Bayer to Stop Selling Contraceptive Implant Essure After Threats by FDA
(Bloomberg) -- Bayer AG said it would discontinue sales of a female contraceptive implant in the U.S. after the Food and Drug Administration threatened the company with civil and criminal penalties if it didn’t tell patients about the product’s serious health risks.
Bayer said in a statement Friday that it will stop marketing the Essure device in the U.S. after Dec. 31 because a decline in sales made the business unsustainable. The German drugmaker said it would continue to stand behind the product’s safety and efficacy. The company halted sales of the device outside the U.S. last year.
Essure is a permanent contraceptive developed as an alternative to surgical techniques such as tying or severing the fallopian tubes. U.S. regulators found that some doctors weren’t always telling women about the Bayer device’s risks, which can include bleeding, pain and organ damage.
In 2016, the FDA ordered the company to conduct a study of patients who had received an implant, part of a series of steps the agency has taken to monitor the product after reports of serious adverse effects. Essure is estimated to have been used by more than 750,000 patients worldwide, according to the FDA.
“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 an increase in side effects, the FDA added new warnings for Essure two years ago, including a checklist that doctors were supposed to go through with patients. Under restrictions imposed in April, only doctors and health facilities that discuss those risks with all patients were legally allowed to implant Essure. The FDA threatened to impose civil or criminal penalties if Bayer didn’t make sure patients were informed.
Under Gottlieb, the health agency has been aggressive about expanding its reach, and the pressure on Essure in April marked the first time the FDA had threatened such penalties using its authority to regulate medical devices after they’re on the market. Last year, the FDA asked Endo International Plc to pull its powerful opioid painkiller Opana ER from the market based on what it called public-health risks.
Essure already has what’s known as a black-box warning, the agency’s strongest. The device, which is an alternative to sterilization surgeries, was first approved in 2002 and is the only product of its kind on the market. Sales of the device have declined sharply since the warnings were added.
About 16,000 women have sued Bayer over alleged harm they suffered because of the device. The largest group of cases is consolidated before a state court judge in Oakland, California. Plaintiffs’ lawyers want the first test trial of their Essure claims held in that court next year.
The number of Essure cases has surged since Bayer beefed up its safety warnings on the device. The company reported that it faced just 3,000 Essure suits in October 2016. As of April, that number had surged 460 percent to 16,800 users, according to court filings.
“Additional lawsuits are anticipated,’’ Bayer said in a May 3 regulatory filing.
Bayer’s decision to halt sales could easily facilitate a global settlement of those cases, said Elizabeth Burch, a University of Georgia law professor who teaches about mass-tort cases. Taking the device off the market will trigger legal deadlines that will eventually cut off the flow of Essure suits, she added.
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