PHOENIX, Sept. 28, 2015 /PRNewswire/ -- A panel of experts from the U.S. Food and Drug Administration (FDA) heard arguments Thursday regarding the regulation of the permanent birth control device Essure, which has been linked to at least two deaths and has been the subject of thousands of recorded complaints.
According to the New York Times' Sabrina Tavernise who covered the public meeting held by the FDA's Obstetrics and Gynecology Devices Panel, experts drilled representatives from Bayer Healthcare Pharmaceuticals about their small, coiled sterilization device, which has held an FDA approval since 2002. Several Essure patients, calling for the recall of the device, also gave their testimony at the public meeting.
Tavernise reported that several experts on the panel recommended that more testing be done as the device has been poorly tracked since being available, and clinical testing results released by Bayer failed to include some women who had experience problems. The FDA doesn't necessarily have to act on the panel's advice, but it is said that it often does.
According to the article, several women in attendance rejected the panel's recommendation, calling for the outright recall of the device on behalf of the more than 21,000 women in a growing Facebook network of Essure patients.
The hearing was called after growing concerns over the safety of the device. According to Aboutlawsuits.com, a woman testified before the National Center for Health Research on Capitol Hill last summer over alleged injuries incurred by the Essure Implant. In February 2015 a petition was filed with the FDA to remove the device from the market, following a uterine puncture death by Bayer to the FDA.
Later in 2015, the FDA opened an investigation of the Essure in response to allegations that the company falsified and altered medical records during clinical trials, failed to report adverse events, made fraudulent claims about the device's safety and efficacy and used defective materials in manufacturing.
"Women chose to have this procedure without being informed of the debilitating and in many cases, life altering side effects," says Robert Arentz, founding partner of the Arentz Law Group.
The FDA reports that, since 2002, the agency has received 5,093 medical device reports regarding Essure, including at least six death reports. The agency states that two of the four adult deaths in the reports was "...reportedly due to uterine perforation during device placement, one death related to an air embolism during device removal surgery..."
The Arentz Law Group is offering free legal consultations to all women who have suffered negative health effects due to Essure Permanent Birth Control Implant. Essure Implant victims are encouraged to visit http://arentzlaw.com/essure-injury-lawyers/ or call 1-800-305-6000 for more information about their legal options.
Arentz Law Group
Press release distributed by PRLog
SOURCE Arentz Law Group