FDA Finalizes Essure Warning Label Guidelines and Patient Decision Checklist

In October 2016, the FDA finalized the “black box” labeling guidelines for permanent contraceptive device Essure and all other similar devices warning consumers of safety risks. The FDA also finalized a “Patient Decision Checklist,” outlining Essure’s effectiveness and potential side-effects, to be signed by the patient receiving Essure and her doctor prior to device implantation. Manufactured by Bayer HealthCare, the device has been implanted in thousands of women since it was approved by the FDA in 2002. However, Essure has been linked to a litany of dangerous side-effects, ranging from device migration, perforation of the uterus or other organs, chronic pelvic pain, excessive bleeding, ectopic pregnancy, miscarriage, and in some reports, death. If you or a loved one suffered complications after receiving an Essure implant, please contact us by submitting the form or by calling us at 888-985-7228 for a confidential evaluation of your potential claim.

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