At last! . . . The FDA is looking into Mentor's practices!

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At last! . . . The FDA is looking into Mentor's

practices!

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US FDA investigators said asking about Mentor Corp

Wed Jan 25, 2006 6:19 PM ET

By Richwine

WASHINGTON, Jan 25 (Reuters) - A consumer activist and

a former Mentor Corp. (MNT.N: Quote, Profile,

Research) employee said on Wednesday they had been

interviewed by U.S. criminal investigators about the

company's experimental silicone breast implants.

Zuckerman, president of the National Research

Center for Women & Families, told Reuters she spoke

last Friday with investigators from the Food and Drug

Administration's (FDA) Office of Criminal

Investigations.

Zuckerman, who has questioned the long-term safety of

silicone implants, said she was asked in part to

recount allegations from former or current Mentor

employees who had told her the company failed to

accurately report the difference in rupture rates

between smooth and textured implants.

Mentor said in a statement: " We have not been notified

by the FDA of an investigation regarding that issue. "

A former Mentor employee also said in an interview he

was questioned by an FDA criminal investigator in

December. He spoke to Reuters on condition of

anonymity.

FDA spokeswoman Bro said she could not confirm

or deny whether the FDA had launched a criminal probe

of Mentor.

Mentor and rival Inamed Corp. (IMDC.O: Quote, Profile,

Research) are seeking FDA approval for silicone breast

implants. The FDA has told both companies it would

approve the implants for sale if certain conditions

are met. The conditions have not been disclosed.

Zuckerman said FDA investigators asked her about

allegations from three former and one current Mentor

employee who had contacted her.

The investigators asked in part about charges that

Mentor did not report rupture rates for the implants

accurately.

" That's one thing I know interested (the

investigators), the idea that the rupture rate is

higher than has been reported, " Zuckerman said.

Zuckerman said she had no way of knowing whether any

of the allegations were true. Continued ...

© Reuters 2006. .