More than one million hernia repairs are performed in the U.S. each year. Hernias repaired with surgical mesh implants may cause serious side effects. Individuals experiencing hernia mesh complications might require removal or revision surgeries.

 


The Truth

Studies + Science

Regulation Recap

The Next Steps
Hernia mesh may cause pain, infection, and other serious side effects.Studies show more than one-third of hernia surgeries may result in complications.Due to adverse events manufacturers have recalled faulty hernia mesh devices.Individuals with hernia mesh complications may be eligible for compensation.

 

The Truth

Hernia mesh is a medical device used to repair muscle or tissue damaged by a hernia. A hernia occurs when an organ, intestine, or fatty tissue breaks through a tear, weak point, or other abnormal openings in the body.

Types of Hernias

  • Inguinal: occurs in the inner groin
  • Femoral: occurs high in the thigh
  • Incisional: occurs through an incision or scar in the abdomen
  • Umbilical: occurs at the belly button
  • Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm

An estimated 800,000 hernia repairs are for inguinal hernias, the most common type of hernia injury. Associated with a high recurrence rate, treatment for hernias may include surgical repair with or without hernia mesh implants.

Hernia mesh implants are available as patches, plugs, or customized sheets. Mesh devices may be produced from absorbable, non-absorbable, coated, synthetic, or animal-derived materials.

Though studies show surgical mesh repairs may result in a lower rate of hernia recurrence, complication risks significantly increase with hernia mesh implants.

Studies + Science

There are various approaches toward hernia repair. The two most common treatment options are both surgical:

  • Herniorrhaphy: Repairs the weak spot in the muscle wall by sewing the edges of healthy muscle tissue together.
  • Hernioplasty: Repairs the weak spot in the muscle wall by implanting synthetic hernia mesh plugs, patches, or customized sheets.

With hernioplasty, surgical mesh repairs the weakened or torn muscle wall and protects organs or tissue from bulging through. The mesh is implanted over the point of damage and secured with stitches, tacks or surgical glue.

After selecting the type of hernia mesh repair, physicians will recommend a type of mesh material. Absorbable mesh will degrade to make space for new, stronger tissue to grow. Non-absorbable mesh is intended to be a permanent option for hernia repair.

Most synthetic meshes are made from plastic known as polypropylene. Synthetic polypropylene meshes are associated with higher rate of side effects.

Hernia Mesh Complications

Adhesion
Loops of the intestines adhere to each other or the mesh
Obstruction
Blockage of intestines and bowels
Fistula
Abnormal connection between organs, vessels, or intestines
Seroma
Fluid build-up at the surgical site
Perforation
Hole in neighboring tissues or organs

Excessive pain and chronic infection are two side effects commonly associated with hernia mesh complications. These symptoms are often related to a mesh complication, perhaps compounded by more than one issue.

One study, published in the journal Surgical Infections in August 2012, found that polypropylene surgical mesh for hernia repair was “unsuitable for intra-abdominal placement because of its tendency to induce bowel adhesions.” Bowel adhesions may cause obstruction, a blockage that causes the inability to urinate or defecate.

In 2014, a study published in the Journal of the American Medical Association showed hernia mesh may lead to an increased risk of seroma and surgical site infection. Infections may also link to bowel adhesions, obstructions, and fistula.

In 2015, a study published in the journal of the American College of Surgeons found 33 percent of 768 patients had a hernia mesh infection. In total, 10 percent developed an infection in the first 30 days post-surgery. Seven percent had a Methicillin-resistant Staphylococcus aureus (MRSA) infection prior to the surgery.

In 2016, a study published in the journal Hernia measured MRSA infections for hernia mesh patients over time. The results showed 31 percent of patients developed infections within two years, and 9.8 percent of patients needed medical assistance. 

Hernia Mesh Recurrence, Removal + Revision

Failed Hernia Mesh Symptoms

  • Pain
  • Bruising
  • Swelling
  • Skin Rash
  • Bleeding
  • Chronic Infection
  • Difficulty urinating

Indicated for a permanent repair, surgical hernia mesh is intentionally crafted with small openings. The pores in the surgical mesh make way for tissue to combine with the device for optimum strengthening.

Hernia mesh may cause a number of complications, some of which could require removal or revision surgeries. In more severe cases, bowels or testicles may need to be removed as well. Adding insult to injury, wounds from hernia mesh implants may not heal.

 

Regulation Recap

First introduced in the 1950s, hernia mesh was regarded as an innovative solution to hernia injuries. The use of hernia mesh has increased since its introduction. By 2000, 90 percent of hernia repairs used mesh. Hernia mesh has become a standard treatment to repair hernias.

Because of the likelihood of complications, the Food and Drug Administration (FDA) has dedicated a page to hernia mesh risks. In 2014, the FDA issued a safety communication to warn patients about the complications.

Surgical Mesh: FDA Safety Communication

“FDA wants to inform you about complications that may occur with the surgical mesh that is sometimes used to repair hernias, and to provide you with questions you may want to ask your surgeon before having this procedure. This is part of our commitment to keep the public informed about the medical products we regulate.

Hundreds of thousands of hernia repair operations are performed each year both with and without surgical mesh, and patients generally recover quickly and do well after surgery.

However, FDA has received reports of complications associated with the mesh. The complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels . Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence.”

The agency has overseen multiple manufacturers’ recalls attempting to mitigate the damage to patients with failed mesh. The reasons for recalling include packaging issues, poor performance, and adverse events.

Recalled Hernia Mesh Devices
Bard ComposixBard VentralightBard Ventralex STBard DavolCovidien Parietene Atrium CQUREthicon PhysiomeshEthicon J&J Proceed

Mesh recalls have also been attributed to faulty design. Manufacturers have also been targeted for not informing patients of the risks linked to hernia mesh.

The Next Steps

Hundreds of thousands of hernia repair operations are performed each year, both with and without surgical mesh. While hernia mesh implants may benefit some individuals, others may develop serious injuries.

Though the FDA continues to track complications and adverse events, hernia mesh patients continue to develop serious injuries.

Thousands of individuals suffer with side effects from hernia repairs each year. Compensation may be available.