Lawsuits are being filed against the manufacturers of the hernia mesh 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 their pelvic repair systems from the market because of their alleged risks.
Bellwether Trial Date: Agust 2018
Injury: Revision Surgeries, foreign body reactions, adhesions, shrinkage
Manufacturer: Ethicon Inc, C.R. Bard, Boston Scientific Corp. and American Medical Systems Inc.
Settlement Amounts: EST – $400,000 over $1,000,000
What Is a Hernia Mesh Device?
Hernia meshes are thin membranes which are used to strengthen and repair the damaged stomach tissue. They are usually made of a 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% of surgical hernia 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.
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Why are Hernia Meshes considered dangerous?
The contact with this type of plastic is, however, linked to severe inflammatory reactions, systemic
Hernia Mesh Recalls
In 2016, the FDA acknowledged the fact that hernia 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 pelvic repair system 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.
Hernia Mesh 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.
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Hernia Mesh Lawsuit 2017 Multiple Multidistrict Litigations get Consolidated
Since they received approval by the FDA in 1994, Ethicon Inc, C.R. Bard, Boston Scientific Corp. and American Medical Systems Inc. made millions by selling meshes to US patients. Their surgical plugs, however, quickly proved to be much more dangerous than they predicted. They were linked with numerous cases of migration, shrinkage, organ damage, obstructions and perforations (holes), leading to additional surgeries.
Thousands of patients who suffered one of the many complications caused by those allegedly defective
Recently, due to the large amount of cases that the attorneys kept submitting to state and federal courts, the pelvic repair system lawsuits have been centralized in several Multidistrict Litigations. As per April 2017, the MDL No. 2327 held in the United States District Court Southern District of West Virginia and overseen by Judge Joseph R. Goodwin counts more than 32,000 cases against Ethicon Inc. The same judge is currently coordinating the legal proceedings of the MDL No. 2326, 2325 and 2187 against C.R. Bard, Boston Scientific Corp. and American Medical Systems Inc., which include at least another 25,000 hernia mesh lawsuits.
Previous Hernia Mesh Verdicts
Companies have 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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