FDA to Review Safety of Essure Sterilization ImplantOctober 14, 2015 — Women who are implanted with sterilization device Essure were 10-times more likely to need follow-up surgery than women who underwent laparoscopic sterilization, a new study has concluded.

The study was published in the British Medical Journal and based on data from 52,326 women who were sterilized in New York between 2005-2013.

One year after the initial procedure, 2.4% of Essure patients needed follow-up surgery, compared to 0.2% of patients who underwent minimally-invasive “tube tying” procedures. Researchers wrote:

“A more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern.”

Researchers estimated that more than 10,000 Essure patients in the United States have needed additional surgery.

The findings cast doubt on the safety of the device, which has been on the market since 2002. The FDA has received over 5,000 complaints about the serious complications like chronic pain, heavy bleeding, fatigue, painful intercourse, allergic reactions, and more.

Last month, an advisory panel to the FDA met to review the safety of Essure. Expert lashed out at Bayer for not collecting data that could have helped predict the risks, according to the New York Times.

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