FDA Issues Order Restricting Sales of Contraception Device

Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement. The labeling will now restrict the sale and distribution of the device only to healthcare providers and facilities that provide the required information to the patient. The patient must also be given the chance to review and sign the acknowledgement, as well as the physician implanting the device. Bayer, the device manufacturer, is required to implement the restrictions immediately and ensure that the process going forward results in health care provider compliance with the sales restriction. The FDA will review and monitor Bayer’s plan to ensure the company complies with the restriction. The FDA plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties. FDA Commissioner Scott Gottlieb, M.D., stated, “We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option. We take the concerns of all women affected by Essure very seriously. I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs