WASHINGTON — The Food and Drug Administration on Monday said it would require Bayer to restrict sales of its Essure birth control implant to medical practices like doctors’ offices that agree to fully inform women about the device’s risks.
Since the implant became available 16 years ago, thousands of women have sued Bayer, Essure’s manufacturer, with many claiming they suffered severe injuries, including perforation of the uterus and the fallopian tubes from the metal implant.
Two years ago, the F.D.A. declined to pull the device off the market, and instead ordered placement of a “black box warning” on the product package that said it could cause those types of injuries. The warning also noted that the implant can travel into the abdomen and pelvic cavity, causing pain and possibly requiring surgical removal.
Consisting of two small coils, made of a nickel alloy and a polyester-like fiber, the device is placed in the fallopian tubes through the vagina, and is designed to create an inflammatory response that causes scar tissue to form and block the tubes.
The F.D.A. said on Monday that from Nov. 4, 2002, when Essure was approved, through December of last year, the agency had received 26,773 reports of adverse events related to the device, although some might be duplicates.
The most frequently reported problems, the F.D.A. said, were pain, menstrual irregularities and headache. Most reports listed multiple conditions suffered by individual patients. There were also reports of deaths, pregnancy loss, ectopic pregnancies and other serious problems.
Steven Immergut, a spokesman for Bayer, said that roughly 750,000 devices had been sold worldwide. “We have experienced a decline in sales due to the broad dissemination of misleading and inaccurate information on social media that is influencing women’s choices,” he said.
Dr. Scott Gottlieb, the F.D.A. commissioner, met in February with a group of women concerned about continuing injuries connected to the device. Some again demanded that the device be withdrawn from the market, while others sought a stronger warning.
“One of our other large concerns is that women who got Essure had no idea there was a warning on the device, or a doctor-patient discussion checklist,” said Holly Ennis, a lawyer who represents hundreds of women who are suing Bayer over the device.
The action announced on Monday will require doctors to ensure that patients sign a form with a checklist acknowledging that they have been advised of the implants’ risks, and also require the doctor’s signature.
Bayer released a statement on Monday saying that it had issued a new label for the birth control device, emphasizing that health care providers must discuss the risks with patients.
“The benefit/risk profile of Essure has not changed and remains positive,” the company said.