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Groups call for implant probe, threaten suit

August 9, 2005

By Susan Heavey

WASHINGTON (Reuters) – The National Organization for Women,
Public Citizen and 13 other consumer groups on Tuesday called
on U.S. regulators to postpone their final decision on Mentor
Corp’s silicone breast implants and urged Congress to widen a
related probe.

The consumer advocates also threatened legal action if the
U.S. Food and Drug Administration refuses to release related
documents.

Last month, the FDA said Mentor could market its product
once it met certain conditions that were not make public.

But the groups questioned the FDA’s policy of approving
devices then asking for more data. They are concerned about a
possible link between leaking silicone and certain diseases.

Implant makers and surgeon groups have said the newer
silicone products are more durable and have low rupture rates.

“It’s time for Congress to step in and conduct a thorough
investigation of how the FDA came to make this compromise and
deceptive decision,” said National Organization for Women
President Kim Gandy.

The Senate health committee is already looking into
allegations of conflicts of interest among members of an FDA
panel that recommended approval of the implants in April.

The FDA had investigated whether Mentor falsified records
but ended it in 2002 without filing charges. On Tuesday the
groups petitioned for all documents related to that
investigation, Mentor’s current application and the FDA letter
about the conditional approval.

If the FDA does not provide them or approves the device,
“we will seriously consider filing a lawsuit,” said Public
Citizen’s Sidney Wolfe.

FDA spokeswoman Julie Zawisza said the agency cannot
legally provide data on the company’s new bid but that some
documents from the earlier inquiry may be made available.

Mentor President and Chief Executive Officer Josh Levine
dismissed the groups’ concerns as “old news.”

In a Securities and Exchanges Commission filing on Tuesday,
Mentor said it was working to satisfy the FDA’s conditions but
did not list them. The agency “will most likely recommend
additional post-approval conditions or requirements,” it said.

Mentor’s rival Inamed Corp. is also seeking U.S. approval
for its silicone implants.




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