What is hernia mesh?

Hernia mesh is a type of implantable surgical mesh meant to repair hernias.

People have a hernia when an organ, intestine, or fatty tissue squeezes through a hole or a weak spot in the muscle or other type of connective tissue, according to the U.S. Food & Drug Administration (FDA). This generally occurs as a result of pressure, often caused by lifting heavy objects, obesity, constipation, or persistent sneezing or coughing. Some hernias are noticeable as a bulge when a person stands up, but then disappear when the person lies down.

Hernias often occur in the wall of the abdomen, but may also occur in the inner or outer groin, upper thigh, at the belly button, along the upper stomach or diaphragm, or through a pre-existing incision or scar in the stomach or abdomen.

Hernia mesh is made of flexible material, most often polypropylene plastic, that has holes in it. A surgeon implants the mesh, through either an open or a laparoscopic procedure. The intention is that new tissue grows into these small holes to anchor the mesh as the body heals from the surgery.

According to the FDA, hernia mesh is used in approximately 80 percent of hernia repairs in the U.S. More than 1 million hernias are repaired in the country every year.

However, although the use of this surgical device is widespread, many types of hernia mesh have been recalled due to the dangerous side effects associated with them.

Problems with hernia mesh

Problems with hernia mesh can interfere with the recovery process.

The most common complications associated with hernia mesh surgery recovery include the following, according to Shouldice Hernia Hospital:

• Rejection of the mesh: When the body identifies the mesh as a foreign object, it may try to expel the mesh by sending fluid to try to flush the mesh away. The fluid can collect, becoming a seroma that causes a lump that may appear to resemble the original hernia.
• Mesh migration or shrinkage: Even when the mesh is stapled or glued in place, the mesh may shrink or become misshapen over time. If it loosens, the mesh may migrate to another part of the abdomen. Some mesh hardens or disintegrates even after scar tissue has grown into it, causing pieces of plastic to become embedded in places that cause discomfort.
• Bowel obstruction or perforation: If hernia mesh becomes adhered to the intestines instead of the intended tissue, the mesh may cause a bowel obstruction. When mesh moves, it’s possible the intestines can become trapped in the mesh. Sharp edges of hernia mesh or eroding mesh may puncture the bowel or even the wall of another internal organ.

What hernia mesh has been recalled?

The FDA recall on hernia mesh included brands that were either associated with the above issues, recorded high failure rates, or were inadequately packaged for sterility.

Brands that have recalled hernia mesh products include Atrium Medical, Bard Davol, and Ethicon. Between 2005 and February 2019, more than 211,000 units of hernia mesh have been recalled or withdrawn from the market by these manufacturers, according to Drug Watch.

Many of the recalled mesh products are responsible for causing patients to suffer dangerous injuries and side effects. The FDA tracks reports of hernia mesh injuries and complications.

Recalled hernia mesh is the main cause of bowel perforation and bowel obstructions in patients who have been implanted with mesh, according to the FDA.

Atrium Medical, Bard Davol, and Ethicon hernia mesh products have all been added to the hernia mesh recall list for multiple reasons. While some companies have recalled the mesh due to packaging errors, most have recalled it due to serious complications associated with the products.

What are the complications of hernia mesh?

There are many possible serious complications associated with hernia mesh.

Some of the most dangerous side effects include organ perforation, obstruction, or adhesion between the mesh and internal organs. The most common hernia mesh complications include pain, infection, hernia recurrence, adhesion between the mesh and internal organs, and bowel perforation, according to MedNews 365.

Although hernia mesh has a coating on it that is intended to prevent adherence between the mesh and patients’ internal organs, this coating often fails and the mesh attaches to the tissues. This adherence may result in severe pain, as well as internal injuries, including bowel obstructions.

Bowel obstructions may cause symptoms including nausea, vomiting, constipation, and pain. In some cases, intestines may need to be removed in order to resolve problems caused by hernia mesh adherence, infection, or perforation.

Pain that begins or lasts longer than three to six months after surgery may be indicative of a failed mesh implant. Hernia mesh may cause pain due to contact with nearby nerves.

If the body rejects the mesh as a foreign object, chronic inflammation may give rise to chronic pain, too.

When mesh shrinks or moves somewhere beyond its intended position, pain is usually the first indication this has occurred.

Many patients who have received a hernia mesh implant claim to suffer from long-term damage that may be just as painful and debilitating as the hernia the mesh was meant to fix, according to ABC Newcastle.

Several victims have reported the size of the mesh made it painful for them to lose or gain weight, as the size of their stomach changed the way the mesh fit in their body.

Other patients have reported experiencing incontinence or sexual dysfunction, making it difficult for them to date and lead a normal life.

Many people have reported changes in their physical abilities, including being more fatigued, experiencing chronic pain, and losing mobility.

One woman who was implanted with mesh in order to fix both a hernia and pelvic prolapse claims she has been in and out of the hospital for years since the initial surgery. Multiple surgeries to attempt to repair or remove the mesh have resulted in infections and chronic pain.

“They destroyed my life — the mesh,” she told KVUE ABC.

A study published in the Journal of the American Medical Association (JAMA) looked at 3,242 patients who had hernia repairs between 2007 and 2010. Researchers said that at five years post operation, 5.6 percent of patients who had open surgery with mesh repair and 3.7 percent of patients who had laparoscopic surgery with mesh repair suffered complications related to the hernia mesh.

In comparison, patients with open surgery and no mesh only experienced complications at a rate of 0.8 percent.

Why would hernia mesh cause problems?

While some hernia mesh is made of pig or cow tissue, many brands use a particular plastic: polypropylene.

Atrium’s C-Qur hernia mesh has been recalled for myriad reasons, according to Drug Watch.

The mesh is made of this plastic, which has been found not to be biologically compatible with human tissue, according to UCI Health. As a result, patients may “reject” the mesh, which the body perceives as foreign matter.

As the body rejects the mesh, lymphatic fluid flows to the surgical site to try to flush away the mesh. Trapped fluid can become a seroma, which may resemble a tumor, but is actually a pocket of trapped fluid that can become painful or develop an infection.

Atrium’s C-Qur mesh was coated with Omega 3 fatty acids extracted from fish. This coating was intended to keep the mesh from sticking to the internal tissues upon implantation, but some patients experienced a severe allergic reaction to the fish-based coating. Patients with fish allergies were at risk of dying from anaphylactic shock.

Another problem cited in lawsuits was Atrium alleged use of a chemical to keep the mesh sterile within its packaging.

The chemical required a certain amount of moisture to keep the substance an active means of preventing infection. Too many of the packages dried out, which also caused the fish-oil coating to lose adherence to the hernia mesh.

According to one lawsuit, Atrium repeatedly conducted a “stealth recall,” which meant the company changed its manufacturing methods with no notice to the FDA, the medical community, or patients.

Hernia mesh revision surgery

In cases in which the mesh has broken or migrated and is causing pain or damage to internal organs, patients may opt to have the mesh removed. Patients who have implants that were included in the hernia mesh recall may also opt to have their implants removed. However, hernia mesh removal surgeries may be more complicated, time consuming, and dangerous than the original implantation.

If the mesh has fractured, it may be difficult for surgeons to locate all of the pieces of the mesh, especially if it has migrated throughout the abdomen. Additionally, these pieces may puncture or adhere to other organs.

If the mesh has adhered to an organ, removing it may be difficult or even impossible.

Filing a hernia mesh lawsuit

A growing number of patients are coming forward with allegations of major hernia mesh repair complications, claiming they were not adequately warned about the potential complications associated with the surgical device. Indeed, thousands of affected patients have filed lawsuits against hernia mesh manufacturers. In summer 2021, several hernia mesh manufacturers face initial trials for mesh complication litigation.

Victims who have suffered from complications due to hernia mesh that has been recalled may be eligible to hire an experienced attorney and file a class action lawsuit against the mesh manufacturer.

Victims who file lawsuits may be able to collect compensation for their injuries, mental anguish, physical pain and suffering, loss of income or earning capacity, medical expenses for care and the cost of revision surgeries, and other costs associated with mesh complications.