NOW Makes FOIA Request for Criminal Investigation Documents

June 9, 2005

In response to press reports that employees of breast implant manufacturer Mentor Corporation had hidden defective implants from Food and Drug Administration (FDA) inspectors, the National Organization for Women on Thursday, June 9, sent a Freedom of Information Act (FOIA) request to the FDA for copies of all relevant files and records. Between 1998 and 2002, the FDA conducted a criminal investigation of Mentor based on disclosures from two former Mentor employees who reported flawed manufacturing processes, faulty and contaminated products and orders by company officials to destroy reports about high rupture rates of breast implants.

Of the FOIA request, NOW President Kim Gandy said, "We suspect that evidence obtained in the criminal investigation was not provided to the FDA advisory committee nor to the FDA's own scientific review staff. They need to see these documents."

In April, the advisory committee turned down the application from Inamed Corp. but recommended approval of Mentor's application to market their silicone breast implants, primarily because Mentor's safety data appeared to be stronger. Now those sworn statements of former Mentor employees call that data into question, and this evidence must be considered by the FDA in deciding whether to accept the advisory committee's split recommendation.

NOW and other women's health groups - along with FDA scientific reviewers - maintain that data set supplied by both Mentor and Inamed was insufficient to demonstrate long-term safety of their implants. Silicone implants were removed from the general market in 1992 following reports that thousands of women were injured or become seriously ill after receiving implants.

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Letter to the FDA
Read more on NOW's work on breast implants