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Essure ® Sterilization Device Readdressed by FDA Panel of Medical Experts after Sever Complications Reported

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Essure (R) device
Essure (R) device

Essure ® is a nonsurgical, nonhormonal permanent birth control device for women that was approved by the Food and Drug Administration (FDA) in 2002. It consists of tiny coils made of nickel-titanium alloy that doctors insert into a woman’s fallopian tubes to permanently block them. Since it was introduced to the market, thousands of patients reported complications associated with the device, such as severe/chronic pain, heavy bleeding, fatigue, and reactions of the immune system.

In response to these negative reports, the FDA pulled together a panel of Medical Experts to reassess the safety of the nonsurgical sterilization option, which is provided by Bayer Healthcare. After a day-long hearing Thursday, September 24th, the expert panel recommended more data be collected on Essure ®. In short, the panel urged the FDA to conduct a formal study on the device that would gather further information on complications and side effects related to Essure ® device insertion. The data collected from continued studies would be used to train doctors on how to best select appropriate Essure ® candidates and educate potential Essure ® patients on possible risks linked to using the sterilization device.

For more information on the FDA Medical Expert Panel hearing of the Essure ® permanent birth control device, click here: http://www.npr.org/sections/health-shots/2015/09/24/443233454/fda-advisors-call-for-more-safety-data-on-sterilization-device

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