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Attorney Van O'Steen

Essure Side Effects Prompt FDA to Restrict Sales

Van O'Steen

April 9, 2018

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The FDA issued an order restricting the sale and distribution of Essure implants, a response to reports that side effects attributed to the device pose a risk to women. The FDA action is intended to ensure that women considering the Essure device for birth control are provided adequate information regarding its risks from medical providers.

The FDA already mandated a black box warning in 2016, a decision credited with causing Essure sales to decline by about 70 percent in the United States. In spite of the black box warning and an order that Bayer conduct a post-market study regarding the safety of Essure, the FDA concluded that some women still are not receiving adequate information about the known risks and side effects of Essure before implantation.

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. We take the concerns of all women affected by Essure very seriously. I've personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.

Scott Gottlieb, M.D., FDA Commissioner

Based on its concerns regarding serious side effects, the FDA limits the sale of the device to those doctors who provide information to patients about the risks of the device. Specifically, patients must be given a Patient-Doctor Discussion Checklist — Acceptance of Risk and Informed Decision Acknowledgment form that is reviewed with the physician and signed by the patient prior to implant.

What You Should Do

If you have experienced serious side effects associated with the Essure birth control device, promptly consult your physician for an evaluation.

If you have suffered a perforation of the uterus or fallopian tubes, or migration of the device into the abdomen or pelvic cavity, you may be entitled to compensation. You should act immediately to contact an attorney experienced in matters involving defective medical devices.

If you or a loved one has been harmed by the Essure device, please contact us for a free consultation to discuss your legal rights. You can call us toll-free at 800.883.8888 or complete our online contact form.

 

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