WASHINGTON – The Food and Drug Administration said on Monday that Bayer would have to restrict the sale of its Essure implant to medical practices, such as doctors' offices, that were willing to fully inform women about the risks of the device. 19659005] Since the implant became available 16 years ago, thousands of women have sued Bayer, the manufacturer of Essure. Many claim that they have suffered serious injuries, including perforation of the uterus and fallopian tube from the metal implant.
Two years ago, the FDA declined to pull the device off the market, and instead ordered a "black box warning" on the product package that could cause this type of injury. The warning also noted that the implant can enter the abdominal cavity and pelvic cavity, causing pain and possibly requiring surgical removal.
The device consists of two small coils consisting of a nickel alloy and a polyester-like fiber, the fallopian tubes through the vagina, and is designed to produce an inflammatory reaction that causes scar tissue to form and block the tubes.
The F.D.A. Www.euro.who.int/mediacentre/pr/200…guage=German On Monday, November 4, 2002, when Essure was approved until December of last year, the agency received 26,773 reports of adverse effects to the device, although some duplicates can be.
The most commonly reported problems that F.D.A. said, were pain, menstrual disorders and headaches. Most reports listed several conditions suffered by individual patients. There have also been reports of deaths, pregnancy loss, ectopic pregnancies and other serious problems.
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