People who received hernia mesh implants in a hernia repair surgery may have been placed at risk for serious injury. Thousands of surgical hernia mesh lawsuits have been filed against manufacturers like Ethicon, Atrium Medical and Davol/C.R. Bard for serious injuries caused by their surgical mesh products.
About Surgical Hernia Mesh
Surgical hernia mesh is a mesh-type of medical device implanted surgically to stabilize tissues during an abdominal hernia repair surgery. Over 800,000 hernia surgeries are performed in the U.S. each year and about 90% of these are done with a surgical mesh product. Though the products were intended to decrease the chance for hernia recurrence, thousands of people may have been placed at a higher risk of complications.
Thousands of lawsuits have been filed against hernia mesh manufacturers like Atrium Medical (C-QUR), Ethicon/Johnson & Johnson (Physiomesh), and Davol-C.R. Bard (Composix) for injuries caused by their hernia mesh products. Though some of these lawsuits may have been settled, over 20,000 surgical hernia mesh lawsuits remain in federal and state courts.
What is Surgical Hernia Mesh?
Hernia mesh is similar to other types of surgical mesh, including transvaginal mesh and bladder sling products. It is an implantable mesh, constructed out of polypropylene which is a type of plastic polymer. Polypropylene mesh was intended to minimize tissue reduction and increase the chance for a stable hernia repair, but it may be prone to degradation, resulting in serious side effects.
Hernia mesh may cause serious side effects including:
- Severe pain
- Intestinal obstruction
- Tissue adhesion
- Mesh migration
- Mesh erosion
- Mesh shrinkage
- Organ perforation
- Hernia re-emergence
When complications of hernia mesh implantation are severe, and when hernia re-emergence has occurred, the patient may require additional surgery or surgeries to remove, repair and replace a defective mesh device. Each additional surgery will increase the risk for pain, infection, and further complications.
Manufacturers of Surgical Hernia Mesh Products
Of the nearly 800,000 hernia repair procedures performed annually in the U.S., until recently, about 90% have been done using a surgical mesh device. The majority of these devices are manufactured by one of three companies, C.R. Bard’s Davol unit, Johnson & Johnson subsidiary, Ethicon and Atrium Medical.
Many hernia mesh devices were approved under the FDA 510(k) process which is a ‘fast-track’ approval process which allows manufacturers to avoid costly clinical trials. Manufacturers can begin marketing a product without testing it in humans by claiming that it is “substantially similar” to products already in use. This may result in high numbers of complications due to failure of the devices.
Current and past manufacturers and products include:
|Manufacturer||Hernia Mesh Product|
|Covidien / Medtronic||
Some of these products have been recalled or discontinued, largely due to injuries and complications that may have been caused by the devices.
Hernia Mesh Recall
Though thousands of patients have suffered severe side effects and complications from hernia mesh, few recalls have been issued by the Food and Drug Administration or the manufacturers. Most products remain on the market.
Recalls have included:
- A 2006 Class I recall was issued due to threat of severe injury that could be caused by the Composix Kugel Patch, manufactured by C.R. Bard. Other Bard products are still on the market.
- In 2013, Atrium recalled a number of products due to packaging issues including the C-QUR V Patch, C-QUR meshes, and TacShield Edge. These packaging errors were reportedly caused by high humidity at the plant which could cause the mesh to stick to packaging.
- In 2015, manufacturing of Atrium Medical’s C-QUR mesh was temporarily halted after the FDA had issued numerous warning letters, in 2009, 2010 and 2013, regarding sterility and defects of the product. Despite these concerns, manufacturing was resumed and the C-QUR line remains on the market.
- In 2016, Johnson & Johnson subsidiary, Ethicon issued a safety alert and voluntarily withdrew its Physiomesh Flexible Composite Mesh line of products from the market. This was after studies showed the devices had a higher-than-expected rate of required revision surgeries and thousands of serious adverse event reports had been filed with the FDA. Other Ethicon mesh products are still being marketed.
“In one case, the patient reported that a surgeon had to remove previously healthy tissue, including previously healthy muscle tissue, because of the damage done by the C-QUR mesh, with the patient subsequently developing a life-threatening infection requiring prolonged hospitalization.”
Hernia Mesh Revision Surgery and Complications
Over the last several decades, hernia mesh has been used in about 90 percent of hundreds of thousands of hernia repair surgeries performed every year. While most surgeries are successful, many patients have experienced serious side effects and complications which may result in hospitalization, disability, revision surgery or may be life-threatening.
Recent evidence shows that hernia repair surgery may be just as successful without hernia mesh implantation. Because of high rates of complications, several products have been discontinued and many experts are now recommending that surgical hernia mesh be used only when medically necessary.
Severe hernia mesh side effects may include:
- Intense pain
- Intestinal blockage
- Mesh migration
- Mesh shrinkage
- Organ erosion
- Hernia recurrence
In most cases, serious side effects that occur due to hernia mesh complications will require additional surgery to remove the mesh, repair the original hernia and reconstruct damaged tissue. In some cases, multiple surgeries will be required, exposing the patient to additional risk with each successive surgery.
Status of Hernia Mesh Lawsuits
Over 20,000 lawsuits are still pending in federal and state courts against Atrium Medical, Ethicon/Johnson & Johnson and Davol/Bard for injuries caused by their hernia mesh products. A number of these cases which were set for bellwether trials had been delayed due to the COVID-19 pandemic. Bellwether trials were restarted in August 2021 with a Bard-Davol Hernia Mesh Lawsuit.
Atrium Medical – Over 2,900 federal lawsuits have been consolidated into multidistrict litigation (MDL 2753) in the U.S. District Court for the District of New Hampshire. Atrium may also be facing lawsuits in numerous state courts and may expect more federal cases as well. The federal MDL was set to begin February 2020 but was delayed due to COVID-19 until July 2021. This first bellwether case was reportedly settled out-of-court, and a second trialhas yet to be announced. An estimated 2,900 cases are still pending, and a settlement mediator has been appointed.
Ethicon and Johnson & Johnson – Over 3,500 federal lawsuits have been consolidated into multidistrict litigation (MDL 2782) in U.S. District Court for the Northern District of Georgia for injuries caused by Physiomesh Flexible Composite Mesh. Federal hernia mesh lawsuit trials were set to begin in September 2019, were rescheduled for March, June and September 2021, but were ultimately cancelled after a global settlement agreement was reached.
Davol and C.R. Bard – About 2,600 class-action lawsuits were settled for Bard’s Composix Kugel mesh and transvaginal mesh in 2011 and another 6,000 were settled in 2014. About 18,000 remaining Composix E/X and Composix LIP surgical hernia mesh lawsuits have been consolidated in case MDL 2846 in the U.S. District Court for the Southern District of Ohio. The company is also facing hundreds of hernia mesh lawsuit cases in state courts and may expect lawsuits for additional brand names of surgical mesh.
The first federal MDL bellwether case was set for trial in May 2020 but was delayed a number of times due to COVID. It finally went to trial in August 2021 and resulted in a defense verdict. A second bellwether trial was held in March 2022 and resulted in a $250,000 verdict in favor of the plaintiff. Both parties have objected to the results and a number of new cases have been filed, some of which may be consolidated into a separate MDL. Though no additional trials have occurred, a settlement mediator has been appointed.
Filing a Hernia Mesh Lawsuit
People or loved ones of those who suffered serious side effects or of surgical hernia mesh implantation may be eligible for compensation for their medical costs, future costs, lost wages and pain and suffering.
Patients or loved ones of those who were diagnosed with one or more of the following after receiving a surgical hernia mesh implant may be eligible for compensation.
- Hernia recurrence
- Mesh erosion, migration, or shrinkage
- Organ perforation
- Bowel obstruction or intestinal paralysis
- Severe or chronic pain
- Pelvic Inflammatory Disease or Sepsis
- Have required or been recommended to have hernia mesh removal and repair
Each case of hernia mesh injury is unique and must be evaluated separately.