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FDA Requires Black Box Warning on Essure Birth Control

FDA requiring Bayer AG to include a “black box” warning on the labeling of Essure “designed to call attention to serious or life-threatening risks.”

The U.S. Food & Drug Administration (FDA) has announced that it will require German drugmaker Bayer AG to include a “black box” warning on the labeling of its Essure contraceptive “designed to call attention to serious or life-threatening risks.”

Free Confidential Lawsuit Evaluation: If you or a loved one suffered complications after undergoing an Essure procedure, 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?

February 29, 2016 – In addition the new black box warning (PDF), FDA will require Bayer to perform additional safety studies in order to better understand the health risks associated with Essure after thousands of women reported suffering adverse complications after receiving the birth control device.

FDA’s decision drew criticism from at least 2 lawmakers on Capitol Hill, as well as from a community of women who claim Essure caused them severe health problems including pelvic pain, stomach swelling, dizziness, cramping, bleeding and fatigue. They have waged a relentless social media campaign to have Essure recalled immediately.

“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and [to] ask the manufacturer to perform another study while leaving Essure on the market,” said Rep. Mike Fitzpatrick (R-PA). Rep. Rosa DeLauro (D-CT) agreed, saying the FDA must ensure that Bayer follows through on follow-up studies and that “Essure should be off the market until the requested studies are completed.”

A Facebook group called Essure Problems, which consists of thousands of women allegedly injured by the contraceptive, said it was “outraged” by the FDA’s decision.

“These studies could take several years, and leaving the device on the market will only put more women’s lives at risk,” the group said. “We are disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device.”

Last fall, FDA held a public meeting to discuss the growing number of adverse event reports linked to Essure. The women who spoke detailed injuries they say were caused by the device, including unplanned pregnancies and painful surgeries to remove it after suffering complications. On Monday, William Maisel, chief scientist at FDA’s Center for Devices and Radiological Health, said that among the thousands of reports associated with Essure, 631 involved women becoming pregnant after being implanted with Essure. Of these, at least 294 included pregnancy loss.

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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 Confidential Case Evaluation: Again, if you were injured by Essure side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and our lawyers can help.

Free Confidential Case Evaluation

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