Hernia Mesh
Hernia mesh is a net-like implant that prevents organs, tissue or fat from bulging through weak muscle walls. While 90% of groin hernia repairs use mesh, complications can include pain, hernia recurrence and infection. Hernia mesh materials and surgical techniques used affect complication rates.
Hernia Mesh and Hernia Surgery
Hernia mesh is a net-like implant, often made from polypropylene plastic, treats hernias. It prevents the tissue, organs or fat from bulging through weak muscle walls. Doctors commonly use mesh to treat patients with hernias because of the low hernia recurrence rate.
- According to the Food and Drug Administration, doctors in the U.S. treat 1 million inguinal hernia every year and use hernia mesh in about 90% of these cases.
- More than 20 million hernia surgeries occur worldwide each year, with 1 million relying on meshes.
- Statistics show the complication rate for mesh is between 12% and 30%.
While typically a safe procedure, there are possible complications, including infection, chronic pain, hernia mesh failure and hernia recurrence. These can lead to additional surgeries. Patients should discuss possible complications and surgery alternatives with their doctors.
Pros and Cons of Using Hernia Mesh
Hernia mesh can successfully repair hernias, but there is the possibility of complications. Infection, for example, is a risk. One study found that when infected hernia mesh was tested, staphylococcus aureus was present in 64% of those cultures, meaning staphylococcus aureus was the primary driver of the tested mesh infections.
- Lower rate of hernia recurrence
- Mesh can repair larger weak areas
- Decreased operative and recovery time
- Mesh can migrate, shrink or cause other complications
- Mesh may get infected, requiring removal
- Mesh failure requires one or more revision surgery
Sometimes, the risks of hernia mesh may outweigh the benefits. The likelihood and severity of complications depend on the material of the mesh, the surgeon and surgical technique and the response of the patient’s body.
Research estimates that less than half of patients choosing mesh repair require repair surgeries, with non-mesh or suture-based repairs experiencing higher recurrence rates. The ideal hernia mesh resists infection and an inflammatory response, while staying flexible and quickly incorporating into the body’s tissue.
How Long Does Hernia Repair Last?
Non-absorbable hernia repair mesh should be a permanent fix, but absorbable mesh typically dissolves in six to 18 months. Hernia recurrence is possible even with non-absorbable mesh.
Research suggests that mesh materials may affect recurrence rates after hernia repair. Polypropylene mesh is extremely durable, but because of its heavy weight, it can lead to inflammation in the area. This has a shrinking effect on the mesh, creating higher recurrence rates.
Hernia Mesh Complications
The FDA is aware of complications arising from recalled meshes and current market products. While many people experience improved quality of life following hernia treatment, others report mild to serious complications.
- Adhesion: Unwanted attachment of the mesh to loops of the bowel or other tissue
- Bowel obstruction: Perforation of the intestines that creates a blockage
- Hernia recurrence: Reappearance of a hernia at the original site
- Mesh migration: Movement because of poor adhesions or pressure
- Mesh shrinkage: Shrinking mesh that pulls on tissue and causes pain
- Persistent pain: Discomfort or pain near the leg, groin, abdomen, stomach or testicles
- Seroma: Painful lump or mass of clear fluid
- Sexual problems: Erectile dysfunction and pain
- Wound infection: Infections occurring around the site
You may experience symptoms such as fever, flu-like symptoms, nausea, vomiting or constipation. Other signs of hernia mesh failure include chronic pain and severe swelling or tenderness at the surgery site.
Hernia mesh failure can happen a few weeks or a few years after your surgery. Talk to your doctor as soon as you notice something wrong or out of the ordinary after your hernia surgery.
Types of Hernia Mesh
Hernia mesh materials fall into different categories: Synthetic, biological, coated, composite and hybrid meshes. Mesh is available in different weaves, sizes and strengths and is available as patches, plugs and sheets.
This indicates that type of mesh may be associated with outcomes, and mesh choice could therefore depend on hernia type.
Different mesh materials lead to different rates of complications. In an April 2023 meta-analysis, researchers formed a conclusion that biologic meshes increase the complications of surgery site infections and hernia recurrences. As an alternative, uncoated, macroporous synthetic mesh is suitable for open ventral hernia repair.
Absorbable or Biologic Hernia Mesh
Biologic hernia mesh uses animal or human donor tissue, often decellularized intestines or skin of cows and pigs. The material breaks down over time and absorbs into the body.
A surgeon may choose this mesh for a strangulated hernia or if there is an infection in the location. Recurrence is a potential complication.
Non-Absorbable or Synthetic
With a synthetic mesh, a surgeon could use a woven or nonwoven sheet. These materials remain in the body indefinitely and include polyester, polypropylene or expanded polytetrafluoroethylene. These types of mesh are chemically inactive and should minimize reaction complications.
While polypropylene is one of the more common mesh materials, it can wear away or break down over time. If this occurs, the mesh could protrude or cause injury to surrounding tissue.
Hybrid, Coated or Composite
These materials have non-absorbable or absorbable coatings such as cellulose, beta glucan, omega-3 fatty acids or collagen. The coatings minimize the body’s inflammatory response.
A leading benefit of choosing a coated or composite mesh is the ability of surgeons to use it in intraperitoneal space with little adhesion formation risk. Studies show varying degrees of inflammation risk from composite mesh, depending on the materials used.
Glue vs Suture
Glue fixation had shorter operating time and lower haematoma formation than suture fixation. Chronic pain and seroma formation were comparable.
Evidence to support less chronic pain with glue is not very strong. It mostly comes from the shorter operating time and less trauma during the procedure.
Hernia Mesh Recalls and Market Withdrawals
Several manufacturers voluntarily withdrew or recalled their hernia mesh from the market. Some actions were initiated because of packaging errors, higher than normal failure rates or the risk of serious complications such as adhesions, pain and hernia recurrence.
- December 2020: Ethicon, Inc. issued a recall on the Proceed surgical mesh device because a hair was found inside the packaging of a unit.
- March 2019: ACell, Inc recalled Gentrix Surgical Matrix Thick because a sample from the lot failed to meet company tensile strength specifications.
- November 2018: Covidien LLC recalled Parietex Composite Parastomal Mesh after receiving reports of parastomal mesh failure.
- October 2018: Covidien/Medtronic recalled its Parietex Composite Parastomal Mesh for mesh failure occurrences.
- August 2016: Novus Scientific issued a recall to add to the product’s instructions and present additional information relating to clinical study results.
A company will voluntarily withdraw a product when the violation is minor and not subject to legal action from the FDA. A drug or device recall occurs when there is evidence or a belief that the product is harmful or defective.
Hernia Mesh Brands and Manufacturers
There are currently more than a dozen major hernia mesh manufacturers dominating the U.S. market. Product options come in various sizes across brands.
Manufacturer | Products Lines and Brands |
---|---|
Atrium | C-QUR, Vitamesh, Proloop, Prolite, Prolite Ultra |
Autosuture | Surgipro |
B. Braun | Sefil, Premilene |
C.R. Bard/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 | Surgisis |
Covidien/Medtronic | Parietene, Parietex, Permacol, ProGrip, Symbotex, Versatex, Prolene Light, Optilene, Permacol |
Ethicon/Johnson & Johnson | FlexHD Structural, Mersilene, Physiomesh, Proceed, Proline, Ultrapure, Ultrapure Advanced, Vicryl, XCM Biologic, Vypro, Vypro II |
FEG Textiltechnik | Dynamesh |
Genzyme | Sepramesh IP Composite |
GfE | Ti-Mesh |
Gore Medical | Bio-A, Dual mesh, Micromesh, Gore-Tex Soft Tissue Patch, Sinecure |
LifeCell | Strattice |
Meadox | Trelex |
Syneture | Dexon |
Manufacturers that issued a recall for one or more of their hernia mesh products include Atrium Medical, Bard Davol, Ethicon/Johnson & Johnson and Covidien/Medtronic. If you have questions about which hernia mesh was used in your surgery, your surgeon’s office will be able to confirm that information for you.
Hernia Mesh Lawsuits Filed Over Complications
Thousands of hernia mesh lawsuits accuse manufacturers of producing devices that caused serious complications. Four major mesh makers are at the center of separate multidistrict litigations, large court actions that combine similar lawsuits in a single federal court. In MDLs, plaintiffs receive a portion of the settlement award, often based on the severity of their case.
Active Hernia Mesh MDLs
Active Hernia Mesh MDLs
Atrium Medical | |
---|---|
Brands Named | C-QUR |
MDL Location | New Hampshire District |
Pending Lawsuits | 564 |
Expected Trial Dates | In settlement |
Ethicon | |
---|---|
Brands Named | Physiomesh Flexible Composite Hernia Mesh |
MDL Location | Georgia, Northern District |
Pending Lawsuits | 16 |
Expected Trial Dates | In settlement |
Bard Davol | |
---|---|
Brands Named | All polypropylene mesh brands |
MDL Location | Ohio, Southern District |
Pending Lawsuits | 24,100 |
Next Expected Trial Date | April 2024 |
COVIDIEN | |
---|---|
Brands Named | All hernia mesh brands |
MDL Location | Massachusetts |
Pending Lawsuits | 1,566 |
Expected Trial Dates | To be determined, motions to appear issued 2023 |
Hernia mesh manufacturers often settle out of court with plaintiffs to avoid going to trial. In February 2023, the Attorney General for the state of Kentucky announced that Ethicon settled litigation for close to $10 million.
45 Cited Research Articles
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