Bayer announced on Friday that it would discontinue sales of its controversial Essure birth control implant by the end of the year.
The device has been problematic for years, prompting lawsuits from thousands of women who claim the metal implant caused severe injuries, including perforation of the uterus and the fallopian tubes.
In April, after meeting with advocates for women who say they were injured by Essure, the Food and Drug Administration required Bayer to limit sales to doctors’ offices and medical practices that agreed to fully inform women about the product’s risks. At that time, the agency said that from 2002, when Essure was approved, through the end of 2017, it had received nearly 27,000 reports of adverse events — although the F.D.A. noted that some might have been duplicates.
Madris Tomes, a former F.D.A. medical device official, who runs a company that analyzes adverse event data, puts the figure closer to 30,000.
“With side effects ranging from hair loss and tooth loss to chronic pain, severe bleeding, miscarriages and even death, the benefit risk profile touted by Bayer simply didn’t jibe with the data that was pouring into the F.D.A. from both patients and physicians,” Ms. Tomes said.
Earlier, the F.D.A. had ordered placement of a “black box warning” on the product package that warned of the possible injuries, and added that the implant could travel into the abdomen and pelvic cavity, possibly requiring surgical removal.
Bayer said its decision was based on declining sales, and blamed “inaccurate and misleading publicity,” as a key factor. The company also said that American women were becoming less interested in permanent contraception, and instead were increasingly relying on other birth control options, like long-acting reversible contraceptives.
“The benefit-risk profile of Essure has not changed,” the company said, “and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research.”
The Essure implant consists of two small coils, made of a nickel alloy and a polytester-like fiber. It is placed through the vagina into the fallopian tubes, and is designed to create an inflammatory response that causes scar tissue to form, blocking the tubes.
Public health advocates have long been troubled by what they see as lack of solid data on Essure’s safety and effectiveness.
“Thousands of women have reported serious complications from Essure, and there has been no unbiased long-term research to refute or confirm those reports,” said Diana Zuckerman, president of the National Center for Health Research. “Both the F.D.A. and the company are responsible for a situation where women could not make informed decisions.”
The company said it will continue to enroll patients in a postmarket surveillance study and will work with the F.D.A. to ensure appropriate follow up.