The Food and Drug Administration (FDA) has updated its “Problems Reported with Essure” webpage to include medical device reports received in 2019.
Essure, which was approved by the FDA in 2002, is a permanently implanted contraceptive device. The flexible coils are inserted through the vagina and cervix and into the fallopian tubes. Over approximately 3 months, as tissue forms around the inserts, a barrier is formed that prevents sperm from reaching the egg.
In 2018, following an order to restrict the sale and distribution of the device, Bayer discontinued selling Essure citing declining US sales. However, the Company was still required to conduct postmarket surveillance based on continued reports of adverse events associated with the device. In 2019, the agency received 15,083 reports related to Essure.
“Even though the device is no longer being manufactured or distributed, and hasn’t for some time, the FDA continues its engagement with Bayer on postmarket safety monitoring of Essure,” said Terri L. Cornelison, MD, PhD, director of the FDA’s Health of Women Program in the Center for Devices and Radiological Health. Part of this reporting includes information from social media related to litigation that began in November 2016.
“We are committed to ensuring that all reportable adverse events identified from this information are submitted to the agency and that they are made publicly available,” added Cornelison. Bayer will be required to provide reportable adverse events from social media information in connection with ongoing litigation related to Essure starting July 2020.
Based on a search of the Manufacturer and User Facility Device Experience (MAUDE) database, the most frequently-reported patient problems included pain/abdominal pain, heavier menses/menstrual irregularities, headache, foreign body/device fragment in patient, perforation, fatigue, weight fluctuations, depression/anxiety, hypersensitivity/rash, and hair loss, while some common device-related problems included patient-device incompatibility, device migration and breakage. Moreover, since 2002, there have been a total of 3829 reports of pregnancies in patients with Essure.
For more information visit fda.gov.