Hernia mesh products have been linked to a host of severe side effects, including hernia recurrence and re-operation. Many patients have suffered chronic pain and racked up enormous medical bills. Now, hundreds of injured patients are pursuing justice:
- Physiomesh - Withdrawn From Market
- Atrium C-Qur
- Bard Perfix, Composix, Sepramesh
Legal experts believe that thousands of hernia patients may be eligible to pursue compensation. Contact our experienced product liability attorneys today for a free consultation.
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Hundreds of patients have filed product liability lawsuits against leading medical device manufacturers, arguing that a range of hernia mesh patches are defective in design and hold the potential to cause severe complications.
Hernia Patients File Suit After Suffering Side Effects
Major healthcare companies, from Johnson & Johnson to Atrium Medical, have been drawn into federal courts across the country. 2017 has seen a literal explosion in mesh litigation.
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In Georgia, Johnson & Johnson-subsidiary Ethicon has been hit by more than 100 lawsuits filed over the company's now-defunct Physiomesh Flexible Composite Mesh, a product that Ethicon's own studies found could cause high rates of hernia recurrence and re-operation.
A similar litigation is playing out in New Hampshire, where over 100 product liability lawsuits accuse Atrium Medical of failing to warn the public about the potential risks posed by its C-Qur line of mesh implants.
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Potential Mesh Side Effects
Mesh products have become a leading tool for surgeons who hope to patch wounds, close surgical incisions and reinforce muscle walls made weak by illness or injury. But in a wave of new lawsuits, FDA side effect reports and medical studies, hernia mesh products have been linked to a wide range of severe, and often life-threatening, side effects:
- chronic pain
- seroma - fluid build-up around incision site
- adhesion - a primary risk factor for fistula, adhesion occurs when the mesh becomes attached to other internal organs
- fistula - an abnormal passage between vital organs
- internal bleeding
Needless to say, many of these complications can force patients back into the operating room, as surgeons struggle to reverse the life-threatening consequences of a mesh failure. These "revision" procedures have become increasingly common and, for Physiomesh, led to the downfall of the product, which was removed from the market in 2016.
Hernia recurrence is another leading complaint; some of these mesh products just don't seem to work very well. That increases the risk of further pain and discomfort, but also burdens patients with the added risks of further surgical procedures.
How Does Surgical Mesh Work?
Surgical mesh came into limited use during the 1950s, but saw wider recognition twenty years later when gynecologists began to use mesh patches to correct pelvic organ prolapse, when organs in the lower belly drop downwards and apply pressure to the vaginal walls. Just ten years after that, the products were also being used for stress urinary incontinence, a condition in which urine leaks from the bladder during physical exertion.
Meanwhile, similar developments were taking place in the treatment of hernias, conditions in which organs or tissues push through weak or ruptured muscle walls. The first patch, made from synthetic polymer polypropylene, was introduced in the 1940s. Over the following decades, various materials and mesh styles were proposed to improve the treatment, Michigan Surgery reports, culminating in the first non-invasive mesh repair in 1989.
Today, hernia mesh products almost universally begin with a lattice-work patch made from plastic. Both Physiomesh and C-Qur patches feature a polypropylene mesh as their starting point, but that's where the similarities end.
Patch Design Blamed For Severe Complications
Ethicon's Physiomesh, which was initially advertised as a revolutionary innovation in mesh technology, is laminated in four distinct layers of synthetic polymer. C-Qur mesh products, on the other hand, are coated in Omega 3 fatty acids, a form of fat found in fish oil.
These designs, according to manufacturers, were intended to reduce the risk for a common side effect of hernia repair:
- adhesion - a type of internal scarring
Adhesions happen when a mesh product becomes attached to surrounding internal organs. It's a natural part of the healing process, but may also lead to severe complications. Mesh products that adhere to internal organs can eat away at body tissue, creating fistula, abnormal passages between organs, or obstructing the intestines and preventing digestion. Ethicon and Atrium both thought they had a solution to this problem.
Patients: Ethicon, Atrium Sold Dangerous Products
Atrium took a rather obvious route, coating their C-Qur patches with slippery Omega 3 fatty acids to prevent the mesh from becoming bound to other organs. Ethicon's Physiomesh products feature a specially-designed "anti-adhesion barrier" to serve the same function.
Tragically, hundreds of current and former hernia patients say that these "innovative" designs are a total failure. Instead of preventing adhesion, Physiomesh and C-Qur patches actually increase the risk for serious side effects, according to numerous lawsuits filed in court.
Plaintiffs Say Physiomesh Causes Migration, Adhesion
With its synthetic anti-adhesion barrier, Physiomesh prevents reabsorption, plaintiffs claim. The patch, lawsuits say, cannot be absorbed by existing body tissues due to its unique design. That leaves the patch intact, within a patient's body, for lengthy periods of time, creating a risk that the product will migrate from its site of implantation and come to threaten other vital organs. Moreover, patients accuse Ethicon of using "biologically incompatible" materials, increasing the risk of dangerous inflammatory responses.
Infections are also commonly reported, a fact that plaintiffs explain by referring to Physiomesh as a "breeding ground" for deadly bacteria.
C-Qur Is "Biologically Incompatible," Lawsuits Claim
The problems alleged in Atrium's C-Qur family of mesh patches are similar. Plaintiffs point to the product's Omega 3 fatty acid barrier, derived from fish oil, a known allergen and well-documented "immunogenic" compound - exacerbating immune system responses.
Further, lawsuits contend that C-Qur's polypropylene mesh is biologically incompatible, triggering the immune system even more. These immunological responses have a dangerous effect, plaintiffs continue, increasing the risk that the mesh will fragment prematurely and creating the potential for a host of additional complications.
Physiomesh Withdrawn From Market
At least one manufacturer has taken note of these potential risks and done something about it. Ethicon, the Johnson & Johnson-subsidiary responsible for Physiomesh Flexible Composite Mesh, issued a voluntary "market withdrawal" for the product in May 2016.
While Ethicon has yet to call its decision a "recall," Physiomesh Flexible Composite Mesh products are no longer available, because two unpublished studies found that patients with Physiomesh patches were far more likely to experience hernia recurrence, and require invasive re-operation, than people who had received other meshes. Unfortunately, Ethicon has never made these studies available to the public and has given professionals little guidance on why Physiomesh appears to be more dangerous.
In an Urgent Field Safety Notice issued to medical facilities, Ethicon attributed the patch's failures to "a multifactorial issue," citing "possible product characteristics, operative and patient factors" as potential explanations. As many observers have noted, the company's apparent admission that "product characteristics" could underlie the high failure rates may suggest that Physiomesh was defectively designed.
No similar recall efforts have been attempted for Atrium's C-Qur products.
Multi-District Litigation (MDL)
Both the Physiomesh and C-Qur litigations have been "consolidated." Since all of the hernia mesh lawsuits share common allegations, a panel of federal judges decided that the claims should proceed as a group.
In order to facilitate this process, the US Judicial Panel on Multi-District Litigation has ordered all federally-filed Physiomesh lawsuits to be transferred to the US District Court for the Northern District of Georgia, in Atlanta. Likewise, the hundred or so lawsuits filed in federal courts against Atrium have been sent to the US District Court of New Hampshire in Concord, the State's capital.
What Is MDL?
In their new, centralized courts, the two major hernia mesh litigations will progress through pre-trial proceedings. In Atlanta, Physiomesh lawsuits together will undergo discovery, the process of civil litigation in which evidence is gathered through witness testimony, corporate documents and personal medical records.
A comparable process will take place in New Hampshire, where issues common to every C-Qur mesh lawsuit will be hashed out under the guidance of Judge Landya B. McCafferty. The Honorable Richard W. Story has been tapped to lead the Physiomesh litigation in Georgia.
Once pre-trial proceedings are complete, federal judges presiding over a Multi-District Litigation usually select a small slate of individual lawsuits for trial. These "bellwether trials" are held first, and serve as "test cases," in which plaintiffs and defendants are able to gauge a jury's reaction to the evidence and arguments.
The jury's decision is only binding on the individual plaintiff at issue, but these preliminary trials often come to inform settlement negotiations. Defendants who lose a number of bellwether trials may be more likely to settle the remaining cases, rather than take each lawsuit to trial. When defendants win their bellwether trials, on the other hand, they may conclude that fighting in court is the better option.