July 11, 2002

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

Dear Dr. Crawford: 

On July 9, 2002, two saline breast implant manufacturers, Mentor Corporation and Inamed, presented studies at an FDA advisory committee hearing that showed more than a quarter of women who receive saline implants to increase the size of their breasts will undergo another breast operation within five years.  Two-thirds of these women getting re-operations need additional surgery to correct problems ranging from leakage and wrinkling to deflation of the implant and tightening of the scar tissue around the implant.  According to the Washington Post, some members of the FDA advisory panel expressed serious concerns about both the results and the nature of the studies such as “mind-boggling poor results,” “high rates of product failure,” and “astoundingly weak.”  In recent years, the Committee has examined several matters concerning FDA’s oversight and regulation of breast implants.  

In light of the recent public health concerns raised and the Committee’s continuing interest in assuring the safety and efficacy of these important products, pursuant to Rules X and XI of the U.S. House of Representatives, please provide the following by July 25, 2002: 

1.        All records relating to the saline breast implant studies presented at the July 9, 2002 FDA advisory panel meeting.

2.          All records relating to Mentor Corporation since January 1, 2001.  This request excludes FDA’s criminal investigative file. 

In addition, we request that you obtain a briefing directly from the FDA’s Office of Regulatory Affairs and the FDA’s Office of Criminal Investigations concerning the true status of the long-standing and ongoing criminal investigation of allegations relating to Mentor Corporation.   If you ascertain that this investigation is in fact still ongoing, we further request that you then brief Committee members and/or the Committee staff, with appropriate information and substantiation (e.g., time records of the FDA criminal investigators), to assure the Committee that FDA is actively conducting a criminal investigation.  If you ascertain that this investigation is in fact inactive or closed, we request all records of the criminal investigation of the allegations against Mentor Corporation.  We request that you inform the Committee by no later than July 25, 2002, of your conclusion about the status of the FDA criminal investigation.  

Please note that, for the purpose of responding to these requests, 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,

W.J. “Billy” Tauzin
Chairman

James C. Greenwood
Chairman, Subcommittee on Oversight and Investigations

cc:  John D. Dingell, Ranking Member

       Peter Deutsch, Ranking Member    Subcommittee on Oversight and Investigations