FDA Schedules September Meeting to Discuss Safety and Effectiveness of Essure Permanent Contraceptive Device

The U.S. Food and Drug Administration (FDA) has received 5,000 adverse event reports since 2002 concerning Essure, an implant designed to make women permanently sterile.  Most of the reports were submitted since 2013, however.

From November 4, 2002, when the FDA approved Essure, through May 31, 2015, the agency received 5,093 adverse event reports through its Manufacturer and User Facility Device Experience (MAUDE) database, the agency reported Wednesday in updates to its web page on the device. From 2002 through October 25, 2013, the FDA only received 943 reports, meaning that 81 percent of the grand total were received in the past 19 months. The majority of the reports were submitted voluntarily, mostly by women who had received the implants, according to Medscape.com.

The FDA told Medscape.com that one post-approval study of Essure “did not demonstrate any new safety problems or an increased incidence of problems since the time of the device approval.” The agency’s Obstetrics and Gynecology Devices Panel will hold a hearing September 24 to discuss the device’s safety and effectiveness.

The Essure device is a small, metal and polyester coil that a doctor inserts into a woman’s fallopian tubes by a catheter that passes through the vagina into the cervix and uterus. The implant causes tissue growth that renders fertilization of an egg impossible, The Wall Street Journal (WSJ) reports.

Medscape.com explains the FDA launched its investigation into Essure after a law firm asked the agency to take the implant off the market. The firm said it had made the request on behalf of hundreds of women who alleged the device migrated from their fallopian tubes and caused them serious injury included perforated organs and pain.

Of the 5,093 Essure adverse event reports submitted to the FDA, the most common complaints included pain (3353), heavier menses and menstrual irregularities (1408), headache (1383), fatigue (966), and weight fluctuations (936). The majority of reports included more than one patient complaint. Hundreds of problems with device itself were also reported including patient-device incompatibility, such as a possible nickel allergy (941), migration of the device or one of its components (482), the device operating differently than expected (301), device breakage (259), and malposition of the device (133). Some of these reports cited more than one problem, according to Medscape.com.

Four deaths were reported through MAUDE. One resulted from an infection after the implant procedure, one was caused by uterine perforation, surgery to remove the device resulted in one death, and one patient committed suicide. Five fetal deaths were also reports in pregnancies where the mother conceived despite Essure, WSJ reports.

On Wednesday, the FDA updated its explanation of Essure benefits and risks, Medscape.com notes. Besides pain during and immediately after placement, short-term risks include cramping, vaginal bleeding, and pelvic or back discomfort. Some of the long-term risks are ectopic pregnancy, pelvic pain, device migration into the lower abdomen and pelvis, perforation of the uterus or fallopian tubes, and rash and itching associated with a possible nickel allergy.

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