Contact: Ken Johnson (202.225.5735)

Washington (September 27) - In light of reported concerns about the safety of saline breast implants, Oversight and Investigations Subcommittee Chairman James Greenwood (R-PA) sent the following letter to the FDA this week:

September 25, 2002

Lester M. Crawford, D.V.M., Ph.D.
Deputy Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Dr. Crawford:

The Food and Drug Administration (FDA) recently advised us that its four-year criminal investigation of Mentor Corporation has been closed.

In our July 11, 2002, letter to you regarding Mentor Corporation and the issue of breast implants, Chairman Tauzin and I requested all records of the criminal investigation of Mentor if the criminal investigation of Mentor was determined to be closed. Therefore, since FDA has advised us that the criminal investigation has now been closed, pursuant to Rules X and XI of the U.S. House of Representatives, please provide the following information by October 9, 2002:

1. All records relating to the FDA's criminal investigation of Mentor Corporation.

Please note that, for the purpose of responding to this request, the terms "records" and "relating" should be interpreted in accordance with the attachment to this letter.

Thank you for your assistance. If you have any questions, please contact Alan Slobodin of the Majority Committee staff at (202) 225-2927.

Sincerely,

James C. Greenwood
Chairman, Subcommittee on Oversight and Investigations

cc: W.J. "Billy" Tauzin, Chairman
John D. Dingell, Ranking Member
Peter Deutsch, Ranking Member
Subcommittee on Oversight and Investigations