The safety concerns raised about the Essure device have prompted the Food and Drug Administration (FDA) to ask Bayer to conduct a new clinical study regarding the complications that have been reported in Essure injury reports.

The Essure device has become a controversial subject for Bayer and its customers, as the product has been reportedly causing thousands of injuries in women including perforation of the uterus and fallopian tubes. While the FDA stated that it would not remove the Essure device from the market, the agency does acknowledge the numerous injury reports.

The agency further stated that Essure will remain available to patients, due to its many benefits and is currently the only non surgical female sterilization method. Approved by the FDA in 2002, the Essure consists of metal coils that are inserted directly into the fallopian tubes.

These coils cause the tissue to grow around the device, which blocks eggs from being released and the ovaries being fertilized. Compared to traditional tubal ligation, the procedure is non invasive and has a significantly shorter recovery time of less than a day.

At the time of its release, Essure was considered a breakthrough sterilization technique but has since been linked to numerous complications in patients. Reported Essure procedure problems include allergic reactions and fallopian tube and uterine perforation.

Essure Complications and Concerns

Given these and other concerns, the FDA recently announced that it is mandating Bayer to conduct a new clinical study regarding Essure procedure problems.

The study will analyze 2,000 patients for three years, and will compare the side effects of Essure with the side effects of tubal ligation. Under the Food Drug and Cosmetic Act, Bayer has 15 months to begin the study even the observational trial will take years to complete. In the mean time, Bayer will still be required to provide interim data as it is collected.

The FDA added its recommendation of a black box warning of uterine perforation risks for the Essure, but did not impose an actual warning. The agency stated that it would deny the public input by making its own decision regarding the warning language.

“We could have required Bayer to adopt the black box warning, but we felt it was critical to get feedback from stakeholders, including patients themselves, before finalizing the language. We want to make sure that the warnings are understood by patient community,” William Maisel of the FDA’s Center for Devices and Radiological Health stated.

Since its approval in 2002, the FDA stated nearly 5,100 Essure complication reports including four deaths. The agency indicated that the number of these reports increased from 115 in 2011, to 2,260 in 2014. The FDA contacted a review in September 2015, to address the rising concern.

However, this information is little help to patients who have already suffered Essure procedure problems. Women who suffered uterine perforation other other injuries after receiving an Essure device may qualify for legal action. Potential claimants should contact specialized lawyers as soon as possible, to see if they are eligible to file an Essure lawsuit.