WASHINGTON -- The maker of a permanent contraceptive implant subject to thousands of injury reports from women and repeated safety restrictions by regulators said Friday that it will stop selling the device in the U.S.
Bayer said the safety of its Essure implant has not changed, but it will stop selling the device at the end of the year due to weak sales. Last year, Bayer stopped selling the device in Europe.
The 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 U.S. women are suing Bayer over Essure.
Bayer received FDA approval to sell Essure in 2002 and promoted the product to women as the only non-surgical option for permanent birth control. Essure consists of two 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 said Friday the agency would work with Bayer to continue the study, but noted "Bayer will not be able to meet its expected enrolment numbers" for new patients. The study was designed to follow patients for three years to better assess complications.
Essure's original label warned that the device's nickel can result in allergic reactions, such as itching and hives.
But many women have attributed other problems to the implant, including mood disorders, weight gain, hair loss and headaches. Those problems are listed in the current FDA labeling for the device, with the qualifier: "It is unknown if these symptoms are related to Essure or other causes."
