Case Detail

In re Silicone Breast Implants - Citizen's Petition
(Regulatory Proceeding)
On October 11, 2005, WLF filed a brief with the Food and Drug Administration (FDA), opposing a petition by Public Citizen and others designed to block FDA approval of the marketing of silicone gel-filled breast implants. WLF argued that the manufacturers seeking approval have provided adequate assurances that their products are safe and effective and that (contrary Public Citizen's contention) a demonstration of absolute safety is neither possible nor required. WLF also challenged Public Citizen's claim that approval of silicone breast implants would somehow be inconsistent with past FDA practice. WLF noted that silicone breast implants were freely marketed in this country for decades with FDA's acquiescence and that there is no epidemiologic evidence suggesting that they have ever caused serious health problems. WLF argued that opposition to implants is based on political considerations, not sound science.
Case Status:
Awaiting FDA decision.
More Information and Downloads:
10/11/2005: Download the Comments

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