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.
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