FDA Is No Longer Messing Around with Bayer & #039;s Essure

FDA turned up the heat Monday on Bayer to make sure women who are considering the implantable contraceptive device are adequately informed of its risks. Now, patients must be given the opportunity to sign an acceptance of risk and informed decision acknowledgment, and the same "patient-doctor discussion checklist" must be signed by the physician implanting the device. The agency said Bayer will be required to implement the restrictions immediately and ensure that the process going forward results in healthcare provider compliance with the sales restriction. FDA said it will review and monitor the company's plan to ensure it complies with the restriction, and the agency threatened to take "appropriate action for failure to comply, including applicable criminal and civil penalties." 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. It seems some women, however, never received that information before having the Essure implanted. "Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information," said FDA Commissioner Scott Gottlieb, MD. "That is simply unacceptable. Every single woman receiving this device should fully understand the associa...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Business Source Type: news