Essure Complication Complaints Doubled Since November: Report

An increasing number of women and their doctors are complaining to the FDA about complications from Essure birth control, with many indicating the implants caused pain, bloating, and other problems where it migrated to other areas of the body.  

According to an investigative report by KATU, a Portland, Oregon news station, the FDA has received at least 2,049 adverse event reports involving Essure complications as of March.

These numbers are up from just 850 complaints received by U.S. health regulators between the launch of the birth control implant in 2004 and October 2013, when Bayer updated the label warnings provided with their product to include mention of complications involving abdominal pain and device migration.

Essure birth control was first approved by the FDA in 2002. It was originally designed and manufactured by Conceptus, before recently acquired by the pharmaceutical giant Bayer. More than 750,000 women have undergone Essure birth control surgery, according to prior data released by Conceptus.

The birth control implant is offered as an outpatient procedure by many medical facilities. 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.

Complaints Led to Essure Concerns

In recent months there have been increasing concerns about the potential side effects of Essure birth control, following the report of at least one death last year and protests by women who have experienced complications, including the launch of a webpage launched by the prominent activist Erin Brockovich.

In October, the FDA released the results of their own investigation into Essure, finding that the complications, for the most part, were known during clinical trials, including the risk of pain and migration. However, the agency did note that some of the complaints, including depression, extreme fatigue, and weight gain, were not seen during the clinical trials.

The agency concluded that the benefits outweighed the risk of Essure injuries and decided to leave the device on the market. However, the agency has indicated that it will continue to monitor the complaints and reports of problems.

Among complaints submitted to the FDA are indications that women suffered intense abdominal pain and other problems. In some cases, doctors have reported seeing Essure devices migrate out of the fallopian tubes, perforating other organs and sometimes breaking. There are even cases of pregnancies alongside the devices, which are supposed to prevent them.

Experts who reference the FDA’s adverse event reporting program say that while it is imperfect, and does not establish a cause-and-effect relationship, reports are routinely very low, with possibly only one out of every 10 adverse events associated with a device reported to the agency.

Bayer has stressed that Essure should not be judged on the adverse events alone. The company states that the complaints being heard are the rare side effects that were already known to be associated with the device and say that it is more than 99% effective. The company also claims that the complaints represent just a fraction of the 750,000 devices sold worldwide.