More than a million Americans undergo hernia repair surgeries every year, making the procedure among the most common surgeries performed in the United States, according to the U.S. Food and Drug Administration. About 4 in 5 of those operations are for groin hernia repairs, which almost always involve hernia mesh.
Research shows hernia repairs have long been “bread and butter” procedures for hospitals. The mesh medical device allows more surgeries in shorter amounts of time.
Hernias form when organs, intestines or fatty tissue push through a tear or weak area of the muscle or tissue that holds them in place. Before the invention of modern surgical mesh in the 1950s, doctors would stitch the torn tissue back together. But the hernia often returned — a condition called recurrence.
By the 1980s, mesh was increasingly seen as the best way to reduce recurrence. Instead of putting tension on torn tissue, mesh works as a surgical scaffold. Surgeons stitch the tissue to the mesh and the tissue grows back together, eventually incorporating or absorbing the mesh. Manufacturers claim this creates a stronger repair. But it comes with other complications, and some can be severe or even life-threatening.
A 1995 article in the journal OR Manager declared “there’s no consensus on the best way to do hernia repairs.” But by 2000, mesh accounted for 90 percent of groin hernia repairs, according to the FDA.
In 2018, experts with organizations such as Americas Hernia Society and International Endohernia Society together released new industry guidelines. The International Guidelines for Groin Hernia Management recommended surgeons use mesh in all repairs of groin hernias, despite five major types of suture-only options.
The authors further recommended surgeons only consider alternatives to surgical mesh when mesh is not available or when a patient specifically requests mesh not be used. They mentioned the Shouldice repair as the “first choice” for non-mesh surgery. However, they said surgeons should only bring up the alternatives after discussing the results of mesh.
Two major surgical mesh manufacturers, Johnson & Johnson and Bard, provided grants that funded the guidelines. And 50 authors and editors who worked on the guidelines disclosed they had received money from Bard and Johnson & Johnson to cover meeting expenses. Another 15 authors reported they had taken money from other hernia mesh makers.
Medical guidelines are not legal or government requirements. They are simply recommendations, but they can carry great weight in the medical community.
At the same time, it has become more difficult to find surgeons in the United States who perform non-mesh or suture-only repairs.
A 2018 Turkish Journal of Surgery review of the international guidelines pointed out there are several different options for hernia repair, but surgeons tend to “select the technique that they learned from their seniors.” As more doctors have moved toward mesh in the United States, fewer new surgeons have learned to perform non-mesh repairs.
Pros and Cons
Mesh and suture-only techniques offer their own advantages and disadvantages. For example, in addition to lowering the chances of a hernia coming back, the FDA says, mesh may also reduce how long a hernia surgery lasts and speed up a patient’s recovery time.
But a 2016 study in JAMA found that over time, the chances of other complications from mesh repairs offset many benefits. The researchers looked at 3,200 hernia patients in Denmark between 2007 and 2010. They then followed-up on the patients after about five years.
“Mesh implantation prevented the need for subsequent reoperation in relatively few patients, suggesting that the benefits associated with the use of mesh are partially offset by long-term complications associated with its use,” the authors wrote.
Mesh implantation prevented the need for subsequent reoperation in relatively few patients, suggesting that the benefits associated with the use of mesh are partially offset by long-term complications associated with its use.
The authors warned of a risk of selection bias. They explained surgeons tend to use mesh to repair larger, more difficult hernias, and they opt for non-mesh surgeries to treat small, uncomplicated hernias that are less likely to cause long-term problems.
Patients should discuss their particular circumstances with their surgeons before surgery.
The most common hernia mesh complications reported to the FDA are pain, infection, recurrence, adhesion and bowel obstruction. Other possible problems include the mesh shrinking or the implant moving around inside the body.
Recalled mesh brands have been the main cause of two of the most serious complications reported to the FDA: bowel perforation and obstruction. These are medical emergencies that can be fatal if patients don’t receive immediate attention.
Global news reports since 2018 have highlighted growing complaints of debilitating pain and suicidal complications blamed on hernia mesh. Most of the coverage has come from the UK, Australia and Canada.
- A series of reports in September 2018 revealed the complication rate in the UK ranged from 12 percent to 30 percent of people who had received hernia mesh in the previous six years. That came to 170,000 patients. Men and women interviewed for the program cited complications including pain, the inability to walk or work, and suicidal thoughts or behavior.
- In December 2018, the Australian Broadcasting Corporation reported an uptick in men who had complained about chronic pain following hernia mesh surgeries. Men account for up to 9 in 10 hernia mesh surgeries. Marc Russell told the network the pain felt like razorblades in his groin or being “doused in a flammable liquid” and set on fire.
- In July 2018, the Canadian broadcaster highlighted women who suffered pain following hernia mesh surgery. The report claimed several had contemplated or even attempted suicide because the pain was so severe.
Media reports of chronic and debilitating pain are anecdotal, but research on the long-term consequences of chronic pain from hernia mesh has often been lagging.
Still, the FDA lists pain as the leading complication following hernia mesh surgery. Chronic pain is often defined as any pain that lasts more than six months or a year. Current research suggests that it affects between 15.2 percent and 51.6 percent of mesh patients.
Types and Materials
Since the earliest mesh repairs, surgeons and manufacturers have sought a perfect hernia mesh material.
Polypropylene, one of the world’s most widely produced plastics, was used in the first modern hernia mesh surgery in 1958. Since then, manufacturers have produced mesh from other synthetic materials that include brand names like GoreTex, which is used in outerwear, and Teflon, which is used in cookware.
Manufacturers have also created mesh from animal tissue or from other materials that are absorbed into the body over time.
They’ve also created composite products, which often coat a polypropylene or other synthetic mesh with some other material. Atrium Medical’s C-QUR mesh, for instance, coats a polypropylene frame with a coating derived from medical-grade fish oil. Composite meshes are often marketed as being able to better integrate into the body.
Polypropylene remains the most common type of material used to make hernia mesh. It is favored in part because it is considered inert, or chemically inactive. This is a good quality for a material placed inside the body because it shouldn’t react with chemicals or tissue.
But studies and reports to the FDA of complications have questioned that quality.
A 2012 study in the Journal of Urology concluded polypropylene is no longer inert after it is implanted in a person’s body. They did not find a reason why that happens. But they did find physical properties of polypropylene had changed in samples they had removed from patients. They also cited other studies that report a wide variety of chemical changes in polypropylene mesh taken from patients.
“The quest for a perfect mesh must continue,” the authors wrote.
Manufacturers and Brands
Manufacturers marketed 477 models of hernia mesh in the United States from 1976 to 2015, according to a 2018 study in PLOS One.
More than a dozen major hernia mesh makers market products in the United States. Each produces different sizes of its various brands.
Major Mesh Manufacturers and Brands
- C-QUR, Vitamesh, Proloop, Prolite, Prolite Ultra
- B. Braun
- Sefil, Premilene
- Bard Davol
- 3DMax, AlloMaxBard Soft Mesh, Bard Mesh Sheets, CollaMend, Composix, Dulex, Kugel, MK Patch, OnFlex, PerFix Plug, Phasix Mesh, Phasix, Sepramesh IP Composite, Ventralex, Ventralight, Ventrio, Visilex, XenMatrix Surgical Graft
- Cook Medical
- Covidien (Medtronic)
- Parietene, Parietex, Permacol, ProGrip, Symbotex, Versatex, Prolene Light, Optilene, Permacol
- Ethicon (Johnson & Johnson)
- FlexHD Structural, Mersilene, Physiomesh, Proceed, Proline, Ultrapure, Ultrapure Advanced, Vicky, XCM Biologic, Vypro, Vypro II
- FEG Textiltechnik
- Sepramesh IP Composite
- Gore Medical
- Bio-A, Dual mesh, Micromesh, Gore-Tex Soft Tissue Patch, Sinecure
FDA Regulation and Recalls
A search of the FDA’s medical device recall database shows manufacturers recalled at least 23 hernia mesh products between 2006 and 2018. But some of the most problematic products from that time were never recalled, despite complaints, complications or lawsuits.
Notable Recalls & Market Withdrawals
|Atrium Medical - Recall|
|Products||C-QUR TacShield, C-QUR Edge Mesh, C-QUR V-Patch Mesh, C-QUR Mesh (all sizes)|
|Date/Units||July 19, 2013 (145,251 units)|
|Ethicon – Market Withdrawal|
|Products||Physiomesh Flexible Composite Mesh|
|Date/Units||May 25, 2016 (all units in circulation)|
|Reason||Two European hernia registries reported higher than average revision surgery rates|
|Ethicon - Recall|
|Date/Units||Feb. 19, 2014 (223 units from specific lots)|
|Reason||Packaging defect possibly damaged mesh, allowed potential for adhesions in patients|
Surgical meshes, like most medical devices, don’t go through rigorous tests like prescription drugs do to be deemed safe and effective. Most win FDA clearance through the agency’s 510(k) process, which gets its name from a section of the law that created it. In this process, a manufacturer only has to show its product is “substantially similar” to another product on the market.
In their 2018 PLOS One study, Nasim Zargar and Andrew Carr set out to trace the family trees of surgical mesh products on the United States market. They described how new mesh products won clearance based on comparisons to older products that in turn had been found similar to still older devices. In the vast majority of cases, this pattern was repeated all the way back to the 1970s.
They looked specifically at 77 mesh products the FDA had cleared between 2013 and 2015. Zargar and Carr found the devices’ clearances were based on similarities to more than 400 brands of mesh that had previously been on the market. But 97 percent of those devices were descended from just six mesh products that had been around before the FDA started regulating medical devices in 1976.
On top of that, Zargar and Carr found 16 percent of the mesh products in their study were descended from three brands of mesh that had been recalled due to faulty designs or serious complications.
Thousands of lawsuits have accused mesh manufacturers of producing devices that caused serious complications. About 3,000 such lawsuits currently target three major mesh makers in three separate multidistrict litigations, or MDLs. These are large court actions that combine similar lawsuits in a single federal court.
Active Hernia Mesh MDLs
|MDL Location||New Hampshire District|
|Expected Trial Dates||February 2020|
|Brands Named||Physiomesh Flexible Composite Hernia Mesh|
|MDL Location||Georgia, Northern District|
|Expected Trial Dates||Late 2019 or in 2020|
|Brands Named||All polypropylene mesh brands|
|MDL Location||Ohio, Southern District|
|Expected Trial Dates||Too early to tell|
In 2011, Bard Davol essentially ended one of the largest hernia mesh MDLs when it agreed to pay $184 million to settle 2,600 claims that involved the company’s Kugel Patch.
Meanwhile, additional cases are pending in state courts, including 62 Physiomesh cases that have been consolidated in New Jersey. And people are also suing Covidien over its Parietex mesh.
22 Cited Research Articles
- Baylon, K., et al. (2017, August 22). Past, Present and Future of Surgical Meshes: A Review. Membranes. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5618132/
- Bilsel, Y. and Abci, I. (2012, May 12). The Search for Ideal Hernia Repair; Mesh Materials and Types. Science Direct. Retrieved from https://www.sciencedirect.com/science/article/pii/S1743919112000921
- BMJ News. (2017, September 27). Hernia Mesh Complications May Have Affected up to 170,000 Patients, Investigation finds. The BMJ. Retrieved from https://www.bmj.com/content/362/bmj.k4104.full
- Branley, A. (2018, December 1). Hernia Mesh Concerns Grow Among Men as More Patients Report Surgery Complications. ABC News (Australia). Retrieved from https://www.abc.net.au/news/2018-12-02/hernia-mesh-concerns-grow-among-men-surgery-complications/10570182
- Collinson, A. and Furst, J. (2018, September 2018). Hernia Mesh Complications “Affect More than 100,000.” BBC Victoria Derbyshire Programme. Retrieved from https://www.bbc.com/news/health-45604199
- Getinge Group. (n.d.). C-QUR Mesh. Retrieved from https://www.getinge.com/siteassets/products-a-z/c-qur-mesh/009967-c-qur-mesh-flyer.pdf?disclaimerAccepted=yes
- HerniaSurge Group. (2018, January 12). International Guidelines for Groin Hernia Management. Hernia. Retrieved from: https://link.springer.com/article/10.1007%2Fs10029-017-1668-x
- Jathias, J.M. (1995, November). Don’t Expect a Consensus on Hernia Repair. OR Manager. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/10172505
- Judicial Panel on Multidistrict Litigation. (2019, January 17). MDL Statistics Report. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-January-15-2019.pdf
- Kokotovic, D., Bisgaard, T., and Helgstrand, F. (2016, October 18). Long-Term Recurrence and Complications Associated with Elective Incisional Hernia Repair. JAMA. Retrieved from https://jamanetwork.com/journals/jama/fullarticle/2565771
- Kuffner, A. (2011, July 6). Settlement Disclosed in Lawsuits over Hernia Patches. Providence Journal. Retrieved from https://www.providencejournal.com/article/20110706/business/307069999
- Kulacoglu, H. (2018, July 1). Comments on the New Groin Hernia Guidelines: What Has Changed? What Has Remained Unanswered? Turkish Journal of Surgery. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6048651/
- Lockhart, K., et al. (2015). Mesh Versus Non-Mesh for Inguinal and Femoral Hernia Repair. Cochrane Database of Systematic Reviews. Retrieved from https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011517/epdf/full
- Lundstrom, K.J., et al. I2017, November 15). Patient-Reported Rates of Chronic Pain and Recurrence After Groin Hernia Repair. BJS (British Journal of Surgery). Retrieved from https://onlinelibrary.wiley.com/doi/full/10.1002/bjs.10652
- Nikkolo, C. and Lepner, U. (2015, November 15). Chronic Pain After Open Inguinal Hernia Repair. Postgraduate Medicine. Retrieved from https://www.tandfonline.com/doi/abs/10.1080/00325481.2016.1121090
- Otis, D. (2018, July 28). “I Have Tried to End My Life”: Hernia Mesh Patients Overwhelmed by Pain. CTV. Retrieved from https://www.ctvnews.ca/health/i-have-tried-to-end-my-life-hernia-mesh-patients-overwhelmed-by-pain-1.4032190
- Sternschuss, G., Ostergard, D.R., and Patel, H. (2012, May 12). Post-Implantation Alterations of Polypropylene in the Human. Journal of Urology. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/22578730
- Trabuco, E.C. and Gebhart, J.B. (Reconstructive Materials Used in Surgery: Classification and Host Response. UpToDate. Retrieved from https://www.uptodate.com/contents/reconstructive-materials-used-in-surgery-classification-and-host-response
- U.S. Food and Drug Administration. (2017, December 28). Hernia Surgical Mesh Implants: Information for Patients. Retrieved from https://www.fda.gov/medical-devices/hernia-surgical-mesh-implants/hernia-surgical-mesh-implants-information-patients
- U.S. Food and Drug Administration. (2018, February 4). Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/medical-devices/implants-and-prosthetics/hernia-surgical-mesh-implants
- U.S. Food and Drug Administration. (2019, January 15). Medical Device Recalls Database. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/textsearch.cfm
- Zargar, N. and Carr, A. (2018, June 19). The Regulatory Ancestral Network of Surgical Meshes. PLOS One. Retrieved from https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0197883