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Everything You Need to Know About the Contraceptive Implant FDA Approval Means US Women Now Have a Progestin-Only Implant Among Their Birth Control Options

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Everything You Need to Know About the Contraceptive Implant FDA Approval Means US Women Now Have a Progestin-Only Implant Among Their Birth Control Options OBGM_0906_Darney.final 8/18/06 11:36 AM Page 50 OBGMANAGEMENT Everything you need to know about the contraceptive implant FDA approval means US women now have a progestin-only implant among their birth control options n July 17, the US Food and Drug or even monthly action on the part of the Administration (FDA) approved user, it is well-suited for: Philip D. Darney, MD, MSc what may be the most effective • Women who wish to or need Professor and Chief, Department O of Obstetrics, Gynecology, and hormonal contraceptive ever developed, a to avoid estrogen Reproductive Sciences, University single-rod implant that goes by the trade • Teens who find adherence to a of California-San Francisco, name Implanon. The implant contains 68 contraceptive regimen difficult San Francisco General Hospital ® Dowden Health Media mg of etonogestrel (ENG), the active • Healthy adult women who desire metabolite of desogestrel, in a membrane long-term protection ofCopyright ethylene vinylFor acetate. personal In clinical usetrials only• Women who are breastfeeding involving 20,648 cycles of exposure, only 6 pregnancies occurred, for a cumulative 1 Pearl Index of 0.38 per 100 woman-years. ❚ IN THIS ARTICLE This article reviews: Pros and cons • the 2 contraceptive mechanisms Advantages include: ❙ How the • indications and patient selection • Cost. A study2 of 15 contraceptive progestin-only • pharmacology, safety, adverse effects methods found the implant cost-effec- implant prevents • patient satisfaction and discontinua- tive compared to short-acting methods, tion rates provided it was used long-term. As of fertilization • insertion and removal press time, the manufacturer had not Page 52 • key points of patient counseling released the price. Unlike Norplant, a multi-rod implant • Short fertility-recovery time. ❙ Take a lesson from which garnered a million American users • No serious cardiovascular effects.3 the Australians before it was removed from the market, Drawbacks. Progestin-only contraceptives Page 63 the single-rod implant is easy to insert and also have disadvantages: remove. Before you can order the implant, • Implants require a minor surgical pro- you must complete a manufacturer-spon- cedure by trained clinicians for inser- sored training program. tion and removal. • Cost-effectiveness depends on duration of use; early discontinuation negates 2 ❚ Which patients this benefit. • The implant does not protect against are suitable candidates? sexually transmitted infections—this is Because the subdermal implant contains a disadvantage of all contraceptive only progestin, provides up to 3 years of methods except condoms and, per- protection, and requires no daily, weekly, haps, other barrier methods. 50 OBG MANAGEMENT • September 2006 For mass reproduction, content licensing and permissions contact Dowden Health Media. OBGM_0906_Darney.final 8/18/06 11:36 AM Page 51 Everything you need to know about the contraceptive implant ▲ A forgettable contraceptive—that’s its allure After Implanon is inserted just below the dermis 6 to 8 cm above the elbow crease on the inner aspect of the arm, it remains effective for up to 3 years. To remove it, make a 2-mm incision at the distal tip of the implant and push on the other end of the rod until it pops out. Insertion Implanon implant 40 mm Dermis Fat Removal Muscle The implant resides beneath the dermis but above the subcutaneous fat. It remains palpable but invisible, releasing about 60 µg of etonogestrel per day IMAGES: RICH LAROCCO ❚ The Norplant experience ing intrauterine system (Mirena), and FAST TRACK Research and development of progestin- injectable methods (Depo-Provera) are Average insertion only subdermal implants began more than safer than oral contraceptives (OCs) 35 years ago, but early research involving because they lack estrogen, which can pro- time: 1 minute very-low-dose implants found that they voke deep venous thrombosis.6,7 did not prevent ectopic pregnancies. This LNG, the gonane progestin used in Average removal problem ended with Norplant, a 6-capsule Norplant, binds with high affinity to the time: 3 minutes implant using the potent progestin lev- progesterone, androgen, mineralocorti- onorgestrel (LNG). coid, and glucocorticoid receptors, but not Norplant was highly effective. Over 7 to estrogen receptors. ENG, also known as years of use, fewer than 1% of women 3-keto-desogestrel, demonstrates no estro- became pregnant.4 Despite low pregnancy genic, anti-inflammatory, or mineralocorti- rates and few serious side effects, limita- coid activity, but has shown weak andro- tions in component supplies and negative genic and anabolic activity, as well as media coverage on complications with strong antiestrogenic activity. removal led to its withdrawal in 2002, Unlike LNG, which binds mainly to leaving no implant available in the US.5 sex hormone-binding globulin, ENG binds mainly to albumin, which is not affected by varying endogenous or exogenous estradiol levels. The safety of ENG has been demon- ❚ The antiestrogenic effect strated in studies of combined estrogen- Long-acting, progestin-only contraceptives progestin OCs and progestin-only OCs such as the new implant, the LNG-releas- that use desogestrel as a component. CONTINUED www.obgmanagement.com September 2006 • OBG MANAGEMENT 51 OBGM_0906_Darney.finalREV2 8/22/06 10:09 AM Page 52 ▲ Everything you need to know about the contraceptive implant How the progestin-only implant prevents fertilization The progestin-only implant has 2 primary to support the production, growth, and mechanisms: maturation of ovarian follicles.11 • Inhibition of ovulation • Restriction of sperm penetration of Oocytes are not fertilized, even if follicles cervical mucus28 grow during use of the progestin implant. If the follicle ruptures, abnormalities of the ovu- Ovulation is suppressed. LNG implants latory process prevent release of a viable egg. disrupt follicular growth and inhibit ovulation by exerting negative feedback on the hypo- Sperm cannot penetrate the cervical thalamic–pituitary axis, causing a variety of mucus. The antiestrogenic action of the changes, from anovulation to insufficient luteal progestin renders the cervical mucus vis- function. A few women using LNG implants cous, scanty, and impenetrable by sperm.12 have quiescent ovaries, but most begin to ovulate as LNG blood concentrations gradual- Contraceptive effects occur ly fall.29 The ENG implant suppresses ovula- before fertilization tion by altering the hypothalamic–pituitary No signs of embryonic development have –ovarian axis and down-regulating the been found among implant users, indicating luteinizing hormone surge, which is required the implant lacks abortifacient properties. Desogestrel in combination with ❚ Pharmacology of Implanon ethinyl estradiol may slightly increase the Implanon is a single nonbiodegradable attributable risk of deep venous thrombo- rod of 40% ethylene vinyl acetate and sis, but this response has not been shown 60% ENG (40 mm x 2 mm) covered with without estrogen. a membrane of rate-controlling ethylene FAST TRACK vinyl acetate 0.06 mm thick. The progestin-only Bioavailability implant suppresses ❚ Design features The 68 mg of ENG contained in the rod are ovulation and The single-rod design means little discom- initially absorbed by the body at a rate of 60 renders the fort for patients at insertion or removal, an µg per day, slowly declining to 30 µg per day cervical mucus unobtrusive implant, and almost no scar- after 2 years. ring. Insertion and removal are predictably Peak serum concentrations (266 impenetrable brief. In US and European trials, which pg/mL) of ENG are achieved within 1 day by sperm began 10 years ago, average insertion time after insertion, effectively suppressing ovu- was 1 minute, and removal time was 3 min- lation (which requires 90 pg/mL ENG or utes. In contrast, Norplant required up to more).11,12 10 minutes to insert and 1 hour to remove.8 The steady release of ENG into the Because only 1 rod is implanted, there circulation avoids first-pass effects on the is no risk of dislocating previously placed liver. capsules.9 Nor is it necessary, as it was with The bioavailability of ENG remains Norplant, to create channels under the nearly 100% throughout 2 years of use. skin, which made implants difficult to pal- The elimination half-life of ENG is 25 pate after insertion. hours, compared with 42 hours for Finally, ethylene vinyl acetate, the plas- Norplant’s LNG. tic from which Implanon is made, is less likely than Norplant’s Silastic to form a Rapid return to ovulation fibrous sheath that can prolong removal.10 After removal, serum ENG concentra- 52 OBG MANAGEMENT • September 2006 OBGM_0906_Darney.final 8/18/06 11:36 AM Page 55 Everything you need to know about the contraceptive implant ▲ tions become undetectable within 1 week, ic effects of the ENG implant are unlikely to and ovulation resumes in 94% of women be clinically significant, including its effects within 3 to 6 weeks after the implant is on lipid and carbohydrate metabolism, liver removed.11,12 function, hemostasis, blood pressure, and thyroid and adrenal function.14–17 ❚ Efficacy and safety Adverse event rates Overall, implants, including the ENG Liver enzyme-inducing drugs implant, appear to be safe. The rate of lower ENG levels adverse events is comparable to rates in Like other contraceptive steroids, serum nonusers18 (death, neoplastic disease, car- levels of ENG are reduced in women taking diovascular events, anemia, hypertension, liver enzyme-inducing drugs
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