ovarian cysts, increased intracranial hypertension, premature birth, birth defects, and other hormonal-related injuries

  • Silastic-related claims, including autoimmune problems and other injuries alleged to be related to the silicone elastomer tubing containing the levonorgestrel.

In late summer 1995, the FDA affirmed support for Norplant in written testimony before the US. House of Representatives Committee on Government Reform and Oversight, Subcommittee on Human Resources and Intergovernmental Relations10 but by 1996, annual U.S. sales of Norplant had dropped to $3.7 million and insertions had decreased by 90 percent.11

As of August 1997, 50,000 U.S. women nationwide were reported to have sued Wyeth-Ayerst, alleging that it failed to adequately warn users of side effects ranging from headaches and weight gain to ovarian cysts and depression. In addition, 2,800 lawsuits involving about 30,000 women were pending in a Beaumont, Texas, federal court but, as of that date no motion for consolidation of suits as class actions had been granted and no individual award had been made. On August 8, the Texas Supreme Court issued an order indefinitely delaying the trial set for August 11 that was to hear the suits brought by eight Texas women against Wyeth-Ayerst, so that the court could consider a motion by Wyeth attorneys to have several plaintiffs' attorneys disqualified for alleged misconduct.12 While the principal defendant has been American Home Products and/or its subsidiary, Wyeth-Ayerst Laboratories, there have been suits against individual physicians and health care providers (including Planned Parenthood) involved in insertion or removal of the implant and/or treatment; manufacturer Leiras Oy or its parent company, Huhtamaki Oy;13 Dow Coming or other Dow entities supplying the silastic tubing; Schering AG, the European supplier of bulk levonorgestrel; and the Population Council.

ENDNOTES

1.  

Dimethylsiloxane/methylvinylsiloxane copolymer. The capsules are sealed with silastic (polydimethylsiloxane) adhesive.

2.  

MF McCann, and LS Potter. Progestin-only oral contraception: A comprehensive review. Contraception 50(Suppl 1):9-S195, 1994.

3.  

The "second-generation" progestin-only implant systems include:

• Two-rod levonorgestrel implant system, tested since 1981. developed by the Population Council, and manufactured by Leiras Oy of Finland. the system was approved by the FDA on 15 August 1996 as safe and effective for 3 years of contraceptive use.

• NestoroneTM, a single-rod implant with a core that is half silastic. half hormone. effective for 2 years, currently in clinical trials.

• Implanon, a single implant made of ethylene vinylacetate, containing 3-keto desogestrel, effective for 3 years, undergoing large-scale testing.



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