EDITORIAL – One boobie-maker for all, maybe not

Mentor Corporation has won the approval from a Food and Drug Administration advisory panel to… Mentor Corporation has won the approval from a Food and Drug Administration advisory panel to be the sole manufacturer of silicone-gel breast implants in the United States.

The recommendation came a day after the panel decided not to approve a similar product from Inamed, another manufacturer.

Of course, this decision comes with mixed reviews.

Diana Zuckerman, President of the National Research Center for Women and Families, noted the companies provided different kinds of data. She pointed out, “The company that provided more research information was the one that didn’t get approved. The company that provided less information got recommended for approval. That sends a really bad message.”

She added that the message is “a very illogical and conflicting message to the FDA, and a confusing message to women across the country who might have breast implants.”

Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, said neither product should have gotten the panel’s approval. Considering the advisory panel did not hold the two products to the same standard and none of the week’s hearings showed any significant improvement in quality of life from silicone implants, Wolfe is right.

The rupture rate of implants was reportedly the panel’s deciding factor. While Inamed gave data covering a three-year time period, with the highest rate in the third year, Mentor’s data only covered two years and had a much lower rate. But neither group provided any evidence that their respective products are any better than what was previously offered on the market.

It was concern over the rupture rate that originally led the FDA to keep the favored breast implants off the market in January 2004, against an advisory panel recommendation, upsetting some consumers and plastic surgeons that favor the more natural-looking devices.

In an effort to address valid health concerns, the advisory panel set conditions for ultimate FDA approval, which may take months. First, patients must acknowledge their awareness that their implants may break. Also, Mentor can only sell silicone implants to board-certified plastic surgeons who complete special training to insert the devices in a way that minimizes the chance of breakage. In addition, Mentor must keep a record of how patients do in the long term, and it must study how often implants rupture within 10 years — something no one knows.

The FDA should wait until someone knows for sure what happens to breast implants 10 years after insertion before approving the device’s return to the market. And if they turn out to be safe, they should be manufactured by more than one company. After all, is this country’s economic system not based on competition? If Mentor is the only manufacturer, there will be no reason to improve the product.