Doctors use surgical hernia mesh to repair weakened or damaged tissue that causes hernias. A hernia occurs when an abdominal organ, fatty tissue or intestine breaks through a weakened area in the surrounding muscle or connective tissue. Most hernias occur at the abdominal wall (ventral), but they can also occur in the inner groin (inguinal), outer groin (femoral), or belly button (umbilical) or at an incision or scar site (incisional and along the diaphragm (hiatal).
Hernias can be painful and repairing them is common. A doctor may choose to monitor a hernia — a treatment option called watchful waiting — if it is not causing problems or getting bigger, but surgery is the only treatment that can repair a hernia. Doctors perform more than one million hernia repairs each year in the U.S. Inguinal hernia repairs account for about 800,000 of them.
Hernias have a high rate of recurrence, or of returning. Most doctors use hernia mesh to repair damaged muscle walls because it decreases the chance of a hernia coming back. According to a 2014 study published in the Journal of the American Medical Association, using mesh leads to a lower chance of hernia recurrence than just stitching the torn tissue closed. This is because surgical mesh strengthens the weakened or torn tissues while stitches alone do not.
What Is Hernia Surgical Mesh?
Surgical mesh is a medical device that can be made of animal tissue or synthetic materials. These pieces of mesh come in many sizes including patches, plugs and larger sheets of mesh.
Surgical mesh made of synthetic materials come in woven or non-woven sheets. The synthetic materials can be absorbable, non-absorbable or a combination of both. The most popular types of surgical mesh are made of synthetic plastic called polypropylene, and some may come coated with absorbable fatty acids, cellulose or collagen.
Mesh can also be made of animal tissue, such as intestine or skin. The tissue — typically from a pig or cow — is processed and disinfected so that it’s suitable for use as an implanted device. This type of mesh is absorbable.
Absorbable mesh will degrade and lose strength over time and is not used to provide long-term reinforcement to the repaired hernia. “As the material degrades, new tissue growth is intended to provide strength to the repair,” according to the U.S. Food and Drug Administration (FDA). Non-absorbable mesh, on the other hand, is considered a permanent implant, remaining in the body indefinitely. Non-absorbable mesh is intended to provide lasting reinforcement to the repair site.
Hernia Mesh Surgery
Doctors may perform hernia repair surgery with or without mesh. Hernia repair surgery with mesh is called hernioplasty; without mesh it is called herniorrhaphy. In the 1940s, surgeons began using the first surgical meshes to repair hernias to combat the high recurrence rate. Since the 1980s, there has been an increase in mesh-based hernia repairs. By 1989, surgeons were using minimally invasive laparoscopic surgery with mesh in hernia repairs. By 2000, non-mesh repairs represented less than 10 percent of groin-hernia-repair techniques. Today, hernia repair with synthetic mesh is the standard procedure.
The surgical mesh acts as flexible scaffolding to repair muscle walls and prevent organs from coming through. After placing the mesh over the hernia defect, doctors use sutures (“stitches”), tacks or surgical glue to hold the mesh in place. Over time, the patient’s tissue should grow into the small pores in the mesh and strengthen the muscle wall. Most mesh repairs are permanent, meaning the implant remains in the body for the rest of the patient’s life.
According to the FDA, the use of surgical mesh may improve a patient’s outcome by decreasing the time the surgery takes and minimizing the recovery time. However, recovery time can vary depending on the type of hernia, the patient’s condition both before and after surgery, and the surgical approach.
There are two types of surgery to repair hernias: laparoscopic repair and open repair.
Laparoscopic Repair Surgery
During laparoscopic repair, the surgeon makes several small incisions and inserts surgical tools through the openings to repair the hernia. This procedure typically involves a shorter healing time and less blood loss, but it is more challenging to perform and costs more. Surgeons use laparoscopic repair to fix a hernia recurrence because it avoids old scar tissue. Recovery time is one to two weeks, and strenuous exercise is generally allowed after about four weeks.
Open Repair Surgery
For an open repair, the surgeon makes an incision near the hernia to repair the weak muscle area. This procedure can be done with or without surgical mesh. Recovery time is about three weeks, and strenuous exercise is generally allowed after six weeks. Open repair that uses sutures without mesh is referred to as primary closure and is used to repair inguinal hernias in infants, small hernias, or strangulated or infected hernias.
Hernia Repair Techniques
Surgeons may use three main techniques to repair hernias with mesh: transabdominal preperitoneal (TAPP) repair, totally extraperitoneal (TEP) repair and intraperitoneal onlay mesh technique (IPOM). Most surgeons use the TAPP or TEP techniques.
- TAPP — This technique requires the surgeon to enter the peritoneum, the thin membrane covering the abdominal organs, and place the mesh through a small incision.
- TEP — For this technique, surgeons do not enter the peritoneal cavity; doctors place mesh from the outside of the peritoneum. TEP is considered more difficult to perform but may have fewer complications.
- IPOM — This technique is faster and easier to perform than TAPP or TEP and grew in popularity in the 90s. Surgeons enter the peritoneal cavity and place mesh on the inside of the peritoneum in direct contact with intestines and other organs.
The FDA cautions that the use of surgical mesh for hernia repair may not be the best treatment option for every patient.
“Despite reduced rates of recurrence, there are situations where the use of surgical mesh for hernia repair may not be recommended. Patients should talk to their surgeons about their specific circumstances and their best options and alternatives for hernia repair,” according to the agency.
Hernia Mesh Surgery Complications & Side Effects
Depending on the surgical technique and type of mesh, complications and side effects following hernia repair surgery may vary. Patients generally recover quickly and do well after surgery, according to the FDA. But, the agency also received reports of adverse events.
The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, bowel obstruction and adhesion — when loops of the intestines stick to the mesh or each other. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).
Many complications linked to hernia repair with mesh reported to the FDA have been associated with recalled mesh products that are no longer on the market, according to the agency. The most common complications associated with recalled mesh are the same as with other mesh products but also include perforation. Recalled mesh products were the main cause of bowel perforation and obstruction complications.
A bowel obstruction occurs when the small or large intestine is partially or fully blocked, causing nausea, vomiting and the inability to pass gas or stools. Perforation occurs when the broken ring punctures the bowel, abdominal wall or another abdominal organ. A bowel perforation, also known as an intestinal perforation, allows fecal matter and bacteria to enter the abdominal cavity, causing inflammation (peritonitis). Symptoms of this complication include nausea, vomiting, severe abdominal pain and abdominal rigidity. Intestinal perforation is life-threatening and is considered a medical emergency. Perforation can also cause sepsis, an infection of the blood stream, which is also potentially fatal.
According to the FDA, reports of adverse events include:
- Pain & bleeding
- Hernia recurrence
- Mesh shrinkage
- Intestinal blockage
- Organ perforations
- Nerve damage
- Autoimmune reactions to mesh
- Mesh migration and rejection
- Tenderness at the implant site
According to a recent study, complications can occur up to five years after surgery. The study by Dunja Kokotovic and colleagues was published in JAMA Surgery and presented at the 2016 Clinical Congress of the American College of Surgeons. It found that the rate of complications increased over the course of five years.
Out of the 3,242 study participants, 1,050 required subsequent abdominal surgery.
“These data suggest that the risk–benefit ratio of mesh is not as clear as previously thought,” Dr. Kamal Itani wrote in commentary published in JAMA. He said the results of the study “call into question the current practice of liberal use of mesh.”
The study’s authors said the extent of the risks and benefits of using surgical mesh for hernia repairs is unknown because very few clinical trial data exist on the subject. The authors partially blamed the FDA’s 510(k) premarket notification clearance process for the lack of trial data on hernia mesh in the U.S. This process does not require clinical trials or detailed case studies to prove safety or effectiveness.
“Demonstration of long-term safety is required for drugs in the United States but not for some devices, such as hernia meshes, which are not subject to similarly strict documentation,” the authors wrote.
Diagnosing and Treating Hernia Mesh Complications
Hernia mesh complications can be hard to diagnose because the complications vary widely and can be related to or caused by other conditions. If a patient experiences symptoms and has received a mesh implant, the possibility the symptoms are caused by the implant should be considered. In the case of an emergency, patients should tell emergency room doctors that they’ve had the implant.
There are several diagnostic tests doctors can use to detect complications with implants, including X-ray, CT scan and a blood test. The blood test may be the most diverse diagnostic test because it can reveal several different problems.
Blood test can detect several different complications such as:
- High white blood cell count, which can indicate infection
- Low hemoglobin count, which can identify blood loss
- Electrolyte imbalances, which can reveal a kidney problem
- Elevated enzymes, which can indicate a liver problem
If a doctor suspects bowel obstruction, they may also choose to perform a colonoscopy. During this procedure, the patient receives a sedative before a camera is inserted into the colon. Images from the camera are projected onto a TV screen where the doctor can fully visualize what is obstructing the bowel, such as a mesh implant.
Just as diagnostic techniques can vary between complications, treatment also varies. Depending on the complication, the patient’s surgeon may decide to perform a revision surgery to remove the mesh implant. Surgery or medication, or a combination of both, may be used to treat an adhesion and fistula.
Bowel obstructions can be treated in several different ways, depending on how severe the obstruction is. While many doctors may prefer to wait and see if a partial obstruction resolves on its own, partial obstruction caused by a foreign object may require surgery to remove. Surgery is also the typical course of treatment for a complete obstruction. Alternatively, a doctor may also try to remove the obstruction non-surgically by inserting a stent into the colon to force it open and clear the obstruction.
Patients experiencing a bowel or abdominal perforation only have one course of treatment: surgery. The procedure will repair the hole, remove the component that punctured it and clear the abdominal cavity of any spilled material such as feces, bile or food.
Hernia Mesh Recalls
The FDA has announced several manufacturer recalls, and the agency issued a Safety Communication in 2014 to warn the public about adverse events linked to hernia mesh. Some recalls were for packaging errors, but others were for poor mesh performance or reports of adverse events. Patients injured by hernia mesh have filed lawsuits against manufacturers claiming the mesh is faulty and poorly designed and that the devices’ makers hid the risks. Companies who issued recalls of their hernia mesh products include Atrium Medical Corporation, Bard Davol and Ethicon.
C-QUR Surgical Mesh
Atrium Medical Corporation, now a part of the Maquet Getinge Group, originally designed and manufactured its C-QUR line of surgical mesh for hernia repair. The FDA originally cleared the Atrium C-QUR mesh through the 510(k) process in 2006. These meshes are intended to be permanent implants.
C-QUR mesh is made of polyethylene plastic and coated with Omega-3 fatty acid fish oil. The fish oil is supposed to prevent inflammation and scarring from tissues adhering to the mesh, but studies show the device has higher adhesion and infection rates than many other hernia mesh brands. On August 9, 2013, the FDA announced Atrium recalled thousands of C-QUR V Patch Meshes and C-QUR Edge Mesh because the fish oil coating on the mesh could stick to the packaging and peel off.
Atrium intended C-QUR for surgical repair of inguinal hernias using the IPOM technique. Surgeons may also use the mesh for chest wall reconstruction, reinforcing fascia — a thin sheet of fibrous tissue enclosing muscle or organs — and traumatic and surgical wounds. This type of mesh is called a tissue-separating mesh because it is coated with a bioabsorbable film that is meant to keep mesh from touching internal organs and prevent mesh adhesions. In its marketing materials, Atrium claims the O3FA coating “has been shown to minimize tissue attachment to mesh.”
However, there are a handful of studies that question the safety and effectiveness of Atrium C-QUR hernia mesh. In animal studies, researchers found the infection rate was higher with C-QUR mesh than with other meshes. One animal died less than two weeks after implantation because of bowel obstruction caused by mesh adhesions. Studies also show the coating interferes with tissue ingrowth into the mesh.
Less than two weeks after surgery implantation, test animals died due to bowel obstructions from mesh adhesion.
One of the first studies on C-QUR mesh was by Dr. M.H. Schreinemacher and colleagues and appeared in a 2009 issue of the British Journal of Surgery. Authors found after 30 days there was a significant increase in adhesions and immune response around the mesh implants. The most recent case study published in February 2016 by C.Y. Kong and colleagues related the case of a 61-year-old woman implanted with C-QUR mesh for an incisional hernia. After 10 months, she complained of pain and upper abdomen discomfort. During surgery, study authors found thick, oozing adhesions around the mesh. Doctors removed the mesh and part of her stomach. They determined the mesh and fish-oil coating created an inflammatory response and caused the adhesions.
After the original C-QUR mesh hit the market in 2006, Atrium produced a number of other product variations from 2008 to 2015. All these brands are still available on the market.
C-QUR Lite Mesh V-Patch introduced for pre-peritoneal repair
C-QUR Edge Mesh V-Patch introduced for intra-abdominal placement
C-QUR V-Patch Mesh introduced for small hernia defects
C-QUR OVT Mesh introduced for open ventral/incisional hernia repair
C-QUR RPM Mesh introduced for mesh with reduced coating for open and laparoscopic repair (later changed to Mosaic)
C-QUR Mosaic introduced for open and laparoscopic repair
C-QUR FX introduced for mesh without tissue separating layer for open and laparoscopic repair
C-QUR TacShield introduced for fixation guidance with large ventral hernias
C-QUR CentriFX introduced for laparoscopic inguinal hernia repair
Kugel Hernia Patch
The Kugel Hernia Patch, a brand-name surgical mesh used to repair hernias, is made by Bard Davol, Inc., a subsidiary of the medical manufacturing giant C.R. Bard. The implant is named after its developer, Dr. Robert D. Kugel. The FDA approved the polypropylene Kugel Hernia Patch in 1996.
Kugel patches are synthetic, made from a double layer of monofilament polypropylene. Designed to be used in minimally invasive laparoscopic procedures, the Kugel patch is folded for insertion before it’s deployed in the body cavity with the help of a memory recoil ring that springs the patch open to its full shape and size.
In some patients, the implant ring has broken or bent, however, causing the implant to move, bowel obstructions, punctures and other complications.
The FDA announced a class I recall — meaning the injuries could result in death — of eight different Composix Kugel patches in 2006 and 2007.
According to documents on the FDA website, the devices could possibly lead to fistulas (abnormal connections between organs) and bowel perforation.
Bard Davol manufactures a number of other hernia meshes, including Sepramesh, 3DMax and PerFix. The FDA approved the 3DMax Light Mesh in 2009 and the PerFix hernia plug in 2009. Sepramesh hit the market in 2007. It is a polypropylene mesh is coated on one side with bioabsorbable polyglycolic acid. Bard issued a class III recall of 232 units of the 3DMax Mesh in 2008 because the product was mislabeled.
Physiomesh and Proceed
Johnson & Johnson’s Ethicon manufactures two main brands of hernia mesh: Physiomesh and Proceed. The FDA approved Physiomesh in 2010 and Proceed in 2003.
Physiomesh is made of polypropylene laminated with polyglecaprone. Proceed is made of polypropelyne with one side coated in oxidized regenerated cellulose (ORC). The ORC layer is bioabsorbable and separates the mesh from underlying tissue and organs.
In May 2016, Ethicon released an Urgent Field Safety Notice for Ethicon Physiomesh Composite Mesh and its Lararoscopic Hernia Kits. Though the company does not consider this a recall, it withdrew these products from the market.
According to Ethicon: “The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”
Ethicon recalled Proceed on January 4, 2006, January 14, 2011, and April 3, 2014. According to the recall announcement, incomplete seals on the product could lead to delamination and compromised sterility.