Fw: Dallas Morning News/ FDA ends inquiry

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Please let us know if you know the Outcome of this FDA Criminal Inquiry of Mentor's Practices!

Thanks, MM

----- Original Message ----- Sent: Tuesday, October 01, 2002 7:57 AM

Subject: Dallas Morning News/ FDA ends inquiry

http://www.dallasnews.com/latestnews/stories/100102dnnatmentor.53653.html

Last modified: 09:55 PM CDT on Monday, September 30, 2002

FDA ends inquiry on maker of implants

Agency won't say if firm with Irving facility cleared of allegations

10/01/2002

By JIM MORRIS / The Dallas Morning News

WASHINGTON – The Food and Drug Administration has concluded its four-year criminal investigation of Mentor Corp., which manufactures breast implants at a factory in Irving, an agency spokeswoman confirmed Monday. FDA spokeswoman Sharon Snider would not say whether the closing of the inquiry meant that Mentor had been cleared of wrongdoing. However, the agency announced no action against the company.

In allegations lodged first with the FDA's Dallas office, employees and former employees had accused Mentor of failing to record some patient complaints and allowing potentially contaminated products to enter the market.

Mentor officials denied the allegations, although they promised in 1998 to improve manufacturing validation procedures, designed to ensure product uniformity. The FDA's Office of Criminal Investigations opened its investigation that summer.

A Mentor spokeswoman said Monday that company officials would have no comment on the end of the investigation because "they have not received any official notification from FDA."

In a letter last week to FDA Commissioner Lester M. Crawford, Rep. Jim Greenwood, R-Pa., asked the agency to provide the House subcommittee he chairs with all records relating to the Mentor investigation. The FDA had rebuffed earlier congressional requests for information on grounds that the investigation was still open.

Mr. Greenwood could not be reached for comment. He told the Reuters news service last week that the FDA had cleared Mentor of charges that it falsified records, and that the House Energy and Commerce Committee's subcommittee on oversight and investigations would examine how the agency had conducted its inquiry.

In his letter, Mr. Greenwood gave the FDA until Oct. 9 to provide the pertinent materials.

"The fact that the criminal investigation has been closed could mean the beginning – not the end – of some kind of public scrutiny," said Dr. Zuckerman, president of the National Center for Policy Research for Women & Families, a Washington-based advocacy group that has questioned the safety of implants.

"It's been the concern for more than a year that [FDA officials] weren't actually doing anything but were keeping the investigation open so they didn't have to make information available to the public or Congress."

California-based Mentor began making saline- and silicone-filled breast implants at the Irving factory in 1994.