Hernia mesh is a surgical product used to stabilize tissue during a hernia repair surgery and is used in about 90% of hernia repairs. It is also a common cause of serious complications that may occur after a hernia repair surgery and in some cases, may increase the risk of hernia recurrence and life-threatening events.
Manufacturers including C.R. Bard, Atrium Medical, and Ethicon/Johnson & Johnson have faced thousands of hernia mesh lawsuits filed by people who were injured or suffered complications due to the use of hernia mesh.
The FDA has addressed a high rate of serious side effects that have been linked to the use of surgical hernia mesh. The FDA has also noted that in an analysis of serious medical events reported to the agency, bowel perforation and obstruction were most commonly caused by recalled surgical mesh products.
What Is Hernia Mesh?
Hernia mesh is a medical device that is used in surgeries to repair hernias. The mesh is implanted into the wall of the organ over the hernia to strengthen the damaged tissue. Hernia mesh is typically made out of either animal or synthetic material.
Hernia mesh can be either absorbable or non-absorbable. Absorbable hernia mesh will, over time, degrade and lose strength, eventually getting absorbed into the body. This type of hernia mesh is designed to provide only temporary support to an organ wall. The tissue itself will provide the necessary support as it grows back over time. Non-absorbable hernia mesh is meant to be permanent and will not degrade.
Who Makes Hernia Mesh?
Surgical mesh was intended to reduce complications and increase the success rate for hernia repair surgeries. Synthetic surgical mesh was first introduced over five decades ago but did not see widespread use until the late 1980s and 90s. By 2000, numerous reports of serious complications began to emerge, but the use of surgical mesh has continued to grow. Today, about 90% of all hernia repair procedures are done using a surgical mesh implant.
Notable hernia mesh products that have caused severe side effects or complications include:
|Manufacturer||Hernia Mesh Product|
|Atrium||Prolite Polypropylene MeshC-QURC-QUR MosaicC-QUR TacShieldC-QUR EdgeC-QUR Lite Mesh V-PatchC-QUR Mesh V-Patch|
|Bard||3D Max MeshBard (Marlex) Mesh DartComposix L/PComposix E/XKugel Hernia PatchModified Kugel Hernia PatchSepramesh IPSeprma-TexVisilex3D Light MeshAlloMax Surgical GraftBard MeshBard Mesh PreShapedDulex MeshPerFix Light PlugPerFix PlugVentralightVentralex Hernia PatchVentralex ST PatchVentralight ST PatchVentrio STVentrio PatchComposixComposix Kugel Hernia PatchMarlex|
|Ethicon||PROLENE 3D Patch Polypropylene MeshPROLENE Polypropylene Hernia SystemULTRAPRO COMFORT PLUGULTRAPRO Hernia SystemPROLENE Soft Polypropylene MeshPhysiomesh Flexible Composite MeshULTRAPRO PlugPROLENE Polypropylene MeshULTRAPRO Partially AbsorbableLightweight MeshPROCEED Surgical MeshPROCEED Ventral Patch|
|Covidien||Parietex Composite Dual Facing Mesh|
|Gore-Tex||Gore-TexGore Bio-A Hernia PlugGore Dualmesh BiomaterialGore Dualmesh Plus Biomaterial|
|Medtronic||Duatene Bilayer MeshParietene DS Composite MeshVersatex Monofilament MeshSymbotex Composite MeshParietex Flat Sheet MeshParietex Plug and Patch SystemParietex Lightweight Monofilament Mesh|
What Is a Hernia?
A hernia is when either fatty tissue or an organ pushes through a weakened spot in the fascia (connective tissue) or a muscle nearby. A hernia can sometimes be seen externally as a bulge, especially when the patient is bearing down or straining.
What Kinds of Hernia Are There?
The most common hernia types include:
- Hiatal (inside the abdomen, near the upper abdomen or diaphragm)
- Femoral (upper thigh, groin)
- Incisional (through a scar or incision in the abdomen)
- Inguinal (inner groin)
- Umbilical (at the belly button)
- Ventral (abdominal/ventral wall)
By far the most common type of hernia is the inguinal hernia, which makes up 96% of all hernias. It’s also more common in men. Incisional hernias are more common in the elderly or in people who are overweight and occur mostly following inactivity post-surgery. The most common type of hernia in women is a femoral hernia, especially in women who are obese or pregnant. Umbilical hernias most commonly affect women who are either obese or who have had a lot of children.
What Causes Hernias?
No matter where they’re located, all hernias have the same basic cause: a weakness in the fascia or muscle and pressure of some kind pushing the organ through that hole or weak spot. It’s possible for that muscle or fascia weakness to be present from birth, but it can also develop later in life as well.
Although anything that can cause pressure in the abdomen (or anywhere else hernias can form) can result in a hernia, the most common causes include:
- Lifting heavy objects (without first stabilizing the abdomen)
- Persistent coughing
- Persistent sneezing
People who are obese, who smoke, or who have poor nutrition are also at greater risk for developing a hernia because these things can weaken the muscles.
What Are the Symptoms of a Hernia?
The symptoms of a hernia depend on the type of hernia and where it’s located. Smaller hernias may not actually produce any symptoms. In more severe hernias, there can be pain and discomfort in the area the hernia is in. In Hiatal hernias, which are in the upper abdomen, patients may experience heartburn. There also may be a bulge visible externally that can indicate a hernia is present. There may also be swelling in the area of the hernia.
What Are the Symptoms of a Hiatal Hernia?
The symptoms of a hiatal hernia can include:
- Chest pain
- Abdominal pain
- Food or liquid regurgitated into the mouth
- Trouble swallowing
- Vomiting blood
- Bloody stools
- Shortness of breath
What Are the Symptoms of an Inguinal Hernia?
The symptoms of an inguinal hernia can include:
- Groin pain or discomfort
- Groin weakness or pressure
- A bulge on either side of the pubic bone
- Burning or aching at that bulge
- A heavy or dragging feeling in the groin
- Pain and/or swelling around the groin
What Are the Symptoms of an Umbilical Hernia?
The symptoms of an umbilical hernia in an infant can include:
- Tenderness, discoloration, or swelling at the hernia site
In an adult, the symptoms of an umbilical hernia can include:
- Bulge near the navel
What Are the Treatment Options for a Hernia?
When it comes to treating hernias, there are two options: surgical and non-surgical. Surgery is the only way to actually repair the hernia, but if a hernia isn’t causing a patient problems, the doctor may recommend the non-surgical route. Non-surgical treatment for a hernia typically involves the doctor keeping an eye on the hernia to ensure it doesn’t get any bigger or any worse. This option is typically only available when no symptoms are present.
There are two types of surgery available to repair hernias:
- Open repair
Both types of surgery can be done either with or without the use of hernia mesh. In laparoscopic surgery, the surgeon makes several small incisions near the hernia instead of a single larger incision as in an open repair surgery. Because hernias often recur, it’s common to use hernia mesh to strengthen the site of the repair.
What Are the Complications of Hernia Mesh?
In April of 2016, the U.S. Food and Drug Administration addressed the high rate of serious side effects which occur with hernia mesh, stating: Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh.
The most common adverse side-effects of hernia mesh include:
- Severe or chronic pain
- Bowel blockage
- Tissue fusion
- Mesh migration
- Organ perforation
- Mesh shrinkage
- Hernia recurrence
The FDA has also noted that in an analysis of serious medical events reported to the agency, bowel perforation and obstruction were most commonly caused by recalled surgical mesh products. In many cases, adverse events or complications have required additional surgeries to remove the defective device, repair the original hernia and repair or reconstruct damaged tissues. Additional surgeries place the patient at added risk and may require lengthy recovery periods.
Has Hernia Mesh Been Recalled?
Despite thousands of serious adverse event reports, only a few hernia mesh products have been removed from the market. A class I recall was issued by the FDA for the Composix Kugel Patch manufactured by C.R. Bard in 2006 but the majority of Bard’s products remain on the market.
In May of 2016, after thousands of reports of serious injury had been received by the FDA and a clinical study showed a higher than normal rate of revision surgeries, an emergency safety alert was issued by Johnson & Johnson’s Ethicon division which withdrew its Physiomesh Flexible Composite Mesh products from the market, but other Ethicon hernia mesh products are still available.
Atrium C-QUR mesh has been the subject of numerous warning letters regarding the sterility of the products, and manufacturing defects. Manufacturing was temporarily stopped in 2015 and the C-QUR line has been named in multiple complaints and lawsuits but it has not been withdrawn from the market.
What Hernia Mesh Lawsuit Settlements Have There Been?
Manufacturers of hernia mesh devices are currently facing thousands of lawsuits for injuries caused by their use. Some trials have already taken place but many have not been settled and more may be expected.
C.R. Bard – Darol Division
C.R. Bard and its device division, Davol, have paid out hundreds of millions for a class-action lawsuit and medical injury lawsuits filed over its Composix Kugel mesh, transvaginal mesh products, and other surgical mesh. The company is currently facing more than 1800 federal lawsuits, most of which have been consolidated into multidistrict litigation (MDL). In addition to federal lawsuits, nearly 200 have also been filed in state courts. The most commonly named Bard mesh products are the Composix E/X and Composix LIP mesh but others are included as well.
As of May 2022, there were more than 16,000 pending cases against Bard. Many of these cases had been delayed due to the COVID-19 pandemic. The cases have been combined into multi-district legislation (MDL) and Bard has requested a docket control order that would limit new cases for the MDL to only those in which the plaintiff could prove via a doctor’s affidavit that their medical injuries had been caused by Bard hernia mesh.
Two Bard bellwether cases have been concluded. The first case resulted in a loss for the plaintiff, but the second case was more favorable, resulting in a settlement of $250,000. Both the plaintiffs and the defendant were disappointed with the results have appealed. Bard claimed in its appeal request that the plaintiffs hadn’t been able to prove that there was a design flaw in Bard’s hernia mesh, while the plaintiffs felt that the jury hadn’t been correctly instructed, which resulted in a lower settlement amount. Additionally, lawyers for the plaintiffs claimed that Bard was incorrect and that defects in Bard’s products had been clearly established in the trial for the second bellwether case.
The MDL is still ongoing and hasn’t yet been settled.
Ethicon and Parent Company Johnson & Johnson
Ethicon and Johnson & Johnson have faced some of the most publicized lawsuits for both transvaginal and hernia mesh. About 1,400 federal lawsuits filed due to injuries caused by Ethicon’s Physiomesh Flexible Composite Mesh have been consolidated into multidistrict litigation (MDL) in Georgia but many more may be expected, and more may be filed in state courts. The first federal trial has been set for September 2019.
An MDL case that included more than 3,000 separate cases has been settled in May of 2022. A global settlement was reached, but the numbers indicating what each plaintiff received haven’t yet been released.
Atrium Medical is facing over 500 federal lawsuits for its C-QUR surgical mesh products. These have been consolidated into multidistrict litigation (MDL) in New Hampshire, but the company may be expecting additional filings for both federal and state cases. Federal lawsuit trials are expected to begin in February of 2020.
As of May 2022, the Atrium MDL case has more than 3,600 cases pending. However, the litigation for these cases is still ongoing and hasn’t yet been settled.
Should I Consider a Hernia Mesh Lawsuit?
Hernia mesh may have been responsible for thousands of injuries, some of which are severe or life-threatening. Past medical injury cases have resulted in compensation for medical costs, lost wages, future medical costs and pain and suffering. Each case is unique and must be considered separately but some cases have resulted in settlements or awards which reach into the tens or hundreds of thousands or more.
If you or a loved one received a hernia mesh implant and were diagnosed with:
- Mesh erosion
- Hernia recurrence
- Pelvic inflammatory disease
- Organ perforation
- Bowel paralysis or obstruction
You may be eligible for compensation.
People or their loved ones who received a hernia mesh product made by C.R. Bard, Ethicon, Atrium Medical, or another company and who experienced complications due to the device, should have their case evaluated by a legal expert.
Attorneys from Seeger Weiss are part of the Executive Committee that will lead the MDL-2846 cases against C.R Bard for injuries and complications caused by Bard Hernia Mesh. Multidistrict litigation (MDL), commonly used to consolidate federal lawsuits into one U.S. district court to allow for the pooling of information and resources, is guided by a small number of experienced lawyers on the MDL executive committee.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- Center for Devices and Radiological Health. “Hernia Surgical Mesh Implants.” U.S. Food and Drug Administration, FDA
- “DAVOL, INC./C.R. BARD, INC., POLYPROPYLENE HERNIA MESH PRODUCTS LIABILITY LITIGATION.” UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION, US. Courts, (08/02/2018)
- DerSarkissian, Carol. “What Is a Hernia? Inguinal, Incisional, Umbilical, Hiatal, and Femoral Hernias.” WebMD, WebMD (20/07/2019)
- “Hiatal Hernia.” Mayo Clinic, Mayo Foundation for Medical Education and Research (15/04/2020)
- “Inguinal Hernia.” Mayo Clinic, Mayo Foundation for Medical Education and Research (26/02/2019)
- Sanders, Bob. “Hernia Mesh Litigation Mounts.” NH Business Review (06/032019)
- “Umbilical Hernia.” Mayo Clinic, Mayo Foundation for Medical Education and Research (27/05/2020)