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Sterilization Device Recommended for Approval -- February 26, 1996

RESEARCH TRIANGLE PARK, NC -- An advisory panel of the U.S. Food and Drug Administration recommended February 26 that the FDA approve the Filshie Clip, a device used in female sterilization. Manufactured by Femcare Limited of the United Kingdom, the clinical trials used to support the panel's decision were conducted by North Carolina-based Family Health International.

Sterilization, the most widely used birth control method, is achieved in women by cutting or blocking the fallopian tubes, thus preventing a woman's egg from becoming fertilized. The Filshie Clip, which is smaller than a penny, blocks the fallopian tube by clamping. It is designed to cause less damage to the tube compared with other widely-used sterilization approaches. Because of this, it is hoped that the clip will improve the prospects for a surgical reversal among women who later regret their sterilization and want to become pregnant. However, no data on reversal were submitted to FDA. Sterilization should be considered permanent since reversal operations are expensive, difficult and do not guarantee success.

In today's hearing before the FDA advisory panel, FHI scientists said their studies show the Filshie Clip is both a safe and effective method for voluntary female sterilization. FHI began clinical trials on the clip in 1984 and has completed 11 studies in 20 countries involving over 6,000 women who volunteered to be sterilized with Filshie Clips. They were compared with nearly 4,000 women using other sterilization approaches, including two other devices that block tubes: the Tubal Ring (also known as the Falope or Yoon Ring) and the Wolf Clip (also known as the Hulka Clip).

More than 8 million U.S. women of reproductive ages are sterilized. Estimates of the number of women who later regret their sterilization vary. In five studies since 1980 conducted in the United States, regret ranged from 2 percent to 26 percent of the sterilized women who were surveyed. Remarriage and the death of a child were among typical reasons for regret.

Femcare, based in Nottingham, England, distributes gynecological and urological devices to more than 40 countries. FHI is a nonprofit research and technical assistance organization that promotes better reproductive health worldwide, with an emphasis on developing countries. Any royalties FHI receives from U.S. public sector sales are expected to be modest and would be used to support FHI's programs.

The FHI studies were supported in part by the U.S. Agency for International Development (USAID), an independent federal government agency that provides foreign assistance and humanitarian aid. Because of USAID assistance, the Filshie Clip would be available at a lower price to governmental and inter-government agencies, as well as to national and international humanitarian aid organizations.