Sat, 21 Oct 2006 00:12:31 -0400

NEW allegations regarding silicone gel breast implants from Diana and the CMAJ coverage

From Diana Zuckerman:

Last week, important and worrisome new allegations about misrepresentation of safety data of their silicone gel breast implants by the Mentor Corporation were made public in the US. The allegations were originally made by a Mentor scientist to his bosses at the company. He was subsequently fired and provided the information to the FDA. Apparently, a mid-level FDA person did not bring the allegations to the attention of the FDA Commissioner, so a nonprofit organization has done so. A new investigation is now apparently underway.

I was not sure if Health Canada has received this information, so I have attached several of the relevant documents. It would obviously be just as important and relevant to Health Canada and Canadian women as it is to the FDA. I have also provided these documents to the CBC and other Canadian media who have expressed interest in this information.

I have not spoken with this former Mentor employee, but other Mentor employees have assured me of the accuracy of his allegations and his access to the information he discussed. I have personally spoken with 5 former Mentor employees with similar allegations. It is the only time our nonprofit organization has ever been contacted by more than one employee making allegations about his or her company.

Sincerely,

Diana Zuckerman, Ph.D.

President
National Research Center for Women & Families

1701 K Street, NW, Suite 700

Washington, DC 20006

(202) 223-4000