Review of Silicone Implants Tentatively Scheduled

January 6, 2005

by Jan Erickson, Government Relations Director

Two breast implant manufacturers, Inamed Corp. and Mentor Corp., both based in Santa Barbara, Calif., announced in December that they have been notified by the U.S. Food and Drug Administration (FDA) that their applications for marketing silicone gel-filled breast implants will be reviewed at a tentatively scheduled meeting of the agency's General and Plastic Surgery Devices Advisory Panel this April. In addition, Inamed Corp. said that the company has submitted a pre-marketing approval (PMA) application for a "cohesive gel matrix implant."

The National Organization for Women has called for the FDA to hold hearings on the Mentor application, to release for public scrutiny additional data submitted by both companies to the FDA, and to publicly release a revamped Guidance Document to advise companies of appropriate clinical research activities. NOW's concerns continue to focus on the FDA's tendency in this admistration to put politics ahead of public health -- and in this case the refusal to demand long-term (10 - 12 years) safety data that would more clearly answer questions about the connection of implants to a variety of illnesses and injuries that women with the implants have reported over the past two decades.

See related article and action alert.