Silicone under scrutiny once again

U.S. health regulators say they’ll convene a meeting of medical advisers next year to discuss new science on breast implant safety, including an independent analysis that was published over the weekend suggesting certain rare health problems might be more common with silicone gel implants.

The Food and Drug Administration said it would hold the meeting even as officials disputed the work.

The study involves nearly 100,000 women and is the largest long-term safety analysis of silicone implants since 2006, when they were allowed back on the U.S. market after a 14-year gap due to safety concerns.

“We completely stand behind this study and we do feel it’s our best data to date,” said lead researcher Dr. Mark Clemens, a plastic surgeon at the University of Texas MD Anderson Cancer Center.

Each year in the U.S., about 400,000 women get an implant and most choose silicone over saline.

Complications can include infections, wrinkling, scarring, pain, swelling and implant rupture.

But the agency decided there was not enough evidence to tie silicone implants to other problems such as immune system and connective tissue disorders, so it approved devices from two makers — Allergan and Mentor Corp. — in 2006.

FDA required them to do more studies.

Critics say there’s a fundamental flaw in the data used for the analysis: One implant maker required proof of diagnosis by a doctor rather than just a patient reporting a problem; the other did not.

“This study is messy,” said Dr. Andrea Pusic, plastic surgery chief at Brigham and Women’s Hospital in Boston.