Correspondence
Norplant
N Engl J Med 1995; 332:821-822March 23, 1995
- Article
To the Editor:
The study by Polaneczky et al. (Nov. 3 issue)1 demonstrates clearly that the choice of the levonorgestrel implant (Norplant) by adolescent mothers for contraception is associated with higher rates of continued use and lower rates of pregnancy than the choice of oral contraceptives.1,2 This is because Norplant does not require the cooperation of the partner or the compliance of the adolescent mother.
Recent controversy, particularly about the difficult removal of these implants, threatens the viability of this safe and highly effective technique. We agree with Drs. Hatcher and Trussell2 that there is a compelling need for improved techniques of removal if the implant is to remain a viable contraceptive option.
We would like to add that there are several emerging techniques for removing Norplant,3,4 in addition to the Emory method mentioned by Hatcher and Trussell.2 A new technique, called “hook and deliver,”5 involves making one or two vertical incisions parallel to the capsules and leaving a 21-gauge needle in place under the capsules for stabilization. This technique was developed specifically for use in removing deeply placed or misplaced capsules.
Health care providers should have a working knowledge of all methods of implant removal to be able to choose the most effective and the least traumatic one for their patients.
5 ReferencesAlfred A. Shihata, M.D.
Ronald G. Salzetti, M.D.
Scripps Institutions of Medicine and Science, Del Mar, CA 920141
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;331:1201-1206
Full Text | Web of Science | Medline2
Hatcher RA ,Trussell J . Contraceptive implants and teenage pregnancy. N Engl J Med 1994;331:1229-1230
Full Text | Web of Science | Medline3
Darney PD ,Klaisle CM ,Tanner S ,Alvarado AM . Sustained-release contraceptives. Curr Probl Obstet Gynecol Fertil 1990;13:87-1254
Praptohardjo U ,Wibowo S . The “U“ technique: a new method for Norplant implants removal. Contraception 1993;48:526-536
CrossRef | Web of Science | Medline5
Shihata AA ,Salzetti RG ,Schnepper FW ,Deutsch J . Innovative technique for Norplant implants removal. Contraception 1995;51:83-85
CrossRef | Web of Science | Medline
To the Editor:
Not surprisingly, the article by Polaneczky et al.1 and the editorial by Hatcher and Trussell indicate a lower rate of discontinuation for Norplant as compared with oral contraceptives. Although it is reassuring to know that there were comparable rates of sexually transmitted diseases in the two groups (since Norplant users may stop using condoms) and that follow-up was better and satisfaction greater in the Norplant group, the mean follow-up for both groups was only 15 months. This is fine for the group using oral contraceptives, but a woefully short time for investigators to draw conclusions about the safety of Norplant users with an expected five-year course. Fifty-five percent of the users studied by Polaneczky et al. reported irregular bleeding,1 and in another study implant removal was associated with substantial pain (24 percent) or with repeated visits, lengthy (>1 hour) procedures, or both (19 percent).2
Most studies of Norplant have had short follow-up periods, as in the above study.2 Longer studies showed higher rates of discontinuation for medical reasons.3 Lipid disturbances have also been reported.4 In one study, only 58.6 percent of subjects continued using the implant after five years; hypertension necessitating the removal of Norplant developed in three, and only one third of the original group opted for reinsertion.5 Furthermore, the long-term teratogenic effects on fetuses born while the mother used Norplant have not been thoroughly explored.
5 ReferencesRobert Ira Lewy, M.D
Baylor College of Medicine, Houston, TX 770301
Polaneczky MP ,Slap G ,Forke C ,Rappaport A ,Sondheimer S . The use of levonorgestrel implants (Norplant) for contraception in adolescent mothers. N Engl J Med 1994;331:1201-1206
Full Text | Web of Science | Medline2
Basnayake S ,Thapa S ,Balogh SA . Evaluation of safety, efficacy, and acceptability of Norplant implants in Sri Lanka. Stud Fam Plann 1988;19:39-47
CrossRef | Web of Science | Medline3
Diaz S ,Pavez M ,Miranda P ,Johansson ED ,Croxatto HB . Long-term follow-up of women treated with Norplant implants. Contraception 1987;35:551-567
CrossRef | Web of Science | Medline4
Affandi B ,Suherman SK ,Djajalelana JP ,Prihartono DJ ,Lubis F ,Samil RS . Serum lipids in Norplant implants users: a cross-sectional study. Contraception 1987;36:429-434
CrossRef | Web of Science | Medline5
Salah M ,Ahmed AG ,Abo-Eloyoun M ,Shaaban MM . Five-year experience with Norplant implants in Assiut, Egypt. Contraception 1987;35:543-550
CrossRef | Web of Science | Medline
Author/Editor Response
The authors reply:
To the Editor: Our study was designed to explore factors associated with the choice of Norplant by adolescent mothers and the effect of its use on their rates of additional pregnancy, sexual activity, use of condoms, and the frequency of clinic visits. We believe the study was long enough to address these issues. We did not intend to compare the safety of oral contraceptives with that of Norplant, and we drew no conclusions in this regard.
Nevertheless, we find it difficult to understand why Dr. Lewy would be comfortable with the duration of our study with respect to the safety of oral contraceptives, but not with respect to the safety of Norplant. Norplant is merely a delivery system for levonorgestrel, a drug that has been a component of oral contraceptives for over 25 years. Furthermore, the dose of levonorgestrel delivered by Norplant is 50 to 75 percent less than that delivered by oral contraceptives.1 We welcome the opportunity to address Dr. Lewy's concern, however, as well as those of others who may hold similar misconceptions.
Norplant's safety has been well established in clinical trials involving more than 55,000 women in 46 countries, including countries in Western Europe. Numerous studies have shown that there is no significant change in blood pressure during Norplant use and no unfavorable changes in carbohydrate metabolism, coagulation profiles, or liver function. The consensus is that neither Norplant nor low-dose oral contraceptives cause abnormal lipid levels or have any known clinical effect on the risk of cardiovascular disease. The absence of a teratogenic effect of oral contraceptives is widely accepted, and there has been no increase in congenital abnormalities among infants conceived while their mothers used Norplant.2,3
Although the irregular bleeding associated with Norplant is a nuisance, Norplant users have a lower annual loss of menstrual blood than nonusers, and hemoglobin levels actually increase during Norplant use.4 Irregular bleeding also occurs in up to 30 percent of oral-contraceptive users during the first month of use,3 and it is a major reason for discontinuing the pill.
The issues surrounding the removal of Norplant were addressed in the editorial accompanying our article. As with any procedure that involves a skin incision, we should always expect low but measurable rates of complications such as infection and scarring. Although there are no data to suggest that long removal times or additional visits for removal are associated with adverse long-term outcomes, new methods of removing implants, such as those mentioned by Drs. Shihata and Salzetti, may shorten the procedure. The two-rod implants currently undergoing clinical trials should facilitate both insertion and removal, while offering the contraceptive benefits of Norplant to women who desire shorter spacing between pregnancies.
4 ReferencesMargaret Polaneczky, M.D.
New York Hospital–Cornell Medical Center, New York, NY 10021Steven Sondheimer, M.D.
Gail B. Slap, M.D.
University of Pennsylvania Medical Center, Philadelphia, PA 191041
Speroff L, Darney P. A clinical guide for contraception. Baltimore: Williams & Wilkins, 1992:75.
2
Darney PD ,Klaisle CM ,Tanner S ,Alvarado AM . Sustained-release contraceptives. Curr Probl Obstet Gynecol Fertil 1990;13:87-1253
Oral contraception. In: Speroff L, Glass RH, Kase NG. Clinical gynecologic endocrinology and infertility. 5th ed. Baltimore: Williams & Wilkins, 1994:715-75.
4
Shoupe D ,Mishell DR . Norplant: subdermal implant system for long-term contraception. Am J Obstet Gynecol 1989;160:1286-1292
Web of Science | Medline
