In re Silicone Gel-Filled Breast Implants
- Case Date: 3/28/2005
- Project Name: Health Care Project
On March 28, 2005, WLF filed formal comments with the Food and Drug Administration (FDA), charging that FDA is violating clearly established rules governing administrative procedure in its handling of premarket applications (PMAs) submitted by two companies seeking permission to market silicone gel-filled breast implants. WLF stated that the Administrative Procedure Act (APA) prohibits FDA from imposing far stricter approval requirements on silicone breast implants than it has imposed on similar medical devices. WLF argued that FDA is requiring implant manufacturers to supply ten years of post-implant clinical data before granting PMAs. WLF said that FDA has never previously required more than three years of data. WLF repeated its charges in testimony it gave to an FDA advisory panel on April 11, 2005; that panel later voted to recommend that FDA approve the sale of silicone breast implants.
|Awaiting FDA action.|
More Information and Downloads:
3/28/2005: Download the Comments