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Ethicon Physiomesh Pulled From The Market

Patient complaints and government warnings have prompted a recall and a cessation of selling the Ethicon Physiomesh Composite Hernia Mesh

Friday, April 13, 2018 - The Ethicon Physiomesh Composite Mesh is a type of screen similar to a home window screen and made of polypropylene. The product, introduced on April 9, 2010, is used to repair ventral (abdominal) hernias. Surgeons use the device to stabilize the weak and stretched tissues surrounding a bulging hernia and is made of non-absorbable plastic filaments that are laminated between two layers of Monocryl (poliglecaprone), a material reduces the risk of inflammation and promotes healing. To date, over 750,000 patients have been implanted with the hernia repair mesh.

Leading European health officials at The Health Agency of Switzerland issued a warning called an urgent field safety notice alerting hospital operating room supervisors, hospital medical materials management personnel, and all chiefs of surgery in Switzerland as well as the US Food and Drug Administration and the European Competent Advisors of the higher than average rates of revision surgery having to be performed on those implanted with the Ethicon Physiomesh Composite Mesh. The revision rate was stated to be approximately two and one-half times as often in patients with that had laparoscopic ventral hernia repair surgery using Physiomesh. The reason for the urgent safety notice stemmed from the product's inclusion of a Polypropylene coating on the mesh that has been linked to the device's rapid failure. Polypropylene can fail to be absorbed into the abdominal tissue and cause inflammation, abscesses, infections, and excessive scar tissue.

In response to the Swiss and European warnings and complaints from thousands of patients, as well as a study by the Ethicon Medical Safety Team of unpublished data from two large independent hernia registries (Herniamed German Registry and Danish Hernia Database, Ethicon Inc., issue the worldwide medical device removal of the Ethicon Physiomesh Flexible Composite Mesh used in laparoscopic procedures citing the same elevated rate of necessary revision surgeries.

Those who have suffered through revision surgery are suing Johnson & Johnson for failing to remove the product from the market in a timely manner once it was known that the product was defective. Plaintiffs also cite the fact that the product was never properly vetted as Johnson & Johnson was able to sway government officials to approve the product using the FDA's fast-track 510(k) approval program. The 501(k) program circumvents stringent product testing requirements requiring only that the manufacturer demonstrates that their product is similar to others on the market. Ethicon, a member of the Johnson & Johnson medical devices unit.

Plaintiffs are suing Johnson & Johnson for injuries that include hernia migration and obstruction of the bowels, infections, and the perforation of surrounding organs and seek reimbursement of medical expenses, lost wages, pain and suffering and other damages. There are 436 lawsuits currently claiming the Physiomesh Flexible Composite Hernia Mesh caused these and other serious health complications. Physiomesh lawsuit against Ethicon and hernia mesh injury lawsuits enable individuals to seek compensation for the medical expenses, pain and suffering that have resulted from this defective product.


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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.