Essure Injury Resource Center

The Food and Drug Administration (FDA) told Bayer-manufacturers of Essure-they must undergo a new postmarket surveillance study due to the heightened risks to patients. While the FDA believes Essure remains an appropriate option for the majority of women, some women may be at risk for serious complications, the FDA said in a statement now removed from their website. Essure was approved on November 4, 2002. According to the FDA, From Nov. 4, 2002, Essure’s approval date, th...rough May 31, 2015, the FDA received 5093 medical device reports related to Essure. The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants. Unfortunately, the FDA still has not selected to revoke the Essure PMA. However, the effort to revoke the PMA application is ongoing. Instead, the FDA released a statement recommending that devices, such as Essure, include a Black Box warning label, a label required for devices that potentially cause death or serious injury, explaining the possible side effects. The agency’s recommendation was published as a draft guidance with labeling recommendations for Essure. The FDA will finalize the guidance information after receiving comments from the public and the industry for two months. Know Your Rights In cases where it can be shown that the manufacturer of the medical device lied to the FDA to obtain approval, or failed to report adverse events with the product, a product liability case may be viable. It is important to protect your legal rights and have a case on file. Contact an Essure injury attorney at Kershaw, Cook & Talley for a free case consultation at 877-925-5011, or fill out our confidential online form found on this page.