Essure, a widely used permanent form of birth control, has been scrutinized because of the numerous accounts of serious complications associated with the device. As a result, thousands of women have filed Essure injury cases in court.

Essure is a non-surgical form of permanent birth control made by Bayer HealthCare. It consists of two metal and polyester coils that are implanted vaginally into the fallopian tubes of a woman wishing to be permanently sterile.

Those coils are implanted during an outpatient procedure with little pain and with few side effects, Bayer claims.

Over time, these coils create a blockage of tissue in each fallopian tube which prevents eggs released from the ovaries to meet with the partner’s sperm. This occurs within three months of implantation, however, and a patient must return to her doctor to be checked to see if proper blockage of the fallopian tubes has happened.

The Essure procedure is marketed as superior to tubal ligation because it does not require a surgical procedure and does not need excessive recovery time. It was approved by the U.S. Food and Drug Administration in 2002 through a fast track process.

However, women who have received the Essure device have complained of a host of side effects, some so severe that the devices must be explanted.

Essure injury cases have been numerous in recent years. Women have reported serious complications such as bloating, rashes, allergic reactions, excessive bleeding, organ perforation, pelvic pain and even miscarriage and ectopic pregnancy.

Some reports have even claimed that women have died from Essure complications.

Those women who report Essure injury cases claim that they were not informed about the possible serious risks associated with Essure. They also claim that the device was not tested properly and that Bayer HealthCare knew or should have known about all the problems.

Response from the FDA to Essure Injury Cases

There have been so many Essure injury cases over the last few years that the FDA, in 2015, called a special Advisory Committee meeting to look at the reports of Essure complications and discuss the ongoing use of the medical device.

As a result, the FDA ordered Bayer to conduct a postmarket study to obtain more data about the benefits and risks of using Essure. In September 2016, the plan was approved by the FDA, and the FDA hopes that data gathered from this survey will help to inform future actions by the agency.

Additionally, the FDA ordered updated labeling and information in the patient guide for Essure. The Advisory Committee noted, according to the FDA, that “medical device labeling for permanent birth control methods, including Essure, is not clear and many patients do not receive enough information before making a decision.”

To avoid future Essure injury cases, the FDA has noted that the boxed warning should better communicate with patients and doctors about the risks and potential needs for removal. Also, a patient decision checklist should be presented to potential Essure patients with key information about the device including its use and safety.

If you or someone you love has been suffered from Essure complications, you may benefit from speaking with an attorney. Essure injury cases have been filed by thousands of women to help alleviate the costs associated with medical bills and lost wages.