Hernia Mesh Litigation: Where Things Stand

Hernia Mesh Litigation: Where Things Stand

Category: Hernia Mesh

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Progress invites criticism, and in surgery, innovation often begets litigation, as most every surgeon whose practice involves mesh-reinforced hernia repair can attest.

“The ads for hernia mesh lawsuits are everywhere, and if you Google ‘hernia mesh lawsuit,’ you’ll see ad after ad after ad for lawyers. We face it every day in our offices; it’s ubiquitous,” said Guy Voeller MD, at the 2021 virtual Abdominal Wall Reconstruction Conference. Dr. Voeller is a professor of surgery at the University of Tennessee Health Science Center, in Memphis.

“But the problem with mesh in hernia repair is that we have to have it; trying to repair many hernias with suture alone is doomed to failure.”

Mesh is now the standard of care in hernia repair for its ability to reduce the rate of recurrence dramatically. But it’s also become a target for lawsuits. What started with a smattering of cases in the 2000s has ramped up considerably in the last five years, so much so that many of them are being tried as multi-district litigation (MDL).

“MDL is a creature of the federal court system; typically, you’ll bring a number of cases that have been filed in a variety of districts around the country under one umbrella,” said Todd R. Bartos, Esq., an attorney with The Bartos Group LLC, in Lancaster, Pa.

“The MDL is basically an efficient way to consolidate common portions of cases and reduce the risk of inconsistent results. MDLs also encourage the quick resolution of these cases by trying one case, the bellwether case,” Mr. Bartos said. “Generally, as goes the bellwether case, so goes the entire group of cases.”

What Are All These Lawsuits About?

The complaints against inguinal and incisional hernia repair with mesh have some similarities, but not entirely; legal issues in inguinal hernia repair revolve mainly around chronic groin pain.

In 2013, a commentary by Josef Fischer in “Fischer’s Mastery of Surgery” argued that mesh is responsible for inguinodynia and that surgeons should stop using it; this provoked a counterargument by Arthur Gilbert that autologous repair, along with its higher recurrence rate, also causes chronic groin pain, Dr. Voeller said.

“Dr. Gilbert’s position was that the pain is due to the absence of technique, not the technique itself.”

Thus, paper after paper examined recurrence rates and pain with or without mesh; in sum, the clinical data find mesh-based laparoscopic inguinal repairs less associated with chronic groin pain than any other type of repair, Dr. Voeller said. “Mesh in and of itself is not a major cause of chronic groin pain.”

This is not to imply that mesh is benign; take the case of mesh in transvaginal pelvic organ prolapse (TV-POP), which was FDA approved for this indication in 2001 as a 510(k) clearance.

“But we had no short- or long-term safety data regarding this use due to the 510(k) approval process not requiring clinical trials; as more surgeons started using mesh, we saw more complications at a rate up to 50% for erosion, pain, infection, dyspareunia and GU [genitourinary] issues,” Dr. Voeller said.

Tips for Surgeons Using Mesh

Maximize patients’ preoperative condition and manage expectations. “We have to let patients know that abdominal wall reconstruction is a very complex surgery with complex issues and the potential for significant complications,” said Guy Voeller, MD, a professor of surgery at the University of Tennessee Health Science Center, in Memphis, at the 2021 virtual Abdominal Wall Reconstruction Conference.

Ultimately, the FDA required all companies to withdraw mesh for TV-POP in 2018. Soon, lawsuits around mesh use in that procedure were big news and big money.

“In 2019, The New York Times reported that seven manufacturers paid nearly $8 billion to resolve more than 100,000 claims. The law firms got a lot of money; having profited from these claims, they decided to look at mesh in inguinal and incisional hernia,” Dr. Voeller said.

Complaints against mesh use in incisional repair are similar to those in TV-POP: pain, erosion, recurrence, bowel obstruction, seroma, infection and death—“all the complications we see with complex reconstruction of the abdominal wall,” Dr. Voeller said.

“In these lawsuits, the material is accused of tearing or breaking, the coatings don’t prevent adhesions, the pore size isn’t right—the complaints go on and on.”

Plaintiffs’ counsels are not just motivated by money, Mr. Bartos said. “Many are truly in it to protect patients and prevent avoidable harm. Where we get into disputes is whether something is ‘avoidable’ or simply a known risk of using a foreign material to repair a fascial defect. Many times, there are issues of what a manufacturer knew and when it knew it regarding risk profiles. But there is no arguing that it is a lucrative business, and there are some who invest heavily in ads to generate a larger group of plaintiffs.”

Where We Stand Now

At this point, many of the manufacturers of mesh used in hernia repair are involved in MDLs. Although many cases were suspended in 2020 due to the coronavirus pandemic, these cases are now working their way through the MDL system; the case against Bard and its Ventralight ST mesh rebooted in August 2021.

“The use of MDL and bellwether cases gives a sense of where a jury would go in each of the other tens of thousands of potential cases. That allows a reasoned risk calculation for both sides,” Mr. Bartos said.

If there is a loss at trial, that is not the end of it. “If Bard loses and there is a damages award, typically the MDL parties would get together to discuss a global settlement, but Bard could appeal a bellwether case defeat,” Mr. Bartos said.

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