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FDA Finalizes Guidance on Essure Birth Control

FDA finalizes guidance requiring “black box” warning and patient decision checklist for the Essure contraceptive.

The U.S. Food and Drug Administration (FDA) has finalized its guidance requiring a “black box” warning and patient decision checklist for the Essure permanent birth control device.

Free Confidential Lawsuit Evaluation: If you or a loved one had problems after receiving the Essure contraceptive, 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?

November 3, 2016 – While the final guidance on Essure retains most of the recommendations made in the draft version, both the language of the boxed warning and patient decision checklist have been updated.

Essure is a nickel-titanium coil that is inserted into a woman’s fallopian tubes during a 15-minute procedure. Over the next 3 months, tissue builds up around the inserts and blocks off the tubes, thereby creating a barrier that keeps sperm from reaching the egg. FDA approved Essure in 2002, but has since required numerous updates to the product’s labeling, including risk disclosures for chronic pain and a chance of pregnancy after implantation, as well as a warning to women with nickel allergies.

Bayer acquired Essure in 2013 and has since faced numerous lawsuits and received over 5,000 reports of complications associated with the contraceptive. Additionally, a Facebook group with more than 20,000 members shares stories of women who have experienced problems with the implant. Bayer estimates that about 750,000 women have received Essure worldwide.

In September 2015, the FDA Obstetrics and Gynecology Devices Panel held a public hearing to review the device’s safety. Earlier this year, the agency said it would recommend a black box warning for the device, noting that “Essure remains an appropriate option for the majority of women seeking a permanent form of birth control” but that some recipients could suffer adverse health complications.

In its final guidance on Oct. 28, FDA said “Accurate product labeling and effective messaging of that labeling is important to make device users and patients aware of the risks associated with permanent, hysteroscopically-placed tubal implants intended for sterilization.”

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 suffered complications after being implanted with Essure birth control, 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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