SAMPLE PROTOCOL
CONTRACEPTIVE IMPLANTS
2011 Version
I.
General Information
Currently, there is only one contraceptive implant marketed in the US. Implanon is a
single-rod implant which is effective for up to 3 years. It contains etonogestrel (3ketodesogestrel), the active metabolite of desogestrel, in an ethylene vinyl acetate
(EVA) core surrounded by an EVA membrane. In clinical trials the pregnancy rates
were extremely low with a Pearl Index of 0.38 pregnancies per one hundred womenyears of use. Follicular development is not completely impeded, so estradiol levels
are not significantly decreased.
Some sites may also care for clients who have had a contraceptive implant inserted
in another country, or who have older implants which are no longer marketed in the
US. These include Jadelle or Norplant 2, a two-rod system as well as the original
Norplant, which is a six-capsule system.
Personnel
1. Only clinicians (APN, PA, or physician) who have undergone a training course in
Implanon insertion and removal approved by the manufacturer are permitted to do
so.
2. Each site may create a system for granting clinical privileges to clinicians (APN,
PA, or physician) who will insert and/or remove the implant.
 The system should include a proctoring program in which there is direct
observation of at least one implant insertion and removal unless the clinician
has been observed successfully inserting and removing Norplant.
3. Only physicians, APNs, or PAs with previous surgical experience, or who have
performed successful removals under the direct supervision of an experienced
clinician shall remove other contraceptive implants. Another clinician with
experience in successful removals should also be available (on site or by phone)
for assistance with difficult procedures.
II. CLIENT SELECTION
Indications — Implant placement may occur if
1. contraindications do not exist
2. a long-term, high-efficacy, not-coitus-dependent, private method is desired
Contraindications —
1. Reproductive Tracts Infections and Disorders
 Breast cancer —current (USMEC, 4), suspected, and past (USMEC, 3)
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SAMPLE PROTOCOL
CONTRACEPTIVE IMPLANTS
2011 Version
Special Conditions Requiring Further Evaluation
Decisions regarding individualized management, follow-up intervals, or the need for
additional testing or referral should be based on protocols approved by the Medical
Director or in consultation with the Medical Director. These conditions include
1. Rheumatic Diseases
 systemic lupus erythematosus (SLE) — only when antiphospholipid antibodies
are positive or unknown. (USMEC, 3)
o Informed Consent should be given and documented in the medical
record.
o The following are NOT special conditions for the implant:
 negative antiphospholipid antibodies (USMEC, 2)
 thrombocytopenia (USMEC, 2)
 immunosuppressive treatment (USMEC, 2)
2. Neurologic Conditions
 currently being treated for meningioma — consult with oncologist or
neurosurgeon
3. Reproductive Tract Infections and Disorders
 undiagnosed abnormal uterine bleeding that is suspicious for a serious
condition (USMEC, 3) — the condition must be evaluated before inserting the
implant
o Women ≥ age 35 with undiagnosed abnormal uterine bleeding suspicious
for cancer must have an endometrial biopsy prior to insertion of the
implant.
o Endometrial biopsy should be considered in women < age 35 with
abnormal bleeding who have risk factors for endometrial
hyperplasia/cancer prior to insertion of the implant.
 personal or family history of ovarian, breast, colon or endometrial
cancer
 tamoxifen use
 chronic anovulation
 obesity
 unopposed estrogen therapy
 prior endometrial hyperplasia
FYI — Abnormal Bleeding: What is suspicious for cancer?
Bleeding that is suspicious for endometrial cancer is characterized by the following
 non-cyclic (anovulatory)
 unpredictable
 abnormal pattern persisting for at least three months
Bleeding that is not suspicious tends to be cyclic (ovulatory, monthly) but may be longer
or heavier than normal. It is often due to a structural abnormality rather than
anovulation.
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SAMPLE PROTOCOL
CONTRACEPTIVE IMPLANTS
2011 Version
4. Gastrointestinal Conditions
 current severe liver dysfunction (severe cirrhosis, end stage liver disease)
(USMEC, 3)
o Mild compensated cirrhosis and viral hepatitis (acute, carrier, chronic) are
not special conditions to implants. (USMEC, 1)
 liver tumors —
o benign — history of or current hepatocellular adenoma (USMEC, 3)
o malignant — history of or current hepatoma (USMEC, 3)
o focal nodular hyperplasia is not a special condition to implants.
(USMEC, 2)
III. CLIENT EDUCATION AND INFORMED CONSENT
Client education and informed consent should include:
1. education regarding all contraceptive options available
2. discussions about the implant that supplement and reinforce the required written
materials
3. signing and maintaining in client’s medical record:
 Consent form for placement of Contraceptive Implant for each insertion and
Consent form for Removal for each removal
4. education regarding the purpose, importance, and scheduling of well-woman
screening and prevention visits, when indicated
5. providing the client with
 written information on the use, effectiveness, and medically recognized
benefits and risks of the available methods of contraception for new
contraceptors. Written information should be offered to all others.
 a copy of manufacturer’s FDA-approved, Patient Labeling leaflet. The
importance of reading the leaflet should be explained.
 written information on the use, effectiveness, and medically recognized
benefits and risks of Contraceptive Implants
 for clients with systemic lupus erythematosus (SLE) — when antiphospholipid
antibodies are positive or unknown, Informed Consent intended for Use of
Hormone Birth Control by Women with Special Conditions
 other written materials
o after-care instructions including signs to report to the provider and
emergency contact information
o the user card that comes in the package
o a copy of the request form(s) signed by the client, if the client so requests
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SAMPLE PROTOCOL
CONTRACEPTIVE IMPLANTS
2011 Version
IV. PRESCRIBING IMPLANTS
Prescription — Single rod implant (Implanon) is approved for three years of use.
Requirements for Prescribing —
1. There is no time at which a pelvic exam is required for continued provision of the
method as long as all eligibility requirements are met.
 Targeted history should have been completed within the past year.
Components of targeted history include:
o contraindications and special conditions (as listed above)
o evaluation of risks for sexually transmitted infections
o possible pregnancy
o history of breast mass
o post-delivery and lactational status
 Clients with an undiagnosed breast mass or history of an unresolved followup of a breast mass that is not being managed by another healthcare
provider should be evaluated (internally or by referral.)
o If breast mass is suspicious for carcinoma must not insert the implant.
o Should offer an alternative contraceptive, if needed, while breast
evaluation is being arranged.
 When “Special Conditions” exist (See above, Item II, Special Conditions
Requiring Further Evaluation)
o Further medical evaluation should be performed by a qualified, licensed
health care provider before prescribing the method.
o Medical evaluation should be performed before each reinsertion.
 Clients who report symptoms of, or partner contact with, STIs should be
managed by the provider or referred for management
 Whenever a client presents with symptoms of a possible problem, an
appropriate physical examination should be performed, if indicated.
2. Clients should be encouraged to obtain a periodic well woman visit, regularly
scheduled Pap tests, follow-up for any abnormal Pap tests or other screening
tests, and indicated STI screening (consider offering test at visit). This must be
documented in the chart.
3. For women 40 and over, both an annual breast exam and a screening
mammogram should be recommended. However, clients who obtain either an
annual breast exam or an annual screening mammogram may receive the
implant.
 The client’s self-report (of previous breast exam or mammogram results) is
adequate proof and must be documented in the chart.
 Clients in this age group who refuse both the annual clinical breast exam and
screening mammogram and wish to initiate the implant
o Should sign a Release When Test/Service/ Consultation Will Not Be
Obtained As Recommended and annually after that if she requests other
services
o should be educated on the benefits of annual clinical breast exam and
mammography as well as the risks of undiagnosed breast cancer. This
must be documented in the chart.
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SAMPLE PROTOCOL
CONTRACEPTIVE IMPLANTS
2011 Version
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SAMPLE PROTOCOL
CONTRACEPTIVE IMPLANTS
2011 Version
Timing of Initiation — The table below should be followed when initiating the implant.
Alternative timings should be individualized to ensure contraceptive protection.
CURRENT
METHOD
No effective
contraception in
current cycle
INSERT IMPLANT
BACKUP
Anytime in cycle if it is reasonably certain client is
not pregnant. (See FYI below.)
 If possibility of pregnancy is suspected, a
highly sensitive urine test must be performed.
If pregnancy test is negative and client
understands risk of possible very early
pregnancy, insert implant and advise client to
repeat urine test in two weeks. Offer EC as
appropriate.
If more than five
days since
menstrual
bleeding started,
backup for seven
days.
See Algorithm A, below.
Current correct
use of hormonal
contraception
Any time in cycle
On or before next DMPA injection is due
Finish COC,
patch, or ring
cycle
NOTE: If switching from DMPA and it had been
initiated beyond first seven days of menstrual
bleeding, urine pregnancy test must be performed
before the implant may be inserted.
IUC
Any time in cycle
 within five days of onset of menses

beyond first five days and has had sexual
intercourse this cycle

beyond first five days and has not had sexual
intercourse this cycle
None, may
remove IUC at
time of insertion
Delay removal of
IUC until next
menses
Back-up for
seven days
Post-surgical
procedure for
elective or
spontaneous
abortion
Immediately up to five days post procedure
None
Post early
pregnancy loss
– no procedure
Immediately up to five days post passing
pregnancy, if known
None
If not known, see “no effective contraception”
above
Post-medication
abortion
OK to initiate prior to confirmation of termination
pregnancy
 Day of misoprostol up to seven days after
None
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SAMPLE PROTOCOL
CONTRACEPTIVE IMPLANTS
2011 Version
CURRENT
METHOD
INSERT IMPLANT

Post delivery
after 24 weeks
– nursing and
not nursing



mifepristone
Beyond seven days after mifepristone and
before resuming intercourse
Less than 21 days postpartum — anytime
More than 21 days postpartum, no
intercourse — anytime
More than 21 days postpartum, intercourse
has been resumed
BACKUP
Backup for seven
days.
None
Back-up for seven
days
See “no effective
contraception”
above
FYI — How can a provider be reasonably certain a woman is not pregnant — by her
history?
The provider can be reasonably certain that the woman is not pregnant if she has no
symptoms or signs of pregnancy and meets any of the following criteria:
 has not had intercourse since last normal menses
 has been correctly and consistently using a reliable method of contraception
 is within the first seven days after normal menses
 is within four weeks postpartum for non-lactating women
 is within the first seven days post-abortion or miscarriage
 is fully or nearly fully breastfeeding, amenorrhoeic, and less then six months
postpartum
(Selected Practice Recommendations for Contraceptive Use, 2002)
Insertion
1. The manufacturer’s instructions for insertion should be followed.
 If the implant cannot be palpated post insertion, client must be advised to use a
non hormonal method of contraception until placement is verified. See item V.
Guidelines for Management of Side Effects and Complications, Lost Implant,
below.
2. Systems and protocols should be in place for the management of vaso-vagal
fainting episodes.
3. A mechanism should be in place to maintain a record of the implant lot numbers
separate from the client chart.
4. Documentation
 A record of the procedure, including date of procedure, which arm it was
placed in, and the lot number of the implant inserted must be documented in
the medical record.
 The record must also document that the clinician and client confirmed
placement by palpating the implant after insertion.
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SAMPLE PROTOCOL
CONTRACEPTIVE IMPLANTS
2011 Version


A peel-off label is included in the package. It can be affixed to a sheet in the
client’s medical record to document the above elements of the insertion
procedure.
Complete the user card and give it to the client.
V. GUIDELINES FOR MANAGEMENT OF SIDE EFFECTS AND COMPLICATIONS
Irregular Bleeding
1. Counseling women about expected menstrual variations before insertion may
decrease the frequency of complaints.
2. Obtain/perform
 interval history, with focus on the possibility of pregnancy or genital tract
infection
 pelvic examination, as indicated, to exclude pregnancy, infection, or an
anatomic lesion
 laboratory tests
o highly sensitive pregnancy test, if indicated
o hematocrit or hemoglobin, if history suggests prolonged, frequent or heavy
bleeding. If hematocrit <30% or hemoglobin <10gm/dl, seek physician
consultation.
o gonorrhea and chlamydia tests, if a cervical or upper tract infection is
suspected.
3. If no obvious cause of bleeding is found, reassure the client that the bleeding
patterns are not dangerous and may resolve with time.
4. If frequent or prolonged bleeding becomes problematic
 Medications may be given that include, but are not necessarily limited to
o Ibuprofen 800 mg PO TID for five days
o ethinyl estradiol (Estinyl) 20–50 mcg, estradiol (Estrace)1-2 mg or
conjugated equine estrogen (Premarin) 0.625–2.5 mg once daily for 21
days
o combined oral contraceptives for one cycle
 Counsel the client that while this regimen may temporarily improve her
bleeding pattern, there is a substantial possibility that the irregular pattern will
return after discontinuation of treatment.
 Removal may be required if women do not respond to treatment and continue
to find the bleeding bothersome.
FYI — Expected Bleeding Patterns
The majority of Implanon users will experience an alteration of bleeding patterns during
the first year of use. Infrequent bleeding, defined as less than three bleeding episodes
in 90 days, is the most common variation, occurring in 50 percent of women in the first
three months of Implanon use, declining to 30 percent after six months. Prolonged
bleeding is defined as at least one episode in 90 days that lasts at least 14 days.
Prolonged bleeding is also more common in the first three months (approximately 20
percent) declining to about 10 percent with time. Frequent bleeding, defined as >5
bleeding episodes in 90 days, occurs less than 10 percent of the time. Less than one
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SAMPLE PROTOCOL
CONTRACEPTIVE IMPLANTS
2011 Version
percent of clients had low hemoglobin levels. Bleeding patterns will vary with time and
will not necessarily show a trend or remain consistent throughout the duration of use of
Implanon.
Amenorrhea/Possible Pregnancy
1. Obtain/perform
 interim history update, focusing on pregnancy signs and symptoms
 pelvic examination, as indicated, to evaluate uterine softening or enlargement,
adnexal tenderness or mass
 highly sensitive urine pregnancy test
o If positive, evaluate for symptoms and signs of ectopic pregnancy; begin
workup or refer immediately if suspected. Strongly consider removal of
the implant if method failure is suspected. Not necessary to remove the
implant if a luteal phase pregnancy is suspected. Must remove if client
intends to continue the pregnancy.
o If negative, counsel and reassure the client that amenorrhea while using
the implant is an expected side effect and not dangerous.
2. If client becomes pregnant while using the implant she should be cautioned about
the possibility of ectopic pregnancy. Studies have reported a higher ectopic
pregnancy risk in progestin-only contraceptive failures compared to pregnancy in
women using no contraception
FYI — About Amenorrhea and Pregnancy
About 20% of the time, while using Implanon, the patient can expect to experience
amenorrhea. The absolute risk of pregnancy while using Implanon is low. (Rate of 0.00–
0.09 per 100 woman-years compared to 43.07 per 100 woman-years for a noncontraceptor.) No ectopic pregnancies were reported in the clinical trials.
Thrombotic Stroke or Ischemic Heart Disease
Must weigh the risks and benefits of continuing implant if woman develops ischemic
heart disease or thrombotic stroke while using the method. (USMEC, 3)
Headache
1. Obtain a headache history to determine if headache is migraine with aura.
2. Must weigh the risks and benefits of continuing implant if a client develops
migraine aura, with or without headache, after implant insertion. (USMEC, 3)
3. If migraine with aura is ruled out, explain that implant removal is unlikely to
change the headache pattern.
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SAMPLE PROTOCOL
CONTRACEPTIVE IMPLANTS
2011 Version
FYI — What is Migraine Aura?
Aura — Most auras (99%) are visual. Sensory symptoms may also occur (31%) — but
rarely in the absence of visual symptoms.
Aura consists of at least one of the following, without motor weakness
 Visual symptoms including positive features (e.g., flickering lights, spots or lines)
and/or negative features (i.e., loss of vision)
o Most visual auras start as flickering uncolored zig-zag lines in the center of the
visual field, gradually progressing laterally to the periphery of one hemifield, or a
laterally spreading scintillating scotoma (area of lost or depressed vision within
the visual field, surrounded by an area of normal or less depressed vision)
o Scotoma typically perceived as a bright spot, gradually increasing in size to the
shape of the letter “C,” developing scintillating zig-zag edges.
 Sensory symptoms including positive features (i.e., pins and needles) and/or
negative features (i.e., numbness). They rarely occur in the absence of visual
symptoms or in the leg.
 Dysphasic speech disturbances (MacGregor & Mishell, 2005)
Onset of visual aura typically occurs over several minutes. From onset to full
enlargement of the zig-zag lines is usually about 10-20 minutes. Duration of aura is less
than one hour — typically 20-30 minutes. It is fully reversible. If a headache occurs
(99% are followed by headache), it begins after the aura has resolved. There may be a
gap between aura and headache of one hour or less.
Premonitory phase symptoms that occur one or two days before a migraine attack are
not aura. Neither are generalized visual spots or flashing occurring during the
premonitory phase or during the headache itself. In addition, blurry vision is not
diagnostic of migraine with aura. (MacGregor & Mishell, 2005)
Diagnosing Aura — three key questions to ask clients to determine if they have aura:
Do you ever have visual disturbances that
 start before the headache?
 last up to one hour?
 resolve before the headache begins?
Ask the woman for a description of her visual disturbance if any of the above questions
are answered positively. Watch her hands as she describes her symptoms. If her hand
moves up in a wavy circular area beside her head, aura is more likely than if she leaves
her hand down. Ask the woman to draw her visual symptom — women with aura
commonly draw a jagged crescent or indicate a scintillating letter “C” with a dark spot
within it. (MacGregor & Mishell, 2005)
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SAMPLE PROTOCOL
CONTRACEPTIVE IMPLANTS
2011 Version
Distinguishing Migraine with Aura from Headache with Focal Neurological
Symptoms or Headache with Symptoms Suggesting Cerebral Ischemia
Features of Migraine with Aura
 slow onset of aura, taking several
minutes to spread to maximum
distribution
 visual symptoms
o usually symmetrical
o typical — scintillating scotoma that
spreads gradually
o not typical — transient monocular
blindness
 sensory symptoms
o positive — “pins and needles”
o rarely effects legs
o past history of similar attacks
common
Features of Cerebral Ischemia
 rapid spread of motor/sensory
symptoms, taking only seconds to
spread
 visual symptoms
o visual loss is monocular
o not typical — scintillating or
spreading features
o typical — transient monocular
blindness
 sensory symptoms
o sensation of numbness
o sudden, new onset
Use the web link below to view the “Burnhill Lecture” presentation given by Dr. Anne
MacGregor at the ARHP/NMC meeting in September 2004:
http://www.arhp.org/files/RH04_MacGregor.ppt. Accessed January 4, 2006.
(Gervil M, 1998), (MacGregor, 2001)), and (Russell & Olsen, 1996)
FYI — Headaches
Headache is a relatively common complaint among implant users, although it is unclear
whether implant significantly increases the frequency of headaches. Headache is an
infrequent cause for removal.
Weight Gain
1. Counsel regarding control of weight gain with adequate exercise and moderate
dietary restriction. Many women notice weight stabilization or improvement with
time.
2. If these measures fail and weight gain becomes problematic, implant removal may
become necessary. However, only 2.3 percent of women in clinical trials
discontinued Implanon because of weight gain.
FYI — Weight Gain
In clinical trials 6.4 percent of Implanon users report weight gain. In another trial, the
weight gain with Implanon over two years was essentially the same as with non-medicated
IUDs, suggesting that there is a normal weight increase over time unrelated to
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SAMPLE PROTOCOL
CONTRACEPTIVE IMPLANTS
2011 Version
contraceptive method.
Infection or Bleeding at Insertion Site — Rare, seen in fewer than one percent of
clients.
1. Evaluate for acute infection, hematoma, or localized superficial thrombophlebitis.
2. Obtain temperature; inspect insertion site, proximal and distal arm, and axillary
lymph nodes.
3. If bleeding, manage with application of steri-strip and pressure dressing to the
insertion site.
4. If infection,
 Obtain culture from insertion site.
 Clean site with a skin antiseptic, e.g., Betadine or Hibiclens.
 Provide prescription for dicloxacillin or cephalexin 500 mg PO QID for seven
days.
 Suggest the use of moist, warm compresses or a heating pad at home.
 Ask the client to return in 3-4 days to evaluate her progress.
 If the infection does not appear to be responding, removal of the implant by an
experienced clinician may be necessary.
Expulsion — Rare, related to infection or placement of the implant too close to the
insertion site.
1. If partial expulsion, gently remove implant with a hemostat. Do not reuse. Clean
incision with antiseptic and close with a steri-strip. If bleeding, apply pressure
dressing.
2. Advise client to use another method of contraception until a replacement implant
has been inserted. Offer EC if appropriate.
3. A replacement implant can be inserted in a different site.
Lost Implant — Unable to palpate
1. Carefully palpate.
2. If not palpable, refer for high-frequency linear array ultrasound (see FYI —
Visualizing Implanon, below)
3. If not visible on ultrasound, refer for MRI.
4. If not visible on MRI, contact the manufacturer for the procedure for measuring
ENG blood levels.
5. Until the presence of implant is confirmed, client must use another contraceptive
method.
FYI — Visualizing Implanon
Implanon is not easily visualized with plain film x-ray. It must be identified by utilizing
ultrasound with a high frequency (>10 mhz) linear array transducer to detect the posterior
acoustic shadow cast by the implant (Shulman and Gabriel, 2006). The equipment used
for thyroid or breast ultrasound can be used for localization. Magnetic Resonance Imaging
(MRI) may also be useful.
Cancer — If a woman develops a hormone sensitive cancer (such as breast cancer)
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2011 Version
while on the implant, consultation with her cancer specialist must be obtained to
continue the method.
VI. Follow-up
Implant-Related Visits — At each implant-related medical visit
1. Client should be queried about changes in personal history, possible side effects,
and her menstrual cycle/bleeding pattern.
2. Physical exam and laboratory testing should be performed, as indicated.
3. Presence of implant should be documented in the client’s record.
Return Visits — The implant-user should be advised to return for
1. Evaluation if a significant implant-related problem is suspected and if any of the
following occur
 unable to palpate rod
 very heavy vaginal bleeding or bleeding that lasts longer than 14 days
 delayed menses after a long interval of regular cycles
 concern about a possible pregnancy
 arm pain; pus, redness, or bleeding at the insertion site
 onset or worsening of episodes of migraine, aura, or severe headache
 client decides she wants the implant removed
2. follow-up and surveillance of special conditions as per protocol and instructions
3. periodic well-woman visits, regularly scheduled Pap tests, and indicated STI
screening
VII. Removal of Implant
Personnel —
Only clinicians (APN, PA, physician) who have undergone a training course approved
by the manufacturer and who have demonstrated skill in successful insertion and
removal shall remove implants.
Informed Consent —
A consent form for removal of implants must be signed each time an implant is
removed.
Duration of Use —
1. Clients should be counseled to return at or near the end of the third year of use to
discuss removal.
2. The implants should be removed by the end of the third year of use. Unless
pregnancy is desired, an alternative method of contraception should be offered.
3. Another implant may be inserted immediately after removal through the same
incision and in a track parallel to the one removed.
Procedure —
The manufacturer’s instructions for removal should be followed.
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Documentation —
Documentation of the removal procedure should include length of time to remove if
any problems or complications are encountered.
ALGORITHM A — QUICK START FOR CONTRACEPTIVE IMPLANTS
1st day LMP ≤ 5
days ago
Insert
Implant
today.
No Backup.
1st day LMP > 5
days ago
Yes
Urine
pregnancy test
Negative**
Possibility of
pregnancy?
No
Insert
implant
today.
Backup x7d.
Advise that negative urine pregnancy test not
conclusive but hormones not harmful to fetus.
Document client’s understanding of risk.
Unprotected sex since LMP?
≤ 5 days
ago
> 5 days
ago
None
Insert
Implant
today.
Backup x7d.
ECP today?
Yes
No*
Insert
Implant
today.
Backup x7d.
Insert
Implant
within 24
hours.
Backup x7d.
Advise client to
repeat urine
pregnancy test
in 2 weeks.
*ECP should be provided, if possible.
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**If urine pregnancy test is positive, refer as appropriate.
(RHEDI, 2005)
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