FDANews
The QMN Weekly Bulletin

FDA to Examine Safety and Effectiveness of Essure Implant

Aug. 21, 2015

Following more than 5,000 complaints including reports of patient injuries and four deaths, the FDA is taking a second look at the safety and effectiveness of Bayer’s Essure birth control implant.

The agency’s Obstetrics and Gynecology Devices Panel will hold a public meeting Sept. 24 to gather feedback about the device before determining what action to take. Bayer acquired Essure when it bought Conceptus in 2013.

The Essure procedure involves permanently placing a flexible insert into each fallopian tube. Tissue forms over these inserts, creating a barrier that prevents sperm from reaching the eggs. The company claims the product is 99 percent effective in preventing pregnancy permanently, based on five-year clinical study data.

However, women using the device have reported experiencing pain and other health problems. According to the FDA, some symptoms — such as extreme fatigue, depression and weight gain — are not in the labeling and were not observed in postapproval studies or described in clinical literature.

The FDA identified 5,093 medical device reports related to Essure from the time of its 2002 approval through May 31 of this year. Commonly seen complaints include patient-device incompatibility (e.g., nickel allergy), migration of the device or one of its components, the device operating differently than expected, breakage and malposition of the device.

Of the death reports, one was related to a post-procedure infection, another to uterine perforation, a third to an air embolism during device removal surgery and the fourth due to suicide.

Bayer says it has communicated regularly with the FDA about the risk-benefit profile of Essure and welcomes the upcoming panel discussion.

No matter how well you think you may have a responded to a complaint, you may still end up with a warning letter. Learn how to integrate all your operations into a cohesive complaint management system by ordering our Secrets of Medical Device Complaint Management DVD today!