Bayer Healthcare recently updated investors on the status of the rapidly escalating litigation over its permanent birth control device causing debilitating and often irreparable injuries, indicating that there are now nearly 17,000 Essure lawsuits pending in the nation’s court system and the flood isn’t expected to slow anytime soon.
Essure is a permanent form of birth control that Bayer touts as a superior, nonsurgical alternative to tubal ligation. The outpatient procedure involves the placement of coils into the fallopian tubes that cause scar tissue to develop, preventing pregnancy. However, thousands of women allege that the device does not meet adequate performance expectations and causes serious damage.
Countless women have experienced painful and debilitating injuries when the coils moved out of position, perforating nearby reproductive organs – sometimes becoming lost entirely. The FDA has also received tens of thousands of reports of ectopic pregnancies, alopecia, allergic reactions, insufferable menstrual cycles, tooth loss, debilitating chronic pain, heavy bleeding, and even death. Furthermore, most injuries require the surgical removal of reproductive organs to even address.
The FDA received nearly 12,000 Essure injury reports in 2017 alone. The Essure lawsuits allege that Bayer and Conceptus actively concealed considerable risks by failing to report thousands of additional adverse events from the device to the FDA.
In July, Bayer announced it will remove Essure from the U.S. market after December 31. The healthcare behemoth claims that a decline in Essure sales has made continuing to market the product line unsustainable. Bayer said it still stands behind the product’s safety and efficacy despite tens of thousands of women raising continual alarms about debilitating and often permanent injuries from the defective female sterilization implant. The company stopped Essure sales outside of the U.S. this past year, citing similar financial reasoning rather than worldwide outcry over the dangerous medical device.
Essure Lawsuits Report
In its 2018 interim second quarter financial report, Bayer indicates that Essure lawsuits continue to mount in the U.S. with at least 17,000 plaintiffs with claims pending so far and does not anticipate the deluge of lawsuits to slow down anytime soon. The company also reported that at least two Essure class action lawsuits are now pending 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.”
Following a series of controversial regulatory hearings that featured testimony from larger numbers of women and medical experts, the FDA decided not to recall Essure in the U.S. However, the agency did mandate that Essure carry black box warnings pertaining to its high-risk profile. These warnings are the strongest that the FDA can require a medical device to include.
In the face of continuing adverse event reports detailing gruesome injuries, the FDA made significant changes to Essure’s premarket approval, requiring both doctors and patients to sign off on an Essure checklist of potential complications.
Approximately 750,000 women worldwide have received the dangerously defective device. Analysts estimate that approximately 70 percent of Essure patients are American women.
In 2017, Bayer spent about $413 million on defending the blooming Essure litigation and could face staggering liabilities if it chooses to face off against the thousands of injured women in court rather than reaching an Essure settlement to resolve the litigation.