FDA to Review Safety of Essure

A U.S. Food and Drug Administration (FDA) panel of health experts will review Bayer’s permanent contraceptive device Essure to help deteremine whether it is safe. The review is being conducted due to growing complaints over potential side effects, NBC News reports. Angela Lynch, who suffered problems after Essure, runs a Facebook group called “Essure Problems”. More than 17,000 women have joined and complained of issues such as chronic pain, heavy bleeding, fatigue and skin allergies. The meeting will discuss whether changes should be made to the label and whether more research is needed to assess risks.

Angela Lynch was implanted with Essure at the age of 28 after having three children. “Because I had just had a kid I wrote off all my symptoms as hormonal, my body trying to adjust,” she said, according to NBC News. “After two years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting.” She had the device removed in 2012 and underwent a hysterectomy. “After three days it was like I woke up from a five-year flu,” she said.

Bayer says approximately 750,000 units of Essure have been sold. The device is a small metal spring that is placed in each fallopian tube. Pregnancy is prevented because scar tissue grows around the spring. “We want to understand as a company what is going on,” said Dr. Patricia Carney, medical director for Essure. “We want to know whether there is a link to the product.”

Some practitioners are welcoming the discussion, hoping that more light will be shed on potential risks. Dr. Sebastiaan Veersema, a gynecologist at St. Antonius Hospital Nieuwegein in the Netherlands, implanted Essure in nearly 1,400 women. He has also trained dozens of physicians on how to use the device. Dr. Veersema now says more research should be conducted, according to NBC News. “If there is something wrong with the device I want to know,” he said. Veersema said a stricter screening process may be necessary so that women with fibroids and other uterine problems do not get Essure.

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