Hernia Mesh: Risks, Complications and What Patients Need to Know
Hernia mesh is used in most U.S. hernia surgeries to reinforce weakened tissue and lower the risk of recurrence, but complications can include chronic pain, infection and mesh migration. Hernia mesh failures have also led to recalls and thousands of lawsuits.
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What Is Hernia Mesh?
Hernia mesh is a medical device, usually a screen-like or scaffold-like patch that surgeons place over or under weakened muscle or tissue to strengthen the area and help prevent the hernia from returning. As new tissue grows into the mesh, the repair becomes stronger and tension-free. This approach has reduced the risk of hernia recurrence compared to repairs without mesh.
Surgeons often choose mesh because research shows it reduces the risk of hernia recurrence. There are about 1.5 million hernia repair surgeries done each year in the U.S., with roughly 80% using mesh as of 2017.
Mesh may prevent hernia recurrence in 90% to 99% of hernia repairs. However, 5% to 15% of hernia repairs relying on mesh can lead to chronic pain.
Using mesh in groin hernia repairs can reduce the chance of the hernia coming back by 64% compared to repairs without mesh. Chronic pain after mesh repair does not seem to be clearly higher than after repairs without mesh. One review found the rates were similar, and the FDA reports that chronic pain rates vary a lot, but up to 3.8% of cases can have a significant impact on quality of life.
Types of Hernia Mesh
Mesh is classified by how it works in the body and what it’s made from. There are four main types of hernia mesh.
- Non-absorbable (permanent):
- Designed to stay in the body indefinitely to provide lasting reinforcement; the most common synthetic type is polypropylene.
- Absorbable:
- Breaks down over time as new tissue grows in; not intended for long-term reinforcement.
- Synthetic:
- Human-made polymers such as polypropylene, polyester or PTFE can be used to produce knitted or non-knitted sheets.
- Biologic (animal-derived):
- Processed animal tissue (porcine or bovine) that is absorbable; used in select cases but associated with higher recurrence in some studies.
The material type affects how the mesh might fail. Permanent meshes can move or shrink over time, while absorbable meshes may not provide lasting support.
How Hernia Mesh Works and Why It Can Fail
Hernia mesh is placed over or under weakened tissue to reinforce the repair and act as a scaffold for tissue ingrowth. The goal is to strengthen the abdominal wall and reduce the risk of hernia recurrence, which is why mesh is widely used in modern hernia surgery.
But sometimes problems with the mesh can happen. If the mesh moves, does not stay in place, or does not work with your body, it can cause pain, infection or other issues. The U.S. Food and Drug Administration says problems may include mesh moving or shrinking, pain, infection, hernia returning, scar tissue, blockage or holes in tissue.
Ways Hernia Mesh Can Fail
Hernia mesh can fail if it moves out of place, does not join well with nearby tissue, or is not compatible with the body. According to the FDA, problems can include mesh moving or shrinking, pain, infection, hernia recurrence, scar tissue, blockage and tissue damage.
- Mesh migration
- This is a rare but serious hernia mesh complication. The mesh moves from where it was placed, causing pain or infection. It may even block the bowels. Problems might show up months or even years after surgery.
- Mesh shrinkage (contraction)
- The mesh can shrink by 30% to 50% and pull on tissue, causing pain, tension or a hernia recurrence.
- Infection
- Bacteria can grow on the mesh, requiring the mesh to be removed or replaced.
- Bowel adhesion
- Mesh can stick to organs or tissue and cause scar-like attachments (adhesions), potentially creating an obstruction that blocks normal bowel movement.
- Hernia recurrence
- If the mesh does not heal into place as it should, the hernia can come back and another surgery might be needed.
These problems are common after hernia surgery, whether or not mesh is used. If the hernia comes back, it means the repair did not work. This can happen if the mesh did not stay in place or did not work well with the tissue. When this occurs, another surgery might be needed.
Hernia Mesh Complications and Risks
The FDA has collected over 55,000 reports of problems with surgical mesh used in hernia repairs, including inguinal, ventral, incisional and other types. It also reviewed 45 full scholarly articles — written over an 11-year period — researching hernia repair with mesh. The FDA’s review, last updated in 2023, found ventral and incisional hernia surgeries accounted for 60% of the reports to the FDA. The type of hernia surgery was not specified in another 20% of the reports.
Most Common Hernia Mesh Complications
The FDA reviewed 22 years of adverse event reports it received involving hernia mesh. It also reviewed 45 research papers published over 11 years. From these sources, the agency identified the 10 most frequently reported complications in 2023.
- Additional surgical procedure
- Adhesions
- Disability
- Hernia recurrence
- Infection
- Inflammation
- Injury
- Nausea
- Pain
- Tissue injury
Who Is at Higher Risk for Complications?
Some people are more likely to have hernia mesh complications than others, especially if they have certain health issues or risk factors. A 2024 study in Cureus found that obesity and other medical problems can affect recovery and surgical results.
- Adults who are obese or have a high BMI
- People who have diabetes
- People who smoke
- People who are in poor overall health
The study found that complication rates went up as body mass index (BMI) increased. Obesity is linked to slower wound healing, more infections and a higher chance that the hernia could come back after surgery.
Diabetes was also closely linked to complications. People with diabetes may have a higher risk of wound infections and healing problems after hernia repair. Researchers also found that patients with several health conditions, known as comorbidities, were more likely to have complications than healthier patients.
The most common complications were seroma formation (fluid build-up under the skin) and wound infections. Researchers said that careful surgical techniques, good wound care and managing health conditions before surgery can help reduce these risks.
Hernia Mesh Recalls and FDA Oversight
The FDA regularly looks at reports of problems with surgical mesh used in hernia repairs. These reports come from manufacturers, hospitals, doctors, and patients. So far, the agency has received over 55,000 reports about hernia mesh. This information helps the FDA monitor safety and decide when to recall certain mesh products. Over the years, this process has led to several recalls of specific mesh brands.
Notable Hernia Mesh Recalls
Faulty hernia mesh products have led to serious health problems, including infections and device failures. Manufacturers have recalled hernia mesh due to defects, contamination or counterfeiting. These issues have prompted major actions by the FDA and manufacturers, along with hernia mesh lawsuits.
| MANUFACTURER | BRAND | RECALL DATE | REASON |
|---|---|---|---|
| Ethicon | Proceed Surgical Mesh (18,270 units) | Dec. 2005 | Coating separated from mesh, increasing the risk of adhesion |
| Ethicon | Prolene Polypropylene Mesh (365 boxes) | Nov. 2003 | Counterfeit products found on the market |
| Atrium | C-QUR Mesh (1,500 units) | July 2013 | Inadequate storage instructions leading to safety concerns |
| Bard (C.R. Bard) | Composix Kugel Patch (more than 131,451units) | Dec. 2005 | Device failure leading to the risk of serious injury |
What the FDA Recommends
The FDA offers helpful advice for people who are thinking about hernia mesh surgery or are recovering from it. This guidance helps patients stay informed and know how to report any problems.
Before surgery, you should ask your surgeon for details about the mesh and learn about your repair options. After surgery, watch for signs that the mesh might not be working and report any issues to the FDA’s MedWatch system.
Steps to Take Before and After Hernia Mesh Surgery
- Before surgery:
- Ask your surgeon for the brand, type and Unique Device Identifier (UDI) of the mesh they plan to use.
- Keep a record of your mesh product details and make sure you understand your repair options, including the differences between mesh and non-mesh procedures.
- After surgery:
- If you have pain, infection, mesh movement or other problems after surgery, report these complications to the FDA through the MedWatch system.
- Be aware of signs that the mesh might be failing, such as movement, shrinkage, infection, blockage or the hernia coming back.
Drugwatch monitors hernia mesh recalls. However, not all hernia mesh complications are caused by recalled mesh. If you develop complications, you may have legal options for your injuries.
Hernia Mesh Lawsuits and Legal Action
Thousands of people have filed hernia mesh lawsuits since the early 2000s, with four major multidistrict litigations (MDLs) still active. MDLs allow federal courts to combine similar lawsuits to make the legal process more efficient.
| MDL NUMBER | MANUFACTURE | CASES PENDING |
|---|---|---|
| MDL-2753 | Atrium | 172 |
| MDL-2782 | Ethicon | 0 |
| MDL-2846 | Davol, Inc./C.R. Bard | 23,573 |
| MDL-3029 | Covidien | 2,408 |
If you had hernia mesh surgery and experienced complications such as chronic pain, infection, mesh migration, bowel obstruction or you required revision surgery, you may be eligible to file a hernia mesh lawsuit.
Frequently Asked Questions About Hernia Mesh
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