implant size or shape. ___ I clearly understand and accept that all choices and decisions that Dr. [Surgeon’s Name] makes will be based ENTIRELY ON MY WRITTEN REQUESTS in the documents that he provides me during our consultation and preoperative communications, NOT ON ANY VERBAL DISCUSSIONS NOT VERIFIED IN MY WRITTEN REQUESTS. ___ I understand and accept that Dr. [Surgeon’s Name] cannot read my mind, and it is my complete responsibility to be absolutely honest in my written requests. I have absolutely no other requests, expectations, or agendas other than those specifically defined in the written documents I have completed and signed. ___ I am confident and comfortable that I have completely and honestly specified my desires and expectations in the written documents I have completed for Dr. [Surgeon’s Name]. I also understand that if any of this information changes prior to surgery, it is my responsibility to see that new, written documents are completed and signed by me. I understand and accept that Dr. [Surgeon’s Name] will NOT consider any verbal communications without written confirmation and documentation signed by me. _____ If, for any reason in the future, I commence, join in, or in any other manner attempt to assert any legal claim or cause of action against Dr. [Surgeon’s Name] for any item in this form that I have specifically acknowledged responsibility for by my initial or signature, I agree to pay all of Dr. [Surgeon’s Name]’ attorneys fees associated with defending my claim or cause of action. Please initial on the line and check the appropriate box: _____ I have I have not read The Best Breast: The Ultimate Discriminating Woman’s Guide to Breast Augmentation, the informational book about breast augmentation by John B. Tebbetts, M.D. and Terrye Tebbetts. I feel fully informed, and have had an opportunity to have all of my questions answered to my satisfaction. Signed this _____day of the month of ________, 200___ in the presence of the witness listed below. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) ______ I have been given a copy of this document for my personal records. Will Anyone Else Be Involved in Your Choices or Decision-Making? Part 1 (Document 5) If any other person will be involved in the choices or decisions you will make regarding your augmentation, or will be involved in any discussions with Dr. [Surgeon’s Name] or his staff following surgery regarding your choices or your result, they will need to be as informed as you are to prevent their misinterpreting your choices, your decisions, or your result. They will need to understand all of the choices, tissue limitations, tradeoffs, and risks that we discuss with you. We will provide you with the necessary information and copies of your documents to review and discuss with them, but you are responsible for encouraging them to become familiar with your information and choices. Will anyone else be involved in the choices or decisions you will make regarding your augmentation, or in any discussions with Dr. [Surgeon’s Name] or his staff following surgery regarding your choices or your results? Yes /No ______ (Please circle one and initial) If yes, please specify: Name: ____________________Relationship: __________________. Please read and if you understand and accept the statements, initial each of the following items: _____ Prior to my patient educator consultation, I was asked if anyone else would be involved in the choices or decision-making process for my breast augmentation, and I was encouraged to bring them with me during each consultation visit or have them participate in patient educator telephone calls. _____ If I do not specify in this document another person who will be involved in my choices or decision-making, I specifically request Dr. [Surgeon’s Name] and his staff to have no discussions following surgery about any aspect of my care or results with anyone other than me. I understand and accept that Dr. [Surgeon’s Name] and his staff will not discuss any aspect of my choices, decisions, requests, or result following surgery with anyone who was not educated, informed, or who did not answer all of the items in the second section of this document. _____ If I do not specify another person who will be involved, following surgery I accept total and complete responsibility for dealing with other peoples’ opinions regarding my choices or my result. I will not involve anyone else in discussions with Dr. [Surgeon’s Name] or his staff following surgery regarding any aspect of my result if I did not specify and involve that person to assure that they are educated and informed prior to my surgery. _____ If I choose to involve anyone else in my choices, decision-making, or in any evaluation or comment on my results, I will be personally responsible for providing that person a copy of The Best Breast book, a copy of Dr. [Surgeon’s Name]’ choices documents, informed consent documents, operative consent forms, and my breast implant manufacturer’s information and operative consent forms. Further, I will encourage that person to read the documents in detail so that we reach a common understanding and acceptance of choices, risks, and tradeoffs prior to my surgery. Lastly, I will invite and encourage that person to participate in all of my consultations with my patient educator (in person or by phone) and in person for my consultation with Dr. [Surgeon’s Name]. _____ I understand and accept that I alone am ultimately responsible for the decisions I make and the requests that I make of Dr. [Surgeon’s Name]. If I involve anyone else in my decisions, it is my responsibility alone to reconcile their wishes and thoughts with what I choose for my own body. Dr. [Surgeon’s Name] will rely solely on my written requests that I will complete during my education and consultation process, and any other person’s input must be included in my written requests prior to surgery. Prior to surgery, I alone am responsible for making my choices and decisions. Following surgery, I alone will accept responsibility for my choices and decisions, and I alone will discuss any concerns I have with Dr. [Surgeon’s Name] and his staff. Please ask the person you choose to involve in your choices or decision-making prior to your breast augmentation procedure to please complete and sign the document entitled Will Anyone Else Be Involved – Part 2. You are then responsible for returning the form to our office at least two weeks prior to your surgery date. If you have specified a person to be involved, and this form is not returned to us at least two weeks prior to surgery, we will be unable to perform your surgery. _____ I have been given a copy of Will Anyone Else Be Involved- Part 2 and am aware that it must be returned to Dr. [Surgeon’s Name]’ office two weeks prior to my surgery date. Signed this _____ day of the month of _______, 200___ in the presence of the witness listed below. ________________________________ Patient: (please print) __________________________________ Witness: (please print) ___________________________ _____________________________ Will Anyone Else Be Involved in Your Choices or Decision-Making? Part 2 (Document 6) Please ask the person you choose to involve in your choices or decision-making prior to your breast augmentation procedure to please complete and sign the following form. You are then responsible for returning the form to our office at least two weeks prior to your surgery date. If you have specified a person to be involved, and this form is not returned to us at least two weeks prior to surgery, we will be unable to perform your surgery. Patient’s Name: _____________________________ The person I choose to involve in my choices and decision making for breast augmentation is ______________________, my _________________________(relationship). Patient signature: _____________________Date: _________________ Witness: ____________________________Date: _________________ Please ask the person listed above complete initial each item and sign the following: I ___________________________ , will be involved in the choices and decision-making process prior to breast augmentation for ________________________, my ____________ (relationship). We appreciate your involvement and support in our patient’s choices and decision-making process for breast augmentation. In order for you to become familiar with essential information regarding the many choices and decisions that we must make, you will need to carefully read and consider all of the information that we have provided our patient and which she will provide you. We strongly encourage you to attend consultation visits so that we all understand and agree on the patient’s choices and desires, and the inherent tradeoffs, limitations, and risks that are involved. Each patient has different tissues and tissue limitations and tradeoffs, and we individualize our decisions to try to achieve the best possible long-term results with the fewest risks and tradeoffs. Only by being involved can you thoroughly understand choices and decisions, and the reasons behind those decisions. Please circle the appropriate choice and initial each line. _____ I have/have not completely all information materials sent to the patient. _____ I have/ have not completely read Dr. [Surgeon’s Name]’ Patient Choices Document. _____ I have/ have not completely read Dr. [Surgeon’s Name]’ How Did We Do Informing You Document. _____ I have/ have not completely read Dr. [Surgeon’s Name]’ Operative Consent Forms. _____ I have/ have not completely read the breast implant manufacturer’s information and consent forms. _____ I have been given an opportunity to attend all consultation visits with Dr. [Surgeon’s Name] and Dr. [Surgeon’s Name]’ patient educator, or to participate in patient education telephone calls. I chose to accept/decline these opportunities. _____ I understand and accept that any input I have into choices or decisions must be reconciled with the patient having surgery, and that Dr. [Surgeon’s Name] will only consider the specific written requests of the patient alone when making all surgical and implant choice decisions. _____ I have absolutely no specific preferences or desires regarding any aspect of the patient’s surgery or implant choices, including implant size or type or desired breast size or appearance that are not clearly expressed on the Patient Choices Document and the How Did We Do Informing You Document listed above. I understand that Dr. [Surgeon’s Name] cannot read my mind or the patient’s mind, and that in order for our desires to be met, we must be totally honest and forthright in our written requests of Dr. [Surgeon’s Name] prior to surgery. _____ I have been provided opportunities by Dr. [Surgeon’s Name] and his staff to read all informational materials, patient choice forms, and informed consent documents, and I understand and accept all risks, limitations, and patient choices as listed on these forms. I am satisfied that I have been provided all information necessary for me to understand and I am satisfied that Dr. [Surgeon’s Name] and his staff have satisfactorily answered all of my questions regarding breast augmentation. I am/am not totally comfortable with the choices made by the patient, ________________________, who is my ___________________ (relationship). I clearly understand that Dr. [Surgeon’s Name] does not wish to proceed with any surgery if I have any unsatisfied concerns or questions until those concerns are addressed and I become totally comfortable. _____ If I am not totally comfortable with any of the above items, I have made my concerns known to Dr. [Surgeon’s Name] personally (or through notification of ___________________, a member of his staff, on ___________________ date.) _____ Following surgery, I understand and accept that any criticism or disagreement that I may have regarding the results of surgery will be discussed by Dr. [Surgeon’s Name] or his staff only in terms of the written choices made by the patient prior to surgery. My input must be through the patient and must be expressed clearly on the documents listed above. I am totally comfortable that all of my concerns and input are expressed in the written choices made by the patient, and I will not express any concerns following surgery regarding breast size or appearance that are not clearly specified in the documents prior to surgery. Signed this _____ day of the month of _______, 200___ in the presence of the witness listed below. ________________________ Name: (please print) _______________________________ Witness: (please print) ________________________ ________________________________ Augmentation Mammaplasty Clinical Evaluation for (Document 7) Patient Preferences, Objectives, Preparation, History, Limitations, Exam, Implant Selection Size: Pt. Desires: Natural appearing breast Unnatural, bulging upper breast Proportionate to protect tissues Very large Approximate Desired Cup ________Requests specific cc’s: ________ Pt.Chooses Size Pt. Leaves Size Choice to Dr. Tebbetts Implant: Round Anatomic Smooth Textured Saline Silicone Pt. Leaves Type Choice to Dr. Tebbetts Pocket Location: PRP RM Dr. Tebbetts to decide Incision Location: IM PA AX UMB Pt. Leaves Incision Choice to Dr. Tebbetts Pts. Initials ________ Age _____ Height _____ Wt._____lbs Frame: Sm Med Lrg Torso: Nl Wide Nr Gravida _____ Para _____ Bra Band Size: 32, 34, 36 Breast Cup Size (Approx.) Prior to pregnancy____ Largest with preg _____ Current Cup Size _____ Desired Cup Size _____ Previous Breast Disease: None Biopsies: No Yes _____________________ Family Hx. Breast Cancer No Yes Mother Grandmother Aunt Maternal Paternal Capsular Contracture and Tissue Stretch Factors: Implant choice may affect risk Pt.accepts full responsibility for all costs for any surgery necessary to treat any capsule or tissue stretch deformities and costs exceed costs of original surgery Pts. Initials_______ Specific Limitations Discussed with Patient: Your breasts will never match You may lose some or all sensation You may see or feel edges of your implant due to thin tissues You may require reoperations and additional costs in the future due to implant size requested , your tissue stretch characteristics or capsule you form We give no guarantee of cup size Any reoperation may require an inframammary incision Other: _______________________ Patient vocalizes under-standing and acceptance of all items checked above. Pt. Initials __________ Previous Mammograms: No Yes Date: _______________ Interpretation: Normal Other: _____________ Pertinent Medical History: None ______________________ ______________________ Smoker: No Yes ____ Allergies: NKA ______________________ Current Meds, Herbs, Vits: ______________________ ______________________ ______________________ Companion: ____________ Relation: _______________ Clinical Breast Measurements L/R Patient Has Completed, Read and Signed: Pt. Educator Consult Choice Documents The Best Breast Book Pt. Ed. Initials: _______ Discussed/Patient Accepts That: Implants will be removed/not replaced if one infection or 2 capsular contracures occur The larger the implant , the more risks of sensory loss, tissue damage, and need for reoperations Pts. Initials_______ Breast Masses None Size and Location: ______________________ ______________________ Larger Breast: Left Right Est. Vol. Diff. _____ cc TBD Nipple Level Discrepancy _____ cm N/A IMF Level Discrepancy _____ cm N/A Envelope Compliance Nl Inc Dec Constricted Lower Env. Short, fixed IMF Other: ______________________ Estimating Desired Breast Implant Volume Based on Breast Measurements and Tissue Characteristics The TEPIDTM System Base Width Parenchyma (cm) 10.5 Estimated Initial Implant Volume 200 (cc’s) If APSS < 2.0, - 30cc If APSS > 3.0, + 30cc If APSS > 4.0, + 60cc If N:IMF > 9.5, + 30cc If PCSEF < 20%, + 30cc If PCSEF > 80%, - 30cc If McGhan 468 implant, –30cc Base Width APSSMaxStr STPTUP STPTIMF N:IMFMaxSt PCSEF IDFDD Copyright 2001 John B. Tebbetts, M.D. 11.0 11.5 12.0 12.5 13.0 13.5 250 275 300 300 325 350 14.0 375 14.5 375 15.0 400 Pt. request Total Estimated Implant Volume Estimating the Optimal Level of the Inframammary Fold Relative to the Nipple For each volume indicated 200 250 275 300 325 Set new IMF at A:IMF distance (cm.) 5.0 5.0 5.5 6 6 (measured under maximal stretch) Set new IMF at N:IMF distance (cm.) 7.0 7.0 7.5 8 8 (measured under maximal stretch) OR Implant Selected: ____________________ Volume: _______ cc Breast Dimension Ranges (cm) Cup Size A.D. A:IM F N:IMF B 3 4.5 3.5 5.5 5 8 C 4.5 6.5 5.5 7.5 8 11 D 5.5 7.5 > 7.0 9.0> 8.0 11.0 5.5 7.5 > 8.5 9.5> 9.0 11.0> DD McGhan 468 Anatomic Base Pro j Vol 10.0 10.5 11.0 11.5 12.0 4.0 4.2 4.3 4.6 4.8 195-205 230-240 270-285 300-315 350-370 12.5 4.9 380-400 13.5 14.0 14.5 5.5 5.7 5.9 495-520 560-590 620-650 Mentor Siltex Textured Round Base 9.5 10.0 10.6 11.0 11.5 11.9 12.3 12.6 13.0 13.6 14.2 14.8 Pro j 3.0 3.1 3.3 3.4 3.5 3.6 3.7 3.7 3.8 4.0 4.1 4.2 350 6.5 375 7.0 400 7 8.5 9.0 9.5 Base Width: _______ cm. Mentor Smooth Round Vol Base 125+25 150+25 175+25 200+25 225+25 250+25 275+25 300+25 325+50 375+50 425+50 475+50 9.5 10.0 10.6 11.0 11.5 11.9 12.3 12.6 13.0 13.6 14.2 14.8 Pro j 3.0 3.1 3.3 3.4 3.5 3.6 3.7 3.7 3.8 4.0 4.1 4.2 Vol 125+25 150+25 175+25 200+25 225+25 250+25 275+25 300+25 325+50 375+50 425+50 475+50 Surgeon Consultation Notes for (Document 8) 13.0 5.3 450-475 McGhan 410 FM Base Pro j Wt.Gms. 10.5 11.0 11.5 12.0 3.8 4.0 4.2 4.4 195 235 270 310 12.5 13.0 13.5 14.0 4.6 4.8 5.0 5.2 350 395 440 500 Surgeon Consultation Notes for (Document 8) Date: __________ Procedure(s) selected: Augmentation Mammaplasty (all options): Transaxillary approach Smooth, saline filled prosthesis Inframammary approach Textured, saline filled prosthesis Periareolar approach Textured, anatomic saline filled prosthesis Umbilical approach Other: _________________________ Discussed in detail with patient all items on our information sheet regarding the procedure(s) listed above. I have given the patient detailed written information material to read and review, and have encouraged the patient to make a list of questions or items for clarification to be discussed prior to a surgical decision. Discussed with patient that this surgery is totally elective and not absolutely necessary. Emphasized alternatives available for treatment, including no treatment at all, with relative benefits, risks, and tradeoffs as described in the written information materials given to the patient. Emphasized to patient the possibility of complications including possible life threatening and deforming complications, and that if complications occur, additional time off work or normal activity and additional expenses will be incurred. Please make a second visit appointment with me if the patient desires after having thoroughly read all written information reiterating our initial discussion. At that visit we will review all items on information sheet and answer any questions. Scheduling and fees information per attached sheet. Letter to patient’s referring source ( Dictated). Letter to patient's insurance company ( Dictated). I reviewed with patient all items on the above listed information sheet(s), clarifying and answering all of the patient’s questions. Preoperative photographs taken. Projected prosthetic and special instrument requirements: _________________________ Short Stay Form or H&P completed. Patient Images Analysis Factors Unlikely to Change or be Totally Corrected after Your Breast Augmentation (Document 9) Patient: _____________________________ Date: ____________ L/R breast larger- breasts will never match L/R nipple-areola higher on chest- will not be totally corrected L/R fold beneath breast higher on chest- will not be totally corrected Nipple position on the breast mounds is different on the two sides and cannot be totally corrected Gap between breasts can only be narrowed somewhat- a gap of at least _____cm. will likely remain Chest wall asymmetries exist that cannot be corrected and will affect breast shape The position of the entire breast on the chest wall will not change. If one fold beneath the breast is lower than the other, it will also be lower after your augmentation. The basic shape and configuration of the breasts will be similar to their current appearance and not change drastically, but will be larger Other: ___________________________________________________________ Other: ___________________________________________________________ Other: ___________________________________________________________ Other: ___________________________________________________________ Other: ___________________________________________________________ Patient Please Initial below to document your understanding and acceptance of the above. _____ Dr. [Surgeon’ Name] has reviewed my patient images with me in detail. I have seen, understand, and accept each of the factors listed above that will not change or may be only partially improved following my augmentation. I totally understand and accept that my breasts or components of my breasts will never match on the two sides, and that perfection is not an option, only improvement in the size of my breasts. Disclosure and Consent for Augmentation Mammaplasty for (Document 10) You have the right, as our patient, to be informed about your condition and the recommended surgical, medical, or diagnostic procedure to be used so that you may make the decision whether or not to undergo the procedure after knowing the risks and hazards involved. This disclosure is not meant to scare or alarm you; it is simply an effort to make you better informed so you may give or withhold your consent to the procedure. I voluntarily request Dr. [Surgeon’s Name] as my physician, and such associates, technical assistants and other health care providers as they may deem necessary, to treat my condition which has been explained to me as: Inadequate size of my breasts (Hypomastia) I understand that the following surgical, medical, and/or diagnostic procedures are planned for me and I voluntarily consent and authorize these procedures: Augmentation mammaplasty- breast enlargement by placing a breast implant I understand that Dr. [Surgeon’s Name] may discover other or different conditions which require additional or different procedures than those planned. I authorize Dr. [Surgeon’s Name], and such associates, technical assistants and other health care providers to perform such other procedures which are advisable in their professional judgement. I understand that no warranty or guarantee has been made to me regarding result or cure. Just as there may be disadvantages in continuing my present condition without treatment, there are also risks and hazards related to the performance of the surgical, medical, and/or diagnostic procedures planned for me. I realize that common to surgical, medical, and/or diagnostic procedures is the potential for infection, blood clots in veins and lungs, hemorrhage, allergic reactions, and even death. I also realize that the following risks and hazards may occur in connection with this particular procedure: • Postoperative infection • Unsatisfactory cosmetic result • Postoperative bleeding that may require drainage or • Prostheses will make mammograms more difficult reoperation to read • Pain or discomfort • The life of a breast implant is not known, • Removal or replacement of any implanted device or replacement or removal (additional surgery) material may be required • Loss of skin over breasts • Other risks, side effects, diseases or potential • Nipple numbness hazards as yet unsubstantiated • Extrusion of implant • Recurrence of Hematoma • Increased risk of capsular contracture I have read completely Dr. [Surgeon’s Name]’ information sheets on augmentation mammaplasty. I understand all of the information contained in the sheets, and have had an opportunity to discuss and ask questions about this information. I have been given an opportunity to ask questions about my condition, alternative forms of treatment, risks of nontreatment, the procedures to be used, and the risks and hazards involved, and I believe that I have sufficient information to give this informed consent. I understand that this is an elective cosmetic procedure and is not reimbursable by Third Party payers. I hereby give permission to Dr. [Surgeon’s Name] to take clinical photographs with the understanding that such photographs will remain the property of Dr. [Surgeon’s Name]. If in Dr. [Surgeon’s Name]’ judgement, education, medical research, or surgical knowledge may be benefitted by their use, then these photographs or related information may be published and republished in professional journals or medical books, or used for education or any other purpose which Dr. [Surgeon’s Name] may deem proper. It is specifically understood that in any such publications or use, I shall not be identified. I certify this form has been fully explained to me, that I have read it or have had it read to me, that the blank spaces have been filled in, and that I understand its contents. Signed this _____day of the month of ________, 200___ in the presence of the witness listed below. _______________________________________________________________ Patient or other Legally Responsible Person Name (Please print) and Signature _______________ Date: _______________________________________________________________ Patient or other Legally Responsible Person Name (Please print) and Signature _______________ Date: Verification Of Informed Consent Regarding Breast Implants And Breast Augmentation Surgery for (Document 11) Please initial each blank to indicate your complete understanding and acceptance of the information presented. _____ Dr. [Surgeon’s Name] has provided me detailed, written information sheets which he has compiled regarding breast augmentation surgery. He has also provided me the manufacturer’s package insert for the type of implants I have selected, and also the telephone number and address of the Food And Drug Administration from whom I can seek additional information if I desire. I have read and thoroughly understand all of the information contained in Dr. [Surgeon’s Name]' information sheets as well as the manufacturer’s package insert materials regarding breast implants and breast implant surgery, and I have had an opportunity to discuss all of my areas of concern in detail with Dr. [Surgeon’s Name] and his staff prior to making a decision about having breast augmentation surgery. _____ I understand that a breast implant is a medical device, and am comfortable that Dr. [Surgeon’s Name] has supplied me all of the information pertinent to this device which is currently available, and has provided me additional sources to seek information or verification of information pertaining to breast implants and breast implant surgery. _____ Having been given this information, having had an opportunity to discuss and ask any questions I desire regarding the information, and having had the opportunity to seek verification or additional information from other sources, I thoroughly understand the alternatives, risks, and limitations of breast implants and breast implant surgery. I accept these risks and limitations, understanding: _____ 1) The life expectancy of a breast implant is not currently known, and I may require removal or replacement of my implant at some future time either as the result of medical necessity or my desire for a different or better implant. _____ 2) The technology of breast implant design, development and manufacture will undoubtedly continue to progress and improve as it has in the past, and that implants which may be better in some way or another will inevitably be developed in the future. _____ 3) Current scientific data does not clearly establish any definite cause and effect relationship between breast implants and cancer or other systemic diseases, but Dr. [Surgeon’s Name] has thoroughly informed me that he cannot absolutely assure me that there is not a remote possibility that a breast implant could cause or contribute to a systemic disease, though in over 25 years of use clinically in over 1 million patients such a link has not been clearly established. _____ 4) That all current breast implants interfere to some degree with mammographic examination of the breast and may affect early detection of breast cancer. _____ 5) That breast cancer as well as other systemic diseases such as connective tissue disorders, scleroderma, rheumatoid arthritis, and numerous other diseases occur in the normal adult female population with a certain frequency, whether a woman has breast implants or not, and I understand that I may develop breast cancer or another of these diseases after having breast implants simply because I am a woman and not because of the implants. _____ 6) That because bra cup size is such a variable depending on bra type, manufacturer, and my own personal preferences regarding the fit of a bra, that Dr. [Surgeon’s Name] has clearly discussed with me and I understand that he cannot guarantee any specific bra cup size or result. After our discussions and consultation, I am comfortable that Dr. [Surgeon’s Name] understands my wishes regarding my breasts and I have requested that he use his best medical and aesthetic judgement in determining the best appearance for my breasts. _____ I thoroughly understand all of the above information which has been given me, I have had an opportunity to discuss it or ask additional questions to any degree required for my satisfaction, I understand and accept any risks which may be associated with breast implants or breast implant surgery, and request that Dr. [Surgeon’s Name] proceed with my augmentation mammaplasty. I certify this form has been fully explained to me, that I have read it or have had it read to me, and that I understand and accept its contents. Signed this _____day of the month of ________, 200___ in the presence of the witness listed below. _______________________________________________________________ _______________ Patient or other Legally Responsible Person Name (Please print) and Signature Date: _______________________________________________________________ Patient or other Legally Responsible Person Name (Please print) and Signature _______________ Date: Informed Consent for Patients Desiring Augmentation Mammaplasty With a Round Breast Implant (Document 12) I__________________________ have discussed with Dr. [Surgeon’s Name] and fully understand and accept the following with regard to my desire for breast augmentation using round breast implants. I acknowledge that I fully understand each item listed below. I have had an opportunity to have all my questions answered, and I feel informed and I accept each risk or tradeoff listed below as indicated by my initial(s) ________ beside each item. (Please place your initial in the blank at left, then initial each box beside each item below.) Every currently manufactured round breast implant may be underfilled if filled to manufacturer’s recommended volumes, so that when filled to recommended volumes and placed upright in my breast, the upper portion of the implant may collapse, causing the shell of the implant to buckle or fold in the upper portion. Buckling or folding of an implant shell may increase wear and stress on the shell of the implant and cause the implant shell to fail sooner, causing me to need additional surgery for implant replacement with possible additional risks, costs, recovery time, and time off work. If an implant is underfilled, there is more risk of my seeing or feeling rippling of the implant in the upper portion or other areas of the breast, and there may be more risk of feeling or hearing a sloshing sensation or sound in the breast. Whenever any surgeon places a currently manufactured, round implant in a patient’s breast, the surgeon and patient face a difficult choice: a) fill the implant to the manufacturer’s recommended fill volume, risking the consequences of an underfilled implant listed above, or b) fill the implant more than the recommended volume, voiding the manufacturer’s warranty and risking legal consequences to the surgeon for exceeding manufacturer’s recommended fill ranges. This fact is true regardless of whether the round implant has a smooth or a textured shell, and regardless of the surgical techniques and pocket location used for implant placement. If Dr. [Surgeon’s Name] adds more saline filler to the implant than the manufacturer recommends in order to try to avoid the above listed risks, tradeoffs and complications, he is violating the manufacturer’s recommendations and this may void the manufacturer’s warranty of the implant or cause the manufacturer to oppose Dr. [Surgeon’s Name] should any litigation ever arise. If Dr. [Surgeon’s Name] adds more saline filler to the implant than the manufacturer recommends in order to try to avoid upper shell buckling, rippling, sloshing, or premature shell failure, I expect and accept the following: a) My breast will feel much firmer- this is true when any filler is increased to avoid folding of the implant shell- but the breast will definitely be much firmer than a normal breast b) The upper portion of a round implant will bulge more as more filler is added, usually producing more risk of unnatural bulging in the upper breast or a sharper step off from the chest wall to the breast instead of a more straight or sloping natural profile to the upper breast. c) My breasts will probably appear quite unnatural out of a bra and in a bra with an excessively globular, round appearance with bulging and/or a step off in the upper pole of the breasts. d) I may be able to feel or see the edges of the implant in the upper, middle, side, or lower areas of the breast. It is impossible to predict the life span of any medical device such as a breast implant, because of the many factors that can affect the implant shell. I am fully aware and accept that I may have to replace my implant(s) in the future, and that means additional surgery with additional risks. If I select a round SMOOTH shell implant, I may have a higher risk of developing capsular contracture that may require additional surgery with possible additional risks, costs, recovery time, and time off work. Understanding and accepting all of the above information, I hereby request ROUND breast implants and request Dr. [Surgeon’s Name] do the following: PLEASE SELECT ONLY ONE OPTION IN EACH SECTION BELOW, NOT BOTH. Check the box that indicates your choice, and write your initials beside the boxes you checked, then sign the form and have another person witness your signature). Round Implant Fill Volume Choices Fill the implant to the upper end of the manufacturer’s fill range, understanding that this will still leave the implant underfilled in the upright position, risking all of the factors listed above for an underfilled implant, including possible premature shell failure (implant rupture), upper breast rippling or wrinkling, possible sloshing of the implant, and all other factors listed above. Overfill the implant past the manufacturer’s recommended fill range to avoid the risks of an underfilled implant listed above. I understand that I am asking Dr. [Surgeon’s Name] to exceed the manufacturer’s fill volume and that when he does this, the implant warranty will not be in effect and that I will incur additional costs for implant replacement and surgery if the implant shell fails. I further fully indemnify Dr. [Surgeon’s Name] in any legal actions arising from his violating the manufacturer’s recommendations for the implant (this means I assume all responsibility for legal costs in defending Dr. [Surgeon’s Name] against any such legal actions), and I personally hold Dr. [Surgeon’s Name] harmless or not responsible for any consequence of filling the implant past the manufacturer’s recommendations. Round Implant Shell Choices Place a ROUND, SMOOTH SILICONE SHELL implant. Place a ROUND, TEXTURED SILICONE SHELL IMPLANT. Round Implant Pocket Location Choices Place the implant ABOVE THE PECTORAL MUSCLE (this risks my implant being more visible and easier to feel than if it is placed partially beneath the muscle, and may impair my mammogram more than if the implant is placed partially beneath the pectoral muscle.) Place the implant PARTIALLY BENEATH THE PECTORAL MUSCLE (this reduces the risks listed above for placing the implant above the muscle, but carries the following additional tradeoffs: a) the implant may move to the side over time, widening the space between the breasts, b) when the muscle contracts, there may be distortion of the breast shape and appearance, c) the upper middle portion of the breast cannot be filled quite as much as when the implant is above the muscle. Round Implant Size Choices I have discussed my desired breast size with Dr. [Surgeon’s Name] and am comfortable that he understands what I want. I also understand the limitations that my personal tissues place on Dr. [Surgeon’s Name] and on the size of implant that I may desire. I understand and accept that the larger my implant, regardless of my tissue characteristics, a) the worse my breast will look as I get older, b) the greater the stretching and sag that will occur in my breast, c) the more the likelihood that I will need additional surgery in the future with additional risks, tradeoffs, costs and recovery time, and d) the thinner my tissues will become and the greater the risks of tissue compromise in the future. I understand that if I can feel my ribs with my finger (and I can), with currently manufactured saline filled implants, I will be able to feel the edge(s) of my implant, and if my tissues are quite thin, I may be able to see the edges of the implant, and Dr. [Surgeon’s Name] cannot prevent either of these consequences because he cannot change the characteristics of my tissues. Understanding and accepting all of the above, I hereby request Dr. [Surgeon’s Name] do the following: Place an implant size THAT WILL INCREASE THE FULLNESS OF MY BREAST AS MUCH AS POSSIBLE WITHOUT RISKING THE CONSEQUENCES OF AN EXCESSIVELY LARGE IMPLANT. I leave the ultimate decision of implant size entirely up to Dr. [Surgeon’s Name]’ professional judgement. Place an implant THAT IS EXCESSIVELY LARGE FOR MY TISSUES AND THAT RISKS ALL OF THE CONSEQUENCES LISTED ABOVE FOR AN EXCESSIVELY LARGE IMPLANT. I SPECIFICALLY REQUEST AN IMPLANT SIZE OF _______CC., AND FULLY UNDERSTAND AND ACCEPT THAT I WILL INCUR ALL OF THE CONSEQUENCES LISTED ABOVE. Round Implant Incision Location Choices I have discussed the various incision location choices with Dr. [Surgeon’s Name], and understand and accept that each location has its own advantages and tradeoffs. I understand and accept the tradeoffs involved with my choice of incision location, and fully understand and accept that neither I or Dr. [Surgeon’s Name] can control or predict the ultimate quality of my healing and the quality and visibility of my scar. I hereby request Dr. [Surgeon’s Name] place my incisions in the following location: Inframammary incision (underneath the breast) Axillary incision (in the armpit) Periareolar incision (around the areola) Umbilical (in the area of my belly button) Signed this _____day of the month of ________, 200___ in the presence of the witness listed below. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) Informed Consent for Patients Desiring Augmentation Mammaplasty With an Anatomic Breast Implant (Document 13) I__________________________ have discussed with Dr. [Surgeon’s Name] and fully understand and accept the following with regard to my desire for breast augmentation using anatomically shaped breast implants. I acknowledge that I fully understand each item listed below. I have had an opportunity to have all my questions answered, and I feel informed and I accept each risk or tradeoff listed below as indicated by my initial(s) ________ beside each item. (Please place your initial in the blank at left, then initial each box beside each item below.) Buckling or folding of an implant shell may increase wear and stress on the shell of the implant and cause the implant shell to fail sooner, causing me to need additional surgery for implant replacement with possible additional risks, costs, recovery time, and time off work. An anatomically shaped implant allows more filler to be placed in the implant to prevent shell folding while still achieving a more natural appearance to the upper breast compared to round implants. Nevertheless, it is impossible to predict the life span of any medical device such as a breast implant, because of the many factors that can affect the implant shell or valve. I am fully aware and accept that I may have to replace my implant(s) in the future, and that means additional surgery with additional risks. I understand and accept that regardless of implant type or filler material, the more filler material that is placed in the implant to reduce risks of the shell folding and wearing out sooner, the firmer the implant will feel in my breast. I accept that the implant may feel firmer in order to try to protect the shell from folding and make my implant last longer. I understand and accept that an anatomically shaped breast implant is more demanding of the surgeon than a round implant, and that an anatomically shaped implant must have a textured surface silicone shell for the texturing to help maintain proper implant position in my breast. Regardless of the texturing, however, I understand that it is possible for an anatomic implant to rotate in the pocket of the breast, requiring additional surgery for correction or implant exchange. I understand that implant malposition is a relatively rare occurrence, but nevertheless may occur. I understand and accept that my implants are manufactured with a thicker shell compared to older implants in order to try to make the shell more durable and last longer to reduce risks of premature shell rupture that would require me to have replacement surgery sooner or more often. I fully understand and accept that if I can feel my ribs with my finger, I may be able to feel the edge of my breast implant. All currently manufactured implants with thicker shells are easier to feel in the breast, especially if I have thin tissues, and I understand and accept that Dr. [Surgeon’s Name] cannot prevent my feeling my implant in some areas of the breast, regardless of whether we place the implant above the pectoral muscle or partially beneath the pectoral muscle (see below). Understanding and accepting all of the above information, I hereby request anatomic breast implants and request Dr. [Surgeon’s Name] do the following: PLEASE SELECT ONLY ONE OPTION IN EACH SECTION BELOW, NOT BOTH. Check the box that indicates your choice, and write your initials beside the boxes you checked, then sign the form and have another person witness your signature). Anatomic Implant Pocket Location Choices Place the implant ABOVE THE PECTORAL MUSCLE (this risks my implant being more visible and easier to feel than if it is placed partially beneath the muscle, and may impair my mammogram more than if the implant is placed partially beneath the pectoral muscle.) Place the implant PARTIALLY BENEATH THE PECTORAL MUSCLE (this reduces the risks listed above for placing the implant above the muscle, but carries the following additional tradeoffs: a) the implant may move to the side over time, widening the space between the breasts, b) when the muscle contracts, there may be distortion of the breast shape and appearance, c) the upper middle portion of the breast cannot be filled quite as much as when the implant is above the muscle. Anatomic Implant Size Choices I have discussed my desired breast size with Dr. [Surgeon’s Name] and am comfortable that he understands what I want. I also understand the limitations that my personal tissues place on Dr. [Surgeon’s Name] and on the size of implant that I may desire. I understand and accept that the larger my implant, regardless of my tissue characteristics, a) the worse my breast will look as I get older, b) the greater the stretching and sag that will occur in my breast, c) the more the likelihood that I will need additional surgery in the future with additional risks, tradeoffs, costs and recovery time, and d) the thinner my tissues will become and the greater the risks of tissue compromise in the future. I understand that if I can feel my ribs with my finger (and I can), with currently manufactured saline filled implants, I will be able to feel the edge(s) of my implant, and if my tissues are quite thin, I may be able to see the edges of the implant, and Dr. [Surgeon’s Name] cannot prevent either of these consequences because he cannot change the characteristics of my tissues. Understanding and accepting all of the above, I hereby request Dr. [Surgeon’s Name] do the following: Place an implant size THAT WILL INCREASE THE FULLNESS OF MY BREAST AS MUCH AS POSSIBLE WITHOUT RISKING THE CONSEQUENCES OF AN EXCESSIVELY LARGE IMPLANT. I leave the ultimate decision of implant size entirely up to Dr. [Surgeon’s Name]’ professional judgement. Place an implant THAT IS EXCESSIVELY LARGE FOR MY TISSUES AND THAT RISKS ALL OF THE CONSEQUENCES LISTED ABOVE FOR AN EXCESSIVELY LARGE IMPLANT. I SPECIFICALLY REQUEST AN IMPLANT SIZE OF _______CC., AND FULLY UNDERSTAND AND ACCEPT THAT I WILL INCUR ALL OF THE CONSEQUENCES LISTED ABOVE. Anatomic Implant Incision Location Choices I have discussed the various incision location choices with Dr. [Surgeon’s Name], and understand and accept that each location has its own advantages and tradeoffs. I understand and accept the tradeoffs involved with my choice of incision location, and fully understand and accept that neither I or Dr. [Surgeon’s Name] can control or predict the ultimate quality of my healing and the quality and visibility of my scar. I hereby request Dr. [Surgeon’s Name] place my incisions in the following location: Inframammary incision (underneath the breast) Axillary incision (in the armpit) Periareolar incision (around the areola) Umbilical (in the area of my belly button) Signed this _____day of the month of ________, 200___. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) Informed Consent for Patients Desiring Augmentation Mammaplasty with a Family History of Breast Cancer(Document 14) I__________________________ have discussed with Dr. [Surgeon’s Name] and fully understand and accept the following with regard to my desire for breast augmentation. I acknowledge that I fully understand each item listed below. I have had an opportunity to have all my questions answered, and I feel informed and I accept each risk or tradeoff listed below as indicated by my initial(s) ________ beside each item. (Please place your initial in the blank at left.) _____ I am fully aware that I have a family history of breast cancer, and that I may be at a higher risk of developing breast cancer than a woman with no family history of the disease. _____ Dr. [Surgeon’s Name] has informed me and I am fully aware that any breast implant can impair the detection of breast cancer, regardless of the type of implant or where it is placed in relation to the breast. _____ I am fully aware and accept that by choosing to have breast implants, I could be interfering with detection of breast cancer in my breasts. _____ I am fully aware and accept that if my breast implants interfere with detection of breast cancer, I could die of the disease earlier or could miss earlier treatments that might change the course of the disease and prolong or save my life. _____ Dr. [Surgeon’s Name] has recommended that I seek other expert opinions about these issues, and I have either sought those opinions or chosen not to seek those opinions based entirely on my personal preference. _____ I choose to have breast implants, regardless of their possible effects on detection of breast cancer and regardless on their possible effects on the course of the disease should I develop breast cancer. _____I understand and accept all of these risks, limitations, and tradeoffs, and request that Dr. [Surgeon’s Name] proceed with augmentation of my breasts. I have had an opportunity to have all of my questions answered to my satisfaction, and am totally comfortable with my decision. Signed this _____day of the month of ________, 200___ in the presence of the witness listed below. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) Informed Consent for Patients Desiring Augmentation Mammaplasty With a Large (>350cc) Implant (Document 15) I__________________________ have discussed with Dr. [Surgeon’s Name] and fully understand and accept the following with regard to my desire for breast augmentation using large (greater than 350cc volume) implants. I acknowledge that I fully understand each item listed below. I have had an opportunity to have all my questions answered, and I feel informed and I accept each risk or tradeoff listed below as indicated by my initial(s) beside each item. _____ (Please place your initial in the blank at left, then initial each box beside each item below.) As I get older, my breast skin will age, stretch and become thinner even without an implant. The larger any breast, augmented or not, the worse it will look over time. Adding any implant to my breast adds weight and will produce stretch and thinning of my tissues over time. The larger the implant, the greater the amount of stretch that will occur. Adding excess weight to the breast almost guarantees that it will look worse over time, with increased stretch and sagging. It is impossible to predict whether or when this will occur in any individual patient. Adding weight to my breast with a large implant may cause me to need further surgery in the future, especially mastopexy (breast lifting) with additional scars and possible loss of nipple sensation and I will incur additional costs, time off work, risks, and tradeoffs if additional surgery is necessary. Excessive tissue stretch from a large implant can make me more likely to have surgical complications with healing problems if the tissues become very thin. As tissues thin, I will definitely be able to feel my implant, portions of the implant may be visible through my skin, and visible rippling or wrinkling may occur. If excessive stretch or complications occur (and this is unpredictable), it may even become necessary to remove the implants, with compromise in the appearance of my breasts and probable visible scarring if breast lifting (mastopexy) is necessary when the implants are removed. When I request implants larger than Dr. [Surgeon’s Name] feels are optimal for my tissues and body proportions, I am overruling Dr. [Surgeon’s Name] years of experience and judgement and I accept full responsibility for every possible outcome of my decision, whether that outcome or risk is known or unknown to me and to Dr. [Surgeon’s Name]. I understand and accept all of these risks, limitations, and tradeoffs, and request that Dr. [Surgeon’s Name] proceed with large implant (>350cc) augmentation of my breasts. I have had an opportunity to have all of my questions answered to my satisfaction, and am totally comfortable with my decision. Signed this _____day of the month of ________, 200___ in the presence of the witness listed below. _________________________ __________________________ Patient: (Please print) Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) Informed Consent for Patients Desiring Augmentation Mammaplasty With a Larger Implant than Dr. [Surgeon’s Name] Feels is Optimal for the Patient’s Tissues (Document 16) I__________________________ have discussed with Dr. [Surgeon’s Name] and fully understand and accept the following with regard to my desire for breast augmentation using an implant larger than Dr. [Surgeon’s Name] feels is optimal for my tissues and my body proportions. I acknowledge that I fully understand each item listed below. I have had an opportunity to have all my questions answered, and I feel informed and I accept each risk or tradeoff listed below as indicated by my initial(s) ________ beside each item. (Please place your initial in the blank at left, then initial each box beside each item below). As I get older, my breast skin will age, stretch and become thinner even without an implant. The larger any breast, augmented or not, the worse it will look over time. Adding any implant to my breast adds weight and will produce stretch and thinning of my tissues over time. The larger the implant, the greater the amount of stretch that will occur. Adding excess weight to the breast almost guarantees that it will look worse over time, with increased stretch and sagging. It is impossible to predict whether or when this will occur in any individual patient. Adding weight to my breast with a large implant may cause me to need further surgery in the future, especially mastopexy (breast lifting) with additional scars and possible loss of nipple sensation and I will incur additional costs, time off work, risks, and tradeoffs if additional surgery is necessary. Excessive tissue stretch from a large implant can make me more likely to have surgical complications with healing problems if the tissues become very thin. As tissues thin, I will definitely be able to feel my implant, portions of the implant may be visible through my skin, and visible rippling or wrinkling may occur. If excessive stretch or complications occur (and this is unpredictable), it may even become necessary to remove the implants, with compromise in the appearance of my breasts and probable visible scarring if breast lifting (mastopexy) is necessary when the implants are removed. When I request implants larger than Dr. [Surgeon’s Name] feels are optimal for my tissues and body proportions, I am overruling Dr. [Surgeon’s Name] years of experience and judgement and I accept full responsibility for every possible outcome of my decision, whether that outcome or risk is known or unknown to me and to Dr. [Surgeon’s Name]. I understand and accept all of these risks, limitations, and tradeoffs, and request that Dr. [Surgeon’s Name] proceed with larger than optimal implant augmentation of my breasts. I have had an opportunity to have all of my questions answered to my satisfaction, and am totally comfortable with my decision. Signed this _____day of the month of ________, 200___. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) Informed Consent for Patients Desiring Augmentation Mammaplasty Through a Belly Button (Umbilical) Incision (Document 17) I _____________________ , in choosing an incision in my belly button area for augmentation mammaplasty, am fully aware and accept all of the potential risks and tradeoffs of this approach as listed below. I acknowledge that I fully understand each item listed below. I have had an opportunity to have all my questions answered, and I feel informed and I accept each risk or tradeoff listed below as indicated by my initial(s) ________ beside each item. (Please place your initial in the blank at left, then initial each box beside each item below.) A visible scar will be present in my belly button area A change or distortion of my belly button can occur It is necessary to create a tunnel through the fatty tissue from my belly button to my breast on each side by pushing a blunt tipped tube instrument forcefully through the fat, creating a tunnel from my belly button to my breast on each side. It is possible for the fat in the area of the tunnels to shrink or atrophy following the forceful passage of the blunt tipped tube, leaving visible depressions on my upper abdomen that may be uncorrectable. If infection or bleeding occur (rare, but possible), the infection and/or bleeding can extend into the abdomen and not remain confined to the breast. Infection or bleeding extending into the abdomen can cause additional complications that may require more extensive surgery and create additional deformities than can be temporary or permanent. The pocket for my breast implant will be created by a blunt instrument that separates the tissues, and then by an inflatable expander (balloon) that tears the tissue planes apart rather than dissecting them apart with other instruments under direct vision. All dissection or creation of the pocket for my breast implant is done blind- that is, the surgeon has no direct visualization of the inside of the pocket while the pocket is being created. Strong manual manipulation of the inflatable device may be necessary to create the pocket for my implant. This may result in tearing or bruising of tissue. Tearing of tissue rather than direct dissection under direct vision with electrocautery, in Dr. [Surgeon’s Name]’ experience, causes more bleeding, more swelling, more bruising, and a more prolonged recovery compared to other approaches where all dissection is done under direct vision with electrocautery. Your return to work and normal activity will be at least twice as long as with the other three incisional approaches. The belly button only allows placement of the implant in front of your pectoral muscle. If you are thin (Dr. [Surgeon’s Name] will measure your tissue thickness), this can allow your implant edges to be more visible following surgery. The accuracy of the pocket created for the implant is what controls implant position. Because the pocket through the belly button approach is created by blind, blunt dissection, the surgeon cannot create as precise and accurate a pocket, and hence there is a greater risk of the following: Visible irregularities around the edges of your breasts Implant displacement or shifting from its ideal position that can result in a visible deformity Differences in the position of the implants on the two sides, for example one higher than the other, or one shifted to the side more than the other. One of the most important borders is the lower border that creates the fold beneath the breast and determines the position of the implant in a head-to-foot direction. It is impossible to directly visualize this critical area through the belly button approach, hence there are greater risks of the following: Visible irregularities along the fold beneath the breast Improper position of the implant Differences in the appearance of the folds and/or lower breasts on the two sides. If I develop capsular contracture or any complication following augmentation through the belly button, it will be necessary to make additional incisions in one or more of the following areas: in the fold under the breast, around the areola, or in the armpit area. These additional incisions will result in additional visible scars. I fully understand and accept each of the above listed risks and tradeoffs, and request that Dr. [Surgeon’s Name] proceed with augmentation mammaplasty through an incision in my belly button area. Signed this _____day of the month of ________, 200___ in the presence of the witness listed below. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) Informed Consent Documentation for Patients Desiring Endoscopic Axillary or Umbilical Augmentation (Document 18) I__________________________ (please sign and place your initials beside your signature) request Dr. [Surgeon’s Name] to perform breast augmentation using an (initial one) _____1) an axillary or armpit incision, or _____2) an umbilical (belly button) incision. Please place your initials beside each of the following items to indicate that you fully understand the information and accept the potential risks, tradeoffs, potential complications, costs, and time off work that could result from your decisions and choices regarding endoscopic breast augmentation. _____ I am aware that endoscopically assisted breast augmentation procedures have been used for over ten years in thousands of patients, and that the procedures are safe for patients and implants, but, like all operations or incision approaches, endoscopic approaches have potential risks, tradeoffs, and complications. _____ I am aware, understand, and fully accept the following: In the late 1990’s, breast implant manufacturers began studies to meet FDA criteria for approval of saline implants for breast augmentation. Although endoscopically assisted procedures were being widely used at the time, implant manufacturers unfortunately neglected to specifically include endoscopic procedures in the studies. As a result, when the FDA reviewed the data from the studies, they approved saline filled implant for breast augmentation, but because the manufacturers had not accumulated data on endoscopic approaches, the FDA required manufacturers to state in their implant brochures that implant approval does not include approval for endoscopic approaches. Simply stated, the FDA has not approved saline implants for placement using endoscopically assisted techniques. _____ I am aware, understand, and accept that the manufacturer’s implant insert data sheet contains the following sentence: “Do not use endoscopic placement or periumbilical approach in placement of the implant.” When performing either axillary or umbilical augmentation approaches, Dr. [Surgeon’s Name] uses endoscopic assistance to accurately form the pocket to receive the implant. Dr. [Surgeon’s Name] never places the implant into the pocket through any type of endoscopic instrument, tube, or device, so technically, he is never “placing” the implant endoscopically as prohibited in manufacturer’s literature. _____ I am aware, understand, and fully accept the following: Because the FDA has not approved saline implants for placement using endoscopically assisted techniques or through a periumbilical incision, if I request that implants be placed using these techniques, I am requesting that the implants be used in a manner not authorized by the wording in the implant manufacturer’s brochures. Although the implant manufacturers have verbally assured surgeons that they will continue to honor the implant warranties for implants used by endoscopic approaches, their warranties and brochures do not specifically state that they will continue to honor the warranty. As a result, if I request my implant be placed by axillary or umbilical approaches, I fully understand and accept that technically, I may be voiding the manufacturer’s warranty for my implants. _____ If my implants are placed through an armpit incision or an umbilical incision and I develop capsular contracture or any other complication or problem requiring an additional operation, a second incision beneath my breast may be necessary to address the complication or problem, and I will have an additional visible scar beneath my breast. _____ I fully understand and accept that if one or both of my implants rupture or partially deflate, an additional operation will be necessary to replace my implant(s). This operation may require an additional incision beneath my breast, and I will have an additional visible scar beneath my breast. There are additional charges or costs associated with replacing any implant, and although the manufacturer usually assists with some of these charges, I accept full responsibility for all charges that may be associated with replacing a ruptured or partially deflated implant. _____ I understand and accept that I am fully responsible for all additional charges for Dr. [Surgeon’s Name]’ surgical fees, implant costs, surgery center fees, anesthesia fees, lab and drug fees, and costs of time off work for recovery for the following conditions: 1) treatment of any capsular contracture or pocket closure problem that could result in breast deformity or malposition of my implants, 2) treatment of any problem that may result from excessive stretch of my tissues, causing malposition of my implants or excessive tissue thinning, or 3) any exchange of breast implants for any reason, including a change in breast implant size or shape. _____ Although placing a larger implant can increase the fullness in the upper breast, the weight of the larger implant will cause more stretching of the lower breast skin envelope. After the envelope stretches, the implant will displace into the stretched lower portion and I will lose some or all of the upper fullness I gained. In other words, placing a larger implant usually increases upper fullness, but only temporarily. When the lower breast stretches from the additional weight, upper fullness decreases. _____ I have read this document thoroughly, and fully understand and accept its contents. _____ I have had an opportunity to ask questions of Dr. [Surgeon’s Name] and his staff, and have had all of my questions fully and completely answered to my satisfaction. _____ I freely and voluntarily request Dr. [Surgeon’s Name] perform the procedure checked above on this form, and I fully understand and accept responsibility for all of the potential risks, tradeoffs, and possible additional costs associated with performing this procedure. _____ If, for any reason in the future, I commence, join in, or in any other manner attempt to assert any claim or cause of action against Dr. [Surgeon’s Name] for any item in this form that I have specifically acknowledged responsibility for by my initial or signature, I agree to pay all of Dr. [Surgeon’s Name]’ attorneys fees associated with defending my claim or cause of action. Signed this _____day of the month of ________, 200___ in the presence of the witness listed below. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) Informed Consent and Questions for Patients Desiring A Change to a Larger Breast Implant Size (Document 19) I__________________________ (please sign and place your initials beside your signature) have previously had an augmentation mammaplasty (placement of breast implants) by Dr. [Surgeon’s Name], and I now want to replace my current implants with larger implants. At the time of your initial consultations and surgery, Dr. [Surgeon’s Name] and you agreed that he would fill your tissue envelope as much as he felt he could possibly fill it, staying in a safe and reasonable range. For your augmentation, Dr. [Surgeon’s Name] selected the largest implant that he felt he could safely place in your breasts without risking additional risks, tradeoffs, complications, and damage to your tissues and your appearance in the future. Dr. [Surgeon’s Name] places the maximum fill he feels is safe, depending on your specific tissues, unless you specifically request a smaller breast size. We want you to be happy with your result, and we are happy to replace your implants with larger implants providing you are fully informed regarding possible risks, complications, and tradeoffs. Replacing your current implants with larger implants is usually possible, but carries certain risks and tradeoffs that you must carefully consider, understand, and fully accept to ensure that Dr. [Surgeon’s Name] has made every possible effort to inform you thoroughly and completely of the potential consequences of this decision. Please place your initials beside each of the following items to indicate that you fully understand and accept the potential risks, tradeoffs, potential complications, costs, and time off work that could result from your decisions and choices regarding larger implants. _____ As I get older, my breast skin will age, stretch and become thinner even without an implant. The larger any breast, augmented or not, the worse it will look over time. Larger implants will likely make my breasts look worse over time. _____ Adding a larger implant to my breast adds weight and will produce more stretch and thinning of my tissues over time. _____ The larger the implant, the greater the amount of stretch that will occur. _____ When my tissues stretch with a larger implant, they become thinner. I am much more likely to see and feel the edges and the shell of my implant in any area of the breast, but especially in the cleavage area between the breasts and at the sides of the breasts. _____ When my tissues become thinner from the stretch of a larger implant, the additional weight of a larger implant is more likely to pull downward on the thinner tissues and cause visible rippling or wrinkling in several areas of the breast. This wrinkling and rippling may be uncorrectable. _____ Although placing a larger implant can increase the fullness in the upper breast, the weight of the larger implant will cause more stretching of the lower breast skin envelope. After the envelope stretches, the implant will displace into the stretched lower portion and I will lose some or all of the upper fullness I gained. In other words, placing a larger implant usually increases upper fullness, but only temporarily. When the lower breast stretches from the additional weight, upper fullness decreases. _____ Adding excess weight to the breast almost guarantees that it will look worse over time, with increased stretch and sagging. It is impossible to predict whether or when this will occur in any individual patient. _____ Adding weight to my breast with a larger implant may cause me to need further surgery in the future, especially mastopexy (breast lifting) with additional scars and possible loss of nipple sensation and I will incur additional costs, time off work, risks, and tradeoffs if additional surgery is necessary. _____ Excessive tissue stretch from a larger implant can make me more likely to have surgical complications with healing problems if the tissues become very thin. _____ As tissues thin, I will definitely be able to feel my implant, portions of the implant may be visible through my skin, and visible rippling or wrinkling may occur. _____ If excessive stretch or complications occur (and this is unpredictable), it may even become necessary to remove the implants, with compromise in the appearance of my breasts and probable visible scarring if breast lifting (mastopexy) is necessary when the implants are removed. _____ When we reoperate, I am running all of the risks of the initial augmentation that are listed on my consent form, and I am running additional risks. When operating on previously operated tissues, a surgeon has less control over the result, and the risks are higher for each of the complications listed for the first operation. If complications occur from my choice to have a reoperation, I understand and accept that I will be responsible for all costs associated with any additional surgery that is necessary, including surgeon fees, anesthesia fees, laboratory tests, implant costs, surgery facility fees, and lost income from time off work or incapacity. _____ If I develop problems due to the larger size of the implants I am requesting, I understand and accept that I will not expect or ask Dr. [Surgeon’s Name] to perform correctional, revisional, or other procedures on me. Since Dr. [Surgeon’s Name] made the best choice he felt he could make that was safest and best for you at your first operation, you must make the decisions regarding implant type and size for placement of your larger implants. Dr. [Surgeon’s Name] does not place larger anatomic implants for reoperations because he cannot control the position of the implant optimally when the envelope is stretched by a larger implant. Hence the shape of the implant must be round. _____ I would like the following type of implant shell: Smooth shell OR Textured shell _____ I would like the following size implant in cc’s: _______ _____ I prefer the following implant manufacturer: McGhan Mentor Other: __________ I understand and accept all of these risks, limitations, and tradeoffs, and request that Dr. [Surgeon’s Name] proceed with placing larger implants in my breasts. Signed this _____day of the month of ________, 199___. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) Informed Consent for Patients Desiring Removal of Breast Implants and Breast Lift (Mastopexy) (Document 20) I__________________________ have discussed with Dr. [Surgeon’s Name] and fully understand and accept the following with regard to my desire for breast additional breast surgery (please initial here______ and initial each line below to indicate your complete understanding and acceptance of each item): ______ I initially requested Dr. [Surgeon’s Name] to perform breast augmentation on me, and advised him during my followup visit with him that I think he did a good job and that I am now wearing the bra cup size I requested prior to my augmentation, but now I feel that my breasts are too large and I advised Dr. [Surgeon’s Name] that I am self-conscious and want my breasts to be smaller and lifted. ______ I request that Dr. [Surgeon’s Name] remove my current breast implants. ______ I understand that when my current implants are removed, I may have a large amount of empty skin envelope, and that my breasts will be empty in the upper portion and markedly sagging in the lower portion, similar or worse in appearance compared to before I had my breast implants placed. ______ I specifically request that Dr. [Surgeon’s Name] perform a breast lift operation (mastopexy) on my breasts after removing my breast implants. ______ I am fully aware and understand that the reason my breasts sagged in the first place is because my skin will not support the weight of my own breast tissue. Even without the additional weight of a breast implant, I understand that as I get older, my skin will stretch further just with the weight of my own breast tissue, and that a breast lift operation only partially improves the appearance of my breasts for a period of time that Dr. [Surgeon’s Name] cannot predict. ______ Dr. [Surgeon’s Name] has advised me that following any type of mastopexy, even if no implant is placed, the skin in the lower breast will stretch, and I will never be able to maintain fullness in my upper breast, with or without an implant. If an implant is added (even a small implant), I understand that I am accelerating the rate and amount of stretching that may occur. ______ Dr. [Surgeon’s Name] has advised me, and I fully understand and accept that I will definitely have risks and tradeoffs associated with breast lift, including visible scars on my breasts (the quality of which the surgeon cannot predict), possible partial or total loss of sensation in any area of the breast, possible loss of the ability to nurse, the fact that my breasts and nipple positions will never be equal on both sides, emptiness in the upper breasts that can occur at any time with stretching of the lower breast skin, and all other potential risks and complications listed on Dr. [Surgeon’s Name]’ operative consent forms. ______ Dr. [Surgeon’s Name] strongly emphasized to me that I might not be happy with the tradeoffs of mastopexy, and that I might not like my breast appearance following mastopexy any more than I like my breast appearance now. Nevertheless, I request that Dr. [Surgeon’s Name] proceed and perform a mastopexy on my breasts. ______ I do not want Dr. [Surgeon’s Name] to place any breast implant in my breast at the time he performs my mastopexy. ______ I fully understand and accept that I might NOT be happy with my breast size, shape, nipple position,or symmetry (matching of the two sides) following mastopexy, but I am choosing to proceed and am certain that I want my current implants removed and my breasts lifted. ______ In the event that for any reason I am not happy with my breasts following mastopexy, I will leave the decision about whether to perform any revision surgery or additional surgery on my breasts entirely with Dr. [Surgeon’s Name]’ judgement. I completely understand and accept all of these risks, limitations, and tradeoffs of breast lifting and removal of my implants, and request that Dr. [Surgeon’s Name] proceed with implant removal and breast lift surgery. I have had an opportunity to have all of my questions answered to my satisfaction, and am totally comfortable with my decision. Signed this _____day of the month of ________, 199___. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) Informed Consent for Patients Desiring Augmentation Mammaplasty With or Following Mastopexy and Patients with Thin or Stretch-Prone Tissues (Document 21) I__________________________ have discusssed with Dr. [Surgeon’s Name] and fully understand and accept the following with regard to my desire for breast augmentation. I acknowledge that I fully understand each item listed below. I have had an opportunity to have all my questions answered, and I feel informed and I accept each risk or tradeoff listed below as indicated by my initial(s) ________ beside each item. (Please place your initial in the blank at left, then initial each box beside each item below.) My tissues are prone to stretch. They stretched with the weight of my breast tissues alone, causing me to need mastopexy. As I get older, my breast skin will age, stretch and become thinner even without an implant. The larger any breast, augmented or not, the worse it will look over time. Adding any implant to my breast adds weight and will produce further stretch and thinning of my tissues over time. The larger the implant, the greater the amount of stretch that will occur. Adding weight to the breast almost guarantees that it will look worse over time, with increased stretch and sagging. It is impossible to predict whether or when this will occcur in any individual patient. Adding weight to my breast with an implant may cause me to need further surgery in the future, especially additional mastopexy that will incur additional costs, time off work, risks, and tradeoffs. Excessive tissue stretch can make me more likely to have surgical complications with problems healing if the tissues become very thin. As tissues thin, I will definitely be able to feel my implant, portions of the implant may be visible through my skin, and visible rippling or wrinkling may occur. If excessive stretch or complications occur (and this is unpredictable), it may become necessary to remove the implants, with probable compromise in the appearance of my breasts and probable visible scarring. I understand and accept all of these risks, limitations, and tradeoffs, and request that Dr. [Surgeon’s Name] proceed with augmentation of my breasts. I have had an opportunity to have all of my questions answered to my satisfaction, and am totally comfortable with my decision. Signed this _____day of the month of ________, 200___. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) Disclosure and Consent and Release of Liability The HIV Antibody Blood Test (Document 22) The Purpose of this form is to document that my physician or I have requested that my blood be tested to deduct whether or not I have antibodies in my blood to the HIV virus, which may be a causative agent of Acquired Immune Deficiency Syndrome (AIDS). I have been informed that the test's reliability is still uncertain and that the test results may, in some cases, indicate that a person has antibodies to the virus when the person does not (false positive) or the test may fail to detect that a person has antibodies to the virus when the person has the virus (false negative). I also have been informed that a positive blood test does not mean that I have AIDS, only that I have been exposed to the virus that may cause AIDS. I understand that no warranty or guarantee has been made to me as to the result. I have had explained to me the risks, reactions and hazards of the test administration. I have been given an opportunity to ask questions about the test, and I believe that I have sufficient information to give consent. I certify that this form has been fully explained to me, that I have read it or have had it read to me, that the blank spaces have been filled in, and that I understand its contents. I voluntarily request and consent to the administration for the test. The confidentiality of my medical records will be maintained. However, my physician or other health care providers, representatives of federal, state and local governmental agencies may ask to see the results for medical or scientific reasons or the results could be released bycourt order. I hereby release [Surgeon’s Name] from responsibility and liability for any consequences resulting from the administration of this test. Signed this _____day of the month of ________, 200___ in the presence of the witness listed below. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign) Important Information for You About Your Anesthesia (Document 23) We are pleased that you have made such a wise choice in selecting Dr. Tebbetts as your surgeon. We would like to provide you with some information about the anesthesia necessary for your procedure. About our Anesthesia Personnel [Brief bio, summary of professional training, certifications, titles here] Prior to Surgery Your anesthesiologist/CRNA will contact you by telephone prior to your surgery. In order to plan a safe and pleasant anesthetic for you, they will ask you some questions, and will gladly answer any questions you may have about your anesthetic. They will want to know if you have any drug allergies, if you take any medications ( prescription or over-the-counter), your experience with any previous anesthesia, and the condition of your teeth. They will also ask you about any health problems you may have. All of this information will help your anesthesiologist/CRNA design an anesthetic plan tailored specifically for you and your health needs. It is very important that you remember not to eat or drink anything after midnight the evening before your surgery. Your stomach must be empty before you go to sleep to prevent any risk of stomach contents coming up and getting into your lungs (a potentially serious problem). Do remember to drink extra water the evening before surgery up until midnight, to help assure adequate hydration. Day of Surgery On the day of your surgery, your anesthesiologist/CRNA will see you in your room or the pre-operative area before you are brought to surgery. They will start an intravenous line through which you will receive fluids and anesthetic medications during your surgery. When you arrive in the operating room, your anesthesiologist/CRNA will attach several monitoring devices before you go to sleep. These include blood pressure, electrocardiogram, and oxygen monitors. Your temperature and the air you breathe in and out will be monitored throughout surgery. The anesthesiologist/CRNA will be with you at all times during your surgery, and will bring you to the recovery room when your procedure is finished and you are waking up. You will continue to awaken in the recovery room while receiving oxygen and additional continuous monitoring. We look forward to visiting with you and answering any questions you may have. We are happy to be of service to you. Sincerely, [Signed by anesthesia personnel with titles] Information For You About Our Financial Policies Scheduling Deposit When you schedule your surgery, we are committing a large block of Dr. [Surgeon’s Name]’ time and the time of 8-10 additional personnel at the surgical facility. We therefore, require a scheduling deposit to reserve your surgical date. A deposit of 10% of your surgical fee is required to reserve a place on Dr. [Surgeon’s Name]’ surgical schedule. This deposit is nonrefundable. Total Payment Information Your scheduling deposit will be applied to the total surgical fee. For cosmetic surgical procedures, your total surgical fee is due two weeks prior to your surgery date. Your total surgical fee is nonrefundable if the surgery is cancelled for any reason other than the following: a. Dr. [Surgeon’s Name] is unable to perform the surgery for any reason. b. The patient has medical indications to cancel surgery. Dr. [Surgeon’s Name] will consult with your treating physician to determine the appropriateness of medical indication for cancellation. Acknowledgement I have read and understand the financial policies above. I understand that all fees paid are nonrefundable unless deemed medically necessary by Dr. [Surgeon’s Name]. Proof of medical condition must be supplied to provide evidence of medical necessity and refund consideration. Signed this _____day of the month of ________, 200___ in the presence of the witness listed below. _________________________ Patient: (Please print) __________________________ Witness: (Please print) _________________________ Patient: (Please sign) __________________________ Witness: (Please sign)