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 provides extra support to repair tissue damaged or weakened by a hernia. While some studies have shown that surgeries using mesh lead to fewer hernia recurrences, others have found there are more complications if mesh is used in the repair.
Top Hernia Surgical Mesh Manufacturers and Products
|Manufacturer||Hernia Mesh Product Lines|
|Atrium||C-Qur, Vitamesh, Proloop, Prolite, Prolite Ultra|
|Bard||3DMax, AlloMaxBard Soft Mesh, Bard Mesh Sheets, Composix, Dulex, Kugel, MK Patch, OnFlex, PerFix Plug, Phasix Mesh, Phasix, Sepramesh IP Composite, Ventralex, Ventralight, Ventrio, Visilex, XenMatrix Surgical Graft|
|B. Braun Melsungen, AG||Premilene, Omyra, Optilene|
|Ethicon||FlexHD Structural, Physiomesh, Proceed, Proline, Ultrapure, Ultrapure Advanced, Vicky, XCM Biologic|
|Gore Medical||Bio-A, Dual mesh, Micromesh, Gore-Tex Soft Tissue Patch, Sinecure|
|LifeCell Corporation||Alloderm Select, Strattice|
|Medtronic||Parietex, Permacol, ProGrip, Symbotex, Versatex|
Types of Hernia Mesh
Hernia mesh products include many sizes shapes suited to different surgical repairs.
These products include:
- Patches – A surgical mesh device designed to go over or under the weakened or damaged tissue
- Plugs – Fit inside the hole in the tissue
- Sheets – Can be custom cut and fitted for the patient’s specific hernia
Each type of hernia mesh may fall into other classifications: absorbable, non-absorbable, coated, synthetic and animal derived.
Absorbable Hernia Mesh
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 Hernia Mesh
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.
Synthetic Hernia 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.
Coated or Composite Hernia Mesh
At least one hernia repair technique can leave mesh in contact with the intestines. This can cause the intestines to adhere to the mesh which can result in severe complications. To prevent adhesions, some polypropylene meshes may come coated with absorbable fatty acids, cellulose or collagen.
Animal Derived Hernia Mesh
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.
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.
Alternatives to Surgery
For patients showing no symptoms of a hernia in the groin (the most common type), doctors once suggested a “watchful waiting” approach — seeking surgery only when symptoms present themselves. That’s no longer the case, with the common recommendation being that patients should undergo hernia surgery as soon as possible.
While most hernia repairs involve mesh, there are alternatives. About 10 percent of hernia repairs in the U.S. are still done without hernia mesh, generally falling into one of five techniques — the oldest of which dates back to the 1880s.
These techniques include:
- Bassini Repair – Introduced in 1884 by Edoardo Bassini, the father of modern inguinal hernia surgery, this technique remains in use today primarily in developing countries. It is called a “tension repair” because it places tension on muscle tissue around the hernia.
- McVay/Cooper’s Ligament – An improvement on the Bassini repair developed in the early 20th century, this tension technique sutures tissue to the Cooper’s ligament. It proved suitable for repairing larger tendons.
- Shouldice Repair – This is a more complicated, tension-repair technique. A surgeon cuts through three separate layers of muscle and connective tissue. The intestine and any fatty tissue that has passed through the hernia are placed back inside the abdomen. Each layer is individually stitched closed, overlapping the previous layer. The pattern reinforces the abdominal wall.
The Shouldice repair was developed during World War II and remains the primary non-mesh hernia repair today. It has very low recurrence rates if performed by a surgeon experienced in the process. It does require a considerable amount of experience — about 200 procedures by some estimates — for a surgeon to become proficient at the technique.
- Descarda Repair – The Descarda hernia repair technique is a tension-free procedure — that is, it places no tension on muscle or other tissue. First presented in 2001, the Descarda repair involves suturing a strip of a patient’s own muscle (the external oblique aponeurosis) to another muscle (the internal oblique muscle) and to the inguinal ligament. A 2012 study of 200 male patients found the results three years after surgery were similar to those of men receiving traditional open surgery using mesh — the Lichtenstein technique.
- Guarnieri Repair – The Guarnieri repair, first used in 1988, is another tension-free technique that can be performed with or without mesh. It involves altering the physiology of the patient’s inguinal canal by overlapping the external oblique aponeurosis – the same muscle involved in the Descarda repair — in a “double-breast” fashion.
Does Hernia Mesh Cause Lifestyle Changes?
Once a patient recovers from hernia repair surgery, whether it involves mesh or not, the patient usually experiences an improved quality of life over a patient’s condition immediately prior to surgery.
However, while some activities improve, hernia repair can result in varying amounts of discomfort and can require additional medical considerations.
Patients who have undergone hernia mesh surgery are usually able to drive within a few days after the surgery.
Patients should not drive if taking opiates or other painkillers that may affect their ability to drive. The type of vehicle a patient drives should also be considered on a case-by-case basis. Sitting or getting in and out of the vehicle may cause pain, discomfort or other problems until the wound heals.
Strenuous exercise, especially lifting anything over 10 pounds, should be avoided for six to eight weeks after hernia surgery.
Limited exercise — particularly walking — is usually encouraged starting as soon as possible.
Patients should be able to return to all athletic activities including running, contact sports, training and competitions within a matter of weeks. Performance may be less than prior to the surgery at first, but should return to pre-surgery levels within days to weeks of resuming activities.
People may feel tugging, burning or other sensations of discomfort for months, but they should diminish over time.
A 2016 study of patients who underwent hernia repair with mesh found that the quality of their sex lives after surgery improved over the quality prior to surgery. Patients should be able to engage in sexual activity as soon as they feel no severe pain.
Though women have had laparoscopic hernia mesh surgery during pregnancy without complications, doctors will usually recommend putting off any elective hernia repair until after delivery. Surgery during pregnancy requires fetal monitoring and creates its own set of risks for the fetus as well as the mother.
There is little research on hernia mesh surgery in fertile women. A 2015 study reviewed 31 published papers, including 31 that were individual case reports. Researchers found women who underwent abdominal wall hernia repair — either with mesh or suture-only surgery — may experience pain in the third trimester of later pregnancies. The researchers also suggested performing hernia repair in conjunction with a C-section appeared to be the best option for pregnant patients with an abdominal-wall hernia.
Different meshes will affect various imaging techniques in different ways. Some versions may be invisible on certain devices while others will always show up in any kind of imaging. Still others may fall anywhere between those extremes. The FDA recommends patients ask their surgeon how their particular mesh will interact with imaging devices.
Studies Show Advantages and Disadvantages
Recent studies have found problems with mesh design leading to adhesions and other serious complications, as well as significant rates of infection among patients who have had hernias repaired using mesh.
2016 study findings
31% of hernia repair patients experienced infections and nearly 10% required medical intervention.
A 2016 study published in the journal Hernia looked at the long-term rate of MRSA infection among 632 hernia repair patients. MRSA is an antibiotic-resistant strain of staph infection. Researchers found 31 percent of patients experienced surgical-site infections within two years of surgery and 9.8 percent required medical intervention.
A 2015 study published in the journal of the American College of Surgeons looked at 768 hernia mesh patients. Overall, 10 percent of the patients developed a hernia mesh infection within 30 days of surgery. Seven percent of those in the study tested positive for an MSRA infection somewhere other than the surgical site prior to their surgery, but of that group, 33 percent suffered a hernia mesh infection.
According to a 2014 study published in the Journal of the American Medical Association, using mesh led to a “small reduction” in the chance of ventral hernia recurrence compared to just stitching the torn tissue closed. But mesh also led to an increased risk of seroma and surgical site infection (SSI).
An October 2013 study in the Indian Journal of Surgery found “no statistically significant difference” between newer composite meshes and more traditional polypropylene meshes when it came to “adhesions, infection, intestinal fistulization, sinus formation, seroma and recurrence.”
In August 2012, researchers writing in the journal Surgical Infections said polypropylene surgical mesh for hernia repair was “unsuitable for intra-abdominal placement because of its tendency to induce bowel adhesions.”
Studies that have Examined C-QUR Coated Hernia Mesh
Atrium Medical’s C-QUR product line of hernia mesh utilizes a unique coating derived from fish oil. The bioabsorbable film is meant to keep mesh from touching internal organs and prevent mesh adhesions. In its marketing materials, Atrium claims the Omega 3 fatty acid (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.
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.
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.
|Manufacturer & Dates/Units||Product||Reason|
Aug. 9, 2013 (145,251 units recalled)
|C-QUR Edge Mesh C-QUR TacShield C-QUR V-Patch Mesh C-QUR Mesh (all sizes)||Recalled for improper packaging|
Dec. 22, 2005 Expanded on Jan. 5 and Mar. 24, 2006 (31,761 units)
|Bard Composix Kugel Mesh X-Large Patch Oval (various sizes) Bard Composix Kugel Large Oval, 5.4” x 7” Bard Composix Kugel Oval, 6.3” x 12.3” Bard Composix Kugel Large Circle, 4.5”||Recalled for potential for ring to break leading to bowel perforation and/or chronic enteric fistula|
Jan. 10, 2007(16,603 units)
|Bard Composix Kugel Hernia Patch Large Oval with EPTFE, 5.4” x 7” Bard Composix Kugel Hernia Patch Large Circle with EPTFE, 4.5”||Recalled for potential for ring to break leading to bowel perforation and/or chronic enteric fistula|
Dec. 21, 2005 (18,000 units) Oct. 18, 2010 (87 units from one lot)
|Proceed Surgical Mesh||Potential to lose laminate coating, exposing mesh to bowels and allowing a possibility of adhesions and bowel fistulization.|
Feb. 19, 2014 (223 units from specific lots)
|Proceed Surgical Mesh||Packaging defect believed to allow delamination allowing potential for adhesions.|
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. That process only requires the manufacturer to show the new device is substantially similar to a device previously on the market. C-QUR meshes are intended to be permanent implants.
What is C-QUR Made of?
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 units of C-QUR V Patch, TacShield, Edge and standard C-QUR Meshes 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.
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 Laparoscopic Hernia Kits. Though the company does not consider this a recall, it withdrew these products from the market.
“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.”
- According to Ethicon
Ethicon issued recalls of Proceed in 2005, 2010 and 2014. According to the recall announcements in each recall, issues could lead to delamination posing an adhesion risk.
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, resulting in bowel obstructions, punctures and other complications.
The FDA announced a Class I recall of eight different Composix Kugel patches in 2006 and 2007. A Class I recall means the defect associated with the use of the Kugel mesh patch could likely cause serious health consequences, including death.
According to documents on the FDA website, there’s a potential for the memory recoil ring to break and the devices could possibly lead to fistulas (abnormal connections between organs) and bowel perforation.
The first recall was issued on Dec. 22, 2005, to all international Kugel patch clients. The same recall letter was delivered to U.S. customers on Dec. 27, 2005. On Jan. 5, 2006, an updated letter was issued. Davol issued a third letter on March 24, 2006, expanding the recall.
Davol issued a second wave of recalls on the Kugel patches in early 2007, extending the recall to include two more models presenting the same risk of a ring break. Customers were notified by letter on Jan. 10, 2007. According to the letter, there had been six reports of ring breaks between 2004 and 2005 — four of which caused complications. These reports include one incidence of ring migration, one incidence of abdominal pain and two incidents of bowel perforation. In the other two cases, the surgeon noted the ring was broken but did not implant it into the patient.
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.