FDA Updates Guidance for Essure Birth Control
Essure is a hysteroscopic implant method of sterilization that provided a less invasive alternative to other hysteroscopic procedures used. The device is intended to provide women with a permanent form of birth control.
However, over the past ten years, thousands of women have filed adverse effect reports with the FDA, detailing complications after receiving the Essure implant. The most common complications reported have related to severe pain in the pelvis, hemorrhaging and migration of the device within the uterus. In March, the Food and Drug Administration mandated that a black box warning be included on the Essure label. Such a warning – the strongest warning the FDA can mandate – is intended to highlight the serious and life-threatening risks of dangerous products.
The FDA mandate comes as a result of intense public scrutiny by thousands of women who were harmed after using the device. The administration has also required Bayer Healthcare, Essure’s manufacturer, to conduct studies of 2,000 women to assess the risks and effectiveness of the device. The results of these studies will be used by the FDA to determine if further action is necessary.
Critiques of the Essure device, including injured victims, their families and advocacy groups, expressed discontent with the measures that the FDA has mandated. Many feel as though the device needs to be removed from the market to avoid further harm, and have suggested that the FDA has failed to act appropriately. Republican Representative, Mike Fitzpatrick has indicated that he intends to introduce multiple legislative actions to Congress in hopes of ultimately having Essure’s FDA approval revoked.
For more information about the risks of the Essure device, or if you have questions related to your individual case, contact the medical device liability attorneys at The Law Offices of Peter Angelos.