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Mon, 16 Oct 2006 14:50:40 EDT

2006/10

By ANDREW BRIDGES, Associated Press Writer 11 minutes ago

WASHINGTON - A private group called Thursday for a criminal investigation into a whistleblower‘s allegations that one of two companies seeking federal approval to sell silicone breast implants withheld safety information from regulators.

Public Citizen asked the Food and Drug Administration to investigate the allegations raised by a former Mentor Corp. employee. The scientist alleged the Santa Barbara, Calif., company concealed, misrepresented or withheld leakage, durability and other data about its silicone-gel breast implants.

In a statement, Mentor said FDA representatives visited the company‘s Santa Barbara facilities in July. "They asked questions and reviewed documents specific to our preclinical testing. To our knowledge, all questions were answered to the satisfaction of FDA," the company said.

In July and September 2005, the FDA first told Mentor and then Inamed Corp. — now part of Allergan Inc. — that it would let them start selling silicone implants once the companies met certain unspecified conditions. The FDA has yet to grant final marketing approval to either competitor. Since a de facto 1992 ban, silicone implants have been used in women only as part of clinical trials.

Referring to the issues he raised, the scientist said, "Some of them are potentially a problem."

The scientist said going public wasn‘t meant as a retaliatory move against Mentor, but was designed to provide information to the FDA as it reviewed the company‘s application.

Most studies have failed to find a link between breast implants and disease. But silicone-gel breast implants do not last a lifetime, according to the FDA. A 2000 Institute of Medicine report found rupture rates as high as 77 percent.

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Food and Drug Administration: http://www.fda.gov/

Public Citizen: http://www.citizen.org/