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.
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.
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.
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:
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.
Most hernias are fixed through surgery, which primarily comes in “open” and “laparoscopic” versions:
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.
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 typically comes in woven (flatter, more symmetrical) and warp (rounded loop) knitted designs.
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.”
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:
In fact, from 2005-2018, the FDA has recalled approximately 211,000 hernia mesh products.
The history of Atrium Medical’s C-QUR hernia mesh has been particularly troubling.
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.
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.
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.
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:
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