Think you can tell which women have breast implants and which don’t? Well, one day there may be a list.
Not that you’re going to be able to check it. ... It’s the idea of n FDA advisory panel to create a nationwide database of women with implants in order to keep track of their health.
NPR reports that, though the FDA required the two manufacturers of silicone implants—Johnson & Johnson and Allergan Inc.—to track women who got them for ten years, the data was inadequate because so many women ended up dropping out of the research study. Without the data, judging whether there are long-term problems with silicone implants is difficult.
Dr. William Maisel, Chief Scientist for the FDA’s Center for Devices, still has faith in the safety of the implants, the New York Times reports, and they will stay on the market though he agreed that the studies by the companies were inadequate. Suggestions were made by an expert panel this week to increase participation in such studies that included paying the women who participate, paying the doctors, making the 27-page form women have to fill out less burdensome and creating that national database.
WebMD/CBS says that the studies recommended regular MRIs to check for “silent rupture,” but that the women had to pay for them— at $2,000 a scan, that wasn't ever going to happen much.
Jason T. Connor, PhD, of statistical consulting in Orlando, a temporary voting member of the panel, said that companies aren’t “incentivized to get the results we really care about.”