Essure Problems, Safety Concerns to be Reviewed by FDA Panel
Amid continuing complaints involving problems with Essure, as well as concerns about the safety and effectiveness of the birth control implant, the FDA will hold public panel hearings to determine what, if any, regulatory actions may be necessary.
The FDA has announced that it will convene a meeting of the Obstetrics and Gynecology Devices advisory panel on September 24, to examine the science and concerns around Bayer’s Essure implant, which has been linked to reports of severe complications among women throughout the U.S.
Essure is an implant offered as an outpatient procedure by many medical facilities to provide long-term birth control. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.
The FDA indicates that it has received 5,093 adverse event reports regarding potential Essure problems between the device’s approval in November 2002 approval date and May 31, 2015. Most of those reports were voluntary from women who received the implants.
According to the FDA adverse event reports, 3,353 of the reports it received were of abdominal pain, 1,408 were of menstrual irregularities, 1383 involved headaches, 966 were reports of fatigue , and 936 were reports of weight fluctuation.
Among the reports were at least four adult deaths on Essure. Two of those fatalities were directly attributable to the Essure implant and included a death due to uterine perforation and one due to an air embolism that occurred when the device was removed. A suicide and a post-operative Group A Strep infection were listed as causes for the other two fatalities.
The uterine puncture death on Essure was reported by Bayer to the FDA in February, just after a citizen’s petition for an Essure recall was filed with the FDA, noting multiple reports of severe and debilitating problems associated with the implant, including extreme abdominal pain, excessive bleeding and internal organ injuries.
In March, the FDA Center for Devices and Radiological Health rejected the petition, saying it was misfiled. However, the petition and its details were forwarded to the FDA’s Office of Compliance, which reportedly will conduct an investigation of the complaints.
Concerns over the birth control implant gained substantial media attention in the summer of 2014, following Congressional testimony involving an Essure injury during a briefing by the National Center for Health Research that called for legislation to improve the FDA approval process.
Bayer, which bought the original company that designed the Essure implant and now markets the device worldwide, has downplayed the complaints, maintaining that there are relatively few cases out of the Essure implants used worldwide.
The results of the proposed advisory committee hearing, and any votes the committee takes, are non-binding on the FDA. However, the agency usually follows the recommendations made by its advisory committees.