Ruby Rahn
rubyrm@mac.com30 mars, 2006 19:14
Letter to FDA/Approval of Mentor implants
March 30, 2006
Andrew von Eschenbach, M.D.
FDA Commissioner
PKLN RM1471 HF-1
5600 Fishers Lane
Rockville, MD 20857
(301) 827-2410
commissioner@fda.govDear Commissioner:
The Food and Drug Administration (FDA) has indicated they will approve marketing of silicone gel-filled breast implants by Mentor Corporation, despite serious allegations from Mentor employees that the company hid and falsified data and misrepresented safety information on their implants.
A New York Times article revealed that sworn statements from former employees indicated that Mentor withheld and hid, from the FDA, key information on the safety and efficacy of their silicone breast implants.
Implant Maker Hid Defects, Workers Said
New York Times, May 22, 2005
By Gardiner Harris
http://www.nytimes.com/2005/05/22/national/22implant.html?ex=1143867600&en=fa10339353c46401&ei=5070Since the late 1990’s, the FDA’s Office of Criminal Investigations (OCI) has conducted criminal investigations of Mentor Corporation. Those investigations officially ended in 2002. For nearly four years now, the public and our representatives have been requesting the results of that OCI investigation but the FDA has never made it public. Will you please explain why?
Greenwood Wants Details On FDA's Breast Implant Investigation
The Committee on Energy and Commerce
Committee News Release: September 2002
Letter to Deputy FDA Commissioner, Lester M. Crawford
James C. Greenwood, Chairman, Subcommittee on Oversight and Investigations
FDA scientists and Advisory Committee members who have reviewed the pending Mentor application have not had access to documents in the OCI’s investigation. The investigation may further reveal they misrepresented and falsified important safety information, as former Mentor employees have stated. The public, as well as those involved in the approval process, have a right to know the results of the investigations before approval is given.
In addition, Mentor has only provided two years of data about implant rupture for a product that women will rely on for more than two years. Post-market approval conditions, recommended by the Advisory Panel, are inadequate to protect women from the known harm caused by ruptured silicone breast implants.
The FDA's primary purpose and mission is to promote and protect "the public health" by helping safe and effective products reach the market, to monitor products for continued safety, and to help "the public" get accurate, science-based information. It's mission is not to promote and protect the health and welfare of plastic surgeons and implant manufacturers.
I strongly urge you to reconsider approving silicone breast implants until long-term safety data can be provided and your own scientists and members of the advisory committee have reviewed the OCI’s investigation.
Sincerely yours,
Ruby Rahn
1350 NW 82nd Street
Kansas City, MO 64118
(816) 468-0111
rubyrm@mac.comcc: National Organization of Women
Command Trust Network
Center for Policy Research
e-mailed on 3-30-06
mailed via US mail on 3-30-06
