An Essure side effects study ordered by the FDA is underway, but it may be several years before it yields final results.

Following a September 2015 advisory committee meeting and thousands of reports of complications associated with Essure birth control implants, the FDA ordered the device’s manufacturer Bayer to conduct an Essure side effects study to gather more information about how the implants are performing in patients.

Bayer responded to the FDA’s order by submitting a plan for the study in March 2016, which the FDA approved with updates in September 2016.

The final report from the study will not be due until 2023.

The agency also required Bayer to change its labeling to better inform patients and doctors about the risks of Essure complications.

The new Essure label contains a black box warning alerting patients to the significant side effects associated with Essure.

Bayer will also be required to include a Patient Decision Checklist with Essure. The checklist is designed to be reviewed by the patient in consultation with her doctor, covering “key items about the device, its use, and safety and effectiveness outcomes.”

Reports of Complications Lead to Essure Side Effects Study

Essure is an implantable birth control system designed as an alternative to permanent surgical sterilization.

Two Essure coils are inserted into the fallopian tubes and left in place, where over the course of a few months they are supposed to stimulate the growth of new tissue that ultimately occludes the fallopian tubes, preventing fertilization.

At least 10,000 reports of complications associated with Essure birth control implants have been filed with the FDA. According to some of these reports, Essure implants have broken, migrated out of position or perforated the fallopian tubes and surrounding tissues.

Women by the thousands have reported abdominal pain, menstrual irregularities, headache, fatigue, and fluctuations of weight. Some women with metal allergies say they suffered an allergic reaction to the nickel inside the implants.

The FDA also notes receipt of over 600 reports of pregnancy that occurred after implantation of Essure. Nearly 100 of those pregnancies were reported as being ectopic.

So far, however, the FDA has allowed Essure to remain on the market.

Congressman Mike Fitzpatrick of Pennsylvania isn’t satisfied with the multi-year time frame for the Essure side effects study.

He expressed concern about the number of women who could be harmed in the years it takes to complete the Essure side effects study.

In a letter dated Sept. 22, Fitzpatrick and six other Congress members have called on the Committee on Energy and Commerce to hold hearings on “the impact unsafe medical devices have had on patient outcomes” and to investigate ways to improve the FDA’s methods of responding to evidence of unsafe medical devices.

Many women who say they suffered excessive complications because of Essure have become plaintiffs in a new wave of products liability litigation.

Generally, these plaintiffs allege Bayer failed to adequately warn them about the risks of Essure complications.

They frequently accuse Bayer of purposely suppressing information about these complications, preventing patients from making an informed choice about their birth control options.