Bayer to stop selling contraceptive device tied to injuries

WASHINGTON (AP) — The maker of a permanent contraceptive implant subject to thousands of injury reports and repeated safety restrictions by regulators on Friday said it would stop selling the device in the United States, the only country where it remains available.

Bayer said the safety of its Essure implant has not changed, but it would stop selling the device at the end of the year due to weak sales.

The German company had billed the device as the only non-surgery sterilization method for women. As complaints mounted and demand slipped, it stopped Essure sales in Canada, Europe, South America, South Africa and the United Kingdom.

The US Food and Drug Administration has placed multiple restrictions on the device following patient reports of pain, bleeding, allergic reactions and cases where the implant punctured the uterus or shifted out of place.

In May, the FDA said doctors must show women a checklist of the device’s risks before implanting it.

More than 16,000 US women are suing Bayer over Essure.

Bayer received FDA approval to sell Essure in 2002 and promoted it as a quick and easy permanent solution to unplanned pregnancies. Essure consists of two thin-as-spaghetti nickel-titanium coils inserted into the fallopian tubes, where they spur the growth of scar tissue that blocks sperm from fertilizing a woman’s eggs.

Because of the reported complaints, the FDA added its most serious warning to the device in 2016 and ordered the company to conduct a 2,000-patient study.

FDA Commissioner Scott Gottlieb on Friday said the agency would work with Bayer to continue the study, but noted that Bayer “will not be able to meet its expected enrollment numbers” for new patients. The study was designed to follow patients for three years to better assess complications.