On March 7, 2018, FDA Commissioner Scott Gottlieb released a statement regarding the agency’s ongoing monitoring and investigations into issues related to Bayer‘s controversial birth control device Essure. More than 750,000 women have received the implant since Essure’s approval in 2002. As of December 31, 2017, the FDA has received 26,773 medical device reports related to Essure describing adverse events such as such as abdominal pain, abnormal uterine bleeding and device migration. In the statement, Mr. Gottlieb noted that the FDA is working to gain more information on the influx reports.
In response to the medical device reports, the FDA first convened a panel of medical experts in the fall of 2015 to better understand concerns regarding Essure. In February 2016, the agency ordered Bayer to conduct a postmarketing study to evaluate the device’s safety. Later that year, the FDA mandated that a black box warning be added to Essure’s labeling and a Patient Decision Checklist be discussed between physicians and their patients to inform patients of the risks of the device. Last September, Bayer halted sales of Essure outside the US.
If you or a loved one suffered complications after receiving an Essure implant, please contact us by calling us at 888-985-7228 for a confidential evaluation of your potential claim.