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New Hernia Repair Device Addresses The High Rate Of Hernia Mesh Revision Surgeries

Deep Blue Medical can sell its multi-pronged hernia repair mesh

Wednesday, August 19, 2020 - The leading cause of a patient requiring multiple hernia revision surgeries is hernia meshes degradation and migration away from the spot atop of a surgically repaired hernia. In addition to migrating, infections also tend to occur at the points where the hernia repair mesh is affixed to the underlying natural tissue causing pain and necessitating revision surgery.

In 2016, Ethicon, the maker of the Physiomesh Hernia Repair mesh, recalled the product in its entirety because of complaints to the European medical device complaint registry Herniamed. When hernia mesh can contract and pull free from its moorings if it is affixed to the underlying tissue insufficiently.

A company called Deep Blue Medical has received FDA clearance for what the company thinks will solve this problem with the T-Line Hernia Mesh, according to Mass "The T-Line Hernia Mesh offers superior anchoring strength and eliminates a key point of failure for conventional mesh fixation, which is the mesh, suture, tissue interface that can lead to mesh migration, contraction, and failure." The founder of Deep Blue, Howard Levinson, issued a press release stating "Sewing a bit of each extension into the abdominal wall, instead of traditional sutures, significantly increases mesh anchoring strength and thus the durability of the repair, " according to MD. The Deep Blue hernia repair mesh received FDA approval under the controversial 501 fast-track designation allowing a medical device to be sold without first passing human testing. MD wrote that, according to Deep Blue, "Deep Blue's hernia mesh is large-pore and mid-weight and the extensions have 15 times more surface area than traditional sutures and act similar to how snowshoes prevent sinking in the snow."

Traditional hernia repair mesh relies on multi-layering polypropylene plastic and natural materials. One layer is to become absorbed into the underlying tissue, and the other to give the unit its strength and flexibility. The problem that has been occurring in up to 33 % of hernia mesh patients is that the plastic layer of the hernia mesh has proven to be incompatible with human tissue and tends to degrade, lose flexibility, and then break free and migrate to other organs. Deep Blue's new hernia repair mesh addresses the problem of hernia mesh device failure. The company's website tells prospective hernia patients and doctors, "Deep Blue has developed a novel hernia mesh to address the unacceptably high rate of hernia occurrence and recurrence."

Polypropylene hernia repair patients using the Physiomesh Composite hernia repair mesh have experienced organ perforation and dangerous bowel blockages. Other hernia repair mesh patients report having to undergo five or more additional surgeries to remove difficult to locate pieces of hernia mesh. Pieces of hernia repair mesh can lacerate the organs they come into contact with and cause internal bleeding and infection.

Hernia repair mesh patient that undergo revision surgery should secure their medical records and remind the surgeon and hospital to preserve the retrieved hernia mesh as evidence in court.

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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.