Countless of lawsuits keep being filed every day against the manufacturers of the hernia mesh Atrium’s C-QUR and Ethicon’s Physiomesh. Numerous clinical studies discovered a disconcerting risk for severe injuries and high recurrence rates associated with these devices.
To date, no full recall of these products has been issued by the Food and Drug Administration (FDA). However, some companies voluntarily withdrew their pelvic repair systems from the market because of the alleged risks.
If you are among the unfortunate patients who suffered serious complications or required patch removal and revision surgery, you might be eligible for a substantial cash compensation.
What Is a Hernia Mesh Device?
Hernia meshes are thin membranes
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” are designed to integrate themselves inside the abdominal wall. Here they form a barrier against other organs, preventing them from adhering to their waxy surface. C-QUR and Physiomesh had this barrier on both sides.
Why are Hernia Meshes considered dangerous?
Specific Hernia Mesh 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.
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 available 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 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.
Current state of the legal proceedings
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 devices, filed a dispute in court to seek proper financial compensation. In their lawsuits, they hold the manufacturers responsible for the damage, claiming they failed to warn the public of the hazards and dangers.
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 June 2018, 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 13,000 cases still pending against Ethicon Inc., over a total of more than 40,000 actions. 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 23,000 hernia mesh lawsuits.
Why you should file a litigation today
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.
Manufacturers have a precise duty: To provide the public with safe products that have been tested thoroughly before they are released to the market. According to court documents, these companies knew about the alleged risks associated with the use of the meshes, yet they purposely failed to adequately warn the public about them. They chose their own profits over people’s safety, and they should now be held liable for all the damage and suffering that patients like you might have suffered.
Our expert lawyers will assist you through the entire legal process until you collect your rightful reward. Contact our law firm today to receive a free and fully confidential consultation.