Thirty women have filed a massive lawsuit against Bayer Healthcare and its related companies alleging that they suffered severe complications from Essure, a permanent birth control device.

Essure was FDA approved in 2002 based on clinical trials of fewer than 1,000 women and was manufactured by Conceptus. Bayer later acquired Conceptus and took over the manufacturing.

The device consists of small metal coils that are implanted during an in-office procedure into a woman’s fallopian tubes. After the coils are placed, the body mounts an inflammatory response to the foreign objects, causing scar tissue to form in the fallopian tubes.

After a period of about three months, the fallopian tubes become completely blocked, blocking sperm from fertilizing any eggs, and preventing pregnancy.

Many women were very excited at the prospect of being able to have permanent sterilization without having to undergo surgery with a traditional tubal ligation procedure.

The Essure device was touted as being noninvasive, and women appreciated that there was virtually no downtime after the device was placed, in contrast to what they would have experienced had they opted for surgery.

However, as the 30 women in this lawsuit and tens of thousands of other women stated,  the complications from Essure have been much more serious than they had ever anticipated. For some, the consequences of having this permanent sterilization device implanted have been simply devastating.

“When the FDA approved the device, the FDA was not aware that the device can cause serious health risks, such as perforation of the uterus, device migration or fracture, chronic pain, and prolonged bleeding, as well as ectopic pregnancies,” the Essure lawsuit reads.

The plaintiffs go on to state that more than 16,000 complaints of complications from Essure were made to the manufacturer, but the manufacturers neglected to properly warn patients and physicians of the potential complications from Essure. The Essure lawsuit also alleges that this information was not reported to the FDA in a timely manner.

“If the Defendants had timely and adequately warned Plaintiffs’ healthcare providers and Plaintiffs of this new risk information, Plaintiffs’ injuries would have been avoided,” the complaint reads.

In addition to alleging that Bayer failed to warn of complications from Essure, the company was also accused of conducting “a nationwide false and misleading marketing campaign, warranting and misrepresenting that Essure was safer than other methods of permanent birth control.”

The complaint states that makers of the device used the following statements in their marketing of the permanent sterilization option: “[Essure] eliminates the risks, discomfort, and recovery time associated with surgical procedures,”  “[Essure devices] stay secure, forming a long protective barrier against pregnancy,” and “[Essure] is worry free” and ”it’s the most effective permanent birth control by far.”

The women named as plaintiffs in this Essure lawsuit report complications from Essure that varied widely.

The complications they reported included severe abnormal pelvic pain, excessive bleeding, fibroid cysts, painful periods, lack of periods, abnormal cycles, uterine perforation, pelvic information headaches, migraines, pelvic infections, painful sex, autoimmune reactions to the device, anxiety, depression, daily vomiting and more.

The plaintiffs all claimed to have suffered physical pain and emotional anguish. Some required partial or full hysterectomies at an early age, sending them into premature menopause, in order to treat the problems allegedly caused by Essure.

A number of counts have been brought against the Defentants including negligent failure to warn, strict products liability for inadequate warnings and manufacturing defect, negligence/negligence per se, breaches of express warranty, misrepresentation and fraud.

The plaintiffs are seeking economic and noneconomic damages, compensatory damages, declaratory judgment, punitive damages, disgorgement of profits, attorneys’ fees and costs, prejudgment interest and any additional relief as deemed just and proper by the Court.

The plaintiffs are demanding a jury trial and did not seek to have their claims tried jointly.

The Complications from Essure Lawsuit is Case No. 3:17-cv-00628-CAB-AGS, in the Superior Court of the state of California, County of San Diego.