Accepting Cases

Hernia Mesh

About 90 percent of hernia repair surgeries in the U.S. use hernia mesh. Surgeons in the U.S. use hernia mesh in one million surgeries every year. Mesh can prevent a hernia from recurring. But hernia mesh can also cause serious complications. The U.S. Food and Drug Administration blames recalled meshes for many reports of hernia mesh complications.

Injured by complications related to Hernia Mesh?

If you or a loved one suffered complications or injury after hernia mesh surgery, you may have legal options.

Example of Hernia Mesh
Hernia Mesh Facts
  1. Used to Treat Hernias
  2. Expected Device Lifespan Permanent
  3. Manufacturers Ethicon (Johnson & Johnson), Atrium Medical, Bard, B. Braun, Gore, Medtronic, among others
  4. Side Effects & Risks Pain, infection, adhesion, bowel perforation or obstruction, migration, shrinkage
  5. Recalled Models Bard Davol Kugel Patch, Atrium C-QUR, Ethicon Physiomesh Flexible Compostie Mesh (market withdrawal)
  6. FDA Approval Status Pre-dates FDA Approval Rules

Hernia mesh reinforces torn or damaged tissue around hernias. Pores in the mesh allow tissue to grow into the device. Mesh may be made of woven fibers or pressed from a sheet of synthetic material. Manufacturers also make mesh from animal tissue. Hernia mesh comes in different shapes and sizes for different hernias.

What Is Hernia Mesh?

Hernia mesh is a surgical implant that provides extra support for damaged tissue. Surgeons place the mesh across the area surrounding the hernia. It helps hold damaged tissue together and strengthen it as it heals. Surgeons attach hernia mesh with stitches, staples or glue.

Why Do Surgeons Use Hernia Mesh?

A main reason surgeons use hernia mesh is to lower the risk of a hernia recurring, or coming back.

There is a high chance of hernias returning after repair surgery. Conventional hernia surgery stitches torn tissue back together. Some studies have shown that surgeries using mesh lead to fewer hernia recurrences. Others have found there are other complications that are more common with mesh.

“Despite reduced rates of recurrence, there are situations where the use of surgical mesh for hernia repair may not be recommended. Patients should talk to their surgeons about their specific circumstances and their best options and alternatives for hernia repair.”

FDA, Hernia Surgical Mesh Implants, February 2018

A 2014 study in the Journal of the American Medical Association looked at hernia repairs. It compared conventional surgery to hernia mesh.

Its authors said using hernia mesh can decrease the chance of a hernia returning. Researchers wrote that surgical mesh strengthens torn tissues while stitches alone do not.

Types of Hernia Mesh

Hernia mesh products come in many sizes and shapes. The different designs can repair specific types or sizes of hernias.

Hernia mesh products include:
Patches
Designed to go over or under the weakened or damaged tissue
Plugs
Fit inside the hole in the tissue
Sheets
Can be custom cut and fitted for the patient’s specific hernia

Each type of hernia mesh may also fall into other categories. These describe how they function in the body or the materials they are made from.

Absorbable Hernia Mesh

Absorbable mesh degrades and loses strength over time. It is not used to provide long-term reinforcement to the repaired hernia. “As the material degrades, new tissue growth is intended to provide strength to the repair,” the U.S. Food and Drug Administration explains on its website.

Non-Absorbable Hernia Mesh

Non-absorbable mesh is a permanent implant. It remains in the body indefinitely. Non-absorbable mesh is supposed to provide lasting reinforcement to the repair site.

Synthetic Hernia Mesh

Hernia mesh made of synthetic materials come in woven or non-woven sheets. The synthetic materials can be absorbable, non-absorbable or a combination of both. The most popular types of surgical mesh are made from polypropylene – a synthetic plastic.

Coated or Composite Hernia Mesh

At least one hernia repair technique can leave mesh in contact with the intestines. This can cause the intestines to adhere to the mesh, which can result in severe complications. Some polypropylene meshes may come coated with absorbable fatty acids, cellulose or collagen. Manufacturers claim these coatings prevent adhesions.

Animal Derived Hernia Mesh

Some manufacturers make hernia mesh from animal tissue. They may use the intestine or skin of animals. It usually comes from a pig or cow. Manufacturers process and disinfect it. This type of mesh is also absorbable.

Hernia Mesh Manufacturers and Brands

Dozens of companies make hernia mesh. Manufacturers range from the start-up TELA Bio to Johnson & Johnson – the world’s largest medical products company.

Top Hernia Mesh Manufacturers and Products
Manufacturer Hernia Mesh Product Lines
Atrium C-QUR, Vitamesh, Proloop, Prolite, Prolite UltraQ
Bard 3DMax, AlloMaxBard Soft Mesh, Bard Mesh Sheets, Composix, Dulex, Kugel, MK Patch, OnFlex, PerFix Plug, Phasix Mesh, Phasix, Sepramesh IP Composite, Ventralex, Ventralight, Ventrio, Visilex, XenMatrix Surgical Graft
B. Braun Premilene, Omyra, Optilene
Ethicon FlexHD Structural, Physiomesh, Proceed, Prolene, Ultrapure, Ultrapure Advanced, Vicky, XCM Biologic
Gore Medical Bio-A, Dual mesh, Micromesh, Gore-Tex Soft Tissue Patch, Sinecure
LifeCell Corporation Alloderm Select, Strattice
Medtronic Parietex, Permacol, ProGrip, Symbotex, Versatex
TELA Bio OviTex

Hernia mesh provides a lucrative market that draws in medical device makers. Grand View Research estimated the global market was worth $177 million in 2016. The market research firm predicted steady growth through 2025. The potential for profit attracts all sizes of companies.

Hernia Mesh Surgery

Suffering complications after hernia mesh surgery? Get a Free Case Review

Surgery is the only treatment that can permanently repair a hernia. Hernia mesh is used in about 90 percent of those surgeries.

Surgeons can perform repairs with or without hernia mesh. But mesh has become more common since the 1980s.

Doctors may use minimally-invasive techniques to implant hernia mesh. This is called laparoscopic surgery. It requires only small incisions. Surgeons place surgical tools through the incisions to implant the mesh.

Open repair is another technique. It requires a large incision that opens the body to the hernia. Surgeons attach the mesh to the damaged tissue then close the wound.

Recovery time is shorter for laparoscopic surgery. But the operation takes longer and is more expensive.

Hernia Mesh Complications and Risks

The U.S. Food and Drug Administration tracks reports on hernia mesh complications. Doctors and patients report complications they have experienced. Manufacturers also have to tell the FDA about reports they receive.

The FDA has analyzed thousands of these reports.

FDA’s list of most common hernia mesh complications
  • Pain
  • Infection
  • Hernia recurrence
  • Adhesion
  • Bowel obstruction
  • Organ perforation

Reports also detail mesh shrinking or migrating in the body after surgery.

The FDA has blamed recalled hernia mesh for most cases of bowel obstruction and perforation. Many of these products are no longer on the market. But some recalled meshes are still available.

Hernia Mesh Recalls

Hernia Mesh manufacturers have recalled more than 200,000 units since 2005. Ethicon also ordered a “market withdrawal,” taking mesh off the market without a recall.

Mesh Recalls
  • 2013

    Atrium Medical recalls 145,000 C-QUR units

  • 2007

    Bard Davol recalls 16,000 Composix Kugel mesh units

  • 2005

    Ethicon recalls 18,000 Proceed mesh units

  • 2005 (expanded in 2006)

    Bard Davol recalls 31,000 Composix Kugel mesh units

Mesh Market Withdrawal
  • 2016

    Ethicon removes all Physiomesh Composite Mesh from the market

Alternatives to Hernia Mesh

Alternatives to hernia mesh include at least five surgical procedures. All involve stitching the damaged tissue back together. But each uses a different method to repair hernias.

Hernia repairs without mesh
  • Bassini Repair
  • McVay/Coopers Ligament
  • Shouldice Repair
  • Desarda Repair
  • Guarnieri Repair

In some cases, doctors may recommend “watchful waiting” before hernia surgery. The doctor will monitor the patient’s condition until it requires surgery. Watchful waiting is an option if the patient exhibits no signs or symptoms. People should only consider this alternative if their doctors recommend it.

Please seek the advice of a medical professional before making health care decisions.

Did you find Drugwatch helpful?

20 Cited Research Articles

  1. University of Michigan Health System. (2014, June 2). Weight Loss before Hernia Repair Surgery. Retrieved from http://www.med.umich.edu/1libr/Surgery/GenSurgery/HerniaObesity.pdf
  2. FDA.gov. (2018, February 4). Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  3. FDA.gov. (2013, August 9). Class 2 Device Recall CQUR Edge Mesh. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119924
  4. Zogbi, L. (2011). The Use of Biomaterials to Treat Abdominal Hernias. Retrieved from http://www.intechopen.com/books/biomaterials-applications-for-nanomedicine/the-use-of-biomaterials-to-treat-abdominal-hernias
  5. Sherwinter, D.A. et al. (2016). Laparoscopic Inguinal Hernia Repair. Retrieved from http://emedicine.medscape.com/article/1534321-overview
  6. Society of American Gastrointestinal and Endoscopic Surgeons. (n.d.). Laparoscopic Inguinal Hernia Repair. Retrieved from https://www.sages.org/publications/patient-information/patient-information-for-laparoscopic-inguinal-hernia-repair-from-sages/2/
  7. FDA. (n.d.) Hernia Surgical Mesh Implants. Retrieved from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  8. Landro, L. (2012, February 28). A Secret for Patients Undergoing Hernia Repair. Retrieved from http://www.wsj.com/articles/SB10001424052970203833004577249344022834000
  9. FDA. (2013, August 9). Class 2 Device Recall CQUR VPatch Mesh. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119925
  10. Brown, C.N. & Finch, J.G. (2010). Which mesh for hernia repair? Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3025220/
  11. Gore Medical. (n.d.) Hernia. Retrieved from https://www.goremedical.com/conditions/hernia
  12. American College of Surgeons. (2016). Groin Hernia Repair. Retrieved from https://www.facs.org/~/media/files/education/patient%20ed/groin%20hernia.ashx
  13. Wake, B.L. et al. (2005). Two different laparoscopic techniques for repairing a hernia in the groin. Retrieved from http://www.cochrane.org/CD004703/COLOCA_two-different-laparoscopic-techniques-for-repairing-a-hernia-in-the-groin
  14. Ethicon. (2016, May 27). Urgent Field Safety Notice: Ethicon Physiomesh Flexible Composite Mesh (All Product Codes). Retrieved from http://www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Field_Safety_Corrective_Action/FSN/2016/May/HSA%206004101-002-16-22_35%20FSN.pdf
  15. Michigan Surgery. (n.d.). A Brief History of Hernia Surgery. Retrieved from http://michigansurgery.com/general-surgery/hernia-surgery/a-brief-history-of-hernia-surgery/
  16. FDA. (2006, January 4). Class 2 Device Recall. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43417
  17. Landro, L. (2012, February 28). A Secret for Patients Undergoing Hernia Repair. Retrieved from http://www.wsj.com/articles/SB10001424052970203833004577249344022834000
  18. FDA. (2017, April 4). Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  19. ACS Surgery News. (2014, October 3). When to Use Mesh in Laparoscopic Hiatal Hernia Repair. Retrieved from http://www.mdedge.com/acssurgerynews/article/87740/general-surgery/when-use-mesh-laparoscopic-hiatal-hernia-repair
  20. Grand View Research. (2017, October). Hernia Mesh Devices Market By Hernia Type (Inguinal Hernia, Incisional Hernia, Femoral Hernia, Others), By Mesh Type (Biologic Mesh, Synthetic Mesh), By Region, And Segment Forecasts, 2014 – 2025. Retrieved from https://www.grandviewresearch.com/industry-analysis/hernia-mesh-devices-market
View All Sources
Who Am I Calling?

Calling this number connects you with Wilson and Peterson, LLP or one of its trusted legal partners. A law firm representative will review your case for free.

Wilson and Peterson, LLP funds Drugwatch because it supports the organization’s mission to keep people safe from dangerous drugs and medical devices.

(844) 807-8916

To contact Drugwatch Managing Editor Kevin Connolly, call (855) 839-9780.

Live Chat Icon livechat loading spinner