FDA Essure Actions Draw Lawmaker Ire, Demand For Product Withdrawal

01 Mar 2016

While FDA has gone beyond an advisory committee recommendation to require a registry to monitor Bayer's Essure permanent contraception device, lawmakers say the agency's call for a new postmarket study and black box labeling requirements spelled out in a draft guidance are insufficient to address serious concerns with safety.

FDA is taking two separate actions in response to concerns about adverse reactions to Bayer AG's Essure permanent infertility implant. However, at least two lawmakers critical of the implant are continuing calls to remove the product from the market.

On Feb. 29, FDA announced its actions after months of review of thousands of adverse events recorded from women who...