Providers in swing with Implanon training
Your patient is a 29-year-old mother of three active young children. She has had limited success with using birth control pills and says that the daily dosing schedule is a challenge. She shakes her head "no" to the contraceptive patch and vaginal ring, and she doesn't want to limit her options with the choice of tubal sterilization.
What is your next step in contraceptive counseling?
U.S. providers are undergoing training to offer the single-rod contraceptive implant Implanon, marketed by Organon of Roseland, NJ, and Oss, the Netherlands. Approved by the Food and Drug Administration (FDA) in July 2006, Implanon releases a continuous low, steady dose of the progestin etonogestrel for up to three years. The average hormone release rate is 40 mcg per day. The device, which is about the size of a matchstick, is inserted subdermally just beneath the skin on the inner side of a woman's upper arm during an in-office procedure.
Faculty training began as soon as the FDA approval was in hand, reports Frances DeSena, company spokeswoman. Physicians in the faculty program are beginning the next wave of education by training physicians in off-site programs around the country, she notes. Providers who are interested in undergoing training can register by calling a toll-free number, (877) 467-5266, or visiting the product web site, www.implanon-usa.com. (Click on "Healthcare Provider," then enter your name, professional designation, specialty, and state license number.)
Company-sponsored training is key. Providers cannot write prescriptions for the implant until they undergo the instructional process and such training is properly documented, says Paul Fine, MD, a member of the physician faculty. Fine, an associate professor of gynecology at Baylor College of Medicine in Houston, also serves as medical director for Planned Parenthood of Houston and Southeast Texas. "I think Organon is doing this in a very structured and wise way to make sure that everybody who is trained inserts it the same way, with the same guidelines and the same technique," explains Fine. "They also are given the same information that matches the FDA patient brochure and the data on which the approval was based."
What is involved?
While U.S. providers are just beginning to work with the device, clinicians on the international front have had years of experience with the one-rod implant. Organon launched Implanon in 1998 following 12 years of research, with Indonesia as the first country to approve the device. Since that time, more than 40 European and Asian countries have approved its use.1
U.S. providers must undergo a three-hour instructional program, which includes a didactic slide presentation that covers data about the implant, as well as a training session using realistic model arms, says Fine. Faculty presenters supervise trainees in the correct insertion technique and demonstrate proper use of the insertion device. They also cover removal techniques and instructions on necessary documentation. "When done correctly, it is extremely safe, it is technically very easy, and I think it will be an excellent addition to a woman's choice for long-term effective contraception," states Fine.
While Implanon is approved in the United States for three years of use, research indicates its contraceptive effect may last at least four years.2,3 In clinical trials, no women became pregnant over the 5,000 woman-years of study.4,5 The implant can be removed at any time, after which fertility is rapidly restored to pre-implant status.
Implanon is particularly good for women with contraindications to or side effects from estrogen.6 However, as with all progestin-only methods, irregular bleeding is a common occurrence. To ensure patient satisfaction with the method, women need to be counseled to expect changes in their menstrual cycle. According to the patient information insert, one in 10 women in Implanon studies discontinued method use due to bleeding problems.7
Tell women to expect that their menstrual periods will be irregular and unpredictable throughout the time Implanon is in place, the patient packaging advises. Women may have more bleeding, less bleeding, or no bleeding. The time between periods may vary, and in between periods, spotting may occur.
"The biggest downside, and counseling is important, is that the bleeding pattern can be totally unpredictable, so that a woman almost needs to have a panty liner or tampon in her purse, because you can't predict it — but that is where counseling comes in," says Fine. "Many women are willing to trade that for a very effective method of contraception that they don't have to think about."
- Upadhyay UD, Adhikary I. New contraceptive choices. Popul Rep M 2005; 19:1-23.
- Affandi B, Korver T, Geurts TB, et al. A pilot efficacy study with a single-rod contraceptive implant (Implanon) in 200 Indonesian women treated for < or = 4 years. Contraception 1999; 59:167-174.
- Kiriwat O, Patanayindee A, Koetsawang S, et al. A 4-year pilot study on the efficacy and safety of Implanon, a single-rod hormonal contraceptive implant, in healthy women in Thailand. Europ J Contracept Reprod Health Care 1998; 3:85-91.
- Affandi B. Long-acting progestogens. Best practice and research. Clinic Obstet Gynaecol 2002; 16:169-179.
- Croxatto HB. Progestin implants. Steroids 2000; 65:681-685.
- Hatcher RA, Zieman M, Cwiak C, et al. Pocket Guide to Managing Contraception. Tiger, GA: Bridging the Gap Foundation; 2005.
- Organon USA. Implanon Patient Information. Roseland, NJ. July 2006.