HealthCentral.com
April 23, 2005

Women's Groups Ask for Review of FDA Breast Implant Vote

The National Organization for Women and five other women's groups have asked Congress to investigate the U.S. Food and Drug Administration's recent review of silicone-gel breast implants. The groups contend that an FDA e-mail suggests agency officials were under outside pressure to approve the controversial devices, the Associated Press reported.

Inamed Corp. and Mentor Corp. are seeking an end to a 13-year FDA ban on most uses of the implants, which many women blame for a variety of health problems caused by leaking silicone. Earlier this month, an FDA advisory panel recommended that Mentor's implants be allowed back on the market under the certain conditions, but Inamed's products required more review. The FDA is weighing that advice as it completes its own review, the AP said.

A month before the advisory panel met, an aide to FDA Acting Commissioner Lester Crawford e-mailed the agency's medical device chief an unsigned "Update on Silicone Gel Breast Implants" that contended the devices were safe and that criticism of them amounted to "junk science," the AP said.

Responding in e-mail to the aide, FDA medical device chief Dr. Daniel Schultz wrote, "The truth lies somewhere in between this very positive perspective and the totally negative viewpoint of the other side," the news service said.

The women's groups sent copies of the e-mail to members of Congress on Thursday, asking that it and other complaints about silicone implants be investigated. "This e-mail implies the FDA had a predetermined interest in approval even before the FDA advisory panel met," they wrote.

A Senate panel -- the Health, Education, Labor and Pensions Committee, which oversees the FDA -- is reviewing the groups' request, a spokesman said.

FDA spokeswoman Julie Zawisza told the AP that the e-mailed "update" was not an FDA document and did not represent the agency's position. "We receive a lot of input from a lot of parties," she said.