Effectiveness of training for implants confirmed

EXECUTIVE SUMMARY

An analysis of a clinical training program instituted at the 2006 introduction of the single-rod etonogestrel contraceptive implant Implanon shows that complications in the first five years have been low.

• Problems related to device insertion and removal led to the market withdrawal of Norplant, the first generation six-rod contraceptive implant system. With Implanon, the manufacturer instituted a unique mandatory clinical training program to ensure that only trained clinicians had access to the implant. A related active monitoring program was instituted to assess insertion, localization, and removal-related events.

• In received reports reflecting more than 25,000 single-rod implant insertions and removals, the overall complication rate for the implant was very low, and no complications resulted in hospitalization.

Data gathered from a clinical training program instituted at the 2006 introduction of the single-rod etonogestrel contraceptive implant Implanon (Merck & Co., Whitehouse Station, NJ) show that complications in the first five years of device use have been low, indicating the success of the program.1

Problems related to insertion and particularly removal led to Wyeth (now Pfizer) removing Norplant, the first generation six-rod contraceptive implant system, from the market, recalls Andrew Kaunitz, MD, professor and associate chair in the Obstetrics and Gynecology Department at the University of Florida College of Medicine — Jacksonville. When Implanon was introduced, Merck instituted a unique mandatory clinical training program to ensure that only trained clinicians had access to the implant. A related active monitoring program was instituted as part of the Food and Drug Administration’s (FDA) postapproval commitment to monitor the program’s effectiveness through tracking insertion, localization, and removal-related events.

Of 42,238 clinicians who completed the training from July 2006 to October 2011, 4,294 (10.2%) enrolled in the monitoring program. A total of 25,629 forms (20,466 insertions, 5,163 removals) were collected and subsequently submitted to the FDA. A total of 1,227 insertion, localization, and removal-related events were reported from 538 women.

Among insertion-related events, "difficult insertion was the most common (80%, 156/195). "Difficult removal was the most common removal-related event that was reported, and it represented 95% (316/334) of events in this category. Most of the difficult removals related to the need for incision enlargement, difficulty dissecting fibrous tissue surrounding the implant, or difficulty grasping the implant. The remaining 698 reports were categorized as localization-related or other.1

Clinically important events included noninsertion (n = 4, two pregnancies), serum ENG positive, but rod not found (n = 1), and possible associated nerve (n = 5) or vascular (n = 4) injury. No event-associated hospitalizations were reported. Seven (0.6%) reports described possible referral for surgical implant removal.1

"In reports received reflecting over 25,000 single-rod implant insertions and removals, the overall complication rate was very low, and no complications resulted in hospitalization, says Kaunitz, who presented findings along with colleagues at the recent annual clinical meeting of the American College of Obstetricians and Gynecologists. "These observations indicate that the mandatory clinical training necessary for clinicians to access the single rod contraceptive implant has been successful.

Check implant as option

The clinical training program has helped Implanon and its successor, Nexplanon, gain solid footing among providers. When Norplant entered the United States market in 1993, it enjoyed brisk initial sales; however, difficulties surrounding its insertion and removal eventually led to its withdrawal from the market.

Nexplanon, introduced in late 2011, is similar to the Implanon device; however, it features an easier-to-use inserter. Also, the implant is radiopaque, which allows it to be located by two-dimensional X-ray, computed tomography (CT), ultrasound scanning, or magnetic resonance imaging (MRI). The Nexplanon implant is approved by the FDA for up to three years of contraceptive use.

It is extremely effective: to date, no pregnancies have been observed in prospective or retrospective cohort studies of the contraceptive implant, which included more than 4,500 women and more than 7,000 women-years of exposure.2 (To read more about Nexplanon’s debut, see the Contraceptive Technology Update article, "New year, new implant: Time to add Nexplanon to contraceptive options, January 2012, p. 1.)

Due to its top-tier effectiveness, "set it and forget it ease of use, and reversible nature, the American College of Obstetricians and Gynecologists has issued a committee opinion advocating the use of the contraceptive implant and intrauterine contraception as safe, effective, and appropriate options for adolescents.3 (To check the guidance, see the CTU article, "Long-acting methods safe for teens — Include options in your counseling, December 2012, p. 133.)

Like all progestin-only methods, Nexplanon causes vaginal bleeding changes in a large proportion of women. These changes may include amenorrhea, infrequent bleeding, irregular bleeding, or less often, prolonged or frequent bleeding. The best approach to reducing the impact of this side effect is to forewarn women about it and counsel that it is generally not dangerous.3 From previous experience with the Norplant implant, research indicates that the quality of counseling before insertion can improve a patient’s satisfaction with her implant and reduce the likelihood she will discontinue it due to side effects.4

Investigators evaluated the use of implants and other reversible birth control methods in the Contraceptive CHOICE project in St. Louis. Seventeen percent of women enrolled in the study chose the contraceptive implant, compared to 46% opting for the levonorgestrel intrauterine device (IUD), and 12% selecting the Copper T 380A IUD. (To read more about the CHOICE project, see these Contraceptive Technology Update articles: "More women moving to LARC methods — Will your facility follow the trend? April 2013, p. 37, and "The Get It and Forget It’ methods are here: Remove obstacles to use, April 2012, p. 37.)

Bleeding with the implant is irregular and is impossible to predict, says Jeffrey Peipert, MD, MPH, MHA, Robert J. Perry professor of obstetrics and gynecology and vice chair for clinical research at Washington University School of Medicine in St. Louis. Peipert spoke on the importance of long-acting reversible contraception (LARC) methods at the 2013 Contraceptive Technology conferences in San Francisco and Washington, DC.5 The bottom line is that unpredictable bleeding is part of implant use, and patients must be willing to accept irregular bleeding, he stated.

REFERENCES

1. Kaunitz AM. The U.S. etonogestrel implant clinical training and active monitoring programs: 5-year experience. Presented at the 61st annual clinical meeting of the American College of Obstetricians and Gynecologists. New Orleans, May 2013.

2. Raymond EG. Contraceptive implants. In: Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive Technology: 20th revised edition. New York: Ardent Media; 2011.

3. American College of Obstetricians and Gynecologists. Committee Opinion No. 539. Adolescents and long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol 2012;120(4):983-988.

4. Chikamata DM, Miller S. Health services at the clinic level and implantable contraceptives for women. Contraception 2002; 65(1):97-106.

5. Peipert JF. The importance of long-acting reversible contraception. Presented at the Contraceptive Technology conferences. San Francisco, March 2013; Washington, DC, April 2013.