Hernia Mesh Lawsuit Guide

A storm of Hernia Mesh lawsuits have been filed against the manufatures Atrium’s C-QUR  and Ethicon’s Physiomesh after Clinical studies showed severe injuries and high recurrence rates. Patients who suffered serious complications required patch removal and revision surgery. No full recall of these products has been issued yet by the Food and Drug Administration (FDA). However, some companies voluntarily withdrew them from the market because of their alleged risks.

Attorneys are accusing the manufacturers of hernia meshes of not adequately warning the plaintiffs they represent about the high failure rate of the medical device. Meshes are, in fact, among the most lucrative devices released to the marked in the last few years, but the design of many of them proved to be inadequate to the patients’ needs. Composite patches, in particular, sell for higher prices and many companies rushed their design knowing they could simply recall it later regardless of the legal consequences.

Device Type: Hernia

Injury:  Revision Surgery.

Manufacturer:  All 

Total Cases: 700

Settlement Amounts: EST – $400,000 over $1,000,000

Bellwether Trial Start Date:        April 2017

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What is a hernia mesh?

Hernias occur when an organ such as the stomach or the intestines protrudes through the muscle wall that holds it in place. Any circumstance that increases the abdominal pressure may cause a hernia, including pregnancy, physical exertion, previous surgeries, obesity, or simply aging.

Hernia meshes are thin membranes which are used to strengthen and repair the damaged tissue. They are usually made of biologic material such as cow fetus skin or pig intestine, or synthetic non-absorbable materials such as polyester or polypropylene. Meshes are implanted within the abdominal cavity where they act like a plug, keeping the organs from bulging. As soon as scar tissue grows through the device, a new layer is formed to further reinforce organ walls.

In the last 20 years, up to 90 percent of the hernia surgical repairs involved the use of a mesh. There are many types of mesh available, depending on their size, shape, and target tissues. Some of them known as “tissue separating meshes” were designed to integrate themselves inside the abdominal wall. Here they formed a barrier against other organs, preventing them from adhering to their waxy surface. C-QUR and Physiomesh had this barrier on both sides.

Why is this device dangerous?

Hernias are difficult to repair on the long-term and have a high rate of recurrence, especially if they were closed with one of those artificial plugs. A reopened hernia may be much larger than it was before, and potential organ adhesions may force the surgeon to remove additional chunks of intestines, abdominal tissues and muscles together with the patch. The scar tissue that grows inside the mesh eventually shrivels, causing the device to shrink together with it. This fibrous mass may cause many chronic adverse reactions that negatively affect a patient’s quality of life.

Specific hernia meshes, however, are associated with different side effects, depending on their unique characteristics. For example, many of them such as Composix Kugel, Bard Davol’s Ventralex ST and Atrium’s C-Qur consist of a coated polypropylene ring. The coating consists of several substances which are designed to be absorbed into patient’s body after a certain amount of time, exposing bare polypropylene to the internal organs. The contact with this type of plastic is, however, linked to severe inflammatory reactions, systemic infections and injuries. Note that the use of polypropylene is explicitly prohibited in any “applications involving permanent implantation into the body.” Since this chemical is extremely porous, the intestinal tissue may grow inside the patch, causing adhesions, bowel obstructions and dangerous foreign body reactions. The consequences may be dire and could require multiple long hospitalization times and additional surgeries to remove entire sections of the bowel.

On the other hand, if the plug’s coating gel is not porous enough, as it often happens with C-Qur’s fish oil, the ability of the mesh to ingrow into the abdominal wall may be substantially reduced, causing detachment and reopening of the hernia. A nonporous mesh can also result in an intensive inflammatory response, which may lead to pain, infection or require a revision surgery to replace the device entirely. Foreign body response may also lead to the formation of a fluid pocket around the plug called seroma, as the body tries to push it away from tissues. Lastly, meshes can shrink and change shape immediately after the surgical procedure, forming creases and folds inside which tissues may grow, leading to adhesions and inflammation.

Hernia Mesh Recall

In 2016, the FDA acknowledged the fact that mesh products were linked to a concerningly high occurrence of complications. The regulator investigated many medical adverse event reports, and found the surgical patches to be the leading cause of bowel perforation and obstruction.
Many hernia meshes are no longer on the market after the manufacturers voluntarily withdrew them. Bard, for example, voluntarily recalled its Composix Kugel Mesh Patch in 2007 after facing thousands of lawsuits filed by patients who accused them of suffering serious medical issues including chronic enteric fistulae. Eventually, the company chose to pay $184 million to settle most of these litigations. Ethicon also withdrew its Physiomesh from the market, although it never admitted that the FDA issued a product recall. However, many of them are still currently sold and used in hospitals and clinic through the country, actually endangering many patients’ lives, and no actual recall has ever been issued.

Poorly conducted tests

Most of the studies that initially demonstrated the hernia patches’ safety and effectiveness just tested them for a couple of months or years, although most complications could manifest 10 to 15 years after implant. Also, many adverse reactions that were not considered as “normal complications” were never properly monitored. In one of the Ethicon’s preclinical animal trials, 100% of the test subjects experienced mesh shrinkage, adhesions, or migration of the device. Another preclinical study conducted in rats found a 50% mesh reduction in size and instances of the implant folding and curling.

At least one Physiomesh Clinical trial was terminated early, potentially due to the incidence of serious adverse events experienced by human patients. However, the company continued to sell its hernia patch without reporting any results of the study to physicians, and only withdrew the product 10 months after the unsettling results of the trial were published.

Other potential issues found with the product included:

  • Watertight implant
  • Waxy, solid films taking 6-8 months for the body to absorb
  • Ingrowth did not occur because the body was unable to incorporate the implant
  • Adhesions to the bowel and other organs

Previous Hernia Mesh Lawsuit Verdicts

Many companies already chose to settle many claims by paying a substantial amount of money to the victims. Back in 2010, a jury in the U.S. District Court for the District of Rhode Island awarded $1.5 million to Christopher Thorpe after the man filed a litigation against the manufacturers of the Kugel patch, Davol Inc. and C.R. Bard Inc. According to court documents, one of the two plastic rings that kept the shape of the patch broke causing it to fold and adhere to the man’s abdomen.

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