Hernia mesh issues across the United States are quickly gaining steam.
While hernia mesh has not yet reached the level of lawsuits and injuries
associated with transvaginal mesh, litigation against hernia mesh manufacturers
is increasing rapidly. Atrium Medical C-Qur hernia mesh cases have been
consolidated into a federal MDL in the U.S. District Court for New Hampshire.
Likewise, Plaintiffs filed a motion to create an MDL in either Illinois
or Florida for Ethicon and Johnson & Johnson’s Physiomesh.
There are currently more than 40 actions against Physiomesh across 10 federal
court districts. Regarding the potential Physiomesh MDL, Johnson &
Johnson is asking the court to deny the MDL request, or, if the MDL formation
request is granted, to place it in Georgia, Kentucky or New Jersey, rather
than Illinois or Florida.
Problems with C-Qur Hernia Mesh
Ethicon and Johnson & Johnson voluntarily recalled Physiomesh in May
2016, however the FDA has not yet mandated a recall of the C-Qur hernia
mesh. The FDA has conducted multiple investigations into Atrium, the manufacturer
of C-Qur hernia mesh, even suing the company in 2015, alleging Atrium
introduced adulterated medical devices into interstate commerce. Because
of alleged medical issues as well as the ongoing litigation against Atrium,
many hospitals and surgeons voluntarily stopped using C-Qur hernia mesh,
despite the fact that Atrium claimed the mesh was much less likely to
fuse with muscle tissue in the abdomen or create scar tissue due to a
unique Omega-3 (fish oil) coating.
Atrium’s claims aside, C-Qur is now being tied to patient infections,
chronic inflammation, bowel obstructions and allergic reactions. Plaintiffs
in the lawsuits against Atrium claim the polypropylene mesh hernia patches
were negligently designed, and that executives and scientists in the firm
knew the patches had potential problems, yet fraudulently convinced surgeons
the mesh was safe. As an example, one of the current plaintiffs in the
C-Qur MDL is a 56-year old, who underwent hernia repair surgery four years
ago. The patient experienced severe abdominal pain following his hernia
repair, however; it was not until a couple of years had passed that the
C-Qur mesh was identified as the culprit.
Although this patient’s mesh was eventually removed, he continues
to experience constant pain. Doctors believe the patient’s body
“fought” against the incompatible foreign product (the hernia
mesh), creating a major cell reaction. The patient currently has extensive
scar tissue surrounding the hernia repair site.
Physiomesh racked up 90 adverse event reports after being on the market
less than two years, and by the time of the 2016 Physiomesh recall, there
were 650 adverse event reports filed with the FDA. The current lawsuits
pending against Physiomesh claim defective manufacture and/or design,
in that the five-layer polypropylene portion of the hernia mesh could
not withstand typical abdominal forces, leading to additional surgical
procedures and medical expenses.
In many cases, patients experienced re-herniation, yet it appears neither
surgeons nor patients were made aware of the potential risks of Physiomesh.
With well over 330,000 Physiomesh devices sold worldwide—and at
least half of those implanted in the United States—the number of
Physiomesh lawsuits is expected to significantly increase, making a solid
case for establishing an MDL.
FDA’s 510(k) Approval Process
Both the Physiomesh and C-Qur hernia meshes received FDA approval through
the controversial 510(k) fast-track approval process. Through this approval
process, the device in question must only be shown to be substantially
similar to another device currently on the market. In the case of the
C-Qur mesh, Atrium garnered approval for the mesh by claiming it was substantially
similar to another hernia mesh which was approved in the 1990’s,
even though the C-Qur implemented an entirely different coating than the
original mesh. Another C-Qur patient claims to have suffered from chronic
pain, nausea, infections, vomiting and other adverse issues after receiving
a C-Qur hernia mesh implant in 2016. It was later discovered that the
mesh had “bunched up,” and “folded up” within
the woman’s body, causing serious injury.
National Defective Medical Device Lawyers
If you have suffered injury from a hernia mesh device such as C-Qur or
Physiomesh, it is important that you speak to an experienced attorney
as soon as possible. Call the defective medical device lawyers at Golomb
& Honik today for a consultation and to learn about your legal options.
Our goal is to get you the greatest maximum recovery for your physical
and emotional suffering.
To learn more about your legal options or to schedule a free consultation call the
Philadelphia product liability lawyers at Golomb & Honik today at
1-800-355-3300 or 1-215-985-9177 or fill out our confidential
The national defective medical device lawyers at Golomb & Honik have
successfully represented individuals in Philadelphia, Pennsylvania, New
Jersey, and throughout the United States