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Jacksonville woman gives emotional testimony on use of Essure to FDA panel

JACKSONVILLE, Fla. — A Jacksonville woman made an emotional plea for the controversial form of birth control Essure to be taken off the market Thursday.
 
The U.S. Food and Drug Administration held a panel meeting that lasted more than 12 hours to discuss the risks and benefits of Bayer HealthCare's product Essure.

Essure is a form of female sterilization that uses metal coils.
 
"There were days when I could not get up out of the bed except to crawl to the bathroom in tears," Rebecca Howell said to the panel.

Howell said she suffered from painful side effects from the device and needed a hysterectomy at age 30.

"I felt less like a woman, less like a human," Howell testified. "I became depressed. It was only my faith in God and my loving family that kept me from ending it all."

In a statement, Bayer HealthCare said:

"Essure is a safe and effective permanent birth control option with a non-surgical procedure for women who have decided they’ve completed their families. The safety and efficacy of Essure is supported by more than a decade of science, with more than 10,000 women studied since Essure was first developed, in addition to more than a decade of real world clinical experience. While there are risks with all medical devices and procedures, including Essure, Bayer’s highest priority is patient safety, and we sympathize greatly with any woman who has experienced any adverse events while using Essure. We thank the women who courageously shared their stories during the Open Public Hearing, and we remain committed to maintaining an open dialogue with any patient, advocate, or physician who has questions or concerns about Essure."

Howell said she wants Essure taken off the market.

"The only, only acceptable solution for the women suffering , the women and children who have died, the families torn apart, is for Essure's pre-market approval to be revoked," Howell said.

Howell said more than 40 people spoke to the panel including patients from across the country, medical professionals and representatives from Bayer HealthCare.


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