News about hernia mesh injuries and lawsuits have dropped off the front page in recent months – but the problem remains, as the market for hernia mesh continues to grow, along with the number of corresponding lawsuits. Furthermore, despite the fact that alternatives to mesh repair exist, hernia mesh continues to be used in 9 out of 10 surgeries, accounting for 1 million mesh repairs per year in the U.S.
According to a report from the U.S. Judicial Panel on Multidistrict Litigation (JPML) released last summer, there were approximately 6,000 hernia mesh lawsuits pending across the nation, about three-quarters of which name either Bard Medical or Johnson & Johnson’s Ethicon division as defendant (the remaining complaints are targeted at Atrium). In most of these complaints, the plaintiffs claim there was no warning about the complication risk, while in others, they say the warning was minimal or inadequate.
The hernia mesh is almost identical to the pelvic mesh that has caused crippling injuries to thousands of women since their introduction. The problem was so serious that the Food and Drug Administration finally issued a ban on pelvic mesh sales in April of 2019. However, despite the fact that hernia mesh is causing similar injuries and complications, the devices remain on the market, and sales are expected to grow over the next several years, projected to reach nearly $6 billion annually by 2026.
There are a number of alternative techniques for hernia repair. One of the most effective is known as the Shouldice repair, a technique pioneered at the Shouldice Hernia Hospital in Canada. It involves the use of the patient’s own tissues to affect the repair, with a very low rate of complication (less than one-half of one percent). Approximately 98 percent of all hernia patients are able to benefit from the Shouldice technique (the surgeons at Shouldice use mesh only when a patient’s own tissues are too damaged or otherwise unsuitable for the procedure).
Also known as the “pure tissue” repair, the Shouldice technique is employed by only a handful of surgeons in the U.S., such as Dr. William Brown of California, who no longer performs mesh repairs. In an interview with a local ABC News affiliate, he said part of the problem is the complexity and length of time it takes to perform a Shouldice repair. Whereas mesh surgery can be completed in as little as 15 minutes, a proper Shouldice repair can take 3 to 4 times that long. Dr. Brown also notes that it is essential for the surgeon to be thoroughly familiar with all the layers of muscle involved.
He also says the majority of patients are never informed about the risks of mesh surgery, or that the pure tissue repair method is even an option. Basically, it comes down to the same problem endemic to a dysfunctional health care system based on the profit motive: dollars and cents.
“It was pushed very hard by all the manufacturers because the profits are so high,” Brown says. “A piece of mesh would cost maybe a dollar to make and they would charge thousands of dollars to do this.”