Patients who experienced adverse side effects after using the Essure permanent birth control device may be eligible for compensation.

Essure is a permanent birth control device that Bayer HealthCare marketed as a non-surgical alternative to tubal ligation. When the device was released, it was considered a breakthrough contraceptive device for permanent sterilization since it was non-surgical and lower risk that a tubal ligation surgery. Due to the breakthrough expectations of the device, the FDA approved Essure through a fast track review in 2002.

The Essure device is composed of two flexible coils made of metal and polyester. One coil is placed in each fallopian tube in a non-surgical procedure. Over the course of a few months, scar tissue develops around the coils, blocking the ovaries from releasing eggs into the uterus. After three months, women are supposed to be evaluated by their doctors to ensure that the procedure worked, and sufficient scar tissue developed.

However, many women have reported serious complications after using the permanent birth control device. Reported complications include bloating, rashes, allergic reaction, excessive bleeding, organ perforation, pelvic pain, miscarriage, and ectopic pregnancy. Since the device’s approval, more than 4,500 adverse events reported have been filed with the FDA.

Many consumers argue that the permanent birth control device was approved too quickly and adequate testing was not completed. Thousands of consumers across the country have lobbied for the FDA to remove Essure from the market due to the excessive adverse reports filed.

In response to consumer lobbying and an influx of reports, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel, a subset of the Medical Devices Advisory Committee, in September 2015. In February 2016, the FDA held a press conference announcing their plan of action regarding Essure. They issued a new, mandatory clinical trial to evaluate the risks of the permanent birth control and implemented changes to the product’s labeling, including a boxed warning and a patient checklist. Bayer was also ordered to conduct a new post-market surveillance study.

“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” said William Maisel during the press conference. Maisel is the deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.

However, new actions and regulations for Essure do not benefit women who have already experienced pain and suffering from the device, leading some women to pursue legal action. Women who file an Essure lawsuit allege that they were not informed about these possible side effects when they decided to get the permanent birth control device. These lawsuits typically argue that Bayer needs to be held accountable for not disclosing all the side effects associated with Essure.

If you or a loved one experienced adverse side effects associated with the Essure permanent birth control device, you may be eligible for an Essure class action lawsuit investigation. An Essure lawsuit could help recover compensation for medical bills, lost wages, pain and suffering, and more.