Bayer Halts Essure Sales in U.S. After FDA Threatens Criminal Charges

By Emily Cox
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Pharmaceutical giant Bayer AG is stopping Essure sales in the U.S. following threats from the FDA that the company would face civil and criminal charges if it didn’t thoroughly inform patients about the birth control implant’s serious health risks.

Bayer released a statement Friday indicating that it will pull the Essure device from the U.S. market after December 31. The healthcare behemoth claims that a decline in Essure sales has made continued marketing of the product line unsustainable. Bayer said it would continue to stand 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 is a permanent form of contraception that Bayer touted as a non-surgical alternative to tubal ligation. However, U.S. regulators found that neither Bayer or doctors were informing women about the device’s significant risk factors, including heavy bleeding, debilitating pain, ectopic pregnancy, severe organ damage, allergic reactions, alopecia, tooth loss, insufferable menstrual cycles, and even death. Countless women have also experienced painful and incapacitating injuries when the coils moved out of position, perforating nearby reproductive organs – sometimes becoming lost entirely. The FDA received nearly 12,000 Essure injury reports in 2017 alone. Furthermore, most injuries require the surgical removal of reproductive organs in order to address.

FDA Steps Intervenes to Control Damage from Essure Sales

In 2016, the FDA ordered Bayer to conduct a safety study of patients with the implant as part of a series of steps the agency has taken to monitor the product in light of escalating serious adverse event reports.

“For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA,” Commissioner Scott Gottlieb said Friday in a statement. “We expect Bayer to meet its postmarket obligations concerning this device.”

After noticing a marked increase in substantial side effects, the FDA added new warnings for Essure two years ago. This included a required checklist for doctors to go through with patients to make sure they thoroughly understood the serious risks. However, injury reports continued to mount. So, the FDA imposed stricter regulations in April, implementing provisions so that only doctors and health facilities that document discussing these risks with all patients were allowed to implant Essure. Furthermore, the agency indicated that Bayer would face civil and criminal penalties if the company didn’t ensure that all patients were aware of the risks before implantation.

Under Gottlieb, the FDA has been more aggressive in expanding its reach. The pressure on Essure sales in April was the first time the agency had ever flexed its authoritative muscle to threaten such penalties. Last year, the FDA asked Endo International to pull its powerful opioid Opana ER from the U.S. market due to public-health risks.

Essure already carries a “black-box warning,” which is the agency’s strongest safety warning. The FDA first approved Essure in 2002. It is still the only product of its kind on the market. Essure sales plummeted after the Bayer added the warnings to the device.

Essure Sales Lawsuits

Thousands of women are stepping forward to take Bayer to task for abusing their trust and bodies for financial gain. According to Bayer’s 2017 annual report, there were more than 16,000 Essure lawsuits pending against the company in the U.S. as of January 30. By April, that number had climbed to almost 17,000. The largest group of cases is consolidated before a state court judge in Oakland, California. Plaintiffs’ attorneys are vying for the first test trial over Essure injury claims to be held in that court this coming year.

The manufacturer also reportedly spent about $413 million defending the Essure litigation this past year. Furthermore, Bayer acknowledges that it doesn’t anticipate the flood of injured women coming forward to slow down any time soon

“Additional lawsuits are anticipated,” Bayer said in a May 3 regulatory filing when the company was still indicating that it would not pull Essure from the U.S. market.

According to Elizabeth Burch, a University of Georgia law processor who specializes in mass-tort litigation, Bayer’s decision to stop Essure sales could easily trigger a global settlement of these cases. Removing the device off the market will activate legal deadlines that will eventually cut the flow of Essure lawsuits.

Bayer’s decision comes at the end of a particularly contentious week in the nation over the Essure device. Netflix began showing early screenings and released the official trailer for its documentary “The Bleeding Edge,” which details the lives the device has derailed with its serious side effects. On Tuesday, Essure activists stormed Bayer’s U.S. headquarters in a massive protest, demanding the company to stop turning a blind eye to the suffering the device continues to cause women the world over.



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