Bayer Gets Reporting Variance on Essure MDRs

FDA has granted a Bayer request for a variance from some medical device reporting requirements, specifically reportable adverse events Bayer is or becomes aware of from social media information received in relation to ongoing litigation regarding its controversial Essure contraceptive. The agency issued a letter to Bayer outlining conditions for submitting additional postmarket information to the agency about Essure implant, which was removed from the market in 2018. The variance will expire after one year, unless FDA grants an extension, and Bayer will be required to follow the regular adverse event reporting requirements for all Essure-associated reportable events.

 

“Under the conditions, Bayer is required to start providing reportable adverse events to the FDA in 7/2020 and continue submitting additional reportable events identified through review of the information on a monthly basis,” the agency says. FDA will make these events publicly available on its Problems Reported with Essure Web page. The conditions under the variance also require Bayer to submit summaries of the reportable events that include information such as the type of event (death, serious injury or malfunction), a description of the reported patient events or device problems, and patient demographics. These summaries will be accessible through the FDA's Manufacturer and User Facility Device Experience database. “The FDA continues to require that Bayer submit Essure-associated reportable events, outside of the events specifically covered in this variance, in accordance with current medical device reporting requirements,” it says.

 

Additionally, FDA is updating the Problems Reported with Essure Web page to include updated information on the MDRs the agency has received on the device since its approval and the MDRs received in 2019. “While the number of MDRs received in 2019 is the largest received for a single year, due to the continued volume of reports citing litigation and using terms related to device removal, the source and nature of the reports are consistent with recent years,” FDA says.

 

MDRs received related to Essure in 2019 is 15,083. In 2018, FDA received 6,000 medical device reports related to Essure. In 2017, it received 11,854 medical device reports related to Essure. “In 2017 and 2018, 73% of all submitted reports cited litigation, and in 2019, 95% of submitted reports cited litigation,” the agency says, adding that litigation reports may reference information previously submitted to FDA.