Six women’s groups Thursday called for a congressional probe into the U.S. government’s review of silicone breast implants, citing an e-mail they said showed U.S. regulators planned to approve the products regardless of any advice from outside experts.
Rival companies Mentor Corp. and Inamed Corp. want the Food and Drug Administration to lift a 13-year-old ban on silicone implants for most women.
The groups, including the National Organization for Women, want more study of implant risks before the products are sold again. They objected to what they said was an internal FDA e-mail with a summary prepared for Acting FDA Commissioner Lester Crawford. The e-mail was dated March 4, weeks before a panel of outside experts met to review breast implant data.
The e-mail said the information in the summary came from ”an outsider who is interested in seeing us come out okay on the b.i. (breast implant) issue.”
“Since the document is a biased summary of breast implant research that clearly advocates for FDA approval, this e-mail implies the FDA had a pre-determined interest in approval even before the FDA advisory panel met,” the groups said in a letter to the Senate Health, Education, Labor and Pensions Committee.
Reuters received a copy of the e-mail and the letter.
FDA spokeswoman Julie Zawisza said the summary was “not an FDA document, and it does not represent the FDA’s position.”
Earlier this month, the advisory panel voted 5-4 against Inamed’s implants, while urging approval for Mentor’s implants by a 7-2 vote.
The FDA still is considering the applications and will base its decision on whether data show safety and effectiveness, Zawisza said.
The e-mail said the source of the implant information had learned the issue likely would be raised at a Senate hearing on Crawford’s nomination to be permanent FDA commissioner. The hearing was held March 17, with no mention of breast implants.
The e-mail shows that it was sent by Susan Bond, director of scientific policy in the FDA commissioner’s office, to Dr. Daniel Schultz, head of the FDA’s Center for Devices and Radiological Health. It asks Schultz for feedback on the summary.
Neither Bond nor Schultz immediately responded to e-mail and telephone requests for comment.
The Senate health committee is reviewing the letter, according to Craig Orfield, a spokesman for Committee Chairman Mike Enzi, a Wyoming Republican.
The groups that sent the letter to the Senate committee include the National Organization for Women, the Command Trust Network, In the Know, Our Bodies Ourselves, the National Research Center for Women & Families and the National Women’s Health Network.
