FDA’s Black Box Warning Labels Essure as Dangerous Device
The FDA announced on Monday, 2/29 that it will recommend a “black box warning” label for the Essure permanent birth control device. According to the FDA website, a black box warning label is “designed to call attention to serious or life-threatening risks” associated with a prescription drug or medical device. The FDA also instructed Essure manufacturer Bayer Pharmaceuticals to conduct additional studies in order to better understand the risks of prescribing this permanent contraception device to women.
The Essure permanent contraception device was approved by the FDA in 2002 and marketed as a non-surgical, permanent birth control solution for women. Bayer Pharmaceuticals, the manufacturers of the Essure implant, told women that this device would be a safe and effective alternative to laparoscopic sterilization.
According to Reuters, there are more than 500,000 women in the United States that are using the Essure device. Since 2002, the FDA has received more than 5,000 serious injury complaints from women using this device. These women have reported device failures, such as fracturing or migration inside the body, as well as autoimmune responses, such as unexplained but significant weight gain, skin conditions, hair loss and abnormally heavy menstrual cycles.
If you suffered injuries after receiving an Essure implantable sterilization device and want to learn more about your legal options, call The Yost Legal Group at 1-800-YOST-LAW (967-8529). When you call, you will speak with one of our experienced Defective Medical Device attorney absolutely FREE.
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