FDA Reveals Essure Birth Control Device Linked To Higher Incidence Of Pain, Bleeding

The Food and Drug Administration (FDA) announced Wednesday, July 8, they found new data on the potential side effects of Essure birth control devices, which are no longer available in the market.

The data is based on the side effects of continually using the Essure birth control device public. Complaints about its side-effects, including chronic pelvic or lower abdominal pain and abnormal uterine bleeding, forced its manufacturer to pull the product off the market two years ago.

The FDA released initial results of the postmarket study it ordered Bayer, the product's manufacturer, to undertake.

Results showed 9.1% of participants in the Essure group and 4.5% in the tubal sterilization treatment group experienced greater incidences of pelvic pain or lower abdominal discomfort following each procedure. Researchers also found 16.3% in the Essure group and 10.2% in the tubal sterilization treatment group suffered abnormal uterine bleeding. Interim data also revealed women fitted with Essure had greater rates of gynecologic surgical procedures, including operations to remove the device, compared to patients who opted for tubal ligation.

Pregnancy rates among patients who got tubal ligation and Essure were similar. Dr. Terri Cornelison, FDA Health of Women Program director, announced the study's findings in a statement. She also revealed 1,128 women participated in the study at 60 different investigational centers in the United States. They were divided into two groups with 788 patients going to the tubal sterilization group and 340 patients enrolled in the Essure group.

The FDA in 2016 ordered Bayer, the pharmaceutical company that sells Essure, to collate additional information on the risks and benefits of the birth control device. The federal agency also told the pharmaceutical company to compare the data with laparoscopic tubal ligation, an invasive birth control procedure characterized by having the fallopian tubes of a woman tied up.

In 2018, Bayer said it would stop distributing or selling the Essure device in the U.S. The FDA then asked Bayer to extend the postmarket surveillance research from three to five years. The federal agency revealed a five-year follow-up of patients involved in the study was ongoing and participants were still completing their one-year follow-up visits.

Dr. Cornelison said while Essure was no longer in the U.S. market, the FDA remained steadfast in its commitment to evaluate long-term safety information in women, particularly those who received the device. This includes information from the FDA-required postmarket surveillance research.

She added the FDA is currently working with Bayer, the manufacturer of Essure, to modify its research to include additional interim examination at one year of follow-up after the patient received the permanent birth control procedure.

"We believe this change is important to continue to closely monitor patient outcomes and communicate about the results in a more meaningful way," she ended.