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Little is Known Why Ethicon Withdrew Physiomesh Composite Hernia Repair Mesh From the Worldwide Market

Ethicon withdrew one model of hernia repair mesh from sale because of its failure yet left a substantially similar one untouched

Tuesday, February 5, 2019 - On May 27, 2016, Johnson & Johnson, the parent company of Physiomesh maker Ethicon, issued an urgent medical device notice in order to remove the Physiomesh Composite Hernia Mesh from the market. Doctors were urged to stop using the product and to send all unused stock back to the company.

Class II medical devices such as surgical meshes are not required pre-market clinical trials prior to being cleared for sale. A class II medical device is one that is not deemed to have the potential to cause a patients death in and of itself. Surgical meshes are fast-tracked under the FDA's 505 k approval process. All that is necessary to bring a medical device to market under this provision in the FDA code is to be able to show that your medical device is substantially similar to one that is already on the market. The voluntary recall was based on the information that the company obtained from Herniamed German Registry and Danish Hernia Database, two large and independent hernia registries. The registries had reported to them that up to one-year postoperatively, Physiomesh patients that had incisional hernias repaired with Physiomesh Composite Mesh using laparoscopic surgery had two and one-half times as many product failures requiring revision surgery than the next nearest competing product.

Interesting to note that the voluntary Physiomesh recall did not apply to all of Ethicon's hernia mesh products, only to the Ethicon Physiomesh Composite Mesh and not the Ethicon Physiomesh Open Flexible Composite Mesh which remains in use to this day. Ethicon failed to pinpoint the difference in these two nearly identical products that could have led to the recall instead citing multifactorial (many potential) reasons why the product was prone to failure. Until litigation against the company is settled, little will be concluded as to why the company chose to withdraw the Physiomesh Composite Mesh and leave the Physiomesh Open Flexible Mesh on the market. Both are made from the same questionable material, polypropylene, a petroleum-based plastic that the National Institute of Health has shown to be incompatible with organic animal tissues.

Ethicon warns that Physiomesh Open Flexible Mesh carries the same potentially dangerous side effects "such as those typically associated with surgically implantable materials, including infection, inflammation, pain, adhesion formation, fistula formation, and extrusion." Physiomesh patients have reported their actual adverse events to the FDA's MAUDE database and include infections, mesh shrinkage, mesh migration, hernia recurrence, autoimmune issues, perforation and blockages of the lower intestines and bowels. Physiomesh failure can cause serious medical complications and even death. If you have had hernia repair surgery using a mesh device between the years of 2010 and 2016 and are experiencing pain in or around the surgical site or lower intestines you need to see your physician immediately. Hundreds of individuals like yourself have hired a hernia mesh attorney and are suing Johnson & Johnson for rushing a faulty medical device to market and have consolidated their cases in multidistrict litigation.

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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.