Hernia Mesh lawsuit Guide
Lawsuits have been filed against the manufacturers of 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: Not Yet Set
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
Hernia Mesh principal lawyer accusations
Since Hernia Mesh 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. This Mesh is used to repair hernias. However, the materials the company used contained polypropylene coating a very dangerous substance. Their Hernia Meshs quickly caused migrations, shrinkage, organ damage, obstructions and bowels perforations (holes), leading tp additional surgeries. Many people who were injured by hernia mesh side effects filed a litigation against the companies who manufacturer the mesh including Ethicon Inc, C.R. Bard, Boston Scientific Corp. and American Medical Systems Inc. All businesses listed failed to warn the public of the hazards and dangers.
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.
Why is your Hernia Mesh considered dangerious?
Specific Hernia Meshr devices are associated with different side effects, depending on their unique characteristics. For example, many of them such as Composix Kugel, Bard Davol’s Ventralex 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.
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.
Poorly conducted medical 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 side effects found with hernia mesh symptoms
- 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
2017 Hernia Mesh Cases consolidated into Multidistrict Litigations
Thousands of patients who suffered one of the many complications caused by those allegedly defective devices, filed a dispute in court to seek proper financial compensation. 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 Settlement Case 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.