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HERNIA MESH

HERNIA MESH: THE COMMON SURGERY CAUSING AN UNCOMMON NUMBER OF PROBLEMS

Judging by the litany of TV hospital dramas, from “MASH” in the 1970s to “ER” in the 1990s and “Grey’s Anatomy” today, hospitals seem like pretty dramatic places.

Punctuated by pitched, urgent music and narrated by witty, rapid-fire dialogue, the heroic feats of doctors and nurses have transfixed viewers for many an episode.

Meanwhile, the steady drumbeat of humdrum, routine hospital procedures—some of which go terribly, painfully wrong—goes unheard and unnoticed.

One such common surgery escaping our attention is hernia surgery, along with the hernia mesh that accompanies it.
About 1 million such surgeries performed each year, but you’ll never see a hernia surgery on a TV drama, with doctors and nurses shouting about codes while the music swells to a crescendo.

  • But make no mistake: hernia surgery can, and does, go wrong!

The side effects of a hernia surgery can range from pain to infection, to bowel perforation, bowel obstruction, and scar tissue to intestinal blockage.
The Clauson Law Firm wants to shine some light on the emerging issue of hernia mesh, and give you the information you need to make an informed decision about your situation.
Hernia mesh may not be the stuff of hospital dramas, but it is a painful fact of life for many Americans nevertheless.

The Mechanics of Hernias

A hernia occurs when an organ, fatty tissue or a piece of intestine pops out through a hole, or a weak spot, in the surrounding muscle or tissue.

They often occur at or near the abdominal wall, and appear as a bulge under the skin that gets more obvious and pronounced as the individual is straining that area. Hernias are discovered from talking with your doctor, physical examination, and even imaging tests like CT scans, MRIs or ultrasound.

  • More than 1 million hernia repairs are done each year in the United States, and an estimated 20 million repairs are done annually worldwide.

Hernias are actually a much bigger problem, though: experts estimate many more people simply live with their hernias, and one treatment protocol is described as “watchful waiting.”

Types of hernias include:

  • Inguinal, around the inner groin. 80 percent of hernia surgeries are for this type.
  • Incisional, through an incision or scar in the abdomen.
  • Umbilical, at the belly button.
  • Hiatal, around the upper stomach/diaphragm.
  • Femoral, at the upper thigh/outer groin
  • Ventral, at the front of the abdominal wall

Men are much more likely to suffer from hernias than women. Experts estimate, for example, that 27 percent of men, versus 3 percent of women, will develop an inguinal hernia at some point in their lives.

Action Plan: How to Deal with Hernias

Most hernias are fixed through surgery, which primarily comes in “open” and “laparoscopic” versions:

  • “Open” hernia surgery makes one cut into the affected area, to see the hernia up close; stitches and surgical mesh (also called hernia mesh) are used to seal the abdominal wall area over the incision. Imagine sewing a patch onto a hole in a pair of jeans.
  • “Open” hernia surgery is more invasive, and takes longer to recover from than laparoscopic surgery.
  • “Laparoscopic” hernia surgery makes several tiny cuts into the abdominal wall, where the hernia is viewed with a tiny camera, and small, long tubes are inserted to carry cutting and sewing instruments to the site.

However, hernia surgery is often not “one and done.” Hernias that come back are called recurrent hernias, and a physician’s trade magazine estimates that each hernia repair creates a 10% risk of recurrence in the same spot, each time it is repaired there.

Hernia Mesh: A History of Risks and Rewards

An Austrian surgeon, Christian Albert “Theodor” Billroth—billed as “the father of modern abdominal surgery”—suggested as far back as 1890 that a prosthetic material could be used to close a hernia defect.

Metal-based hernia meshes were in widespread use by 1946, but their use faded out in the successive decades. It was not until the late 1950s that Francis C. Usher, a renowned herniologist, developed the first woven, non-metal mesh for hernia repair.

Called “Marlex mesh,” it was a polypropylene monofilament—plastic, basically—of the same type that Wham-O used for its “Hula Hoop” toys. Usher had tried, but rejected, materials like nylon and Teflon before settling on polypropylene.

The earliest prototypes were so-called “heavyweight” mesh; the first generation of “lightweight” hernia mesh did not appear until 1998, approximately 40 years after hernia mesh products originally emerged.

The new, lightweight hernia mesh has caught on with surgeons and hospitals: the National Institutes of Health estimate that 80 percent of all hernia repairs involve mesh products, and polypropylene hernia mesh is believed to be the most popular type in use.

  • Hernia mesh surgeries represent an estimated $48 billion to hospitals annually.
  • Advantages of polypropylene hernia mesh include:
    • Durability
    • Comfort
    • Low incidence of infection

Hernia mesh typically comes in woven (flatter, more symmetrical) and warp (rounded loop) knitted designs.

  • But hernia mesh, particularly the polypropylene variants, also has disadvantages:
    • Inflexible—stiffens over time
    • High risk of scar tissue formation
    • Sometimes shrinks, leading to hernia recurrence

And while absorbable hernia meshes derived from animal tissue can reduce the complications listed above, absorbable meshes are not as sturdy and can result in hernia recurrence.

Indeed, the National Institutes of Health have concluded that “it is obvious that the ideal mesh has not been developed.”

Here Today, Gone Tomorrow: Hernia Mesh Recalls

When a product begins to pose a danger to the public, the Food and Drug Administration (FDA) will issue a recall, which requires manufacturers to take the product off the market. Approximately 4,500 drugs and/or medical devices are recalled each year.

In the last twenty years or so, hernia mesh has been a frequent target of FDA-driven recalls, from the following hernia mesh manufacturers and products:

  • Bard Davol, Composix Kugel Mesh, 2005-2006. Danger of bowel perforation.
  • Ethicon (a Johnson & Johnson company), Proceed Surgical Mesh, 2005, and 2010. Loss of laminate coating.
  • Bard Davol, Composix Hernia Patch, 2007. Danger of bowel perforation.
  • Atrium Medical, C-QUR Mesh, 2013. Packaging could degrade mesh coating.
  • Ethicon, Proceed Surgical Mesh, 2014. Risk of adhesion (scar tissue).
  • Ethicon, Physiomesh Flexible Composite Mesh, 2016. High failure rates reported.

In fact, from 2005-2018, the FDA has recalled approximately 211,000 hernia mesh products.

Spotlight: C-QUR Hernia Mesh

The history of Atrium Medical’s C-QUR hernia mesh has been particularly troubling.

  • The FDA had been receiving complaints about the C-QUR mesh as far back as 2008, and four FDA inspections between 2009 and 2013 uncovered violations each time.
  • A 2012 warning letter about the plant’s manufacturing and sterilization shortcomings likewise went unheeded.

The subsequent 2013 C-QUR recall, at more than 145,000 units, was larger than every other hernia mesh recall combined since 2005. But the FDA wasn’t finished.

In February 2015 the FDA sought—and received—a permanent injunction against Atrium’s parent company to stop it from producing the mesh altogether. Atrium agreed to pay $6 million for the violations, and an additional $6 million if it failed to correct them.

However, the company was not required to recall the C-QUR mesh, so any hospital that had it in stock was free to use it.

From Recalls to Courts: Hernia Mesh Litigation

In 2011, C.R. Bard (the parent company of what is now subsidiary Bard Davol) paid $184 million to settle more than 2,600 lawsuits over its Composix hernia mesh products. Plaintiffs had alleged the Composix hernia mesh was breaking apart inside patients’ bodies.
Far from being an ending, however, hernia mesh litigation was just getting started.

ALPHABET SOUP: WHAT IS AN MDL, AND HOW IS IT RELATED TO HERNIA MESH?

When the same product harms a large number of consumers in different states, and those consumers file individual lawsuits in their state courts against the same company, courts will often consolidate the hundreds or thousands lawsuits into what is called an “MDL,” short for Multi-District Litigation, in federal court.

A typical MDL has anywhere from a few dozen to a few hundred cases to be litigated simultaneously, though some MDLs get much larger. For example, asbestos litigation originating in the early 1990s swelled to more than 120,000 cases at one point.

Courts prefer MDLs for cases of nationwide impact because an MDL is more efficient and allows for consistent rulings across cases.

CURRENT HERNIA MESH MDLS

  • Ethicon’s Physiomesh Flexible Composite Hernia Mesh is the subject of an MDL in the Northern District of Georgia, comprising about 2,482 cases as of November 2019.
  • Atrium Medical’s C-QUR Mesh Products are the subject of an MDL in U.S. District Court for the District of New Hampshire. About 1,679 cases are involved.
  • Bard Davol’s Polypropylene Hernia Mesh Products are in an MDL in the Southern District of Ohio, with an estimated 3,550 cases involved.

HERNIA MESH LAWSUITS: PART OF PRODUCT LIABILITY

The primary claim in a hernia mesh lawsuit concerns product liability, an area of tort law that allows you to recover for a manufacturer’s negligence.

While negligence has many facets, your universe of possible claims can include:

  • Defective design. This is a claim that the hernia mesh manufacturer’s design was dangerous in the first place, as opposed to anyone modifying the device to make it more dangerous afterward.
    • Consumers claimed, for example, that the design of the Composix Kugel hernia mesh was faulty, leading the mesh—even when formed according to design—to break apart.
  • Manufacturing defect. This claim means that a hernia mesh manufacturer had an acceptably safe design or plan for the product, but in the process of making the hernia mesh, made it unreasonably dangerous.
    • For example, claims that the packaging of Atrium Medical’s C-QUR Mesh broke down the mesh’s fish oil-like coating would be alleging a manufacturing defect.
  • Failure to Warn. This claim charges that hernia mesh manufacturers knew or should have known that their hernia mesh product was unreasonably dangerous, but did not warn consumers.
  • Medical malpractice. This claim, a form of negligence, puts the blame not on the product manufacturer, but on the doctor or hospital that performed the hernia surgery.
  • There are other possible theories, and these are just a sample. A licensed attorney can explain all the finer points of product liability and personal injury law.

REMEMBER! In any personal injury situation, whether a product is involved or not, keep in mind the statute of limitations for your state. The statute of limitations limits the amount of time you have to sue for your injuries

  • 1 year: KY, LA
  • 3 years: AR, DC, MD, MA, MT, NH, NM, NY, RI, SC, SD, VT, WI
  • 4+ years: FL, ME (6), MN, MO (5), NE, NV, NC (6, from product purchase date), ND (10-11), TN, WY
  • All other states: 2 years

HAVE YOU OR A FAMILY MEMBER BEEN HARMED BY HERNIA MESH PRODUCTS OR SURGERIES?

THE TIME TO ACT IS NOW.
CALL THE CLAUSON LAW FIRM TODAY, TOLL-FREE, AT 833-680-0177 OR REACH US BY
E-MAIL AT [email protected]. WE’RE STANDING BY TO HEAR FROM YOU.

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