PHOENIX, June 8, 2016 /PRNewswire/ -- Essure Permanent Birth Control Coils, marketed as a non-surgical alternative to tubal ligation, first gained FDA approval in 2002. Essure coils are inserted by a certified doctor into each of the recipient's fallopian tubes and work to form a natural barrier that keeps sperm from reaching the egg, thereby preventing pregnancy. The short recovery period made the procedure an attractive option to doctors and patients alike and in just the last 14 years, it is estimated that 750,000 women have been implanted with the permanent birth control device worldwide.
Since Essure entered the marketplace, thousands of women have reported serious complications to the device manufacturer. Recently, major controversy has surrounded the Essure procedure stemming from accusations that the manufacturer underreported complication rates and even intentionally concealed facts and findings in order to keep Essure on the market. In 2015, researchers at Weill Cornell Medicine in New York conducted the first large, controlled study of Essure; finding that women implanted with the birth control device were 10 times more likely to require additional operations compared to women who underwent traditional sterility surgery, according to the Wall Street Journal. In February 2016, an analysis conducted by independent consultancy Device Events found hundreds of fetal deaths due to complications were linked to Essure's failure to prevent conception-a substantially higher number than was previously reported by the manufacturer.
In early March, the FDA announced that it would require a "black box warning" for the Essure device. According to the FDA website, black box warnings are used for "serious or life-threatening risks." Additionally, the FDA will require every potential Essure patient to receive and sign a document detailing the risks now associated with the device. In total, patients must initial or sign the document 15 times before undergoing the procedure.
When the FDA approved Essure in 2002, the agency granted the manufacturer preemption status - meaning those injured by the device cannot file a lawsuit against the company. However, complaints brought by attorneys on behalf of women harmed by Essure claim the original manufacturer, breached its warranty and committed fraud in clinical trials to get the contraceptive approved, according to ABC News.
In response to the ever-growing number of women seeking justice for suffering and injuries caused by Essure, the defective device attorneys of Arentz Law Group created the Essure Legal Help Center. The Essure Legal Help Center provides free legal consultations, information, and online resources to women across the country who have been injured by Essure.
"The device makers should be held accountable for denying thousands of women the right to make an informed health decision; doctors and patients were lead to believe that this procedure was safer than tubal ligation and that could not be further from the truth," says Robert Arentz, principal attorney at Arentz Law Group. "We are bringing these claims not only to get women harmed by Essure the compensation they deserve, but also in hopes that we will finally see this dangerous product removed from the market!"
Through the Help Center, Arentz Law Group has provided free legal consultations to over 1000 women who have had the Essure procedure. Women wishing to take legal action for medical problems caused by Essure or who would like more information can visit the Essure Legal Help Center online or contact the law offices of Arentz Law Group by phone at 1-800-305-6000. The Help Center can also be found on Facebook at www.facebook.com/essurelawsuit/.
Press release distributed by PRLog
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SOURCE Arentz Law Group