Poor breast implant safety data

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NEWS RELEASEFOR IMMEDIATE RELEASEJuly 10 , 2002

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FDA Panel SLAMS Breast Implant Safety DataHigh Failure, Re-Operation Rates Noted, Poor Study Design & Follow-Up Leaves Patients Uninformed

Gaithersburg, MD, July 9, 2002 - At a public hearing on saline breast implant safety, an FDA panel today expressed deep concern about the high failure rate of breast implants, and about the lack of useful information about the safety of implants made by Mentor Corporation.

The meeting was requested by the FDA Advisory panel, which had recommended FDA approval of saline implants in 2000 under the condition that the companies, Mentor and Inamed (formerly McGhan), conduct long-term safety studies. Both companies provided at least five years of safety data at the meeting. However, of the more than 1200 women who were in the Mentor study, only 60 (5 percent) were analyzed at the five-year follow-up. Panel members agreed that women have the right to choose breast implants if they are provided with accurate information about the risks, but said an informed choice was impossible for Mentor patients because the company had not taken the steps necessary to gather useful information about the risks. The concern is that women who did not participate in the study may have very different medical problems than those who did.

One panel member, Dr. LeeLee Doyle, noted that no scientific journal would accept the data. Another criticized Mentor for its "mind boggling poor results," and a panel member from s Hopkins called the data "astoundingly weak." Panelist Dr. Amy Newburger commented that since approximately 300,000 women had received saline implants in 2001, the company must provide better safety information. "If these data were presented to me by an undergraduate student, I would have flunked them." said Dr. Zuckerman, Executive Director of the CPR for Women and Families and a former faculty member at Vassar and Yale, in her testimony before the panel.

The Inamed/McGhan data was better designed, but showed even higher complication and re-operation rates For example, during the first five years of having implants, 45 percent of breast cancer reconstruction patients required additional unplanned surgery, 28 percent had their implants removed, 39 percent had breasts that did not match in appearance, 36 percent had capsular contracture (hardness), 27 percent had implants that were visible or could be felt, and 25 percent had implants that created a wrinkling appearance, 18 percent had implants that had moved to the wrong location, 18 percent had breast pain, and 8 percent had implants that leaked or deflated. The rates of 10 other complications such as infections, skin necrosis (death) and implants extruding through the skin ranged from 3% to 7 percent each.

The panel praised the Inamed study design, but urged them to do more to improve their implants.

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