A hernia mesh is a small type of medical implant product that is widely used in hernia repair surgeries. It is basically a mesh or net that is surgically implanted inside the body to act like a scaffold support for muscle and tissue to grow around. The mesh product must be constructed with special biologically inert materials that can safely exist inside the human body.
Unfortunately, hundreds of thousands of hernia mesh products implanted in patients over the last 10-15 years were defective and are causing serious injuries and even death. Many of the leading hernia mesh products have already been recalled by the FDA for safety reasons. People injured by these defective surgical mesh devices are now filing lawsuits against the manufacturers.
This page will explain exactly what hernia mesh devices are and how and why they are used in hernia repair surgeries. We will also look at the design and manufacturing flaws that made caused so many of these products to fail and led to FDA safety recalls, warnings, and now lawsuits. Finally, we will explain who might be entitled to file a hernia mess lawsuit and how much that claim might be worth.Hernias and Hernia Surgery
A hernia is a relatively common medical condition in which an organ inside the body punches or protrudes thru the muscle wall that normally holds it in place. Hernias almost always occur in the abdominal area. There are many different types of hernias, but the most common hernia types are inguinal, femoral, umbilical, and hiatal hernias. Of these, the inguinal hernia is the most common and it occurs when the intestine pokes through the muscle wall in the groin area.
Once a hernia occurs it will not simply go away on its own. Surgery is the only effective way to repair a hernia. Hernia repair surgery basically involves putting the protruding organ back in its correct place and then repairing muscle wall that it poked through. This surgical procedure can be done with an open incision or through the use of laparoscopic instruments.
Hernia repair surgery is one of the most common surgical procedures with over 800,000 performed in the U.S. each year. The majority of hernia repair surgeries involve the use of some type of surgical mesh / hernia mesh or patch implanted in the body.Hernia Mesh and Patch Devices
Hernia mesh products are like small meshed nets or knitted sheets that function like an artificial support structure for the surgically repaired muscle wall. As part of the surgical repair of the muscle tissue where the hernia occurred the hernia mesh or patch is implanted in or around the repaired muscle wall.
The hernia mesh or patch serves to reinforce and strengthen the repaired muscle tissue, much like structural supports in a building. As the repaired muscle tissue heals and regenerates it will grow into and around the hernia mesh. The mesh or patch helps make the repaired muscle site stronger to help prevent a reoccurrence. There are 2 different types of surgical hernia mesh or patch devices: permanent and absorbable.
Absorbable hernia mesh products are designed to be absorbed by the body so that the mesh gradually disappears after being implanted. These type of absorbable mesh or patch devices function much like dissolvable stiches. The mesh supports the muscle tissue while it regrows after surgery and then basically disappears on its own. Absorbable hernia mesh devices are generally made out of animal tissue which can be broken down inside the body. Absorbable hernia mesh and patch products are generally much safer than permanent mesh devices.
Permanent hernia mesh devices are not dissolvable. They are designed to stay inside the body forever and provide continuous support to the repaired muscle wall. The permanent hernia mesh and patch devices have been plagued by various safety problems. Some permanent hernia mesh devices have been recalled for safety reasons and thousands of lawsuits are being filed across the country by people who have been injured by defective hernia mesh devices. Below is a summary of the various defective hernia mesh and patch devices that are now involved in product liability lawsuits.Ethicon - Physiomesh
Physiomesh was one of the earliest hernia mesh products to become the subject of safety concerns and lawsuits. The Physiomesh Flexible Composite Mesh was manufactured and sold by the surgical device company Ethicon, a subsidiary of Johnson & Johnson. Ethicon's Physiomesh product was first approved for sale by the FDA in 2010. In 2016 Ethicon issued a voluntary recall of the Physiomesh product after a flood of evidence indicating that the mesh was defective and causing major problems in some patients.
The problem with Physiomesh was with the synthetic material that is was made with. The material used to make the mesh was supposed to be inert, meaning that it would not cause a reaction inside the body. Unfortunately, the Physiomesh material proved to be far from inert in many cases. In a certain percentage of cases, the patient's immune system attacked the Physiomesh as a foreign object causing inflammation the surgical site. This resulted in major complications including improper healing, the formation of scar tissue, fluid pockets (seromas), and infections.
The recall of Physiomesh was promptly followed by the filing of hundreds of new lawsuits against Ethicon / Johnson & Johnson by hernia surgery patients who were harmed by the defective mesh product. In June 2017 the Physiomesh lawsuits pending in Federal Courts were consolidated into an MDL and the initial round of bellwether trials are set to begin at the end of 2019.Atrium - C-Qur Mesh / Patch
C-Qur is the brand name of a line of surgical hernia mesh and patch products manufactured by Atrium Medical Corp. The C-Qur patch and mesh devices were permanent implants that were widely used in various types of hernia repair surgeries from 2006 to 2015. The C-Qur products were made from polypropylene with a unique outer coating called the O3FA coating which was made from fish oil derivatives.
Atrium's C-Qur line of mesh products encountered a number of safety issues from the very beginning. All of the issues with the C-Qur products related to the O3FA outer coating. For starters, the O3FA coating had a tendency to degrade and melt off when stored in higher temperatures for any period of time. This was the result of flaws in the manufacturing and packaging of the products which eventually prompted the FDA to an injunction to block Atrium from making any more C-Qur devices. Even if the O3FA coating on the C-Qur product did not degrade before use it still caused similar immune system responses and severe allergic reactions in a certain segment of patients.
The defective fish oil coating on the C-Qur mesh products caused significant injuries to individuals who underwent hernia mesh repair surgery. Soon after the FDA injunction Atrium found itself defending an oncoming wave of C-Qur hernia mesh lawsuits. The C-Qur mesh lawsuits in Federal Court are now consolidated into an MDL in the U.S. District Court for New Hampshire.LifeCell Strattice Matrix
The Strattice Reconstructive Tissue Matrix (also known as the LifeCell Strattice) is the brand name for yet another type of surgical mesh frequently used in hernia procedures. The Strattice is manufactured by LifeCell Corp., a subsidiary of Allergan, Inc. The Strattice Matrix was first released around 2010 and has been widely used since then. LifeCell’s Strattice device is primarily used in parastomal and inguinal hernia repair procedures as well as abdominal wall surgery.
The Strattice is made from a unique material derived from pig skin that is supposed to be “acellular” and compatible with human tissue. Unfortunately, however, the Strattice suffered from many of the same problems as other types of hernia mesh devices. Once inside the body, the unique material of the Strattice had a tendency to break down and tear or come apart. The problems with the Strattice were significant enough to warrant an FDA recall in 2011 which blocked the Strattice from use in stoma reinforcement procedures.How Much Are Hernia Mesh Lawsuits Worth?
There are still thousands of potential hernia mesh plaintiffs with valid claims that have not yet filed lawsuits. Any individual who had a defective hernia mesh product implanted during surgery is entitled to sue for any injuries or harm caused by that device. At this point, we are still in the early stages of the hernia mesh litigation. There are hundreds of pending cases and hundreds more will likely be filed but none of the cases have been settled or gone to trial yet. As a result, we don't know exactly how much hernia mesh claims will likely be worth. However, we can estimate the likely value of hernia mesh cases by looking at settlements and verdicts in other cases involving similar claims and injuries.
Below are summaries of recent verdicts or reported settlements in prior cases which involved similar type of product liability claims or physical injuries similar to those being claimed by hernia mesh plaintiffs.
- Zejneli v Sekons (New York 2017) $3 million: plaintiff undergoes surgery to repair bilateral inguinal hernia but defendant surgeon botches the procedure by failing to properly attach the surgical mesh device to the muscle wall. As a result of the negligent implantation of the mesh plaintiff's hernia reoccurs and he allegedly suffers permanent nerve damage from compression of the nerves when the mesh devices moves after surgery. Jury in Manhattan awards $3,037,000 in total damages.
- Watt v Tshibaka, (Maryland 2014) $2.2 million: plaintiff, a morbidly obese female in her mid-40s, is suffering from a hiatal hernia. Prior hernia surgery without mesh had been attempted unsuccessfully. Defendant surgeon performs surgery to repair a hernia and uses a permanent hernia mesh device despite knowing that mesh had a tendency to erode into the esophagus when used in obese patients. Following surgery, plaintiff experiences continuing pain and complications and eventually undergoes additional surgery at which time it is confirmed that the mesh device from the prior procedure was extruding into her esophagus. She sues defendant surgeon for negligently using the permanent hernia mesh device (instead of safety absorbable mesh) despite the risk of complications. The jury in Baltimore County awards $2.2 million.
- Thorpe v C.R. Bard Inc. (Rhode Island 2010) $1.5 million: plaintiff undergoes hernia surgery and hernia mesh device is used to strengthen the repaired muscle wall. After the surgery, a plastic ring on the mesh implant breaks off causing bowel perforations, an abscess, and intestinal fistula. He has to undergo multiple surgeries to repair his bowel. He sues the manufacturer of the defective mesh device and jury awards $1.5 million.
- O'Connell v Pomeranz (New York 2009) $500,000: plaintiff in late-50s has "mesh and plug" hernia repair surgery performed by defendant general surgeon. Surgeon allegedly fails to properly anchor the surgical hernia mesh product to the muscle tissue. Plaintiff undergoes corrective surgery to fix the problem but the surgeon again fails to properly anchor the mesh. As a result of this mistake, the plaintiff suffers major disruption of blood supply to his testicle resulting in testicular atrophy. He sues based on surgical error and jury in Long Island awards $500,000. The value of this case would probably have been higher if the plaintiff was younger and the injury to his testicle damaged his reproductive ability.
Even though hundreds of hernia mesh lawsuits have already been filed, it is not too late to file your own lawsuit for injuries related to defective hernia mesh products. If you had experienced complications following hernia repair surgery, they may be related to a defective hernia mesh device. The product liability attorneys at Miller & Zois can help determine if you have a potential claim. Call us today at 800-553-8082 or contact us online.