As this was being written, Reps. Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) were introducing a package of bills aimed at fixing the FDA’s flawed medical device approval process. WRIC.com 8News in Richmond, Virginia reports the recent release of a study that shows this proposed legislation is crucial to patient safety, especially in the area of women’s health. The study shows FDA used flawed data to approve devices, including Essure.The study comes from Northwestern University and reviews data regarding OB-GYN devices the FDA approved over the last 15 years. It may surprise some (others not so much) that many of these devices hit the market based on flawed data. Examining 18 medical devices, most used for contraception or to reduce menstrual flow, the researchers discovered that 22% got FDA approval despite failing to show effectiveness during clinical trials.The researchers also found that Bayer’s “permanent” birth control device Essure, partly made of nickel, got its FDA approval with only short-term evidence and a glaring lack of sufficient post-market follow-up. This is not news to those of us following the story and it certainly wasn’t a surprise to 8News. They investigated the issue last year and came to the same conclusions, based on interviews with other researchers.

8News Investigates, image courtesy of www.wric.com.

The official FDA response to 8News is that the agency doesn’t “comment on individual studies but considers them in terms of how they evaluate safety.” Obviously, the system is broken and the bills being announced today to fix it are much needed.Over 30,000 women have been injured by the Essure device in the U.S. alone. As the saying goes, “I’m not a doctor and I don’t play one on TV,” but even I could tell you that an implantable device comprised partly of nickel, one of the most allergenic metals known, was going to cause problems. Many people can’t wear nickel-based jewelry or eyeglass frames; now imagine implanting that same metal in a woman’s fallopian tubes. Ludicrous!Here’s hoping the newly-proposed package of legislation, as well as Rep. Fitzpatrick’s “E-Free Act” (a bill that would take Essure off the market) are well-received in Washington when it comes time to vote on them.Source:

Study finds flawed data to approve Essure