Hernia Mesh Lawsuit
In April 2016, the Food and Drug Administration (FDA) warned that they had received many reports of complications related to hernia repair with recalled surgical mesh products. “Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh,” they stated.
Surgeons have used surgical mesh to help repair various types of hernias for decades, but many of the devices have been the subject of repeated recalls because of design and manufacturing defects that have led to serious and painful complications.
Individuals who have suffered serious injuries because of hernia mesh products may be able to pursue legal claims against the manufacturers. Some of these claims have already resulted in large awards for plaintiffs, including a $1.5 million verdict in a 2010 C. R. Bard Kugel hernia mesh case. In 2011, Bard also agreed to pay $184 million to settle more than 3,000 hernia mesh claims.
More recently, all federally-filed Ethicon Physiomesh product lawsuits were consolidated in the Northern District of Georgia for pre-trial proceedings. Read on to learn more about your potential lawsuit compensation from our experienced defective medical device lawsuit attorneys.
What is Hernia Mesh?
A hernia is a bulge that occurs in an area of weakened or torn muscles. Over time, as the muscles become less able to support related fat, tissues, and organs, they allow those tissues and organs to push through, creating a bulge that can be felt and often seen.
Hernias are most common in the abdomen and groin. They can develop because of a congenital problem present at birth, or as a result of aging, muscle strain, abdominal surgery, obesity, and digestive problems. Smoking can also make hernias more likely.
Traditionally, to repair a hernia, a surgeon simply pushed the bulge back into place and sewed or stitched the muscles closed. Decades of research, however, showed that this type of repair was likely to lead to a recurrence of the hernia. The reason being that surgeons were using already weakened, thinned and damaged muscles around the hernia to repair the hernia, and the result was that the repair just wasn’t very strong.
It was clear that hernia repairs needed additional support if they were to last. According to a 2010 study, the concept of using a mesh product to repair hernias was introduced over 50 years ago, but it was in the late 1980s that the procedure started to gain widespread acceptance.
Mesh products are net-like patches made of sterile, woven material that surgeons use to shore up and support distended muscles and tissues. They were initially made of hard plastic, but these caused numerous complications. Today, they are made of softer, more flexible and lightweight materials that are intended to incorporate easily into the body’s muscles and tissues to help create a permanent hernia repair. Ideally, the mesh stabilizes and strengthens the area, supports organs and muscles, and acts as a scaffold for new tissue growth.
Currently, about one million mesh products are used every year worldwide. Though early studies seemed to suggest that repair with mesh was superior to repair without it, later studies have produced mixed results.
What’s Wrong with Hernia Mesh?
There is a wide range of hernia mesh products on the market, made by many different companies. Each is individually designed and manufactured to provide superior results in hernia repair procedures. Products may vary in shape, size, flexibility, and materials used, and may have unique characteristics to accommodate certain anatomical features.
Mesh may also be designed for a specific type of repair. Minimally invasive laparoscopic procedures, for example, in which surgeons use small incisions and a camera to insert the mesh, require that the mesh be flexible enough to fit through a small tube. More traditional surgical repair can accommodate thicker mesh products.
Studies around the turn of the century seemed to indicate that mesh products improved hernia repair procedures, resulting in fewer recurrences, less postoperative pain, and faster recovery. But in 2016, the scientific journal JAMA published a study that conflicted with these findings.
Researchers followed 3,242 patients who went through hernia repairs from 2007 to 2010 and compared outcomes with and without hernia mesh. Results showed that through the use of mesh was associated with a lower risk of hernia recurrence, the benefits were offset by other mesh-related complications. The risk of recurrent hernia repair was 12 percent for patients with open mesh repair and 10.6 percent for patients with laparoscopic mesh repair, compared with a higher 17.1 percent for patients with non-mesh repair.
Yet during the five years that the researchers followed up on the patients, there was an increasing number of mesh-related complications. These included bowel obstruction, bowel perforation, bleeding, and abscesses. The cumulative incidence of mesh-related complications was 5.6 for patients with open mesh repair, 3.7 percent for patients with laparoscopic mesh repair, and only 0.8 percent for non-mesh repair. Many of these complications required additional surgeries.
“Mesh implantation prevented the need for subsequent reoperation in relatively few patients,” the authors wrote, “suggesting that the benefits associated with the use of mesh are partially offset by long-term complications associated with its use.”
Problematic Hernia Mesh Products
Some hernia mesh products have been associated with a higher rate of complications than others. Some of the following mesh products have been pulled off the market because of higher than normal rates of problems, while others remain on the market, but have had similar complications reported:
- Physiomesh: Manufactured by Ethicon, this mesh was initially advertised as being superior to other meshes because of its unique 5-layer design, which was supposed to encourage incorporation into the body. Instead, it caused fluid buildup that increased the risk of infections and was also prone to migration and shrinkage. In May 2016, Ethicon released an urgent field safety notice telling doctors and hospitals to stop using the Physiomesh because recurrences and reoperation rates after laparoscopic hernia repair were higher than the average rates of comparative mesh products. Proceed, another Ethicon mesh device, was also recalled in 2005.
- C-QUR: Manufactured by Atrium Medical, a Maquet company, C-QUR hernia mesh is made from the same synthetic plastic material as that used in Physiomesh, but it has a different coating on it. The product was recalled in 2013 after reports indicated it could stick to the inner packaging liner during shipping and storage, particularly when exposed to high humidity. A total of about 32,000 products were removed from the market worldwide. Though this recall has not been connected to patient injuries, other studies have shown that C-QUR was associated with an increase in adhesions and infections. In 2015, the District Court of New Hampshire entered a permanent injunction against Atrium, preventing it from manufacturing and distributing C-QUR, but Atrium has produced other variations of the product that is still on the market.
- Kugel: Manufactured by Davol, a C. R. Bard company, Kugel mesh was initially recalled because of problems back in 2005 because it was associated with complications like pain, infection, hernia recurrence, and adhesion. The company updated the design but was recalled again in 2006 and 2007 because of breakage and bowel perforations. Thousands of lawsuits were filed nationwide, and the company has paid out millions of dollars in lawsuit settlements and verdicts. Other brands of Bard mesh linked with complications include the 3DMax, Sepramesh, and PerFix.
- Parietex: Manufactured by Covidien, a Medtronic company, Parietex is made of polyester rather than polypropylene. There were several problems with the initial product, so the company has put it through a number of revisionary designs. It is extremely lightweight, however, which has made it difficult for surgeons to place it correctly. It has unsealed edges, which can perforate the bowel and other organs, and may lead to fraying and tearing. The mesh also tends to contract and shrink. Though there has been no Parietex recall, the product is the subject of lawsuits in which patients seek to hold the company liable for serious injuries.
Types of Injuries Associated with Hernia Mesh
Patients who have been implanted with hernia mesh products and then experienced problems have reported injuries including the following:
- Seromas (fluid build-up)
- Organ puncture
- Bowel perforation
- Fistula formation
- Mesh migration or rejection
- Hernia recurrence
- Intestinal blockage
Hernia Mesh Lawsuits
Plaintiffs claim that hernia mesh manufacturers knew about the problems associated with their products, including the inflammatory properties of the materials, yet failed to provide adequate risk warnings on the labeling or in related product materials. They also claim the companies failed to adequately test the products in clinical trials before releasing them on the market.
The number of lawsuits concerning hernia mesh products continues to increase. If you or a loved one was implanted with hernia mesh and experienced serious complications, you may be eligible to file a hernia mesh lawsuit. Chaffin Luhana is now investigating these cases and invites you to call today at 1-888-316-2311.
Who is Eligible to File a Hernia Mesh Lawsuit?
If you underwent a hernia mesh repair and experienced serious complications, including but not limited to excruciating pain, mesh migration, infection, organ puncture, and bowel perforation – you may be eligible to file a lawsuit. Thousands of injured patients have already done so. And with more than 1 million people undergoing hernia repairs in the United States each year and the widespread use of hernia mesh to complete those repairs, many more hernia mesh lawsuits may be filed in the coming months and years. Many of these lawsuits are consolidated in multi-district litigation against John & Johnson/Ethicon in Georgia, and against Atrium in New Hampshire.
Do I qualify to file a hernia mesh lawsuit?
It is important to speak with hernia mesh lawyer, because your eligibility will depend on the facts of your situation. Some information that you should have handy when you speak with a lawyer is:
- The manufacturer and brand of your implanted mesh product
- Date of implant surgery
- Name and location of the hospital where surgery was performed and the doctor who performed it
- The type of complications suffered
- Dates when complications appeared and/or were diagnosed
Dates of implantation surgery and of complications are important because they affect the statute of limitations; if you do not file your claim by strict time deadlines, you could forfeit your rights entirely.
How do I file a hernia mesh lawsuit?
Because the statute of limitations clock begins to run from the time when you know, or reasonably should know, that you have suffered a mesh-related injury, it is important to speak with a skilled mesh attorney as soon as possible. Look for an attorney who has specific experience with defective medical device claims.
If your attorney determines that you are eligible to file a hernia mesh lawsuit, he or she will also determine the proper forum in which to file it. Because mesh lawsuits are being consolidated in multi-district litigation, the chances are that your lawsuit will be filed locally where you live, but may be transferred during pre-trial proceedings. This means an out-of-state court may make initial determinations on matters like discovery questions. If the case does not settle before trial, it will likely be transferred back to your local court to proceed to trial.
Receive fair compensation for hernia mesh injuries
Those who suffer serious complications due to defective surgical mesh can face mounting medical bills, painful revision surgery, lost income while injured and during recovery, and many other losses. An experienced personal injury lawyer can help determine the full scope of damages, assemble the evidence needed to persuade a jury of your losses, and advocate for full compensation.
If you or a loved one received a hernia mesh implant and suffered serious complications as a result, call Chaffin Luhana today to find out whether you may be eligible to file a claim. We are currently investigating mesh injury cases and invite you to call us for a confidential consultation.
Additional hernia mesh lawsuit resources:
- United States District Court for the Northern District of Georgia, In RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, http://www.gand.uscourts.gov/17md2782
- United States District Court District of New Hampshire, Atrium Medical Corp. C-Qur Mesh Products Liability Litigation, http://www.nhd.uscourts.gov/content/atrium-medical-corp-c-qur-mesh-products-liabilty-litigation
Huge Shout Out!
Just a Huge Shout out and Thank You to everyone involved in my case , Misty , Danielle, Franchesca and especially Patrick you were always there for me if not answering questions and calls you were reading hundreds of papers to make sure we were ready and that we were !! Thank you for working around my schedule like Sunday evenings who does that ? Well someone that cares does and takes the time to make you comfortable and extremely ready for what your going to experience along the way , it took some time and patience along the way from both of us but the outcome was a great one anyone looking for help in a any sort of legal matter please look to Chaffin Luhana Group, you won’t be disappointed you will be impressed by what they can accomplish . I didn’t chose to be in a motor vehicle accident but I did chose this Law team and I’m glad that I did.