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ORIGINAL RESEARCH |
From the Department of Obstetrics & Gynecology, New York University School of Medicine, New York, New York.
Address reprint requests to: Livia S. Wan, MD, Department of Obstetrics & Gynecology, New York University School of Medicine, 550 First Avenue, New York, NY 10016; E-mail: livia.wan{at}med.nyu.edu.
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ABSTRACT |
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METHODS: Voluntary participants, ages 18–40 years and desiring long-acting contraception, were enrolled in the study. The original design was to observe the participants for 5 years. Later, the follow-up period was extended to 6 years.
RESULTS: A total of 249 women underwent two-rod implant insertion and were observed for a total of 823 woman-years. There were two pregnancies observed during the study, yielding a pregnancy rate of 0.24 per 100 woman-years. One pregnancy occurred in the first month, and the other occurred after 6 years of use. The major side effect was menstrual irregularity. No serious side effects were observed during the study. Insertion of the device was easy and took less than 2 minutes; removal time averaged 4.5 minutes.
CONCLUSION: The levonorgestrel two-rod implant system is an effective, convenient, long-acting, and well-tolerated method of contraception.
Levonorgestrel subdermal implants (Norplant; Population Council, New York, NY) have been used by millions of women around the world for long-acting contraception. Since 1980, Norplant’s efficacy and convenience have been reported in many publications.1–3 Norplant was marketed in the United States in 1991, but its use was never popular because of the need for a minor surgical incision required for insertion and removal. Particularly when problems were reported with its removal, the use of Norplant in the United States dropped precipitously. In early 2001, Norplant (Wyeth-Ayerst, Philadelphia, PA) was recalled in the United States because of manufacturing problems, and it has not been available since.
Since 1990, the Family Planning Division of New York University Medical Center has participated in an international multicenter study of the subdermal implants with levonorgestrel in a new two-rod system. Studies were conducted to compare the new two-rod implant with the marketed Norplant and showed the new two-rod system to be as effective as Norplant but much easier to insert and, particularly, to remove.4–6 The two-rod implant is marketed in Europe as Jadelle (Schering, Berlin, Germany) and has recently been approved for 5 years of use by the Food and Drug Administration in the United States. Here we describe our experience with the new two-rod implant in the 10 years from 1990 to 2000.
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MATERIALS AND METHODS |
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General physical and pelvic examinations with Papanicolaou smear were performed at the initial visit. Participants were then scheduled to return within 7 days after next menstruation for the insertion of the two-rod implant. They were asked to record in a diary their bleeding pattern and any side effects. Follow-up visits were scheduled at 1, 3, and 6 months after insertion and every 6 months thereafter up to 5 years or whenever a problem arose. The participants could request removal at any time for any reason.
The protocol was amended later to extend the study to 6 years because data from the international study suggested that the implant efficacy lasted beyond the initial 5 years.
The two-rod implant system consists of two slender rods measuring 0.25 cm in diameter and 4.3 cm in length. This is similar in diameter to but about 1 cm longer than the Norplant capsule (Figure 1
). It contains 75 mg of levonorgestrel in each rod for a total of 150 mg. It releases levonorgestrel at 80 µg per day in the first month, gradually decreasing to 50 µg per day at the end of 9 months and leveling off to 25–30 µg per day thereafter. The mean serum concentration of levonorgestrel was 435 pg/mL at the end of the first month and gradually decreased to 279 pg/mL at the end of 5 years.7
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Removal of the implants was done through a small incision (3 to 4 mm) at the apex of the V shape under local anesthesia. The implants were removed by grasping the distal end of the rod. The incision was taped together with a 0.64-cm (0.25-in.) Steri-Strip (3M, St. Paul, MN).
All examinations and procedures were performed by one of three board-certified gynecologists (the authors) with training in Norplant insertion and removal.
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RESULTS |
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Of the participants, 76.3% were Hispanic, 10.4% white, and 11.2% black. The age range was 18–40 years, with the majority (87.5%) between 20 and 34. Of the participants, 13.7% were nulliparous (5.6% had never been pregnant), 31.7% primiparous, and 54.6% multiparous.
The 249 participants were observed for 823 woman-years, ranging from 0.1 to 9 years. Nearly 75% (186 of 249) of the participants had their implants removed within 5 years, whereas 23.3% (58 of 249) had the implants removed during the sixth and seventh years of use. Five participants did not return for removal until the eighth and ninth years of use.
There were two pregnancies observed in our study, one in the first month and the other after 6 years. The pregnancy rate (Pearl Index) is 0.24 per 100 woman-years. One participant was found to be pregnant before the insertion of the implant. In our analysis, her case was not considered a failure of the implant.
The major side effect was menstrual abnormality. Many women continued to use the implants despite mild to moderate side effects. There was no serious side effect observed during the study. Reasons for discontinuation included menstrual abnormality (10.0%), progestin-related side effects (10.8%), headache (8.8%), and other medical reasons (8.0%) (Table 1). Another common reason for early removal was desire for pregnancy (17.7%), despite the desire for long-term contraception at the time of joining the study.
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DISCUSSION |
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Of the participants, 17.7% (44 of 249) underwent early removal because of a desire for pregnancy. This does not come as a surprise, as 13.7% of the participants did not have any children and 31.7% had only one child.
Our mean removal time, 4.53 minutes (SE 0.22), was comparable to the international study, which reported a mean removal time of 4.84 minutes (SE 0.22) with a complication rate of the two-rod implant lower than that of Norplant (6.9% versus 14.8%, P = .009).6
The two-rod implant system is easier to insert and remove than Norplant and is as effective. Recently, the Food and Drug Administration has approved the two-rod implant for 5 years of use.
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Footnotes |
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doi:10.1016/S0029-7844(03)00482-4
Received January 8, 2003. Received in revised form March 7, 2003. Accepted March 13, 2003.
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REFERENCES |
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2. Gu S-J, Du M-K, Zhang L-D, Liu YL, Wang SH, Sivin I. A 5-year evaluation of Norplant contraceptive implants in China. Obstet Gynecol 1994;83:673–8.[Abstract]
3. Polaneczky M, Slap G, Forke C, Rappaport A, Sondheimer S. The use of levonorgestrel implants (Norplant) for contraception in adolescent mothers. N Engl J Med 1994;331: 1201–6.
4. Sivin I. International experience with Norplant and Nor-plant 2 contraceptives. Stud Fam Plann 1988;19:81–94.[Medline]
5. Sivin I, Alvarez F, Mishell DR, Darney P, Wan L, Brache V, et al. Contraception with two levonorgestrel rod implants. Contraception 1998;58:275–82.[Medline]
6. Sivin I, Campodonico I, Kiriwat O, Holma P, Diaz S, Wan L, et al. The performance of levonorgestrel rod and Nor-plant3 contraceptive implants: A 5 year randomized study. Hum Reprod 1998;13:3371–8.
7. Sivin I, Wan L, Ranta S, Alvarez F, Brache V, Mishell DR Jr, et al. Levonorgestrel concentration during 7 years of continuous use of Jadelle contraceptive implants. Contraception 2001;64:43–9.[Medline]
8. Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al, eds. Contraceptive technology. 17th rev ed. New York: Ardent Media Inc, 1998:800.
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