On Feb. 29, 2016, 2016, The U.S. Food and Drug Administration released the next steps for Bayer AG’s permanent sterilization device, Essure®, including two multipart actions in effort to provide women and physicians with better information about the potential risks associated with using Essure.
The action items include, a mandatory clinical study on Essure to determine heightened risks for certain women. The FDA also provided a draft guidance with labeling recommendations, including a boxed warning label that contains a ‘patient decision checklist’ to influence a more informed conversation between doctors and patients - making sure that potential risk factors of implanting the sterilization device have been discussed. A black box warning is the most stringent warning the FDA issues, indicating that a serious injury or death could result from the product. The checklist also recommends that it be completed and signed by the responsible physician.
“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.
According to the FDA, the mandatory clinical study will require Bayer, the company who manufactures the controversial sterilization device, to conduct a post market surveillance study. The goal of the study is to provide important information about the device in a real world environment, in an effort to better understand the risks associated with Essure in comparison to laparoscopic tubal ligation procedures.
The FDA is seeking comment from the public, industry and other stakeholder’s regarding the draft guidance. The docket will be open for 60 days
Motley Rice attorneys Fidelma Fitzpatrick and Carmen Scott represent hundreds of women who have potential Essure claims. Learn more about Essure lawsuits.