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Physiomesh is Voluntarily Withdrawn From The Market

When billions of dollars in profits are on the line, the decision to walk away from the market cannot help but draw suspicion

Friday, July 27, 2018 - On May 25, 2016, Ethicon Inc., and its parent company Johnson & Johnson officially surrendered their share of the billion dollar market for hernia repair mesh products when the group issued a voluntary market withdrawal of Physiomesh Flexible Composite Mesh. After the Ethicon Medical Safety Team reviewed unpublished data from two independent hernia registries, (Herniamed German Registry and Danish Hernia Database- DHDB) the group decided that higher than average rates of necessary revision surgery warranted the product's market withdrawal. Ethicon refused to point to any one particular factor causing the need for so many revision surgeries but conceded that characteristics of the product could be the cause. Experts now point to the Polypropylene component of Physiomesh as being the most likely reason Physiomesh fails so frequently. Whatever the ultimate reasons for the global Physiomesh recall turns out to be, when a medical device manufacturer the size of Johnson & Johnson voluntarily withdraws a billion-dollar medical device from the market, something must be very, very wrong.

Hundreds of lawsuits against Ethicon and Johnson & Johnson have been grouped into muti-district litigation and are moving forward to the first trial scheduled for September of 2019. Physiomesh patients suffering from pain and other adverse side effects have hired Physiomesh attorneys in order to file claims looking for reimbursement of their medical expenses, lost wages and real monetary compensation for their pain and suffering. Polypropylene's primary use has always been as a durable plastic used in food packaging such as single-use plastic bags and is considered by experts to be "biologically incompatible" with human tissue, thus rejected and attacked by the body's natural auto-immune system. Physiomesh shrinks crumple, and buckles causing the screen mesh to rip painfully away from its intended location resting upon the surgically repaired hernia it was intended to support. Instead, Physiomesh shrinkage can cause a hernia to reoccur, protrude again through the abdominal wall, and require the revision surgeries mentioned above. Once free from its original spot Physiomesh can migrate with the abdominal cavity and puncture the small intestines causing painful and dangerous blockages. If not immediately treated such blockages can lead to tissue death requiring removal of a part of the intestines.

It is impossible to think about the voluntary Physiomesh market withdrawal with drawing a parallel between Physiomesh and another Ethicon medical device disaster. Less than a decade ago, Ethicon brought the transvaginal mesh to market to be surgically implanted and support a woman's urinary tract organs post-childbirth. Made of the same material as Physiomesh, the Transvaginal mesh shrank, buckled, and crumpled and perforated a woman's reproductive organs causing permanent incontinence. The transvaginal mesh fiasco cost Johnson & Johnson hundreds of millions of dollars in legal judgments for bringing a faulty medical device to market without sufficient pre-market testing. It appears that the voluntary market withdrawal of Physiomesh attempts to mitigate the damages the medical device may have already caused.

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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. 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.