No-Cost, No-Obligation Ethicon Physiomesh Attorney Case Review

Ethicon Physiomesh Attorney
Ethicon Physiomesh Lawsuit News

Polypropylene In Physiomesh May Have Never Been Tested

A flaw in the FDA approval system may have allowed faulty medical devices like Physiomesh to come to market

Friday, August 24, 2018 - There are currently over 1350 lawsuits filed in federal court against Ethicon and its parent company Johnson & Johnson for bringing a defective product, Physiomesh hernia repair mesh to market. Patients complained of pain caused when Physiomesh shrank and pulled away from its intended spot overtop of the surgically repaired hernia, sometimes traveling down within the abdominal cavity and perforating the patient's intestines. As a result, an abnormally high number of revision surgeries were required, so many in fact that on May 25, 2016, Ethicon made the decision to permanently withdraw Physiomesh from the US market.

Physiomesh is made from polypropylene, a petroleum-based plastic better suited for use as plastic bags than as an implantable medical device permanently situated in the human body. How polypropylene could ever have made it past the extensive pre-market testing and a panel of expert scientists at the Food and Drug Administration (FDA) and been approved for sale is suspicious. Polypropylene may have slipped through the cracks at the FDA and never actually evaluated. Polypropylene meshes, past and present, may have been brought to market as was Physiomesh using the FDA's 501 (k) fast-track process, thereby bypassing the rigors of pre-market testing. Physiomesh was approved for sale merely by showing that it was "substantially similar" to another device such as the recalled and widely litigated Ethicon transvaginal mesh. And as the recent Netflix documentary "The Bleeding Edge" has pointed out, fast-track approval can be "daisy-chained" meaning that one device is substantially similar to another device that was itself fast-tracked and that device to another, and so on and so on. In fact, ten or more substantially similar medical devices could have evolved with slight changes and slipped past pre-market human testing. Some of the medical devices, such as Ethicon's transvaginal mesh may have failed, been recalled, and cost the company hundreds of millions of dollars in damages and the FDA would be none the wiser. David Kestler, a former chairman of the FDA has stated that the fast-track approval process was intended for exceptional situations but has now become the rule as today over 98% of all medical device approvals are as a result of the FDA's fast-track process.

To compound the failure of the FDA to adequately test Physiomesh, the National Institute of Health (NIH) has stated its reservations with using polypropylene in medical devices that are implantable in the human body. The NIH conducted animal research and found that polypropylene quickly corrodes when placed inside an animal. "New Zealand White female breeder rabbits were implanted with polypropylene mesh, ADSC-fixed polypropylene mesh in the abdomen. After 4 weeks, adhesion was performed and the erosion of the mesh was evaluated. It was found that polypropylene mesh, ADSC-fixed polypropylene mesh all had different degrees of corrosion and adhesion, but polypropylene mesh was more corroded." Ethicon Physiomesh is polypropylene at its core and is attacked by the human body's natural defense mechanisms. Ethicon market withdrawal of Physiomesh failed to pinpoint the reason Physiomesh malfunctions, however, scientists suspect that polypropylene corrosion could be the culprit. Physiomesh hernia lawyers expect for more patients that have suffered from Physiomesh hernia repair side effects to file lawsuits against the makers Ethicon and Johnson & Jonshon.

More Recent Ethicon Physiomesh Lawsuit News:

Lawyers for Ethicon Physiomesh Lawsuits

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. The Onder Law Firm 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. The Onder Law Firm 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.