Mesh Removal: How Much Does Surgical Approach Matter?

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, TheNew 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. ■

By KATE O’ROURKE

Does surgical approach have a role in inguinal hernia mesh removal? At the 2021 annual meeting of the Americas Hernia Society (abstract 50176), researchers of a new study sought to answer this question.

The study led by Desmond Huynh, MD, a PGY-4 general surgery resident at Cedars-Sinai Medical Center, in Los Angeles, included 113 patients, 39 of whom had open, 23 of whom had laparoscopic and 51 of whom had robotic mesh removal. The approach was based on initial mesh placement. Mesh that was placed anteriorly in an open fashion was removed via the open technique, and preperitoneal mesh was removed either laparoscopically or robotically.

Patients were evaluated two weeks after removal, and long-term follow-up occurred at a mean of 2.5 years. The patients in the three cohorts were well balanced in terms of comorbidities and indications for mesh removal, which included foreign-body sensation, meshoma, reaction, neuralgia and infection.

The operative time was longest with the robotic approach (226 minutes), followed by open (181 minutes) and laparoscopic procedures (169 minutes). There was a significantly different rate of intraoperative injury and major vascular injury among the three approaches, with the laparoscopic group having the highest rate of injury (Table). The mean blood loss was 77 mL in open, 96 mL in laparoscopic and 52 mL in robotic procedures, with significant variance. There was no difference in postoperative complications among approaches. There was no difference in pain scores among groups at two-week and long-term follow-up with a mean of 2.5 years. There was a significant improvement in pain scores in all patients after mesh removal. There was no difference in pain score improvement among the approaches.

The authors concluded that all mesh removal approaches were effective in treating chronic postoperative inguinal pain after inguinal hernia repair. The three groups were equally affected by treating postoperative chronic inguinal pain, yielding durable improvement. There was significant variance among the groups with regard to operative time, rate of injury and blood loss, with post hoc analysis suggesting that a robotic approach may confer some advantage, Dr. Huynh said. However, these observed differences were small.

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Table. Operative Complications

Open Laparoscopic Robotic P Value

Intraoperative injury 4 (10%) 8 (39%) 8 (16%) 0.044

Minor vascular (inferior epigastric, gonadal) 4 (10%) 4 (17%) 7 (14%) NS

Major vascular (external iliac) 0 (0%) 3 (13%) 1 (2%) 0.019

Nerve 0 1 (4.3%) 0 NS

Organ 0 0 0 NS