The U.S. Food and Drug Administration (“FDA”) today issued an order to restrict the sale and distribution of the Essure device to ensure that all women considering use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions. The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted.
The new Essure labeling, which will now be legally required when this product is offered to a patient, restricts the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device. Specifically, the patient brochure, titled “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement,” must be reviewed with the prospective patient by the health care provider to ensure the patient understands the risks, benefits and other information about Essure implantation.
Many patients implanted with Essure have experienced adverse events, including perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions. In addition, women have also reported experiencing headache, fatigue, weight changes, hair loss and mood changes, such as depression. It is unknown whether these symptoms are related to Essure. In fact, in November 2016, the FDA also required Bayer to add a boxed warning to the product labeling stating information about adverse events associated with the device “including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions.”
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