Essure Side Effects

Thousands of women have reported problems with the Essure device. It may migrate from the tubes, perforate organs, break into pieces, and corrode (because of the metal content), causing further bodily damage. The FDA notes that some women implanted with the device may be at risk for serious complications, including persistent pain, perforation of the uterus or fallopian tubes, abnormal bleeding, and allergy or hypersensitivity reactions.

Between November 4, 2002—the date the device received FDA approval—and December 31, 2017, the FDA received 26,773 medical device reports related to Essure. The most frequently reported problems were abdominal pain, heavier menstrual periods and menstrual irregularities, headaches, fatigue, and weight fluctuations. The most frequent problems reported with the device included:

• possible nickel allergy
• migration of the device or pieces of the device
• dislodged or dislocation of the device
• device breakage
• device operating differently than expected
• difficulty implanting or removing the device
• malposition of the device

There were 40 reports of deaths, including 10 adult deaths, 20 incidences of pregnancy loss, four infant deaths, and two ectopic pregnancies. The FDA has also received over 1,800 reports of pregnancies in patients receiving the Essure devices between 2002 and 2017. Of those, 365 live births were reported, and 875 pregnancy losses. Over 600 didn’t indicate in the reports whether the pregnancy resulted in a live birth or not. Of the losses, 327 were ectopic pregnancies. The FDA noted that confirming whether the device caused these events is difficult based solely on the reports.

FDA Takes Action to Warn Doctors and Women About Essure

When the FDA first approved the Essure device in 2002, it required the manufacturer to conduct two additional post-approval studies. The first study looked at data from participants in the premarket clinical trials to evaluate how effective Essure was preventing pregnancy, how safe the implanting procedure was, and show safe the device was after it was implanted.

Results showed that some of the women experienced complications, including perforations and expulsion of the device. The FDA, however, stated that “overall results from this study did not demonstrate any new safety problems or an increased incidence of problems since the time of device approval.”

The second study evaluated the implantation procedure, to evaluate training procedures and updating the labeling.

Despite the outcomes of these studies, the FDA remained concerned about the increasing number of medical device reports submitted to the adverse event database. In September 2015, the FDA held a public meeting of the Obstetrics and Gynecology Devices Panel to discuss data pertaining to Essure’s safety and effectiveness.

At the meeting, scientific and medical experts and women who had suffered from problems with the device were heard. The committee was then asked to provide recommendations regarding the appropriate use for the device, product labeling, and the potential need for additional studies.

In a summary of the meeting, the FDA noted that the panel discussed a range of events associated with Essure, including persistent pain, perforation of the uterus and/or fallopian tubes, device migration, abnormal bleeding, allergic reactions, pregnancy, and device removal.

The FDA talked about a need for “better patient materials to support their decision-making process,” and expressed a desire for additional post-market data to better understand the risks. It also suggested that patients with known sensitivities to metal, those with autoimmune diseases, and those with a history of pelvic inflammatory disease may be at a higher risk for developing side effects.

On February 29, 2016, the FDA took additional action to find out more about Essure by issuing a new, mandatory clinical study to determine risks for particular women. The FDA also made clear its intent to change the product labeling to include a boxed warning, the most serious type of warning, “to help to ensure women receive and understand the benefits and risks of this type of device.” It further released a draft guidance for public comment.

On September 2, 2016, the FDA approved an additional study plan to help better understand certain Essure complications. Then on October 31, 2016,  it issued the final guidance for the device, taking into account the advice from the 2015 panel meeting, as well as public comments. The FDA also advised that certain new information should be added to the patient and physician labeling, including:

• a boxed warning on the product to help increase awareness of potential Essure side effects and complications, and
• a “decision checklist” with key items about the device, its use, and safety and effectiveness outcomes, “which the patient should be aware of as they consider permanent birth control options.”

Finally, on April 9, 2018, the FDA announced that they were restricting sales of Essure to only doctors and healthcare facilities who use the aforementioned discussion checklist: “Sale and distribution of Essure is limited to healthcare providers who agree to review this checklist with patients, and give them the opportunity to sign it, before Essure implantation.” These changes were instituted to ensure that every woman was informed of the risks before deciding whether to have the device implanted.

Specifically, doctors must give women the Essure patient brochure. This document includes the patient-doctor discussion checklist, which the patient must review. Once she has read it, she must sign it, and the physician must also sign it before implanting the device.

They also approved Bayer’s new labeling for the product, which includes the checklist and an alert that sales are restricted to facilities that provide the risk/benefit information to patients.

According to CBS News, some public health advocates still don’t believe these changes are enough to protect women, particularly because the product brochure is lengthy and technical, which may discourage some women from reading it before signing their agreement to implantation.