FDA Orders Study Of Essure Contraceptive

The U.S. Food and Drug Administration on Monday instructed the maker of Essure to conduct further studies on the controversial birth control device, and recommended that a warning be added to the product label. “While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications,” the agency said in a statement. “These may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.”

Essure, approved by the FDA in 2002 for women ages 21 to 45, is a flexible coil that is inserted by doctors into the fallopian tubes. An estimated 750,000 women have received the product, manufactured by Bayer. Essure has been the target of thousands of complaints from women across the country, including in Connecticut.

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Alyson Hannan said she experienced back and pelvic pain and a rash and boils, after having Essure inserted in her fallopian tubes.

Essure Contraceptive Under FDA Review After Public Outcry

When Alyson Hannan, 44, decided she was done having children, she chose Essure, a non-surgical permanent birth control option approved by the Food and Drug Administration. The day the tiny metal coils were inserted into her fallopian tubes in her doctor’s office is one that she can’t forget, said Hannan, regional sales director for Met Life who underwent the procedure on Sept. 11, 2014. “I will never forget that date. None of us will.”

Hannan is among tens of thousands of women, now referred to as “E-Sisters,” who have banded together on Facebook to share their stories of adverse health problems, including allergic reactions, chronic pelvic pain, device migration, hair loss and headaches.

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