(Bloomberg) -- Bayer AG said it is pulling a female contraceptive implant off the U.S. market 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 selling 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.

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 perforation.

In 2016, the FDA ordered the drugmaker 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, and Bayer stopped selling the device outside the U.S. last year.

About 16,000 women have sued Bayer over alleged harm they suffered because of the device.

--With assistance from Anna Edney and Naomi Kresge.

To contact the reporters on this story: Mark Schoifet in New York at mschoifet@bloomberg.net;Rebecca Spalding in New York at rspalding@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Timothy Annett

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