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

Ethicon Physiomesh Attorney
Ethicon Physiomesh Lawsuit News

Urgent Field Safety Notice for Physiomesh Hernia Repair Mesh

The Swiss field safety notice has caused Ethicon to issue a US market withdrawal of the Physiomesh hernia repair mesh

Monday, August 7, 2017 - On May 25, 2016, The Health Agency of Switzerland issued an urgent field safety notice accusing the Ethicon Physiomesh Composite Mesh of causing higher than average rates of revision surgery, approximately 250% as many, after patients with hernias underwent laparoscopic ventral hernia repair surgery. The agency stated Polypropylene coating on the mesh could be the cause of the rapid failure of the mesh that is prone to become absorbed into the tissue on which it is placed, causing abscesses, infections, and encasement in scar tissue. The Swiss field safety notice was sent to all operating room supervisors, medical materials management personnel, and all chiefs of surgery in the country and the US Food and Drug Administration and the European Competent Advisors were immediately notified. No field safety alerts were ever issued by the FDA in the United States and patients continued to be implanted with the defective medical device through May of 2016 when Ethicon under the urging of the FDA, issued a voluntary "market withdrawal" of the product.

A market withdrawal differs from a product recall as to the scope of who is required to be notified. In the United States, hospitals, physicians, and patients were never made aware that the product was being taken off of the market due to its defects nor were the patients that were suffering from its side effects alerted to the fact that the mesh itself was causing their medical problems. Old habits die hard and Johnson & Johnson with its history of putting profits before public safety decided that a total recall with its mandatory warnings to the medical community would just be too big a hit on their sales and revenues.

If you are amongst the thousands of misinformed Physiomesh patients or have had a loved one die due to Physiomesh complications from revision surgery, a designation of a "market withdrawal" is no less serious than a compulsory total recall. Independent studies note the high rates of complications such as severe abdominal pain, infections, perforated organs, intestinal blockage, tissue damage, internal bleeding, and ulcers at the site where the mesh was used. Johnson & Johnson may have been aware of the many complaints and the lawsuits that were pending against its subsidiary Ethicon or the company would never have agreed to pull the product from the market and forfeit billion of dollars in profits going forward.

While it is commendable for the company to take the product off of the market, it is of little consolation for the 300,000-plus Ethicon Physiomesh hernia repair patients that suffer from the consequences of the product's malfunctions, infections, ulcerations, and attachment into the surrounding tissue making its removal impossible or risk surgical consequences that include death.

Many feel that the Ethicon Physiomesh product was rushed to market in April of 2010, as the company skipped the more rigorous pre-market research and studies which are required to be passed to get a new product out and onto the market, choosing instead the less informative 510(k) clearance program. The company claimed that the product was substantially similar to another mesh product Ethicon manufactures and markets which was already approved called the "Proceed hernia patch," therefore the company deemed that duplication of the product testing was unnecessary. The FDA agreed and the product which included the deadly new, untested, Polypropylene material was hurried to hernia surgeons around the world.

More Recent Ethicon Physiomesh Lawsuit News:

Lawyers for Ethicon Physiomesh Lawsuits

Onder, Shelton, O'Leary & Peterson, 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. Onder, Shelton, O'Leary & Peterson 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.