FDA Panel Votes 7-To-2 To Lift Restrictions On Mentor’s Silicone Breast Implants, With Unusually Large Number Of Post-Market Conditions

An FDA panel voted to put Mentor Corporation’s silicone gel breast implants back on the market with nine conditions, after rejecting a previous company’s application the day before.

Earlier in the day, FDA staff scientists raised significant questions about the two years of data presented by the company, specifically regarding the validity of the company’s short-term data and lack of meaningful long-term data. Agency scientists and panel members were also concerned that patients that chose to have their implants removed were excluded from Mentor’s study.

“The data were insufficient and may have intentionally left out crucial information,” said Dr. Diana Zuckerman, President of the National Research Center for Women & Families. “We still don’t know what happens to silicone gel implants in the body over time, nor has any of the research adequately addressed the number of women who have debilitating symptoms when the implants leak.”

The unusual number of post-approval conditions reflected the panel’s discomfort with the safety data on the devices. In addition to a patient registry and required doctor training, the majority of conditions focused on improving the research and continuing research for 10 years. They also required an independent annual data review and reconvening the FDA panel in five years to analyze the data.

“I’m very concerned that the patients that develop signs and symptoms are ignored and propose that data be reviewed again in five years by our panel,” said panel member Dr. Amy Newberger. Another panel member, Dr. Stephen Li, said, “This device has a 30-year history that is checkered and we need a higher standard for this device.”

Late last month, FDA released an internal report that concluded that more than half of medical device manufacturers were not performing post-market safety studies (New York Times, April 1, 2005). The agency had no information to indicate whether the studies were actually being done on over half of the products approved between 1998 and 2000.

“The agency clearly has a history of not enforcing post-market approval conditions,” said Dr. Zuckerman. “This unusually large number of post-market approval conditions can’t protect women from a bad product.”

Some panel members were concerned about the outcome. “I think it’s still too soon to define what is happening to that statistically significant group of women with signs and symptoms of connective tissue disease. The urgency was not warranted at this time,” said Newberger. Dr. Lee Lee Doyle added: “I’m very concerned about a subset of women that have a very real sensitivity to the device.”

The National Research Center for Women & Families provides consumer- friendly research-based information on a wide range of health issues affecting women, children, and families. See www.center4research.org and www.breastimplantinfo.org for more information.