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The FDA Bans Pelvic Surgical Mesh

The FDA should have required medical devices like pelvic and hernia repair mesh to be more thoroughly tested before being brought to market

Thursday, April 18, 2019 - In a sudden development, the US Food and Drug Administration has ordered two separate makers of surgical mesh products to cease making and marketing them. The FDA ordered Boston Scientific and Denmark's, Coloplast to "cease the sale and distribution of their surgical mesh products used in transvaginal repair of pelvic organ prolapse (POP) having not demonstrated a reasonable assurance of safety and effectiveness for these devices" according to Plastics Today website. Ethicon hernia mesh attorneys handling national cases offer a free consultation to people harmed by mesh repair.

The FDA is apparently trying to make up lost ground given their lax oversight of the pelvic and hernia repair mesh medical devices market over the early part of the last decade. A recent documentary film brought to light the inefficiencies in the FDA's medical device approval process that permits substandard and dangerous medical devices to be brought to market with little or no premarket testing. The FDA's 501 fast track program was intended to be an exceptional way to get a new and vital, life-saving device to market quicker than having to go through the normally stringent premarket testing and approval process. In the years prior to FDA chairman Scott Gottlieb, medical devices flew through the system as the FDA only requirement was that the device was similar to another device already approved without first checking to see if the older device had been recalled, defective, or the subject of lawsuits. Sources speculate that after the Netflix documentary film entitled "The Bleeding Edge" aired, Dr. Gotleib decided forced to resign after less than two years on the job rather than attempt to clean up the medical devices approval mess he inherited. When the deficiencies of the fast track approval process were brought to their attention, and given a large number of failures of both pelvic support and hernia repair mesh, pelvic devices were reclassified as Type III high risk and required to undergo stringent testing. Both Boston Scientific and Coloplast failed to retest their products that have now been banned. According to Plastics Today " As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of premarket approval (PMA) applications, the agency's most stringent device review pathway, in order to continue marketing their devices in the U.S.," wrote FDA."

Plastics Today went on to highlight the fact that the FDA has had over twenty years to address the problems with approving medical devices that were injuring thousands of women. These meshes were made from polypropylene and inserted to support normal bladder function, usually immediately after childbirth. Women have suffered permanent disfigurement and endured "severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues," from a device that like hernia mesh, should never have made it to the market. Experts around the world fear that hundreds of thousands of patients that have had their hernias repaired using hernia repair mesh may require one or more revision surgeries over their lifetime to locate and retrieve as much hernia mesh as possible.

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OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. OnderLaw has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. OnderLaw has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.