FDA Restricts Sale of Bayer Permanent Contraception Device
FDA to limit distribution of Bayer’s Essure device to guarantee women considering permanent contraception are provided with adequate risk information.
The FDA issued an order to restrict the sale and distribution of Bayer’s Essure device to guarantee that all women contemplating the use of the permanent contraception device are provided with adequate risk information. Recently, the FDA has become aware that women were not adequately informed of Essure’s risks before receiving implantation of the device, despite past significant efforts to educate patients and doctors about the risk associated.
“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,” Scott Gottlieb, MD, FDA Commissioner, said in a statement. “We take the concerns of all women affected by Essure very seriously.”
The FDA is mandating a unique type of restriction on the device to restrict the sale and distribution, imposing additional requirements needed to provide a reasonable assurance of its safety and effectiveness.
In February 2016, the FDA ordered Bayer to conduct a post-market (522) study to better evaluate the safety profile of the device when used in the real world, then in November 2016, the agency required Bayer to add a boxed warning to the product labeling stating information about adverse effects associated with the device. Additionally, the FDA required a more comprehensive patient decision checklist to provide women considering Essure information about the benefits and risk of the device.
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