FDA takes action after hearing complaints about popular birth control
WASHINGTON (WJLA) - The Food and Drug Administration is taking some action after hearing complaints from thousands of women about a popular birth control device.
In January 7 On Your Side exposed concerns tied to Essure, a device implanted in a woman’s fallopian tubes. And now the FDA is ready to hear more from the public and industry experts.
When 7 On Your Side reported about problems associated with Essure in January, the FDA had less than 1,000 adverse event reports linked to the device. Now the agency reports that number has jumped by five times, with 5,093 adverse event reports listed in the official database that tracks issues linked to medical products and devices.
In a recent move, the FDA announced it planned to stage a meeting of the Obstetrics and Gynecology Devices advisory panel on September 24th. That meeting, according to the agency, will allow for feedback about Essure from members of the public as well as presenters and panel members. Additionally, the FDA’s website has been updated with both short and long term risks associated with the device.
The change to the site and meeting announcement came with mixed reaction from the 18,000 women who’ve joined together via social media to share concerns they associate with Essure. The group has been vocal on Facebook, calling for the device to be pulled from the market. It’s a step group administrators are still holding out hope will happen. Members of the group tell ABC7 they plan to attend the FDA’s panel to voice their concerns. The group previously met with FDA representatives in the spring and also lobbied members of Congress for support.
Bayer, which now manufactures Essure after buying the product from its original manufacturer, is also reacting to the FDA’s action. A spokeswoman tells ABC7, “Patient safety is Bayer’s top priority. Given there has been a great deal of interest in the safety of Essure among some patients, we welcome this open dialogue with healthcare providers, patients, researchers, representatives from professional societies, and other members of the public to review and discuss available data regarding the benefits and risks associated with Essure.”