FDA has scheduled a hearing to evaluate the overall safety and effectiveness of Essure sterilization implant. The Food and Drug Administration (FDA) has scheduled a hearing of the Obstetrics and Gynecology Devices Panel for September 24 to evaluate the overall safety and effectiveness of the Essure sterilization implant.
The FDA said it has received more than 5,000 reports of adverse reactions-including some deaths-among women who received the Essure permanent birth control implant. The agency said that over 12 years, it 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 in the U.S. since 2002.
The Essure implant is a nonsurgical sterilization method. A metal and polyester coil is inserted through a catheter into the woman’s fallopian tubes and causes the build-up of scar tissue that blocks the fallopian tubes, preventing fertilization and rendering the woman permanently sterile. About 750,000 Essure devices have been implanted worldwide. The device can be inserted in a doctor’s office and the procedure does not require hospitalization.
FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database
The FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database. From Nov. 4, 2002, Essure’s approval date, through May 31, 2015, the FDA received 5093 medical device reports related to Essure.
In the 5,093 adverse event reports received by the FDA, 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 device problems reported 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 have become pregnant despite the implant and there have been instances of the implant migrating through the fallopian tubes and requiring surgery.
The FDA says that among the deaths reported, one 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 dangerous and life-threatening.
Bayer AG acquired Essure in 2013 when it purchased the manufacturer, Conceptus Inc. In a statement, Bayer said 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. Several lawsuits over Essure have been filed against Bayer.
The FDA said that it plans to monitor the safety of the device to “ensure it does not pose an increased risk to public health.” At the September meeting, the FDA 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.