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Johnson and Johnson Pulls Physiomesh From the Market

Physiomesh Composite Hernia Mesh is proving to be as flawed a concept as the transvaginal mesh Johnson & Johnson tried to sell years earlier

Tuesday, May 1, 2018 - In recent years there has been an unacceptably high number of Ethicon Physiomesh failures necessitating revision surgery. Lawsuits by patients represented by knowledgeable Physiomesh attorneys against Ethicon and their parent company Johnson & Johnson alleged that the product uses a substandard material, polypropylene and that the product failed to undergo sufficient pre-market testing. Ethicon Physiomesh was rushed to market by the US Food and Drug Administration when they deemed the product was substantially similar to other hernia mesh repair products already tested and on the market.

Physiomesh is made from a composite of several materials such as polypropylene filament that is woven throughout the mesh's fabric. During non-invasive laparoscopic surgery, the mesh is placed over the spot of a hernia like repairing a screen door. Patients needing a revision surgery have reported that the mesh was not strong enough to prevent a hernia from reoccurring and causing the mesh to buckle and tear away from the original site. Other cases have reported serious infections at the site of the implantation of the device on the hernia. Many times excessive scar tissue has developed making the removal of the device impossible without also removing the organ to which it was now encased. Occasionally the mesh will migrate to other areas of the body and cause organ perforation.

As a result of the high number of revision surgeries Ethicon Inc. voluntarily and permanently removed Physiomesh from the market requiring physicians to cease use of the device and return unused product to the company. The company issued an urgent field safety notice without making mention of the potential causes of the problems or offering a solution. Physicians are urged to continue to treat existing Physiomesh patients as normal. There have been around 300,000 Ethicon Physiomesh surgeries worldwide. Half are in the United States.

Compliance with the FDA's urging of Ethicon to pull Physiomesh completely off of the market comes as no surprise since years earlier the company had to recall another of its hernia mesh products. Upwards of 100,000 women recently sued Johnson & Johnson for their negligence in bringing the transvaginal mesh to market without adequate pre-market studies and testing. The Ethicon Transvaginal mesh was marketed as a solution for urinary incontinence. A 51-year old woman was awarded $57 million in damages when a court found Ethicon to be liable for the woman's transvaginal mesh injuries. According to the the woman, "was left with a mangled urethra, bladder spasms, and continual pelvic pain after an unsuccessful procedure that led to three revision surgeries to remove mesh that had cut into her urethra and migrated to her bladder."

Those injured by the Ethicon Physiomesh Composite mesh are suing Johnson & Johnson for reimbursement of medical expenses, lost wages, pain, and suffering and seeking punitive damages as the company failed to warn consumers of the potential failure of the product. Given their history of failed mesh products, Johnson & Johnson should have tested the Physiomesh more thoroughly before rushing the product to market.

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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.