Four deaths, thousands of adverse events filed with FDA over sterilization implant side effects.
PHOENIX - Sept. 22, 2015 - PRLog -- The U.S. Food and Drug Administration (FDA) is expected hear 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 FDA, the regulatory agency will convene a public meeting of the Obstetrics and Gynecology Devices Panel on September 24th to review “scientific data regarding Essure’s safety and effectiveness.” The small, coiled sterilization device, manufactured by Bayer Healthcare Pharmaceuticals, Inc., has held an FDA approval since 2002.
According to a report that aired during NPR’s Morning Edition on Monday, National Center for Health Research President Diana Zuckerman called the Bayer selling points of Essure being safe and easy “not accurate.”
"What we'd like to see is new research that's carefully monitored that can actually tell us how often women have these serious complications from Essure and how often the product does not work to prevent pregnancy. That's what we really need," Zuckerman told NPR’s Rob Stein.
The meeting comes after growing concerns over the safety of the device. 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 undergone Essure removal surgery or who have suffered negative health effects due to Essure Permanent Birth Control Implants. 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.
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FDA to hear concerns over Essure Permanent Birth Control; Arentz Law Group reports
September 22, 2015 at 07:54 AM EDT