Summary
When they were introduced to the world market in the 1980s, levonorgestrel subdermal implants offered the promise of an exciting alternative to traditional hormonal contraception. They provide highly effective, long-acting protection from pregnancy, without the need for user compliance. Broad acceptability of the drug has been reported throughout the world.
Recently, however, the implants have met with opposition. The drug is associated with a variety of adverse effects, and removal of implants can be problematic. Serious events have been reported in women using levonorgestrel subdermal implants, although causal relationships have not been demonstrated. Additionally, concerns have been raised over the potential for coercive use of the drug. Numerous law suits have been filed alleging serious problems with implants. As a result, the drug has received considerable negative media attention.
Before the controversy over levonorgestrel subdermal implants erupted, contraceptive development had declined, resulting from limitations to profits and funding, legal threats, and changes in the insurance industry. The levonorgestrel subdermal implant experience may serve to accelerate this trend. While the introduction of levonorgestrel subdermal implants offered an alternative to the current array of medical contraception, its experience may serve to dampen future contraceptive development efforts. Costly litigation and much controversy involving the implants have acted to create disincentives to further research and development of new methods of medical contraception.
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References
Segal S. A new delivery system for contraceptive steroids. Am J Obstet Gynecol 1987; 157: 1090–2
Gehlert S, Lickey S. Social and health policy concerns raised by the introduction of the contraceptive Norplant. Soc Serv Rev 1995; 69 (2): 323–37
Wysowski DK, Green L. Serious adverse events in Norplant users reported to the Food and Drug Administration’s MedWatch spontaneous reporting system. Obstet Gynecol 1995; 85: 538–42
King EA, Stabler CM, Lien WJ. Pap smear compliance among Norplant users [letter]. J Fam Pract 1995; 41 (1): 16
Population group demands halt of Norplant sales: cites health risks to women and targeting of minority populations. PR Newswire 1996 Jun 27: 1
Tyrer LB, Salas JE. Contraceptive problems unique to the United States. Clin Obstet Gynecol 1989; 32 (2): 307–15
Hataska H. Implantable levonorgestrel contraception: 4 years experience with Norplant. Clin Obstet Gynecol 1995; 38 (4): 859–71
Choice and challenge: global teamwork in developing a contraceptive implant. Ontario: International Development Research Centre, 1990
Pre-introductory clinical trials of Norplant Implants: a comparison of seventeen countries’ experience. Contraception 1995; 52: 287–96
Peers T, Stevens JE, Grahm J, et al. Norplant implants in the UK: first year continuation and removals. Contraception 1996;53:345–51
Ollila E, Hemminiki E. Does licensing of drugs in industrialized countries guarantee drug quality and safety for third world countries? The case of Norplant licensing in Finland. Int J Health Serv 1997; 27 (2): 309–28
Krueger SL, Dunson TR, Amatya RN. Norplant contraceptive acceptability among women in five Asian countries. Contraception 1994; 50: 349–61
Brown GF, Moskowitz EH. Moral and policy issues in long-acting contraception. Annu Rev Public Health 1997; 18:379–400
Ollila E, Hemminiki E, Kajesalo K. Physicians’ experiences with Norplant implantable contraceptives in Finland. Scand J Soc Med 1995; 23(1): 47–52
Sivin I. Contraception with Norplant implants. Hum Reprod 1994; 9: 1818–26
Ollila E, Sihvo S, Meriläinen J, et al. Experience of Finnish women with Norplant insertions and removals. Br J Obstet Gynaecol 1997; 104:488–94
Rosenthal SL, Biro FM, Kollar LM, et al. Experience with side effects and health risks associated with Norplant implant use in adolescents. Contraception 1995; 52: 283–5
Levine AS, Holmes MM, Haseldon C, et al. Subdermal contraceptive implant (Norplant) continuation rates among adolescents and adults in a family planning clinic. J Pediatr Adolesc Gynecol 1996; 9 (2): 67–70
Phemister DA, Laurent S, Harrison FNH. Use of Norplant contraceptive implants in the immediate postpartum period: safety and tolerance. Am J Obstet Gynaecol 1995; 172: 175–9
Darney PD, Atkinson E, Tanner ST, et al. Acceptance and perceptions of Norplant among users in San Francisco, USA. Stud Fam Plann 1990; 21: 152–60
Frank ML, Poindexter AN, Cornin LM, et al. One-year experience with subdermal contraceptive implants in the United States. Contraception 1993; 48: 229–43
Datey S, Gaur LN, Saxena BN. Vaginal bleeding patterns of women using different contraceptive methods (implants, in-jectables, IUDs, oral pills) — an Indian experience. Contraception 1995; 51 (3): 155–65
Alvarez-Sanchez F, Brache V, Thevenin F, et al. Hormonal treatment for bleeding irregularities in Norplant implant users. Am J Obstet Gynecol 1996; 174: 919–22
Diaz S, Croxatto HB, Pavez M, et al. Clinical assessment of treatments for prolonged bleeding in users of Norplant implants. Contraception 1990; 42: 97–109
Kaunitz AM. Long-acting contraceptive options. Int J Fertil 1996; 41 (2): 69–76
Chez RA. Serious adverse events in Norplant users related to the Food and Drug Administration’s MedWatch spontaneous reporting system [letter]. Obstet Gynecol 1995; 86: 154–5
Sivin I. Serious adverse events in Norplant users related to the Food and Drug Administration’s MedWatch spontaneous reporting system [letter]. Obstet Gynecol 1995; 86: 318–20
Fraser JL, Millenson M, Malynn ER, et al. Possible association between the Norplant contraceptive system and thrombotic thrombocytopenic purpura. Obstet Gynecol 1996; 87: 860–3
Wagner KD, Berenson AB. Norplant-associated major depression and panic disorder. J Clin Psychiatry 1994; 55: 478–80
Wagner KD. Major depression and anxiety disorders associated with Norplant. J Clin Psychiatry 1996; 57: 152–7
Klavon S, Grubb GS. Insertion site complications during the first year of Norplant use. Contraception 1990; 41: 27–37
Su-Juan G, Ming-Lun D, Ling-De Z, et al. A 5-year evaluation of Norplant contraceptive implants in China. Obstet Gynecol 1994; 83: 673–8
Zuber TJ, DeWitt DE, Patton DD. Skin damage associated with the Norplant contraceptive. J Fam Pract 1992; 34: 613–16
Sivin I. International experience with Norplant and Norplant-2 contraceptives. Stud Fam Plann 1988; 19: 81–94
Dunson TR, Amatya RN, Krueger SL. Complications and risk factors associated with the removal of Norplant implants. Obstet Gynecol 1995;85:543–8
Peers T, Stevens JE, Graham J, Davey A. Norplant implants in the UK: first year continuation and removals. Contraception 1996;53:345–51
Sarma SP, Hatcher R. The Emory method: a modified approach to Norplant implants removal. Contraception 1994; 49: 551–6
Praptohardjo U, Wibowo S. The ‘U’ technique: a new method for Norplant implants removal. Contraception 1993; 48: 526–36
Dunson TR, Amatya RN, Krueger SL. Complications and risk factors associated with the removal of Norplant implants. Obstet Gynecol 1995;85:543–48
Thomas AG, LeMelle SM. The Norplant system: where are we in 1995? J Fam Pract 1995; 40 (2): 125–8
Reynolds RD. The ‘Modified U’ technique: a refined method of Norplant removal. J Fam Pract 1995; 40: 173–80
Cecil H, Holtz JK. Norplant removal facilitated by use of ultrasound for location. J Fam Pract 1995; 40: 182–3
Ward SJ, Sidi IPS, Simmons R, et al. Service delivery systems and quality of care in the implementation of Norplant in Indonesia. New York: Population Council, April 1990
Hunt L. Shot in the arm for birth control. The Independent 1993 Aug 4: 1
Rush for five-year contraceptive. Daily Mail 1993 Oct 8: 11
Cullins VE, Blumenthal PD, Remsburg RE, et al. Preliminary experience with Norplant in inner city population. Contraception 1993; 47: 193–203
Frank ML, Bateman L, Poindexter AN. The attitudes of clinic staff as factors in women’s selection of Norplant implants for their contraception. Women Health 1994; 21 (4): 75–88
Doyle C. Doctors set to issue new contraceptive that can last five years. The Daily Telegraph 1993 Aug 5:4
UBINIG. Norplant, the five year needle: an investigation of the Norplant trial in Bangladesh from the user’s perspective. Issues Reprod Genet Eng 1990; 3 (3): 211–28
UBINIG. “The price of Norplant is TK.2000! You cannot re move it.” Clients are refused removal in Norplant trial in Bangladesh. Issues Reprod Genet Eng 1991; 4 (1): 45–6
Samuels SE, Smith MD, editors. Dimensions in contraception: Norplant and poor women. Menlo Park, CA: Henry J. Kaiser Family Foundation, 1992
Thompson MS. Contraceptive implants: long acting and provider dependent contraception raises concerns about freedom of choice. BMJ 1996; 313 (7069): 1393–5
Bromham DR. Contraceptive implants: users lose out when misleading information limits choice. BMJ 1996; 312 (7046): 1555
People v. Johnson. No. 29390. Court Proceedings of Tulore County, California, USA
Moskowitz EH, Jennings B, Callahan D. Long-acting contraceptives: ethical guidance for policy makers and health care providers. Hastings Center Report 1995; 25 (1) Suppl.: S1–8
Kolata G. Will the lawyers kill off Norplant? The New York Times 1995 May 28; Section 3: 1
Bromham DR, Davey A, Gaffikin L, et al. Materials, methods and results of the Norplant training program. Adv Contracept 1995; 11:255–62
Jenkins L. Women sue over birth control implant. The Times 1995 Aug 19: 1
Glazer SH. Once hailed as ‘dream’ contraceptive, Norplant faces ethical and practical problems. CQ Researcher 1994; 28 (4): 662–8
Mastroianni L, Donaldson PJ, Kane TT. Special report: development of contraceptives — obstacles and opportunities. N Engl J Med 1990; 322 (7): 482–4
Sihvo S, Ollila E, Hemminki E. Perceptions and satisfaction among Norplant users in Finland. Acta Obstet Gynecol Scand 1995; 74 (6): 441–5
Bromham DR. Contraceptive implants: users lose out when misleading information limits choice. BMJ 1996; 312 (7046): 1555
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Frank, M.L., DiMaria, C. Levonorgestrel Subdermal Implants. Drug-Safety 17, 360–368 (1997). https://doi.org/10.2165/00002018-199717060-00002
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DOI: https://doi.org/10.2165/00002018-199717060-00002