Bayer Faces Essure Lawsuits From 17,000 Women, Company Tells Investors
Bayer Healthcare recently updated investors about the massive number of Essure lawsuits filed by women who allege they have suffered complications from the controversial birth control implant, indicating that nearly 17,000 women have filed product liability claims in courts nationwide.
Essure was introduced as a form of permanent sterilization, involving an outpatient procedure where coils are placed in the uterus, which develop scar tissue that prevents pregnancy. However, Bayer has withdrawn the product from the market worldwide, amid reports involving devastating Essure injuries suffered by women, including perforations, bleeding, pain and other complications that often result in the need for a hysterectomy.
In an interim second quarter financial report for 2018, Bayer indicates that a growing number of claims continue to be filed in the United States, with at least 17,000 plaintiffs so far, and additional cases anticipated. The company also reports that at least two Essure class action lawsuits have been served in Canada.
“Plaintiffs allege personal injuries from the use of Essure, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy, and seek compensatory and punitive damages,” Bayer told investors. “Additional lawsuits are anticipated.”
While Bayer has continued to defended the safety profile of the birth control device, lawsuits allege that the company knew or should have known that Essure posed unreasonable risks for women, yet failed to provide adequate warnings.
Although Essure was recalled from the market in most countries last year, Bayer continued to sell the device in the United States. Amid mounting pressure and publicity about the injuries women were experiencing from Essure, the company announced recently that it was removing Essure from the US. market on December 31, 2018.
FDA officials indicate the agency received about 12,000 adverse event reports related to the Essure birth control implant last year. In April, the FDA made changes to Essure’s premarket approval, requiring both doctors and patients to sign off on a checklist of potential Essure complications.
In November 2016, following controversial hearings in the U.S., where testimony was heard from large numbers of women and medical experts, the FDA decided not to recall Essure in the United States. However, the agency did require Essure black box warnings, which are the strongest that the FDA can require a medical device carry.
Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.
The manufacturer has reportedly spent about $413 million defending the litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached.