Washington, DCBayer has announced that it is taking its female sterilization device, Essure, off the market in all countries where it is currently marketed and sold, except the US. The company said it was taking this action due to commercial reasons, and not because of allegations of side effects associated with the device.
Bayer said it will continue to sell Essure in the US and the US Food and Drug Administration (FDA) will continue to monitor the device, which has been on the market for approximately 10 years. The device is a permanent birth form of birth control that involves two nickel-titanium coils placed inside the fallopian tubes to encourage the growth of scar tissue that eventually blocks the tubes to prevent pregnancy.
In 2016, the FDA added its most stringent warning, a boxed warning, to the product, to alert doctors and patients to problems reported with the implant. This came in addition to the pre-existing warning of pelvic pain and bleeding immediately after the implant procedure.
According to a report on CBS News, a Facebook group called “Essure Problems” currently has more than 34,000 members. The group shares their stories and complaints about the device, which has been linked to chronic pain, bleeding, implant migration and the need for surgery to remove the device. The most common side effects associated with Essure include pain, hemorrhaging, headaches, menstrual irregularities, weight fluctuation, device migration and suspected nickel allergy. Some women have reportedly had a hysterectomy or other procedures to remove coils.
According to the statement issued by Bayer and reported by CBS News, "Essure's safety and effectiveness remain supported by more than ten years of scientific research and real-life clinical experience." It cites "an environment unfavorable to its prescription" as the cause of "a continuous decline in demand" for the last several months.
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