According to the FDA, there are more than one million annual surgeries to correct a hernia and 90 percent of them use a mesh patch. Varying complications occur for nearly one-third of all patients, from localized pain to life-threatening bowel perforations, requiring repair or complete mesh removal.
How Hernia Mesh Works
The use of mesh to repair a hernia started in the 1940s, when a stainless steel or tantalum patch was used to address wound infections and drainage issues. These materials eventually went out of fashion and since the late 1990s, doctors have shown a preference for synthetic or animal-based hernia mesh.
Regardless of material used, the mesh patch lessens the amount of pressure a hernia places on the abdominal wall. Based on previous studies, it also offers preferable outcomes compared to standard sutured repair, particularly when it comes to recurrence. During the procedure, a surgeon implants the mesh into the upper stomach, groin or abdomen where the weakened tissue has formed.
There are two types of mesh used today: Permanent, made from polypropylene, plastic or another synthetic material with a coating to reduce adhesion and absorbable mesh, constructed from animal-based tissue. The former is designed to create scar tissue around the mesh, strengthening its hold. However, the body may become irritated and inflamed in the process – especially after the coating wears away – and complications can stem from this reaction.
Based on research from the American Hernia Society, incidence of chronic pain and other complications related to hernia mesh has grown since polypropylene and other synthetic substances became commonplace in the 1990s. Sometimes, the coating disappears within a week of the surgery, putting the intestines in direct contact with the mesh patch.
Hernia Mesh Complications
Studies published in the Journal of the American Medical Association have shown a much lower rate of recurrence for patients given hernia mesh. Yet, when researchers compare mesh to sutures, mesh has far more complications from the body rejecting the patch. How do you know your body is having a reaction post-surgery? Look for the following signs.
Detachment could be caused by worn out coating or related to the patient’s own behavior. Certain activities following surgery can also increase this occurrence, including lifting weights or extreme physical exertion. Prior to the procedure, the surgeon should inform the patient which activities could dislodge the patch or rip out the sutures.
In other cases, the issue is outside the patient’s control. Hernia mesh has been known to shrink, resulting in migration or erosion in the body. The edges may abrade or perforate neighboring tissue.
Patients may experience a range of complications, which could eventually lead to hernia patch rejection:
- Postoperative hematoma and seroma
- Foreign body reaction
- Organ injury or damage, particularly to the intestines and bladder
- Bowel or intestinal obstruction
Although the mesh is said to be made of biologically compatible materials, the body generates an immune response when it rejects the patch. When this occurs, you may have:
- Swelling at or around the surgical site
- Flu-like symptoms
- Difficulty urinating or passing gas and stool
- A high fever
- Nausea or vomiting
- Stiffness in the abdomen
Mild inflammation is common immediately following surgery. The polypropylene intentionally causes this reaction, which initiates tissue growth around the mesh for a stronger, more secure bond. If the inflammation does not go away over time, abdominal pain could make everyday activities unbearable and be a sign your body is fighting off an infection.
Should you notice heat at the incision site, you could also be dealing with an infection, as the body may be fighting off bacteria. When this is not addressed in a timely manner, organized colonies known as biofilms may form, quickly becoming antibiotic-resistant. As a drug treatment plan could make your symptoms worse, your doctor may recommend removing the mesh. Even if biofilms don’t form, the infection may create a fluid buildup at the incision site that prevents the hernia from completely healing.
Patients whose bodies are rejecting the hernia mesh may develop dental problems, which stem from chronic infection. Symptoms include:
- Weakened teeth that may start to fall out
- Tooth infections
- Unexplained chips
In certain instances, the mesh may adhere to the intestines, creating scar-like tissue that sticks together. Although absorbable coatings are designed to prevent this occurrence, their effects eventually go away after seven to 30 days. Because this protective barrier is soon ingested, a patient’s risk of adhesion increases. When this happens, a patient may start to develop chronic pain and could eventually experience bowel obstruction.
Bowel or Intestinal Blockage
As a progression of adhesion, mesh may partially or fully block the intestines, preventing patients from passing stools or gas. Nausea and vomiting indicate mesh may be blocking your bowels and, should it go unaddressed, it cuts off blood flow and may cause part of the intestinal tissue to die. If you suspect a blockage of any kind, report it to your doctor right away. Revision surgery, in which the patch and possibly part of your intestines are removed, may be needed.
What if the mesh doesn’t attach correctly? Migration may occur when the mesh detaches and starts to move through the abdomen. Migration may further indicate the doctor didn’t use enough sutures or the patch was too small for the opening.
If the migrating mesh goes unchecked, it may eventually come in contact with your intestines, gallbladder or other internal organs. As with adhesion, the mesh starts growing into the organ, potentially creating fistulas, abscesses or bowel obstruction.
Mesh not only grows into the organ – it also has potential to puncture or erode the tissues, especially those of the abdominal wall. When this happens to your intestines or bowels, fecal matter and bacteria can enter the abdominal cavity, leading to further complications, including sepsis. Perforations are a life-threatening condition that requires immediate medical attention.
While most cases of rejection happen not long after surgery, a study published in a 2016 issue of JAMA found that complications actually increase within five years after the procedure.
Once the patch is dislodged or migrating, the chance a patient will experience a hernia recurrence increases significantly, as this area no longer has the strength needed to support the weakened tissue or opening. As a precursor to this, patients often have a wound that refuses to heal and, because the patch is not in place, the condition reoccurs within a relatively short period of time.
Hernia Mesh Recalls
Based on figures from the FDA, 211,000 units of hernia mesh patches from multiple manufacturers were recalled from 2005 through 2018. Safety communications pinpoint recalls to:
- Packaging errors
- Organ perforations
- Bowel tears
Products recalled by the FDA over this period include:
- C.R. Bard, Kugel Mesh, associated with bowel damage.
- Atrium Medical Corporation, C-Qur mesh, known for a packaging issue that damaged the mesh.
- Ethicon, Physiomesh, associated with a high number of infections, organ perforation, migration and other adverse events.
Patients who have received these hernia mesh patches require revision surgery. However, the procedure is not straightforward, requiring a mix of laparotomy, mesh resection, bowel resection and anastomosis, and does not prevent the hernia from recurring. Patients may still experience infection following the revision procedure.
Did you receive a hernia mesh patch, only to contend with the painful process of rejection, removal or revision surgery? To hold the medical device manufacturer or doctors involved in your surgery accountable, bring your claim to our attorneys today.