Contraceptive implant will be taken off the market

Bayer announced Friday that it will 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 FDA noted that some might have been duplicates.

Madris Tomes, a former FDA medical device official who runs a company that analyzes adverse event data, puts the figure closer to 30,000.

Earlier, the FDA had ordered placement of a “black box warning” on the product package that warned of the possible injuries.

Bayer said its decision was based on declining sales and blamed “inaccurate and misleading publicity” as a key factor. The company also said U.S. women were becoming less interested in permanent contraception and instead were increasingly relying on other birth-control options.

The Essure implant consists of two small coils, made of a nickel alloy and a polyester—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.

The company said it will continue to enroll patients in a postmarket surveillance study and will work with the FDA to ensure appropriate follow-up.