Understanding the Risks of Hernia Mesh

Posted on Monday, June 11th, 2018 at 5:39 pm

Each year, more than a million patients undergo hernia repairs in the U.S.¹ Since the first use of mesh for hernia repair in 1948, the technique has exploded in popularity. Approximately 10 percent of groin hernia repairs are currently being done without mesh.² Though this technique is widely used, it’s not without risk. Hernia mesh complications have led to tens of thousands of legal claims, with complaints ranging from pain to infection.³ You may be wondering – what is hernia mesh, and why is it linked to medical complications?

What Is a Hernia?

A hernia occurs when an organ, intestine or fatty tissue protrudes through a hole or weak spot in the muscle or connective tissue. Hernias typically occur at the abdominal wall, and may even appear as a bulge that sticks out from the skin. The most common types of hernia are:

Inguinal: inner groin
Femoral: upper thigh or outer groin
Incisional: through an incision or scar in the abdomen
Ventral: abdominal/ventral wall
Umbilical: belly button
Hiatal: inside the abdomen, along the upper stomach/diaphragm⁴

Most hernias are caused by pressure and an opening or weakness in the surrounding muscle and tissue. Sometimes this weakness is present at birth but it usually happens later in life. Causes of hernias include:

Obesity
Heavy lifting
Constipation/diarrhea
Persistent coughing/sneezing
Poor nutrition
Smoking

Treating Hernias

If you suspect you have a hernia, talk to your doctor. They will perform a physical exam to determine if you have a hernia. Coughing and straining can make it more prominent, so you’ll likely be asked to do this.

Once you’ve been diagnosed, your doctor will discuss treatment options. If your hernia is small and isn’t bothering you, your physician may suggest watchful waiting. They will watch the hernia over time and make sure it isn’t growing or causing problems.

Surgery is the only treatment to repair hernias. There are two options:

Laparoscopy – This minimally invasive procedure allows your surgeon to operate through small incisions in your abdomen. Gas inflates your abdomen, making organs easier to see. A small tube equipped with a camera is inserted into one of the incisions, and the surgeon will insert tiny instruments through the other incisions to repair the hernia with mesh.
Open hernia repair – Your surgeon will make an incision near the hernia, and push the protruding tissue back inside. They will sew it up and reinforce it with mesh.⁵

What Is Hernia Mesh?

Hernia mesh is a medical device surgeons use to provide extra support for the damaged tissue. It can be made of synthetic material or animal tissue, and comes in different sizes and shapes for different hernias.⁶

Hernia mesh is commonly used because it can lower the risk of a hernia recurring after the surgery. A 2014 study in the Journal of the American Medical Association compared conventional surgery, which uses sutures to repair the hernia, and surgery using hernia mesh. It found the rate of recurrence with suture repair is 8.2 percent, versus 2.7 percent for mesh repair.⁷ The study also linked mesh to higher rates of surgical site infection (SSI) and seroma, a pocket of fluid that forms near the incision and can lead to an infection.⁸

Hernia Mesh Complications

The use of hernia mesh is linked to other medical complications, such as:

Bowel obstruction
Migration of implant
Organ and tissue perforation
Scar-like tissue

While mesh is the preferred method for hernia repair, the long-term effects haven’t been widely studied. In 2016, researchers looked into complications, and found that 4.5 percent of patients who had their hernias repaired with mesh required additional surgery due to complications, as compared to just 0.8 percent of patients who had their hernias repaired without mesh. The study also found that the larger the mesh used, the greater the risk for complications.⁹

Hernia Mesh Recalls

Many hernia mesh complications reported to the Food and Drug Administration are linked to recalled products. In April 2018, the FDA recalled Versatex™ monofilament mesh made by Sofradim Production due to patient reports of hernia recurrence after surgery.¹⁰ The FDA has recalled more than a dozen hernia mesh products since 2013 due to risk of complications.¹¹ You can find a full list of medical device recalls on the FDA website.

Hernia Mesh Lawsuits

Patients suffering from hernia mesh complications who have filed lawsuits allege that manufacturers were aware of the dangers their products pose and didn’t properly warn doctors and patients of potential complications. Many of these products are included in FDA adverse event reports. As recently as 2017, patients reported that Ethicon’s Physiomesh™ was breaking into pieces or rupturing after surgery and causing bowel obstruction.³

As of May 2018, there are more than 1,200 lawsuits against two hernia mesh manufacturers pending in federal multidistrict litigations (MDLs). Trials are expected to begin in 2019.¹²

If you’ve experienced a hernia mesh failure following surgery using mesh since 2007, are experiencing complications and you had or have scheduled hernia revision surgery, you could also have a case.¹³

Hernia mesh manufacturers have been found liable for hundreds of millions of dollars in lawsuits. The amount you will receive varies depending on your case. Any damages awarded will provide compensation for:

Medical expenses
Lost income
Pain and suffering

Compensation for Hernia Mesh Complications in Birmingham, AL

If you or a loved one have suffered complications from hernia mesh, but aren’t sure how to begin the process of filing a lawsuit, the team at Farris, Riley & Pitt, LLP can help. Our attorneys have extensive experience advocating for victims of defective medical devices, and we’re dedicated to getting you the money you deserve.

Call us anytime at (205) 324-1212 to get your FREE case evaluation.

¹https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm

²https://www.laparoscopic.md/surgery/instruments/surgical-mesh

³https://www.consumersafety.org/legal/hernia-mesh-lawsuit/

⁴https://www.webmd.com/digestive-disorders/understanding-hernia-basics

⁵https://www.mayoclinic.org/diseases-conditions/inguinal-hernia/diagnosis-treatment/drc-20351553

⁶https://www.drugwatch.com/hernia-mesh/

⁷https://jamanetwork.com/journals/jamasurgery/fullarticle/1828521

⁸https://www.healthline.com/health/seroma#complications

⁹https://jamanetwork.com/journals/jama/fullarticle/2565771

¹⁰https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162927

¹¹https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm