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Sales of Essure Contraceptive Restricted by FDA

The U.S. Food and Drug Administration (FDA) announced on Monday that it would be implementing new legislation to protect women from Essure, a birth control implant that has been linked to complications including back / pelvic pain, bleeding, organ perforation, device migration, and other problems that have required removal of the implant.

Moving forward, only women who sit down with their doctors and discuss the risks of the Essure contraceptive, and whom sign a document indicating they understand these hazards, will be eligible to receive the implant.

Free Confidential Lawsuit Evaluation: If you or a loved one suffered from serious side effects after being implanted with the Essure contraceptive, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the problem?

April 11, 2018 – The Essure birth control consists of a pair of coils—one wrapping the other—which are made of nickel and other types of metals. During the implant procedure, one insert is placed into each fallopian tube through the vagina. The coils irritate the surrounding areas, causing scar tissue to develop which prevents sperm from reaching the egg. Unlike most other contraceptives, Essure is intended to be permanent.

Though the contraceptive is estimated to be about 90% effective, thousands of women have filed suit against Bayer since 2002, claiming Essure caused them adverse health consequences. Even under normal conditions, the device has been reported to puncture women’s uterus and fallopian tubes.

However, Essure can also migrate from the implant site into other areas of the body, including the abdomen and/or pelvic cavity, causing pain and possibly requiring surgical removal.

“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” said FDA Commissioner Scott Gottlieb. “We take the concerns of all women affected by Essure very seriously.”

FDA’s new order restricts how the implant can be sold and distributed. Additionally, Bayer will be forced to include a label that mandates Essure can be only sold by medical facilities and healthcare providers which agree to discuss the product’s risks beforehand with their patients. Patients will have to go over a brochure and risk checklist with their doctor, and both patient and doctor will have to sign an acknowledgement that they read it through before the implantation procedure.

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 injury and death cases in all 50 states.

Free Case Evaluation: Again, if you were harmed by a birth control device, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

Free Confidential Case Evaluation

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