FDA Working ‘Expeditiously’ on Review of Bayer’s Essure

In the wake of more than 5,000 adverse events reports, including four deaths, the FDA says it plans to communicate next steps it plans to take on Bayer’s Essure contraceptive implant by the end of next February.

The controversial implant has received a lot of negative publicity, with women saying they had experienced numerous adverse events after implantation with Essure, such as bleeding, autoimmune diseases, painful sexual intercourse, unplanned pregnancies, weight gain, tooth and hair loss and excruciating pelvic and abdominal pain.

The FDA has taken notice. “This is a high priority issue for the agency, and we are working expeditiously to conduct an evidence-based review of the available information and identify appropriate next steps,” the FDA says on a notice posted to its website.

During a September meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, several women testified about pain and other adverse events they had experienced (IDDM, Sept. 25). The panel recommended that a patient registry be created to document these events.

The agency says it is reviewing information from the panel meeting, an associated public docket, as well as medical literature and adverse event reports published or received since the panel meeting.

Several members of Congress have called on the FDA to remove Essure from the market. A bill that would move that effort forward — H.R. 3920, The E-Free Act — was introduced by Rep. Michael Fitzpatrick (R-Pa.) earlier this month (IDDM, Nov. 13). Reps. Marsha Blackburn (R-Tenn.), Christopher Smith (R-N.J.) and nonvoting member Gregorio Sablan (I-N. Mariana Islands) are cosponsoring the effort. The bill has been referred to the House Energy and Commerce Committee. — Elizabeth Hollis