FDA revises 'urgent need' policy on silicone implants

Article Abstract:

Food and Drug Administration Commissioner David A. Kessler announced that the criteria for determining whether a woman is in urgent need of silicone implants would be expanded. In Apr 1992, Kessler told a congressional hearing that silicone gel implants would be available only through research protocols, except for mastectomy patients with temporary tissue expanders in place and women with silicone gel implants that must be replaced. The 'urgent need' criteria was expanded later that month to include mastectomy patients who cannot use saline implants but are in need of immediate reconstructive surgery.

Science and technology policy, Kessler, David A.

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FDA: use saline implants or enroll patients in silicone trials

Article Abstract:

The Food and Drug Administration (FDA) has decided to limit silicone breast implants to clinical trials while it gathers more scientific evidence about the health implications of silicone. Commissioner David Kessler advised women not participating in research studies to use saline devices instead. The ASPRS approved the decision, confident that FDA tests will win over dubious patients. Kessler had been criticized by the organization for placing a moratorium on shipments of silicone prostheses.

Surgical appliances and supplies, Political activity, American Society of Plastic and Reconstructive Surgeons

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Reforms speed FDA process on drug approval

Article Abstract:

The FDA announced new guidelines that speed up the process of drug approval, so that persons, such as AIDS patients, who suffer from life-threatening diseases can receive needed medications sooner. Some observers are dismayed that the process was politicized by having VP Quayle announce the new rules at a news conference six months after implementation by the FDA. The new guidelines also make experimental drugs available to patients earlier in the testing process.

Planning, United States. Food and Drug Administration, Drug approval

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