Hernia Mesh: Patient Safety and Legal Accountability

Dr. Greg Vigna

Experts call for more oversight of hernia mesh devices amid concerns over safety and availability of safer alternative technologies

LOS ANGELES, CA, UNITED STATES, August 27, 2025 /EINPresswire.com/ -- “There needs to be greater consumer protection before introducing faulty products to the market,” states Dr. Oscar Olavarria, MD, general surgeon, University of Texas, Houston.

Dr. Greg Vigna, Board Certified Physical Medicine and Rehabilitation, says, “At issue is the continued use of certain medical devices when safer alternative procedures or designs of devices may be available. There is growing concern regarding accountability when patients are injured as a result."

What does Dr. Oscar Olavarria, MD, surgeon say in “Lack of Regulations and Conflict of Interest Transparency of New Hernia Surgery Technologies” published in Journal of Surgical Research. March 2020 (247) 445-452?

"Owing to the potential earnings and minimal requirements for introduction into the market and adoption into medical practice, industry has introduced many meshes with minimal supporting evidence.

The basis of medical industry is to develop, patent, license, and sell novel products in hopes of making significant revenues and returns on their investments."

Read Dr. Olavarria’s article: https://pubmed.ncbi.nlm.nih.gov/31668430/

Dr. Vigna continues, “The best mesh is one that is fully resorbed, so there are no chronic mesh complications other than recurrence. That design, P4HB mesh, has been available for years, and recurrence rates are no different than with synthetic mesh.”

What does Dr. David C. Chen, General Surgeon say in “Fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for soft tissue repair and reconstruction: A scoping review” published in Frontiers in Surgery 12 April 2023?

“After a thorough evaluation of the clinical studies identified by this scoping review, several major themes emerged, namely: (1) P4HB mesh provides long term strength at the repair site, leading to acceptable rates of recurrence as compared to higher-risk cohorts and those repaired with non-synthetic biomaterials; (2) P4HB mesh performs favorably in contaminated settings where permanent synthetic mesh use may be higher risk or contraindicated, resulting in low incidence of surgical site infection (SSI).

Finally, when P4HB mesh was utilized to replace infected mesh in a single-stage approach, Bueno-Lledo et al., reported a recurrence rate of 6.6% and SSI of 3.3%.

They compared these results to a second cohort in which permanent synthetic mesh was used to replace infected mesh in a two-stage approach. The permanent synthetic mesh cohort exhibited a recurrence rate comparable to P4HB mesh, but 3x greater incidence of SSI."

Read Dr. Chen’s article: https://pubmed.ncbi.nlm.nih.gov/37123542/

Dr. Vigna concludes, “Hernia mesh infections are serious medical complications that result in a prolonged recovery, and sometimes multiple procedures. The use of polypropylene hernia mesh exposes patients to unreasonable risks of complications.”

Complications of abdominal mesh and inguinal mesh infection include: 1) Chronic pain, 2) Mesh-enteric fistula, 3) Reoccurrence of hernia, 4) Sepsis, 5) and Septic shock. Treatments may include 1) Local debridement and VAC pack with antibiotics, 2) Partial mesh excision with antibiotics, 3) Complete mesh removal with antibiotics, and 4) Abdominal wall reconstruction with or without mesh.

Dr. Vigna is a California and Washington DC lawyer who focuses on serious injuries caused by defective devices. He represents the injured from defective hernia mesh and litigates these cases with the Ben Martin Law Group, a national pharmaceutical injury law firm in Dallas, Texas.

To learn more about hernia mesh, click here.

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