OBG_08.06_Update.final 7/21/06 11:07 AM Page 29 UPDATE NEW DEVELOPMENTS THAT ARE CHANGING PATIENT CARE Ram Parvataneni, MD, MPH and Philip Darney, MD, MSc CONTRACEPTION Department of Obstetrics, Gynecology, and Reproductive Sciences, San Francisco General Implanon approved … Why the FDA removed ParaGard’s Hospital, University of California, parity rule … Plan B does not promote high-risk behavior San Francisco hree new developments this year Half of pregnancies are unintended stand to make a difference in the high • The United States has one of the highest Trate of unintended pregnancies in the® Dowdenrates of unintended Health births among Media industri- United States. Increased use of highly effec- alized countries. tive, long-acting, user-independent methods • Of the 6 million pregnancies each year in is an effective way to lowerCopyright the rate of unin-For personalthe US, nearly use3 million only are unintended, tended pregnancies in couples using contra- resulting in 1.4 million unintended births ception. Two such methods are the contra- and 1.3 million abortions. ceptive implant and the intrauterine contra- • Half of these unintended pregnancies are ceptive. Emergency contraception is an due to failure or incorrect or inconsistent IN THIS ARTICLE effective way to reduce the risk of unintend- use of a contraceptive method.1 ed pregnancy after failure of a contraceptive ❙ How to insert and method or unprotected or forced sex. A ran- REFERENCES remove Implanon domized trial showed that direct access to 1. Contraception Counts: Ranking State Efforts. New York: Page 32 EC does not increase high-risk behavior. Guttmacher Institute; February 2006. Implanon essentials: How it works and what to tell patients ❙ Talking with patients about emergency ❙ The single-rod implant (Implanon) is Implanon is independent of user compli- a new, highly effective, long-acting, ance and is rapidly effective and reversible. contraception rapidly reversible contraceptive, It is in use worldwide in more than 30 coun- Page 38 approved by the FDA, July 17,2006. tries since 1998. The new device is a nonbiodegradable new single-rod implant that provides 40 x 2.0 mm rod of 40% ethylene vinyl A highly effective contraception for up to acetate (EVA) and 60% etonogestrel 3 years is expected to be widely available in (ENG) covered with a rate-controlling EVA the United States in 2007. Once inserted, membrane. www.obgmanagement.com August 2006 • OBG MANAGEMENT 29 For mass reproduction, content licensing and permissions contact Dowden Health Media. OBG_08.06_Update.final 7/21/06 11:07 AM Page 30 UPDATE CONTRACEPTION CONTINUED The rod contains 68 mg of ENG, ini- years. The most common reason was tially absorbed by the body at a rate of 60 bleeding pattern changes (13%).5 The µg/day, slowly declining to 30 µg/day after rate of discontinuation was highest 3 years of use.2 Steady release of ENG into during the first 8 months. the circulation avoids first-pass effects on What to tell patients. To improve continua- the liver. tion, counseling should strongly stress the expected change in bleeding patterns. Manufacturer-sponsored training: Call 1-877-IMPLANON Before clinicians can order the implant, they must undergo training sponsored by ❚ Clinical trials the manufacturer, Organon. To take part Outstanding efficacy. In an international in the training, which is set to begin in multicenter trial, there were no intrauter- August, call 1-877-IMPLANON. ine or ectopic pregnancies in a total of 1,200 woman-years (15,000 cycles of How the implant works exposure, 2,000 of which were in the third Ovarian and cervical mechanisms, which year of use).4 The Pearl index was 0 (95% function prior to fertilization, provide high CI 0.0–0.2).4 In the US series, after a total contraceptive efficacy. exposure of 474 woman-years (6,186 Ovulation is suppressed. The ENG cycles), no intrauterine or ectopic pregnan- implant, unlike previous levonorgestrel- cies were observed.5 It should be noted that containing implants, works primarily by phase III data from Indonesia were retract- suppressing ovulation.3 ENG alters the ed by the manufacturer in 2004.6 The 2 tri- hypothalamic–pituitary–ovarian axis and als noted above included a total of 965 down-regulates the luteinizing hormone women and were not included in this surge, which is required to support the retraction. production, growth, and maturation of Reasons for failures. Pregnancies were ovarian follicles. noted from postmarketing data in FAST TRACK Ovulation returns rapidly after Australia; most of these pregnancies Before inserting removal of the implant.3 resulted from either incorrect timing at Cervical mechanisms also prevent fertiliza- the initial insertion or failure to insert the Implanon, counsel tion. Anti-estrogenic actions of ENG make implant. Based on the Australian phase the patient— the cervical mucus viscous, scanty, and IV data, with 204,486 devices inserted, strongly emphasize impenetrable by sperm. the failure of the method itself was esti- 7 that she should Cost-effectiveness depends on long-term mated to be 1 per 1,000 insertions. use; early removal negates this benefit. At Implanon may be less effective in obese expect bleeding press time, the manufacturer had not women or, as the Australian experience patterns to change released the price of Implanon. showed, with concomitant use of drugs Lack of protection against sexually trans- that stimulate the liver’s cytochrome mitted infections is a disadvantage of the metabolism of steroids, such as some ENG implant, as well as all nonbarrier antibiotics (eg, rifampin) or anticonvul- contraceptive methods. sants (eg, phenytoin). Discontinuation rates have varied by region, but are usually due to bleeding pattern Side effects changes. Infrequent bleeding. The main side effect is a • In an international multicenter trial, change in bleeding patterns. In the US series, 31% discontinued by 2 years and only amenorrhea occurred in 14% to 20% of 6% discontinued in the third year.4 women. In the same series, women experi- Again, the most common reason was enced infrequent bleeding (<3 episodes in 90 irregular bleeding. days) in 30% to 40% of the 90-day refer- • In a US series, 49% discontinued by 2 ence periods, making it the most common 30 OBG MANAGEMENT • August 2006 OBG_08.06_Update.final 7/21/06 11:07 AM Page 32 UPDATE CONTRACEPTION CONTINUED How to insert and remove Implanon Although the ENG implant is designed to facilitate rapid and simple insertion and removal, clinicians must first be trained. The manufacturer, Organon, announced last month that it would begin training doctors in August. Insertion Average time: 1 minute4 Removal Average time: 4 minutes4 Location of Applicator implant The single-rod implant is preloaded in a disposable applicator. Insertion is done in the office using local anesthesia. Place the 1.5-inch long implant on the inner aspect of the nondominant arm. Position the applicator needle subdermally and withdraw the cannula, leaving the implant rod in place. After insertion, the implant may not be visible but should be palpable. Timing the insertion • Between days 1 and 5 of menses, in women who either have not been using a contraceptive Removal requires a 2- to 3-mm incision at the distal tip of the implant. Push the other end of the rod until it pops out. method or have been using a nonhormonal method • During a hormone-free week, in women changing from a combination or progestin-only oral Timing the removal contraceptive, or from intrauterine contraception The ENG implant can be removed at any time, • The day on which the next injection is scheduled, but must be removed after 3 years. in women changing from injectable contraception Return to ovulation is rapid following removal, No backup contraceptive is necessary if timing of so women still desiring contraception should begin insertion occurs as detailed. another method immediately or have a new rod LAROCCO RICH In all cases, exclude pregnancy before insertion. inserted through the removal incision. IMAGES: CONTINUED 32 OBG MANAGEMENT • August 2006 OBG_08.06_Update.finalREV 7/25/06 10:31 AM Page 35 UPDATE CONTRACEPTION CONTINUED pattern experienced. Prolonged bleeding Contraindications (>14 days of bleeding in one episode) varied The ENG implant should not be placed in from 14% to 36%, and frequent bleeding women with undiagnosed abnormal geni- (>5 episodes in 90 days) varied from 7% to tal bleeding, known or suspected pregnan- 14%.5 Anemia was not observed in the US cy, or hypersensitivity to any of the compo- series despite the irregular bleeding; in fact, nents in the ENG implant. hemoglobins rise. Unpredictable bleeding pattern. Unlike with REFERENCES Norplant, there was no trend over time 2. Wenzl R, van Beek A, Schnabel P, Huber J. Pharmacokinetics of etonogestrel released from the contraceptive implant toward a particular bleeding pattern. Implanon. Contraception. 1998;58:283–288. Implanon patterns are irregular and unpre- 3. Makarainen L, van Beek A, Tuomivaara L, Asplund B, dictable and vary from one 90-day reference Coelingh Bennink H. Ovarian function during the use of a single contraceptive implant: Implanon compared with period to the next. Similar results were noted Norplant. Fertil Steril. 1998;69:714–721. 4 in the multicenter international trial. 4. Croxatto HB, Urbancsek J, Massai R, Coelingh Bennink H, Possible therapies include estrogen sup- van Beek A. A multicentre efficacy and safety study of the single contraceptive implant Implanon. Implanon Study plementation, nonsteroidal anti-inflamma- Group. Hum Reprod. 1999;14:976–981. tory drugs, oral contraceptive pills, and 5. Funk S, Miller MM, Mishell DR Jr,et al. Safety and efficacy of observation. Implanon, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005;71:319–326. Other side effects. In the US series, the most 6. Rekers H, Affandi B.