In response to more than 5,000 reports of adverse events and side effects of the Essure birth control implant, the Food and Drug Administration (FDA) has scheduled a hearing for September 24 to evaluate the safety and effectiveness device.
The FDA said it has received 5,093 reports of adverse events—including deaths—among women who received the Essure permanent birth control implant. In the twelve years since Essure’s approval, the agency has received reports of four deaths of women who used the device, as well as five reports of deaths of fetuses in women who became pregnant despite the implant, the Wall Street Journal reports. The device has been on the market since 2002.
The Essure implant is permanent birth control method. A metal and polyester coil is inserted through a catheter into the woman’s fallopian tubes. The coil causes scarring that blocks the fallopian tubes, preventing fertilization and making the woman permanently sterile. About 750,000 Essure devices have been implanted worldwide, according to the WSJ. The device can be inserted in a doctor’s office.
In a search of the MAUDE database (Manufacturer and User Facility Device Experience) for the period November 4, 2002 through May 31, 2015, the FDA found 5093 medical device reports related to Essure. In those reports, the most frequently cited problems were pain/abdominal pain (3353), heavier menses/menstrual irregularities (1408), headache (1383), fatigue (966), and weight fluctuations (936). The FDA said most of the reports received listed multiple patient problems.
The most frequent problems related to the device itself were patient-device incompatibility (941), including nickel allergy, migration of the device or a component (482), device operating differently than expected (301), device breakage (259), and malposition of the device (133). Some women with Essure devices have become pregnant and there have been instances of the implant migrating through the fallopian tubes and requiring surgery. Among the deaths reported, the FDA said that one death resulted from an infection following the implant procedure, one related to uterine perforation, another stemmed from surgery to remove the device, and one was a suicide. Women who become pregnant with Essure in place are more likely to have an ectopic pregnancy—where the embryo implants outside the uterus—which can be life threatening to the woman.
Conceptus, Inc., the manufacturer of Essure, was acquired by Bayer AG in 2013. Bayer said in a statement that it “has been in regular communication with the FDA about the risk-benefit profile of Essure and the informational needs of both healthcare providers and patients,” according to the WSJ. A number of lawsuits involving Essure have been filed against Bayer. Women who allege they were injured by Essure mounted a recall campaign, with the assistance of noted activist Erin Brockovich.
At the September meeting, the FDA’s Obstetrics and Gynecology Devices Panel will gather feedback from presenters, panel members, and the public “to inform recommendations and next steps about Essure.” The FDA will consider evidence for complications associated with Essure that occur more than five years after placement.