FDA Issues Final Guidance on Essure
Nov 1, 2016
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Langhorne, PA —Congressman Mike Fitzpatrick (PA-08) today issued a statement following the Food and Drug Administration’s final guidance and nonbinding recommendations on Essure, a medical device for women.
The final guidance recommends all devices like Bayer’s Essure to include a labeled boxed warning and patient decision checklist to inform women and physicians about potential risks and complications with this type of device.
The latest recommendations from the FDA do not go far enough. A boxed warning and patient checklist highlight the severe risks of Essure—but they’re not legally enforceable requirements. Tens of thousands of women have been harmed by this unsafe medical device, including hundreds of fetal deaths.
A year ago, I introduced the E-Free Act to revoke FDA approval of Essure and prevent government agencies from purchasing this device considered to be unsafe. Since then, hundreds of women affected by Essure have shared their stories with my office. And I believe now, as I believed then, if the FDA will not act to protect these women, then Congress must act now.”
The full report containing the patient decision checklist example can be found here.
Fitzpatrick has been the leading voice in Congress calling for the removal of Essure from the market and introduced the E-Free Act in November 2015. He also has introduced the Medical Device Guardians Act and Ariel Grace’s law which would update the reporting structure for unsafe medical devices and ensure medical device manufactures are incentivized to maintain the safest products for all patients.
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