VIRGINIA BEACH — The U.S. Food and Drug Administration has issued a black box warning for Essure while calling for a additional mandatory clinical trial, according to WVEC Virginia. 

EssureA black box warning is the highest level of warning that the FDA can issue and constitutes a need for consumers to approach an Essure implant with extreme caution for fear of major health complications.

However, the FDA has announced that it will not issue a device recall regarding Essure, a measure that many consumers were pressuring the agency to pursue.

Thousands of women who have been implanted with the controversial birth control device claim to have suffered from debilitating pain as a result of device failure. Picabo Street, Olympic gold medalist and former Essure spokesperson, even pulled her name from the product after becoming pregnant while using Essure.

Representative Michael Fitzpatrick of Pennsylvania issued the following statement upon discovering that the FDA had not issued a recall:

“In my view, it should be a revoking of the market approval, a removal of the device from the market, and how it can be made safer.”

Rep. Fitzpatrick has fought to ban the device from the market though his E-Free act that was proposed in 2015.

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