Did FDA Miss the Mark on the Essure Controversy?

FDA has ticked off the E-Sisters again. That's the informal name given to the Essure Problems patient advocacy group, which has been fighting for years to get the controversial birth control device off the market. In a statement released March 7, FDA Commissioner Scott Gottlieb updated the public on the agency's postmarket review of the device, which is now sold by Bayer. Gottlieb said the agency received nearly 12,000 medical device reports for Essure in 2017, the majority of which were received just in the last quarter of the year. Most of this new information comes from cases that were made available by plaintiff attorneys as part of litigation against Bayer, and Gottlieb said the agency is trying to find out if these are new safety concerns or if they have been reported in a prior safety filing. More than 90% of the 2017 reports mentioned issues involving potential device removal, which he said the agency is also further investigating. FDA added a boxed warning to Essure in 2016 and ordered Bayer to run a new postmarket surveillance study on the device, as well as provide a patient decision checklist to ensure that women considering the permanent birth control option were fully informed of the procedure's risks and benefits. Activists argued at the time that these actions were not enough. "Last month I had the opportunity to meet with consumers who have been affected by the medical device Essure to listen and learn about their concerns," Gottlieb said, noting that ro...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Regulatory and Compliance Source Type: news