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Congress Asks FDA to Take Dangerous Essure Off the Market

Posted on Feb 02, 2016

A U.S. Congressman introduced a bill Wednesday aimed at taking Essure permanent birth control off the market. Pennsylvania Congressman Mike Fitzpatrick introduced the E-Free Act, which would force the Food and Drug Administration to revoke Essure’s Premarket Approval, as the number of reports of serious complications associated with it continues to rise.

“If the FDA and the manufacturer of the device aren’t willing to remove this device from the market, then Congress will,” he said in a press release. Fitzpatrick, a Republican, held a press conference in Washington for victims of the device who have joined together with more than 23,000 on social media to fight against the device.

Essure was given Premarket Approval by the FDA in 2002, shielding it from product liability and litigation. The bill would require the FDA Commissioner to withdraw that approval within 60 days of it passing.

Whether or not the bill passes and becomes law, Dr. Diana Zuckerman, President of the National Center for Health Research in Washington, said, “It sends an important message that Congress is concerned about this product and is looking at what the FDA is doing.” Zuckerman has questioned the clinical trials related to Essure for years.

Essure is marketed as permanent birth control without surgery. During the procedure, two metal coils are placed inside the fallopian tubes to block conception.

But, the ABC15 Investigators have been reporting on complications related to the device for more than two years. Women report severe bleeding and pelvic pain, chronic pelvic pain, auto-immune disorders and unintended pregnancies. Many women reported having hysterectomies and having to remove their reproductive organs in order to remove the device. The FDA has received more than 5,000 adverse event reports related to Essure since it was approved in 2002.

The bill’s announcement comes less than two months after the FDA held a day-long public hearing on Essure. Women, doctors and health care professionals for and against the permanent form of birth control testified to the FDA’s Obstetics and Gynecology Devices panel, as well as Bayer Health Care, the current manufacturer of the device. The FDA has not yet announced its recommendations as a result of that hearing.

If you or a loved one suffered tubal/uterus puncturing, bleeding, or other injuries from Essure, please call our experienced products liability attorneys at (888) 606-5297 for a free consultation about your Essure lawsuit.

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