HerniaMeshandLitigation:WhereThingsStand

Hernia Mesh and Litigation: Where Things Stand

By MONICA J. SMITH

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 dramatically reduce the rate of recurrence. 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 to be 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

Have detailed, documented conversations with patients.

“Explain why mesh is necessary, the pros and cons of different types of mesh, and whether there’s an alternative,” said Todd R. Bartos, Esq., an attorney with The Bartos Group LLC, in Lancaster, Pa. “Also, explain post-op instructions. Tell them why it’s important not to lift that 40-pound bag of dog food for the next six weeks.”

Take clear operative notes.

“The op note is the critical piece to keep surgeons out of the hot seat. It’s one thing for mesh manufacturers to bear the risk of litigation of a failed product, but you want to make sure that you’re minimizing your chances that a failed product will be argued to have also been improperly applied,” Mr. Bartos said.

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.