NOW Freedom of Information Act Request for Mentor Records

June 9, 2005

Food and Drug Administration
Office of Management Programs
Division of Freedom of Information (HFI-35)
5600 Fishers Lane
Rockville, MD 20857

Re: Freedom of Information Act Request (Mentor Criminal Investigation Records)

Dear Sir or Madam:

I request, pursuant to the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552, and the regulations issued by the Food and Drug Administration ("FDA") concerning FOIA, copies of all files and records pertaining to the FDA's criminal investigation of Mentor Corporation concerning silicone and saline breast implants. It is my understanding that this investigation was conducted between 1998 and 2002, and that it is now closed.

If the agency is unable to locate any "missing" record or file within the twenty-day period set forth in 5 U.S.C. § 552(a)(6)(A)(i), then please place any such missing record or file on "special locate" status and advise us that you have done so.

Should the FDA determine that any portion of a record is exempt from disclosure under FOIA, I ask that the agency use its discretion to release it. In the event an exemption is claimed, please provide all segregable non-exempt portions of any withheld record, as required by 5 U.S.C. §522(b).

Pursuant to 5 U.S.C. § 552(b), if the request for records is denied either in part or in whole, please specify in writing the exemption(s) that is (are) claimed for each portion of a record withheld. Please provide a detailed description of each record withheld, including the author(s) and any recipients, the date of its creation, its subject matter and its current physical location. In addition, please provide the reason that each record falls within each exemption claimed for it. Please also specify the number of pages in each record and the total number of pages pertaining to this request.

I am the president of the National Organization for Women (NOW), a nonprofit membership organization whose primary mission is to bring about equality for all women. We are currently working to ensure that the U.S. Food and Drug Administration makes decisions about safety and effectiveness of silicone breast implants based on all available data and that the data be derived from soundly-designed medical scientific studies. We are concerned that not all relevant information about studies conducted on women with saline or silicone breast implants has been made available by manufacturers. We are equally concerned about reports that breast implant manufacturers may have failed to fully disclose information about deficiencies in their research and/or manufacturing processes.

I request that the agency waive any fees for these documents. If the agency determines that I should be required to pay for the documents that I am requesting, please contact me if such fees will exceed $300.

As set forth in 5 U.S.C. § 552 (a)(6)(A)(i), I expect a response to this request within twenty working days. Please send documents and records to the attention of Jan Erickson at the address below. If you have any questions or concerns please contact Ms. Erickson at (202) 628-8669, ext. 122.

Sincerely yours,
Kim Gandy
President
National Organization for Women

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