New Findings on Mentor Corporation Reveal Further Disdain for Women's Health

FDA Must Place Science over Politics in Approval Process, says NOW President Kim Gandy

December 6, 2005

News that breast-implant manufacturer Mentor Corp. corrected a malfunction in the samples it provides to doctors—but did nothing to repair the implants that will be placed in women's bodies—provides further proof that the company puts profits first, and that the FDA must take decisive action against Mentor to protect women's health and safety, said National Organization for Women President Kim Gandy.

According to The Washington Post, the company realized last year—during the time it was applying for approval from the Food and Drug Administration (FDA)—that its products were "bleeding" silicone oil. A whistle-blower recently alerted the FDA that although the company fixed the problem in demonstration implants it gives doctors to show to their patients, the modification—which cost pennies more to implement—was never made on the products that would actually be implanted. So women are being shown one product, without being told that an inferior one would be surgically implanted in their bodies.

"These findings are more proof that Mentor Corp. cares more about the bottom line than it does about women's lives," Gandy said. "The FDA has a responsibility to put our health first."

The whistle-blower is the third Mentor employee to come forward about defects in the manufacturer's products. John C. Karjanis, a former product evaluation manager for Mentor, stated under oath in a lawsuit against the company that "top executives instructed him to destroy reports detailing the high rupture rates and poor quality of some types of implants because the products 'are in the customers.'" Karjanis also testified that factory workers hid defective products in the ceiling tiles in an effort to conceal how often the plant failed to make the products properly.

"If the FDA ignores this evidence and approves Mentor Corp. implants for general sale, the agency will once again be placing pharmaceutical company profits over science and common sense," Gandy said. "Millions of women are in danger of long-term health problems because the FDA refuses to investigate these claims."

Silicone particles are known to leak from these implants, and government studies have found higher rates of brain tumors and lung disease in women with implants. In July 2005, Mentor Corp. was issued an "approvable letter"—a preliminary victory for the company in its quest to be approved for general sale.

"The FDA has good reason to revoke the approvable letter and closely examine the safety of these products, and should do so without delay," Gandy said. "Women's well-being depends on it."

 

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For Immediate Release
Contact: Mai Shiozaki, 202-628-8669, ext. 116; cell 202-641-1906

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