Is polypropylene hernia mesh safe?

Hernia repairs remain one of the most common surgical procedures performed today, with over one million performed in the U.S. each year alone. Surgical mesh, which is a medical device used in hernia repair procedures to help provide support to the weakened or damaged tissue, has become increasing popular since the 1980s. Over 80% of hernia repairs performed in the U.S. today use mesh.  

There are currently more than 70 types of mesh available in the market, constructed from various synthetic materials and animal tissue. “Researchers have investigated metals, composites, polymers and biodegradable biomaterials in their quest to attain the ideal surgical mesh and implantation procedure. The sought-after characteristics are inertness, resistance to infection, the ability to maintain adequate long-term tensile strength to prevent early recurrence, rapid incorporation into the host tissue, adequate flexibility to avoid fragmentation, non-carcinogenic response, and the capability to maintain or restore the natural respiratory movements of the abdominal wall (1).  

According to the FDA, some of the most commonly reported adverse events that can occur following hernia repair with mesh are pain, infection, adhesion, hernia recurrence, bowel obstruction, mesh migration, and mesh shrinkage or contraction (2). Polypropylene mesh, touted as both durable and flexible, is the most common type of synthetic hernia mesh on the market today. Although polypropylene meshes are generally considered the current standard of practice, polypropylene-based mesh repairs nonetheless still result in adverse effects and post-surgery complications.  

A 2012 letter published in the Journal of Urology offered a review of polypropylene meshes and the mechanisms by which the mesh changes after implantation. “Polypropylene in mesh form is commonly considered inert and without adverse reactions after implantation in humans. The literature suggests otherwise with reports of various degrees of degradation, including depolymerization, cross-linking, oxidative degradation by free radicals, additive leaching, hydrolysis, stress cracking and mesh shrinkage along with infection, chronic inflammation and the stimulation of sclerosis” (3). The letter concludes, “Based on available evidence the polypropylene used for surgical treatment of various structural defects is not inert after implantation in the human body. The quest for the perfect mesh must continue” (4). Further, U.S. Material Safety Data Sheets (MSDS) from numerous polypropylene suppliers also caution that polypropylene was not to be used for medical applications involving permanent implantation in the human body.

Several polypropylene mesh devices have consequently been the subject of various FDA recalls and ongoing litigation. Lawsuits against several mesh manufacturers, including Bard Davol, Ethicon, and Atrium, allege the polypropylene mesh devices were defectively designed and manufactured and resulted in painful and debilitating complications. As of July 2020, there are currently 8,739 lawsuits pending in three several MDLs (5). The cases have not yet gone to trial.  

If you or a loved one have suffered a severe side effect after hernia repair surgery, especially if you've had revision or removal surgery, we're here to help. Fill out the intake form here for a free and no-obligation review of your case. We’ll help you determine if you have a claim, navigate the process, and maximize your potential compensation often without ever stepping foot in court. If you do not receive a recovery through a lawsuit or settlement, you don’t owe us anything.

‍ References

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5618132/
2. https://www.fda.gov/medical-devices/implants-and-prosthetics/hernia-surgical-mesh-implants
3. https://pubmed.ncbi.nlm.nih.gov/22578730/
4. Ibid. ‍
5. https://www.drugwatch.com/hernia-mesh/lawsuits/

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