Serious injuries suffered from failing hernia mesh implants

Thousands of hernia mesh lawsuits are ongoing under several multidistrict litigations against manufacturers by plaintiffs who claim to have experienced health complications after surgical implantation.

These lawsuits allege that material flaws, manufacturing defects, improper labelling, or medical malpractice led to product failures, requiring revision surgery to correct the resulting injuries. Plaintiffs are seeking compensation to cover damages such as medical bills, lost wages, and compromised quality of life.

A hernia occurs when fatty tissue, an organ, or part of an organ protrudes through the muscle or connective tissue that normally contains it, often as a result of pressure forcing the affected area through a hole or a weak spot. Hernias typically require surgical repair, with the most common corrective measure being hernia mesh, a medical device that supports the point of injury as it heals. In the event of a failure, a patient may experience symptoms such as pain, infection, adhesion of the mesh to other tissues, and bowel obstruction.

Hernia Mesh Lawsuit Updates

• Significant Progress in Bard Hernia Mesh Litigation: Confirmation of Upcoming Stinson Bellwether Trial (8/23/2023)

Is there a hernia mesh lawsuit?

Yes, as of Sept. 15, 2022, more than 24,500 hernia mesh lawsuits were underway against the manufacturers Ethicon, Davol Inc./C.R. Bard, and Atrium Medical Corp. These lawsuits have been consolidated into three primary multidistrict litigations in the states of Georgia, Ohio, and New Hampshire, respectively. Aside from these, hundreds of other lawsuits are pending in state Courts across the country.

The lawsuits generally center on injuries that arose as a result of hernia mesh implantation. To be safe for placement within the body, hernia mesh must be biologically inert, meaning it does not interact or initiate a response with bodily tissue. Otherwise, the mesh could potentially trigger an immune reaction in which the body attacks the hernia mesh implant as a foreign object, leading to complications like rejection, infection, adhesion, bowel perforation, bowel obstruction, bleeding, chronic pain, and hernia recurrence. The mesh may also be capable of shrinking or migrating. Serious complications often require the removal of the hernia mesh.

The plaintiffs in these cases have reported injuries and other complications that were so severe they needed at least one additional surgery to fix their problems. Some required more, and many of them claim their complications continued after revision surgery.

The earliest of the pending hernia mesh lawsuits was against Ethicon, a subsidiary of Johnson & Johnson, and pertained to the company’s Physiomesh hernia mesh product, initially approved for sale by the U.S. Food and Drug Administration (FDA) in 2010. In 2016, evidence of defects and patient complications prompted Ethicon to issue a voluntary recall of the product. By June 2017, a large number of lawsuits against the company became consolidated into a multidistrict litigation. Bellwether trials set to take place in March, June, and September of 2021 were all canceled. In September 2021, Ethicon opted for a confidential settlement.

The Davol/Bard lawsuits became consolidated into a multidistrict litigation in 2017. With over 18,000 cases, it is the largest of the three major hernia mesh multidistrict litigations. These lawsuits concern the company’s polypropylene hernia mesh products. Polypropylene, a type of plastic that is not biologically inert, is capable of shrinking and degrading, which may cause pain and foster bacterial activity. In light of the design flaws, the plaintiffs allege the company failed to adequately test the mesh products before releasing them to market.

The first Davol/Bard bellwether trial, Johns v. C.R. Bard Inc., took place in August 2021 and resulted in a win for the manufacturer. The second bellwether trial, in April 2022, was a win for the plaintiff, Antonio Milanesi, who alleged the defective Bard hernia mesh product resulted in an infection and bowel abscess that required additional surgery. Milanesi won a $255,000 verdict. A third bellwether trial, Stinson v. C.R. Bard et al., was originally set to begin in May 2023 but has been postponed to Oct. 16 of the same year.

The Atrium lawsuits constitute the smallest of the multidistrict litigations, with a little over 3,300 cases as of March 2023. The first bellwether trial, Barron v. Atrium Medical Corporation et al., involved a middle-aged woman with an Atrium C-Qur mesh device that later degraded, supposedly leading to an infection and hernia recurrence. The trial was originally set for July 7, 2021, but Atrium, by then, had agreed to a confidential global settlement, so the trial did not take place.

Aside from the three major multidistrict litigations, some of the cases filed in state Courts have reached trial, the most notable of which resulted in a plaintiff verdict of $4.8 million in August 2022. The plaintiff’s lawsuit alleged one of Bard’s hernia patches had eroded because of its defective design.

Hernia mesh malfunctions linked to complications

Within the last 10 years, several studies have called into question the safety of hernia mesh implants. Across these studies, the most common complications associated with hernia mesh are infections, seromas (localized fluid accumulation), bowel obstructions, bowel perforations, adhesion, nonhealing wounds, and pain.

A subset of those who experience complications from hernia mesh implantation may be predisposed to a systemic inflammatory response. Aside from individual variability, the size and load of the implanted mesh may contribute to the severity of systemic reactions.

The FDA recognizes that the above symptoms may result from mesh implantation but also states that complications have been due to mesh products that have been recalled and are no longer available on the market. However, some researchers feel that it may be necessary to assess the long-term safety of a product such as hernia mesh before speaking conclusively about the benefits it may offer.

2014 JAMA Surgery review and meta-analysis

In a 2014 systematic review and meta-analysis published in JAMA Surgery, researchers examined randomized controlled trials, case-control studies, and cohort studies to compare suture-based ventral hernia repairs with mesh-based repairs, specifically with an eye on outcomes relating to hernia recurrence, surgical site infections (SSIs), and seromas.

Pulling their sources from research platforms and reference lists, the researchers looked at literature published in a 32-year span, from 1980 to 2012. After an independent review of 1,492 articles, the researchers selected nine for analysis. Across all of their research, they pooled data pertaining to 1,145 suture repairs and 637 mesh repairs.

Though the purpose of the research was to evaluate the efficacy of suture repair versus mesh repair, its conclusions appear to suggest a potential relationship between hernia mesh and postoperative complications, with the researchers stating that “mesh use resulted in an increased risk of seroma formation and SSIs compared with suture repair.” A statistical breakdown of occurrences revealed that, of the 637 mesh repairs analyzed, 7.3% would lead to infections and 7.7% would lead to seromas, both of which the researchers describe as “important outcomes associated with significant morbidity and cost.”

2016 JAMA investigation

In 2016, Danish researchers from Zealand University Hospital, Hvidovre Hospital, and the Danish Hernia Database published a cohort study in JAMA that investigated the long-term consequences in patients who had undergone incisional hernia repair. In their study, the researchers note that hernia mesh is used frequently to repair hernias yet the “long-term risks of mesh-related complications” remain unknown. They also state that surgeons use mesh in “at least half of the abdominal wall hernia repairs performed in the United States” because it is “believed to reduce the risk of hernia recurrence.”

The researchers began their study by collecting data on all elective incisional hernia repairs performed in Denmark from Jan. 1, 2007, to Dec. 31, 2010, resulting in a data set amounting to 3,242 patients. Next came a follow-up period in which the researchers both merged data with prospective registrations from the Danish National Patient Registry and performed a retrospective manual review of patient records. The follow-up period lasted until the point of repeat operation for recurrence, mesh removal, emigration, or death or the completion of the study period on Nov. 1, 2014. Ultimately, they obtained a 100% follow-up rate.

The study concludes that while mesh-based repair indicates a lower risk of repeat operation for recurrence over a five-year span, the relative benefits of mesh are “offset in part by mesh-related complications” such as infections, seromas, nonhealing wounds, bowel obstructions or perforations, bleeding, and severe abdominal pain. Specifically, the researchers found that the risk of mesh-related complications “increased continuously with time,” with 1,050 patients undergoing subsequent abdominal surgery, 142 requiring additional operations for complications, and 46 having their mesh removed because of serious complications.

In the discussion segment of the paper, the researchers state that their study highlights the need to evaluate the long-term safety of interventions such as hernia mesh before making conclusions about their benefits. They point out, too, that hernia mesh is in a class of medical devices that are not subject to the same strict safety documentation as medications and that clinical trial data about hernia mesh outcomes is relatively sparse, leading to gaps in knowledge about the product’s risks.

2023 Journal of Abdominal Wall Surgery research

In a 2023 paper published in the Journal of Abdominal Wall Surgery, members of key California medical centers and academic institutions present original research concerning systemic reactions to hernia mesh implants. The authors note they have noticed an increase in the number of patients who have required mesh removal, and their paper focuses on a “unique but rising incidence” of a type of inflammatory response to implant material known as autoimmune/inflammatory syndrome induced by adjuvants (ASIA). They use the term “mesh implant illness” in relation to those whose ASIA stems from hernia mesh.

The authors extracted medical records from a hernia database to identify patients who underwent post-repair hernia mesh implant removal between August 2013 and June 2020, amounting to a total of 847 subjects. As part of their research, they attempted to rule out other causes of illness and followed up with patients in person and by phone.

The authors found that in the seven-year span pertinent to their study, 23% of the operations, or 191 patients, later required implant removal. Of those instances, 28 underwent mesh removal because of probable mesh implant illness, while 137 were experiencing pain, nerve pain, infection, hernia recurrence, and/or mesh shrinkage.

Discussing their findings, the authors mention that others have attributed systemic mesh-related reactions to foreign-body reactions, responses to implant absorption or degradation, or individual variability. However, they note that implant size or load may also contribute to individuals’ reactions.

FDA notice on hernia surgical mesh implants

The FDA has noted reports of “many complications” in patients who have undergone hernia repair with hernia mesh. The most common adverse events have been pain, infection, adhesion, bowel obstruction, bowel perforation, and hernia recurrence. Mesh migration and mesh shrinkage are other potential complications that may arise.

The FDA states that many of the complications related to hernia mesh are associated with mesh products that have been recalled and are no longer available on the market. Based on reports the agency has received, it has concluded that recalled mesh products were the “main cause of bowel perforation and obstruction complications.”

Projected hernia mesh lawsuit amounts

Because thousands of hernia mesh lawsuits remain ongoing, an exact estimate of settlement amounts is not available. However, legal experts have put forward projections, with plaintiffs on the low end receiving anywhere from $65,000 to $80,000 and plaintiffs on the high end getting as much as $1 million.

These projected amounts may be based on developments in the Atrium C-Qur mesh litigation from 2021 and the second bellwether trial against Bard in 2022. In the former, Atrium agreed to a settlement before the first bellwether trial could take place. The settlement amount was confidential, but a December 2021 announcement by Atrium’s parent company revealed it had set aside $66 million to put toward the litigation.

In the latter, the plaintiff, Antonio Milanesi, who had undergone a hernia repair with Bard’s Ventralex mesh in 2007 and later developed an infection and bowel abscess, received a settlement of $255,000. That being said, the amount awarded to Mr. Milanesi represents a single case, and Bard has yet to offer a global settlement.

Outside of the multidistrict litigations, other cases, too, have resulted in confidential settlements. However, in August 2022, a notable case against Bard in Rhode Island resulted in a $4.8 million award to the plaintiff, Paul Trevino, who had had Bard’s Ventralex mesh product implanted in 2008 and later experienced pain, infection, bowel obstruction, and nerve damage after the mesh eroded into his bowel.

Do you qualify for a hernia mesh lawsuit?

You may qualify for a hernia mesh lawsuit if:

• You have undergone hernia repair surgery with hernia mesh.
• You experienced serious complications stemming from hernia mesh implantation, such as infection, adhesion, bowel perforation or blockage, or mesh migration.

Your eligibility for a hernia mesh lawsuit may depend on the law firm with which you work as well as your specific complaints. Meeting the following conditions may indicate greater eligibility:

• Your hernia mesh implant was manufactured by Atrium, Bard Davol, or Ethicon.
• Your injuries arose more than 30 days from the date of the original surgery.
• You scheduled, underwent, or were advised by a surgeon to undergo additional surgery as a result of health complications stemming from your original surgery, even if medical issues prohibit you from pursuing said surgery.

Manufacturers and brands involved in the lawsuit

The table below outlines the manufacturers involved in the numerous multidistrict litigations and other lawsuits across the country as well as the models of hernia mesh products alleged to have caused damages:

Hernia Mesh Lawsuit Timeline

April 18, 2022: 

• Federal jury orders Bard and Davol to pay $255K in a hernia mesh lawsuit. 

June 7, 2022: 

• Covidien hernia mesh lawsuits sent to U.S. Court in Massachusetts. 

July 15, 2022: 

• FDA releases a guide on the benefits and risks of hernia mesh. 

August 17, 2022: 

• Appointment of a settlement master by Judge Sargus in the Bard hernia mesh lawsuit. 

October 1, 2022: 

• A trial in the Bard hernia mesh MDL scheduled for February 21, 2023. 

December 14, 2022: 

• Postponement of the third bellwether Bard hernia mesh trial to May 2023. 

March 2023: 

• Multiple updates on the status and scheduling of the Bard hernia mesh lawsuits. 

April 2023: 

• Judge approves a standard Plaintiff Fact Sheet for bellwether trials against Covidien’s hernia mesh products. 
• Speculations about a settlement in the Bard hernia mesh lawsuit. 

May 18, 2023: 

• Preparation for the bellwether trial Stinson v. Bard. 

June 2023: 

• Significant progress in the Covidien hernia mesh lawsuit, including “Science Day” and case management conferences. 

September 18, 2023: 

• Appointment of Robert King to the Plaintiff’s Leadership Committee in the Covidien Hernia Mesh lawsuit. 

October 4, 2023: 

• Anticipation of the third Bard hernia mesh lawsuit trial. 

October 17, 2023: 

• Start of the pivotal Bard Hernia Mesh Trial (Stinson v. CR Bard). 

November 2023: 

• Jury reaches a verdict in the Bard Hernia Mesh Trial, with mixed outcomes on various claims and a $500,000 award to the plaintiff.