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Essure Study Receives New FDA Protocol

The U.S. Food & Drug Administration (FDA) on Thursday issued an update on new steps to revise Bayer’s post-marketing study of its Essure birth control device, to ensure that accurate long-term safety data is collected following removal of the IUD from the U.S. marketplace.

December 20, 2018 – Dr. Scott Gottlieb, Commissioner of the FDA, said in a posting that the agency is working with Bayer to “revise and strengthen” its post-market study of Essure, which began in 2016. The trial will now follow women who were implanted with Essure for 5 years instead of the initially requested 3, giving the FDA “longer-term information on adverse risks of the device, including issues that may lead women to have the device removed.”

Free Confidential Lawsuit Evaluation: If you or a loved one had problems after receiving the Essure Birth Control IUD, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Bayer and our lawyers can help.

What’s the Problem?

Bayer faces thousands of lawsuits filed on behalf of Essure recipients who claim the IUD pierced their fallopian tubes, and that part of the birth control device became dislodged and migrated to other parts of their bodies.

Bayer announced in July that it would phase out the IUD in the U.S., a move the company blamed on decreased sales rather than health concerns.

Do I Have an Essure Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Essure lawsuits. We are handling individual litigation nationwide and currently accepting new Essure side effects cases in all 50 states.

Free Case Evaluation: Again, if you or a loved one suffered adverse health complications after being implanted with the Essure device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.

Free Confidential Case Evaluation

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