Essure Birth Control Placement May Be Confirmed By Transvaginal Ultrasound: FDA

Bayer Healthcare is reporting that the FDA has approved the use of transvaginal ultrasounds to check on the placement of Essure birth control, a contraceptive implant that has been linked to thousands of reports involving complications and even deaths. 

The new testing method was announced in a Bayer Healthcare press release on July 1, indicating that transvaginal ultrasound (TVU) can be used as an alternative to the current method of confirming the Essure’s proper placement; a modified hysterosalpingogram (HSG), which involves taking an x-ray of the uterus and fallopian tubes. The new TVU technique instead uses sound waves to generate an image.

According to Bayer, the test must be done within three months of the Essure placement. Until the results are confirmed, women should use alternative means of birth control.

“We are very pleased that the FDA has approved the TVU confirmation test for Essure. TVU provides an additional method for physicians to check that the device is properly placed and a woman can rely on Essure for birth control,” said Dr. Patricia Carney, director of Bayer’s US Medical Affairs, Women’s Health division, in the press release. “TVU is approved as a safe and effective confirmation test option for appropriate patients that can be performed in a physician’s office without an x-ray and does not require use of contrast dye.”

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 complications between the device’s approval in November 2002 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 FDA has scheduled an advisory committee meeting in September to discuss the safety and risks of the Essure implant. Following the hearing, the agency will determine what, if any, additional regulatory actions are needed to address Essure safety issues.