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February 29, 2016: FDA Orders Studies OF Essure Complications, and New Patient Warnings

Essure Complications

On February 29, 2016, due to a growing number of adverse event reports, the U.S. Food and Drug Administration (FDA) issued a plan to investigate the safety of Essure, a female sterilization device.

Essure Adverse Events

The FDA’s actions were spurred by several serious adverse event reports, including:

    • persistent pain,
    • perforation of the uterus and/or fallopian tubes,
    • intra-abdominal or pelvic device migration,
    • abnormal or irregular bleeding,
    • allergy or hypersensitivity reactions.

Due to these events, some women have had surgical procedures to remove the Essure, and in other cases Essure failure has occurred due to incomplete patient follow-up, leading to unintended pregnancies.


If you are a loved one has been seriously injured by Essure complications, and you have a question concerning a potential Essure lawsuit, please submit our easy-to-use “Legal Case Evaluation Form”, or contact us toll free at 1-877-934-6274 for a free Essure lawsuit case evaluation.

Learn more about essure complications and your legal rights, visit Essure Lawsuit.

The Weinberg Law Firm serves as local counsel for mesh lawsuits filed against manufacturers C.R. Bard and Johnson & Johnson consolidated in New Jersey Superior Court in Bergen County.

What is Essure?

Essure is a permanent birth control device for women. This form of female sterilization is preferable for some women as this method does not require a surgical incision. The implantation procedure for Essure involves flexible coils, placed by a health care provider, through the vagina and cervix and into the fallopian tubes. Tissue then forms around the inserts; this build-up of tissue creates a barrier that keeps sperm from reaching the eggs. This procedure permanently prevents conception.

FDA Actions For Bettering Understanding of Essure Sterilization Device

In consideration of the risks associated with the Essure method, the FDA announced a plan for additional studies and increased patient awareness of the device complications.

The FDA issued a “new, mandatory clinical study for Essure to determine heightened risks for particular women. […] The FDA has also ordered Bayer, the company that manufactures Essure, to conduct a new postmarket surveillance study designed to provide important information about the risks of the device in a real-world environment.”

In order to insure that patients and health professionals are aware of all issues, the FDA published plans to require changes to product labeling, such as a boxed warning and a “Patient Decision Checklist” to help to ensure women receive and understand information regarding the benefits and risks of this type of device.

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