Patient-Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing
Controlled Carbon Dioxide Inflation: Confirmation of a Feasibility Study
Tony F. Connell, MBBS, BSc, FRACS
Subiaco, Western Australia, Australia
Interim results from the study described in this paper have been presented at the 17th
World Congress of the International Confederation for Plastic, Reconstructive and
Aesthetic Surgery, Santiago, Chile, February 24–March 1, 2013.
Interim results were accepted for oral presentation at 2013 Annual Meeting of The
American Society of Plastic Surgeons, San Diego, CA USA, October 11–15, 2013.
Patient-Activated Breast Expansion
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CORRESPONDING AUTHOR CONTACT INFORMATION
Tony F. Connell, MBBS, BSc, FRACS
3/200 Rokeby Road
Subiaco 6008 WA
Australia
e-mail:
phatconw@iinet.net.au
facsimile:
011-9382-4944
office:
011-9382-4844
Patient-Activated Breast Expansion
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FINANCIAL DISCLOSURE AND PRODUCTS
Disclosure
Mr. Connell was the principal investigator for the study described in this paper. He has
no consulting, shareholder, or advisory relationship with the sponsor of the study. The
sponsor, AirXpanders, Inc., supported the costs of conducting the study. Such costs
included device and surgical materials; operating room, laboratory, and hospital
expenses; surgeon’s fees; monitoring and follow-up of subjects; and other administrative
costs associated with the study.
Product
AeroForm® Patient Controlled Tissue Expander System
Key Words
Breast cancer; mastectomy; breast reconstruction; BRCA1; BRCA2; carbon dioxide
tissue expander; saline tissue expander, breast tissue expansion
Patient-Activated Breast Expansion
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ABSTRACT (≤ 250 words)
Background: Women with breast cancer or those at high risk of developing breast
cancer due to familial history of the disease or genetic mutations are frequently indicated
for therapeutic or prophylactic mastectomy. Prosthetic reconstruction of the breast with
placement of tissue expanders followed by implants offers favorable aesthetic and
psychological results while adding only minimal additional surgical intervention. This
study describes the confirmatory phase of an earlier feasibility trial that involved seven
women who successfully underwent patient-activated controlled expansion for breast
reconstruction with 10 AeroForm® Patient Controlled Tissue Expanders.
Methods: A prospective, open-label, single-arm, single-surgeon confirmatory study in
Perth, Australia evaluated outcomes of two-staged breast reconstruction using the
investigational device. Each subject administered a preset 10-cc dose of carbon dioxide
gas using a remote dosage controller, three times each day, with a three hour lockout
between doses until full expansion was achieved.
Results: Thirty-three women with breast cancer, family history or predisposition because
of the BRCA1/2 gene mutation underwent pedicled latissimus dorsi flap procedures with
placement of 61 carbon dioxide-based tissue expanders. Mean number of days for
subjects to achieve desired expansion was 17 ± 5 days. Operating the dosage controller
was described by the surgeon as very easy in 94% of the cases and by 97% of the
subjects. No serious adverse events were reported.
Conclusions: This study confirms the AeroForm® breast tissue expander has
demonstrated the ability to provide, relative to saline expanders, a needle free, patient
controlled, convenient and time saving method of tissue expansion.
Patient-Activated Breast Expansion
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Level of Evidence: Therapeutic, Level II
Patient-Activated Breast Expansion
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BACKGROUND
For women with breast cancer or for those at high risk of developing breast cancer
due to the presence of BRCA1 or BRCA2 gene mutations or with familial history of the
disease, therapeutic or prophylactic mastectomy is often indicated [1]. If mastectomy is
advised, patients must decide whether to undergo breast reconstruction or to live with an
external prosthesis. Reconstruction of the breast, as a staged procedure with tissue
expanders followed by implants, is a reliable method for these patients [2,3] and offers
favorable aesthetic and psychological results, while adding only minimal additional
surgical intervention [4]. Reconstruction can be achieved with autologous flaps, with
formation of an expanded pocket using a breast tissue expander, or with a combination of
these techniques. Breast tissue expansion currently requires the use of a saline tissue
expander, which is placed immediately following mastectomy or later in a separate
operative procedure (delayed reconstruction). After placement of the expander and
several weeks of healing, the patient undergoes a series of bolus injections of saline
through a magnetic port embedded in the expander. Injections are continued until the
desired breast size is reached. The bolus injections can be painful for the patient and can
place time-consuming demands on both the patient and the surgeon.
This study describes the confirmatory phase of an earlier feasibility trial that was
reported in 2011 and involved seven women with ten expanders who successfully
underwent patient-activated controlled expansion for breast reconstruction with
controlled carbon dioxide-based tissue expanders using the AeroForm Patient Controlled
Tissue Expander System (AirXpanders Inc., Palo Alto, California USA) [5]. The purpose
of the present study is to confirm the earlier results in a larger population of women. The
Patient-Activated Breast Expansion
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primary objective is expansion to and maintenance of clinically desired breast volume
until permanent implant placement unless prohibited by a non-device related failure.
Secondary objectives included the time to achieve desired expansion and placement of a
permanent implant, safety, and overall subject and physician satisfaction.
SUBJECTS AND METHODS
This is a prospective, open-label, single-arm confirmatory study to evaluate the
outcomes of two-staged breast reconstruction using the AeroForm Patient Controlled
Tissue Expander System in women who are undergoing or have had a mastectomy
[ClinicalTrials.gov Identifier: NCT01009008]. The intent of this confirmatory trial was
to acquire data and experience in a larger population (the number of expanders used was
increased six fold [from 10 devices to 61])) and specifically to collect data on expansion
times in a larger cohort. Study parameters were broadened to include delayed
radiotherapy patients, lessen travel restrictions and to study the effect these changes
might have on outcomes. The hypothesis of the confirmatory study was that the initial
results would be reproduced in a larger sample size, while lifting some of the restrictions
associated with the pilot trial experience without negative consequence.
Figure 1 shows a schematic of the AeroForm tissue expander and handheld
dosage controller. Potential subjects were recruited from referral centers within Western
Australia after the local Ethics Committee approved the study. Inclusion and exclusion
criteria determined subject eligibility (Table 1). Potential subjects were informed of the
purpose of the study, the required procedures and assessments, the duration of the study,
and the potential risks and benefits of participation. Thirty-three enrollees signed
Patient-Activated Breast Expansion
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informed consent and were treated in this clinical investigation at Mount Hospital, Perth,
Western Australia. The majority of subjects underwent bilateral implantation (28) with a
total of 61 implants in the population of 33 women.
Prior to surgery, enrolled subjects were taught how to administer the preset
carbon dioxide doses using a handheld dosage controller. After mastectomy either
immediate or delayed, the surgeon inserted the tissue expander and dosed the expander
on average 65cc intra operatively using the dosage controller that the patient would
eventually use at home. Intra operative fill volume was determined in the same manner
used for saline expanders, which is to fill based on pocket size and tissue perfusion with
the goal being to eliminate ‘dead space’ without compromising tissue perfusion.
Each patient was followed at weekly intervals post-operatively and once healing was
complete, they were given the dosage controller and instructed to dose at home. They
were followed weekly throughout the duration of the tissue expansion. The principle
aspect of patient dosing is patient comfort with a patient-administered maximum dose of
10cc, three times each day and a three hour lockout between doses. The system is
designed with this patient limit to prevent over inflation at home. The surgeon could
suppress the daily limits by inserting the Physician Master Key during the intraoperative
placement and office follow-up visits to administer additional volume. After full
expansion was achieved, the patient was instructed to administer one 10cc dose per week
to maintain full volume until the time of implant exchange. Once full expansion was
achieved, each patient was followed at monthly intervals until device explantation and
exchange for a permanent breast implant at or before 6 months. Baseline photographs
were taken prior to the reconstructive process and at each of the follow-up visits.
Patient-Activated Breast Expansion
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Measurements were made prior to expander placement to select the appropriate
base width, volume and projection of the AeroForm expander to create a pocket that
would accommodate the desired permanent implant. Prior to exchange to permanent
implant, bio-dimensional analysis was used to determine the final implant size.
The primary endpoint of this study was analyzed per breast (expander). The
device performance was reported based on the subset of enrolled subjects who met the
primary endpoint or failed expansion due to a device malfunction. Descriptive statistics
were used to report patient characteristics, time to expansion, time to permanent implant
exchange, percentage of subjects with successful exchange to permanent breast implant
following tissue expansion, adverse events, device-related adverse events, and patient and
physician satisfaction. Subject and physician satisfaction questionnaires are included in
Appendix 1 as reference.
RESULTS
Recruitment of 33 subjects occurred from July 2011 to June 2012. Baseline
demographics history of breast cancer and chemotherapy are presented in Table 2. Table
3 presents and type of reconstruction is presented in Table 2. Twenty-six (79%) had
immediate reconstruction, three (9%) had delayed reconstruction, and four (12%) had
immediate reconstruction with delayed reconstruction on the contralateral side. Bilateral
reconstructions (n = 28; 85%) were predominant with 61 total breast reconstructions
completed. Three subjects had a history of radiation therapy. In these subjects, the
surgeon made a preoperative assessment of each patient’s skin texture. All three patients
were a number of years post-radiation and skin texture was assessed as suitable for
Patient-Activated Breast Expansion
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expansion and waivers from the sponsor were given to enroll them in the study. Two
subjects were given a waiver to fly within Australia and did so without any adverse
expansion consequences.
The AeroForm expanders used in this trial were size small (12.5cm width/400cc)
and, medium (14.0cm width/650cc). No large sizes were used in the study (15.5cm
width/800cc). Details of the full dimensions are provided in Table 3A. Unlike saline
expanders, the AeroForm devices cannot be expanded beyond their labeled volume, due
to the pre-formed inner bag that determines the devices final shape. Once this shape is
achieved, the device will not get any larger. All devices in the study were inflated to
their labeled maximum volume (400cc or 650cc). They were exchanged to permanent
implants based on bio-dimensional analysis as described above. Table 3B lists the
specifications of the expanders and permanent implant sizes used for the patients in this
trial.
Overall results of this PACE 2 study indicate that the primary endpoint, expansion
to and maintenance of clinically desired breast volume until permanent implant
placement unless prohibited by a non-device related failure, was met in 100% (61/61) of
the expanders. Figure 2 shows the expansion results for one subject and depicts the
postop phase of 18 days, the active expansion of 14 days and the maintenance phase of
41 days prior to replacement with permanent implants. Further, the secondary endpoint
of safety as evidenced by a low incidence of device related adverse events was also met,
confirming the results noted in the first feasibility study of the carbon dioxide-based
tissue expander.
Patient-Activated Breast Expansion
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The mean number of days for the patients to achieve desired and full expansion
was 17 ± 5 days. Total mean reconstruction time was 90 ± 18 days. Figure 3 depicts
representative patients at pre-exchange (after completed expansion) and post-exchange
(after permanent implant received). Figure 4 shows two views of a representative patient
at preoperative and postoperative visits, while Figure 5 shows an additional patient preop
and postop.
Subjects were asked to complete an ease-of-use questionnaire to which thirty-one
of 32 responding subjects (97%) indicated that the dosage controller “very easy to use”
and one (3%) respondent described it as “moderately easy to use”. In terms of the overall
results of their expansions, 26 (81%) responded that they were “very satisfied”, 4 (13%)
were “moderately satisfied”, and 2 (6%) were “satisfied” with their expansion process.
The surgeon incorporated latissimus dorsi pedicle flap procedures in all 61
reconstructions. Latissimus dorsi flap has been widely reported in the literature to
improve vascularity and reduce subsequent flap necrosis. Intraoperatively, the surgeon
dosed the expanders an average of 65 cc of carbon dioxide and described the majority of
his intraoperative experience operating the dosage controller as “very easy” (94% of the
cases) and a minority as “moderately easy” (6%). He also described his experience
implanting the expander as “very easy” (61%) to “moderately easy” (39%). Lastly, he
rated his overall satisfaction with the use of the tissue expander system as “very easy”
(97%).
Permeation is an inherent property of the AeroForm device due to the fact that a
high solubility gas (CO2) with a known safety profile, is used to fill the expander. In 12
expanders (10 subjects) there was a loss of volume due to permeation that necessitated
Patient-Activated Breast Expansion
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the addition of volume by the physician beyond the pre-set limits to maintain the fill. This
was accomplished by the use of the Physicians Master Key.
Nineteen subjects reported 25 adverse events were reported: breast pain (n = 7),
breast hematoma (n = 1), breast infection (n = 1), back seroma (n = 10), and other
(cellulitis, n = 2; arm pain, n = 1; urinary tract infection, n = 1; muscle spasm, n = 1; and
dizziness, n = 1). Three subjects reported more than one adverse event. All of these
events resolved without sequelae and none were considered serious. (Table 4) All
reported events are those that are typically associated with breast reconstruction and
reported in the literature.
DISCUSSION
This confirmatory study (PACE 2) was designed to further the data and research
acquired during the feasibility study (PACE 1) for the AeroForm Patient Controlled
Tissue Expander System [5]. Both studies were conducted at the same facility in Perth,
Western Australia and implantation was performed by the same surgeon (T.C.). The
protocols were designed similarly, with the exception that the PACE 2 study allowed
older females who otherwise fit all inclusion criteria to be enrolled, 65 vs. 70 years of
age. The surgical procedure for implantation and explanation of the expander and the
dosing regimens, were identical in both studies.
The first report of the carbon dioxide-based tissue expander (PACE 1) in seven
subjects (10 expanders) indicated the potential of the device to offer a new paradigm in
breast reconstruction as subjects were able to demonstrate for the first time, the
possibility of optimizing their own rates of expansion, thus expediting the active
expansion process in a safe and effective manner.
Patient-Activated Breast Expansion
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The positive results seen in the PACE 1 study prompted extension to a larger
population of women using the device. In this series, 61 tissue expanders were
successfully implanted and exchanged for permanent implant in 33 subjects. The
majority of subjects, 79%, underwent immediate reconstruction and 85% were bilateral.
Subjects with a history of radiation therapy were allowed in the trial under waiver with
no ill effect on outcome.
It is known that the volume in the AeroForm expander will increase at higher
altitudes during ascent due to expansion of the CO2. The risk of flying with the expander
in place is relative to the healing status of the incision, tissue perfusion, patient comfort
and fill volume of the expander. An analysis of the expected volume of expansion has
been performed by AirXpanders and is variable depending on the altitude and expander
fill volume. If a patient with an expander in place needs to fly, it is necessary to confirm
that their incision is well healed, tissue perfusion is intact and they are comfortable prior
to the planned flight. In addition, the volume of the expander should be assessed.
Because the expander cannot be inflated beyond its labeled volume, an increase in
pressure could occur if the expander is at full volume. Due to this, it is recommended
that the patient discontinue dosing prior to the flight to allow permeation to occur.
During the course of the trial, two patients needed to travel by air and prior to doing so,
waivers were requested from the Sponsor. Assessment of the patients and an analysis of
the fill volume of the expanders was performed and patients were instructed to
discontinue dosing for a two week period prior to their flight, thus they flew with a
partially filled implant. Patients reported a full sensation but no discomfort or ill effects
from the air travel.
Patient-Activated Breast Expansion
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Active expansion of the device was rapid with the mean number of days for the
subjects to achieve desired expansion at 17 days ± 5 days. The total mean reconstruction
time was three months which compares favorably to the typically longer reconstruction
time frame of up to six months or longer with standard saline tissue expanders [6,7].
Convenience and the ability to optimize control of the expansion process were
illustrated in the data from the first study, PACE 1. These characteristics of the
AeroForm device were further demonstrated in the larger population via the results of an
ease-of-use questionnaire administered after expansion was complete. All but one
subject (97%) indicated the dosage controller was “very easy to use”; the remaining
subject described the device as “moderately easy to use”. This subject noted that she was
confused when the dose controller would not further dose due to the pre-set limits. With
regard to overall expansion results, the majority (81%) of subjects indicated they were
“very satisfied”, with the remaining subjects either “moderately satisfied” (13%) or
“satisfied” (6%) with their expansion process. No subjects reported dissatisfaction with
the expansion process or difficulty using the tissue expander. A high level of ease-of-use
was further confirmed from the perspective of the surgeon. The majority (94%) of the
surgeon’s experience operating the dosage controller intraoperatively, was reported “very
easy” with the remaining 6% noted as “moderately easy”. Implantation of the device was
noted by the surgeon to be “very easy” in 60% of cases with the remaining 40% noted as
“moderately easy”. Overall, the surgeon was “very satisfied” with the expansion in 97%
of the cases using the study device.
While a small number of tissue expanders were noted to have a gradual loss of
volume due to permeation prior to replacement, the physician successfully added more
Patient-Activated Breast Expansion
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volume beyond the pre-set limits to maintain the fill until the permanent implant was
placed. Permeation is an inherent property of the AeroForm device due to the fact that a
high solubility gas (CO2) with a known safety profile, is used to fill the expander.
Current bench testing of the device measures permeation to be approximately 1 – 1.5cc
per day. The device software is programmed based on this rate to provide ‘maintenance’
dosing after the device has registered full volume. The amount of CO2 that is onboard in
the reservoir is approximately 2X the amount required to fill the device. This allows
volume maintenance in women who may have the AeroForm in place during a protracted
period of time. As with all tissue expanders, the AeroForm is intended for implantation
for up to six months. The dosage controller tracks the volume administered and the
programmed permeation rate to approximate the expander volume. A small number of
subjects experienced gradual loss of volume requiring additional dosing beyond pre-set
limits. These subjects were successfully exchanged to permanent implant with no
complications or ill effect on final outcome. It was determined that the loss of volume
was due to flexion damage to the inner bag resulting in creases in the bag through which
the CO2 permeated. Subsequently, the device has undergone improvement to the inner
bag to decrease the observed damage. Bench testing measured the permeation rate (11.5cc per day) in the enhanced version of the device. Ongoing clinical trials are expected
to confirm that in-vivo permeation is reduced in these devices.
The AeroForm device is designed with no internal power source and the microvalve can only be activated when the dosage controller is used. This design is intentional
to ensure that the valve cannot be opened inadvertently resulting in over-expansion. In
this confirmatory trial of the AeroForm, there were no over-expansions reported.
Patient-Activated Breast Expansion
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Of the 19 adverse events noted in the trial, all events commonly occur in this
population undergoing the breast reconstruction process and are similar to those reported
in the literature for tissue expander procedures. None of the adverse events were of a
serious or long-lasting nature. Limitations of this trial include the single site, single
surgeon experience with the same surgical technique used for all subjects. Inability to
remove CO2 from the device remains a concern; however, over-expansion is mitigated by
pre-set limits of 10cc doses. Other limitations include the concurrent use of radiotherapy
with the device and the preclusion of traveling to an altitude above 1000 meters. Further
investigation is necessary to better characterize these limitations with the device prior to
commercial use.
CONCLUSIONS
The PACE 2 trial presents confirmatory data indicating that the AeroForm Patient
Controlled Tissue Expander, relative to saline expanders, provides a time-saving, needlefree, safe and effective method of tissue expansion for breast reconstruction. This
alternative method of tissue expansion makes it possible for the patient to control the
expansion process and is associated with high patient and physician satisfaction. The
reported complications are similar to those experienced in the literature for tissue
expansion procedures. This study represents progress towards the goal of improving the
quality of care for women undergoing the arduous process of breast reconstruction.
Additional development is underway to decrease the bulk of the device, enable a single
dosage controller to operate both expanders in a bilateral reconstruction and increase the
size range offered with this technology.
Patient-Activated Breast Expansion
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REFERENCES
1.
Spear SL, Carter ME, Schwarz K. Prophylactic mastectomy: indications, options,
and reconstructive alternatives. Plast Reconstr Surg. 2005;115(3):891–909.
2.
Collis N, Sharpe D. Breast reconstruction by tissue expansion. A retrospective
technical review of 197 two-stage delayed reconstructions following mastectomy
for malignant breast disease in 189 patients. Br J Plast Surg. 2000;53(1):37–41.
3.
Trabulsy PP, Anthony JP, Mathes SJ. Changing trends in postmastectomy breast
reconstruction: a 13-year experience. Plast Reconstr Surg. 1994;93(7):1418–
1427.
4.
Cordeiro PG, McCarthy CM. A single surgeon’s 12-year experience with tissue
expander/implant breast reconstruction: part II. An analysis of long-term
complications, aesthetic outcomes, and patient satisfaction. Plast Reconstr Surg.
2006;118(4):832–839.
5.
Connell AF. Patient-activated controlled expansion for breast reconstruction with
controlled carbon dioxide inflation: a feasibility study. Plast Reconstr Surg.
2011;128(4):848–852.
6.
Kim JY et al. A Meta Analysis of Human acellular dermal matrix and Submuscular tissue expander breast reconstruction, Plast Reconstr Surg 2012. Jan;
129(1): 28-41, 2012 .
7.
Lanier ST et al. The effect of acellular dermal matrix use on complication rates in
tissue expander / implant breast complications. Ann Plast Surg 2010
May;64(5):674-8.
Patient-Activated Breast Expansion
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Table 1. Inclusion and Exclusion Criteria *
Inclusion criteria
Females, 18–70 years old
Planned breast reconstruction surgery post mastectomy
Able to provide informed consent
Able to understand protocol requirements
Exclusion criteria
Tissue at the intended expansion site determined by surgeon to be unsuitable (ie,
infection, compromised vascularity, history of compromised wound healing,
mastectomy skin flaps of questionable viability, excessively tight skin envelope,
previous radiation treatment, active ulceration)
Residual gross tumor at the intended expansion site
History of or planned adjuvant radiation therapy
Co-morbid condition determined by the surgeon to pose unduly high risk of surgical
and/or postoperative complications
BMI ≥ 33
Current smoker
Psychologically unsuitable patient
Planned flight or ascent to altitude exceeding 1000 meters above baseline during
expansion period
Currently has an electronic implant (eg, pacemaker, defibrillator, neurostimulator)
Pregnant at the time of enrollment or planning to become pregnant during the study
Unwilling to notify study doctor of scheduled MRI procedures during study
Unable to understand the protocol for tissue expansion
*
Abbreviations: BMI, body mass index; MRI, magnetic resonance imaging.
Patient-Activated Breast Expansion
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Table 2. Demographics and Type of Reconstruction Performed.
Variable
Value
Age, years ± SD (median; range)
44.1 ± 8.4 (44; 28–63)
BMI, kg/m2 ± SD (median; range)
24.6 ± 3.8 (23.9; 18.6–33.0)
Breast cancer history, n (%)
21 (64%)
No breast cancer history (family history or
12 (36%)
BRCA ½ gene mutation), n (%)
Mastectomy history, n (%)
8 (24%)
Chemotherapy history, n (%)
13 (39%)
Immediate Reconstruction
26 (79%)
Delayed Reconstruction
3 (9%)
Immediate/Delayed Reconstruction
4 (12%)
Bilateral
28 (85%)
Unilateral
5 (15%)
Patient-Activated Breast Expansion
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Table 3A. Aeroform Expander Specifications
Expander Model
LP105-400
LP120-650
Height
10.0
11.0
Width
10.5
12.0
Projection
9.0
10.0
Volume
400cc
650cc
Table 3B. Expander to Permanent Implant Sizes
Subject #
01-008
01-009
01-010
01-011
01-012
01-013
01-014
01-015
01-016
01-017
01-018
01-019
01-020
01-021
01-022
01-023
01-024
01-025
01-026
01-027
01-028
01-029
01-030
01-031
01-032
01-033
01-034
01-035
01-036
01-037
01-038
01-039
01-040
Expander
(R)
LP105-400
LP105-400
LP120-650
LP120-650
LP105-400
LP105-400
LP105-400
LP105-400
LP105-400
LP120-650
LP105-400
LP105-400
LP120-650
LP120-650
LP105-400
LP105-400
LP120-650
LP105-400
LP105-400
LP105-400
LP105-400
LP105-400
LP105-400
LP105-400
LP120-650
LP105-400
LP105-400
LP105-400
LP120-650
LP120-650
LP105-400
LP105-400
Expander
(L)
LP105-400
LP105-400
LP120-650
LP120-650
LP105-400
LP105-400
LP105-400
LP120-650
LP105-400
LP120-650
LP105-400
LP120-650
LP120-650
LP105-400
LP105-400
LP120-650
LP105-400
LP105-400
LP105-400
LP105-400
LP105-400
LP120-650
LP105-400
LP105-400
LP105-400
LP120-650
LP120-650
LP105-400
LP105-400
Patient-Activated Breast Expansion
I/O Fill
(R)
80
80
60
100
40
40
40
60
40
60
40
80
60
120
120
40
80
40
12
80
40
40
10
80
80
80
60
80
80
80
80
60
I/O Fill (L)
80
40
60
100
40
40
40
60
40
80
80
60
120
120
40
80
40
12
80
8
80
80
80
60
80
80
80
80
60
Implant
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Allergan
Implant Size
(R)
FX 450
MX 370
FX 560
FX 690
MX 370
FF 475
FX 360
FX 450
MX 410
FX 410
FX 450
FX 495
FX 495
FX 615
FX 560
MX 410
FX 560
MX 370
MX 445
FX 495
MX 360
MF 375
FX-410
FX-495
FX-690
FX-410
MX-410
FX-450q
FX 690q
FX-775
MX 370
FX-450
Implant Size
(L)
FX 450
MX 410
FX 560
FX 690
MX 410
FX 360
MX 445
FX 410
FX 450
FX 615
FX 495
FX 495
FX 615
FX 560
MF 420
FX 560
MX 370
MX 445
FX 495
FX-475
FX-495
FX-690
FX-410
MX-410
FX-450
FX 690
FX-690
MX 370
FX-450
20
Table 4. Adverse Events.
Adverse Event Type
Number
Breast Pain
7
Breast Hematoma
1
Breast Infection
1
Back Seroma
10
Cellulitis
2
Arm Pain
1
Urinary Tract Infection
1
Muscle Spasm
1
Dizziness
1
Total Events
25*
*Three subjects had more than one event
Patient-Activated Breast Expansion
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Figure 1. AeroForm expander and handheld dosage controller.
Patient-Activated Breast Expansion
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Figure 2. Expansion Results.
Patient-Activated Breast Expansion
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Figure 3. Representative Views of Pre-Exchange (Completed Expansion) and PostExchange to Permanent Implant.
Patient-Activated Breast Expansion
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Figure 4a-b. Two Views of Patient Preop and Postop.
Patient-Activated Breast Expansion
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Figure 5. Views of Patient Preop and Postop.
Patient-Activated Breast Expansion
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Appendix 1 – Satisfaction Survey Questions
I.
Subject Satisfaction Survey (Post Expansion)
1. Rate your experience operating the dosage controller at home.
Very Easy
Moderately
Easy
Mildly Easy
Neither Easy or
Difficult
Mildly Difficult
Moderately
Difficult
Very Difficult
Moderately
Inconvenient
Very
Inconvenient
2. Rate the convenience of using the AirXpander System at home.
Very Convenient
Moderately
Convenient
Mildly
Convenient
Neither
Convenient or
Inconvenient
Mildly
Inconvenient
3. Was the training and written instructions adequate preparation for the use of the AirXpander System?
Yes/No
4. What was your overall satisfaction with the expansion process?
Very Satisfied
Moderately
Satisfied
Mildly
Satisfied
Neither
Satisfied or
Dissatisfied
Mildly
Dissatisfied
Moderately
Dissatisfied
Very
Dissatisfied
5. Would you recommend the AirXpander device for others who are going through breast reconstruction?
Yes/No
6. Would you be willing to provide a testimonial on your experience with the AirXpander device?
Yes/No
7. Please provide any additional comments, concerns or suggestions.
II.
Physician Satisfaction (Post-Expansion)
1. Rate your experience operating the AirXpander dosage controller.
Very Easy
Moderately
Easy
Mildly Easy
Neither Easy or
Difficult
Mildly Difficult
Moderately
Difficult
Very Difficult
Moderately
Inconvenient
Very
Inconvenient
2. Rate the convenience of using the AirXpander System for office expansion.
Very Convenient
Moderately
Convenient
Mildly
Convenient
Neither
Convenient or
Inconvenient
Mildly
Inconvenient
3. Was the training and written instructions adequate preparation for the use of the AirXpander System?
Yes/No
4. What was your overall satisfaction with the results of the expansion?
Very Satisfied
Moderately
Satisfied
Mildly
Satisfied
Neither
Satisfied or
Dissatisfied
Mildly
Dissatisfied
Moderately
Dissatisfied
Very
Dissatisfied
Moderately
Dissatisfied
Very
Dissatisfied
Moderately
Dissatisfied
Very
Dissatisfied
5. What was your overall satisfaction with the AirXpander System?
Very Satisfied
Moderately
Satisfied
Mildly
Satisfied
Neither
Satisfied or
Dissatisfied
Mildly
Dissatisfied
6. What was your staff’s overall satisfaction with the AirXpander System?
Very Satisfied
Moderately
Satisfied
Mildly
Satisfied
Neither
Satisfied or
Dissatisfied
Mildly
Dissatisfied
7. Do you have any specific comments or improvements that you would recommend to the product,
labeling or training for the AirXpander System?
Patient-Activated Breast Expansion
27
III.
Surgeon Device Evaluation (During Implantation)
1. Rate your experience operating the AirXpander dosage controller during implant.
Very Easy
Moderately
Easy
Mildly Easy
Neither Easy or
Difficult
Mildly Difficult
Moderately
Difficult
Very Difficult
Mildly Difficult
Moderately
Difficult
Very Difficult
2. Rate your experience implanting the tissue expander.
Very Easy
Moderately
Easy
Mildly Easy
Neither Easy or
Difficult
3. Rate your experience filling the expander to the desired volume after implant.
Very Easy
Moderately
Easy
Mildly Easy
Neither Easy or
Difficult
Mildly Difficult
Moderately
Difficult
Very Difficult
4. Was the pre-operative training and instructions adequate preparation for use of the device?
Yes/No
5. What was your overall satisfaction with the use of the AirXpander System during implant?
Very Satisfied
Moderately
Satisfied
Mildly
Satisfied
Neither
Satisfied or
Dissatisfied
Mildly
Dissatisfied
Moderately
Dissatisfied
Very
Dissatisfied
6. Are there any specific comments or improvements that you would recommend to the product, labeling or
training to facilitate implant of the product?
IV.
Surgeon Device Evaluation (Post Explant)
1. Describe your experience explanting the AirXpander Tissue Expander.
Very Easy
Moderately
Easy
Mildly Easy
Neither Easy or
Difficult
Mildly Difficult
Moderately
Difficult
Very
Difficult
2. What was your overall satisfaction with the use of the AirXpander System during explant?
Very Satisfied
Moderately
Satisfied
Mildly Satisfied
Neither
Satisfied or
Dissatisfied
Mildly
Dissatisfied
Moderately
Dissatisfied
Very
Dissatisfied
3. How would you compare the explant of the AirXpander to the explant of a saline expander?
4. Do you have any specific comments or improvements that you would recommend to the product, labeling
or training to facilitate explant of the product?
Patient-Activated Breast Expansion
28