U.S. Food and Drug Administration (FDA) to recall of some of these devices and have prompted thousands of product liability lawsuits across the U.S. Rosenfeld Injury Lawyers LLC is currently accepting cases involving clients who were injured after having hernia mesh surgery.
Since the 1980s, hernia mesh implants have been routinely used to surgically repair abdominal hernias, but medical device manufacturers have long known of their dangers. Even so, they continue to sell their products to an unsuspecting public even though they know or should know that some of the materials used in the implants have been proven unsafe in humans. The polypropylene used to manufacture many popular hernia mesh devices has been directly linked to complications including internal bleeding and the need for corrective surgery.
Are You at Risk for Medical Complications with a Hernia Mesh Product?
The failure rate for hernia mesh implants is significantly higher than was expected when these devices were first approved by the FDA. Patients often experience one or more severe side effects such as bowel obstruction, infection, chronic pain, scar tissue, and even organ damage. The FDA has directly recalled or called for the voluntary recall of some mesh devices from the market, while medical malpractice and product liability attorneys across the U.S. have filed thousands of hernia mesh lawsuits as a result of defective designs and faulty device materials.
Legal claims are currently being filed against numerous hernia mesh device makers for their failure to warn patients and doctors of the health risks associated with defective hernia mesh implants. Anyone who suffered an injury after a hernia was repaired using an abdominal mesh patch might be at risk of additional harm.
If you developed a severe internal injury or your loved one died of complications from a hernia mesh patch, call Rosenfeld Injury Lawyers (888-424-5757) now to discuss your legal options. You might be entitled to receive significant financial compensation. Our legal team has helped many clients win the financial recovery they deserve. It is critical to take legal action before your state statute of limitations expires.
This article will address the following questions:
- What is hernia mesh?
- What are the treatment options for hernia patients?
- What type of mesh is best?
- What are the possible complications with hernia mesh?
- Who manufactures hernia mesh patches?
- Which devices have been the subject of recalls and FDA actions?
- Why is it necessary to file a lawsuit?
- What financial payouts have resulted from hernia mesh lawsuits?
- What is my case worth?
- How do I take the first step?
What is Hernia Mesh?
The use of abdominal mesh material for repairing hernias became popular in the 1980s. Hernia mesh is a prosthetic material used to repair muscle tears in the abdominal wall that have usually taken many years to develop as a result of muscle strain, injury or aging. During the initial stages of a muscle tear, the rip can be minuscule. However, with prolonged weakening of the abdominal wall, the tear becomes significantly bigger, causing the muscle to no longer be able to support the body’s internal organs, especially the intestines. When the stomach, intestines, or other organ protrudes through the wall of muscle that contains it, the result is the common condition known as a hernia.
For decades, surgeons simply sewed the torn area back together; however, the abdominal wall would continue to weaken and the simple repair gave way to a larger rip in the same location. This recurrence of a torn abdominal muscle and peritoneum (lining of the abdominal wall) could cause a small hernia with an intestinal bulge to develop into a large hernia where loops of intestine are pushed through the muscle. In some severe cases, the intestines would become pinched in the muscle wall (strangulated hernia).
Over time, surgeons realized they needed better options to stabilize a weakening muscle and minimize hernia recurrence. This led to the development in the 1950s of mesh material that could support weakened muscle around a hernia and could be surgically inserted and implanted in the patient. Studies have shown a hernia recurrence rate of only one percent in repairs using mesh compared to a four to 20-percent recurrence rate in surgical procedures using sutures only.
What are the Treatment Options for Hernia Patients?
About 800,000 hernia surgeries are performed every year in the U.S., but many hernias do not require surgery at all. The hernia patient, under their doctor’s supervision, can wait and see if the problem worsens and becomes a significant health issue. In many cases, the patient can forgo surgical hernia repair. When surgery is necessary, a doctor might recommend one of several procedures depending on the patient’s health and the severity of the abdominal tear:
- Laparoscopy — Several small incisions are made in the abdominal area where the surgeon can insert tools and repair the damaged abdominal wall. A hernia mesh can also be installed during a laparoscopic procedure.
- Open surgical repair — A larger incision is made in the skin above a hernia to repair the weakened muscle using mesh with sutures, or only sutures (primary closure). This type of procedure is often the first choice in repairing small hernias, hernias of the groin in newborns, or infected and “strangulated” hernias that are common in adults.
By the turn of the millennium, “mesh with sutures” repairs represented more than 90 percent of all abdominal wall surgeries using open surgical repair techniques. Surgeons often choose hernia mesh because studies have shown an improvement in patient outcome, decreased surgery time and minimal recovery time.
Surgeons will elect to use mesh to repair a variety of hernia types including:
- Incisional — A hernia will develop at an old surgery site or incision
- Umbilical — This type of tear occurs near or inside the belly button (navel)
- Bilateral — Bilateral hernias develop on both the right and left side of the abdominal wall
- Femoral — A femoral hernia develops high in the leg area and usually inside or at the front of the thigh
- Inguinal — Many adults and newborn infants develop these hernias in the groin area
- Recurrent — When the original repaired abdominal wall tears again in the same location
However, there are still significant problems with choosing the wrong surgical approach. The use of mesh material known to be defective in some patients can prove devastating to those who suffer serious side effects after the operation.
The FDA has received many reports of serious complications and adverse events from patients who have undergone hernia repair using surgical mesh. The agency has either recalled some mesh devices directly or encouraged manufacturers to voluntarily pull their products from the marketplace.
In 2018, the FDA acknowledged that despite reduced rates of hernia recurrence with mesh products, there are situations where their use may not be recommended.
What Type of Mesh is Best?
The materials used to manufacture hernia mesh devices have evolved over the years, but medical device manufacturers have yet to create a completely safe product that is free of complications.
According to the National Institutes of Health (NIH), by 2010 mesh repairs had become standard procedure in most countries, with a resulting rapid growth in the variety of mesh devices available. The properties of the mesh device are crucial to its success in repairing torn abdominal walls, including the material’s ability to withstand tension and stretching (tensile strength), the type of fiber it’s constructed of, and its porosity (the size of pores or voided areas inside the material).
The introduction of lightweight mesh material with large pores in 1998 was believed to reduce the risk of inflammation and infection while providing greater flexibility and elasticity. The new material also shrank less and caused minimal pain. Some hernia mesh materials are made from biologics including porcine (pig) tissue, pig skin, human cadaver skin, and human tissue. However, most major mesh brands are fabricated out of polypropylene, polyester, or other synthetics which are implanted using a combination of titanium and other materials, which have shown significant disadvantages.
According to NIH researchers, a mesh implant should allow a person’s natural tissue to slowly become incorporated with the mesh, which eventually becomes integrated into the body. Unfortunately, this process appears to compromise the material’s mechanical strength. The researchers argue that “the evolution of mesh is not yet complete, and the ideal mesh has not yet been found,” but that devices manufactured with a minimal surface area and large pores in a lightweight material or a hybrid mesh with an absorbable surface are preferable.
While the type of mesh material is crucial to outcomes, so too is the way the hernia mesh is placed at the surgical site. If the mesh becomes fixed under tension or is too small, complications can arise. The skill of the surgeon plays a crucial role in preventing the recurrence of the repaired abdominal tear.
What are the Possible Complications With Hernia Mesh?
Many physicians promote the health benefits of using mesh to repair some hernias because of the quick results and shorter recovery time compared to other surgical techniques. According to a 2012 article in the Journal of the American Medical Association, surgeons use a prosthetic mesh on nearly 200,000 patients every year undergoing elective incisional hernia repair.
Unfortunately, over time the suture or mesh product can shrink or move, leading to serious health problems that require corrective surgery. There have been significant failure issues with the polypropylene coating used to make hernia mesh devices, which can be especially hazardous if the mesh perforates organs, tissue, veins or arteries and leads to sepsis (a life-threatening blood infection).
In other cases, the mesh device degrades and can cause severe complications and immune responses. Biological implants and polypropylene mesh fibers can become entwined in the body’s organs and surrounding tissue and cause catastrophic injuries and even lasting disability.
For years, patients have reported problems after undergoing hernia mesh surgical procedures. The most typical signs that something is wrong with the device include:
- Chronic pain and discomfort at the surgical site
- The development of abscesses or infections at the surgical site, sometimes accompanied by swelling, fever or severe headaches
- Recurrence of an original hernia
- Allergic reaction to the synthetic properties of the mesh device
- Organ puncture or perforation
- Autoimmune disorders when antibodies attack the synthetic mesh
- Significant changes in bowel function including diarrhea, severe constipation and even total bowel obstruction as a result of the mesh attaching itself to the bowel
- Rashes that develop as a reaction to specific mesh material including Ventralex and V-Patch
- Pain during sexual intercourse (in males) after an inguinal hernia repair when the mesh attaches to the spermatic cord, which might require testicle removal
- A fistula that develops from a severe hernia repair-associated infection
- Neurological changes that have been identified through CT scans
- Debilitating pain in the testes, groin or leg area
- Renal (kidney) failure in patients who underwent procedures with large coated mesh material implantation
- A condition known as meshoma, where the mesh migrates, bunches up, or contracts and forms a tumor-like structure
- Joint pain and aches that are often the result of systemic inflammation and a weakened immune system reacting to the mesh material
- Abnormal sweating caused by a deep underlying infection or autoimmune response
Who Manufacturers Hernia Mesh Patches?
The leading makers of hernia mesh patches and devices that currently sell or have sold their products in the United States include:
- Atrium Medical Corporation
- C-QUR Hernia Mesh
- C. R. Bard
- Onflex Mesh for Preperitoneal Hernia
- Ventrio Hernia Patch
- Ventrio ST Hernia Patch
- Ventralex Hernia Patch
- Parastomal Hernia Patch
- Coviden Parietex Mesh
- Johnson & Johnson (Ethicon)
- Proceed Hernia Repair Surgical Mesh
- Propylene Polypropylene Hernia System
- PVP Hernia Repair Devices
- Ultrapro Hernia Repair Plugs
- Ultrapro Hernia System
- Partially Observable Ultrapro Hernia Repair Mesh
- Polyester Hernia Mesh
In recent years, all these manufacturers have experienced legal issues over medical complications associated with their products. Both Johnson & Johnson and Atrium have recalled their devices because of patient complications.
Which Hernia Mesh Devices Have Been the Subject of Recalls and FDA Actions?
The FDA and mesh device manufacturers have recalled numerous hernia mesh products. In 2016, Johnson & Johnson subsidiary Ethicon, Inc. launched its Physiomesh Flexible Composite Mesh, which is used in laparoscopic hernia repairs. Since then there has been an unacceptable increase in life-threatening complications in patients who underwent procedures with this device, many of whom required corrective surgeries.
Atrium Medical Corp. sold its C-QUR Hernia Mesh between 2006 and 2015. A few years ago, FDA regulators forced its manufacturing facility to shut down under a court order, noting the company’s repeated failures to correct major sterilization problems that compromised patient safety. While Atrium’s recalled products are off the market, many patients who underwent hernia surgery still have the company’s implanted Vpatch, FXpatch, Mosaic Mesh, Texshield, and Film Mesh, which were all recalled.
It is not uncommon for mesh patients to go years or decades before experiencing any serious injuries or complications after their mesh implantation.
Why is it Necessary to File a Lawsuit Against a Mesh Manufacturer?
If you have undergone a painful secondary replacement surgery to repair or exchange your defective hernia mesh, you have legal rights to seek compensation for your harms. Your surgeon decided to use a medical device the manufacturer likely knew was defective and you are suffering the consequences of someone else’s decision.
Filing a claim or lawsuit against those responsible for your injuries can provide you funds to cope with your mounting medical expenses in the time you will need to fully recover. Rosenfeld Injury Lawyers can help you recover the compensation you deserve. Our team of dedicated hernia mesh injury attorneys understands that many medical device manufacturers place profits ahead of patient safety. Our attorneys have handled many cases just like yours and we will successfully resolve your case by holding those legally responsible for your harms financially accountable.
Let us deal directly with the manufacturer, surgeon, and their insurance companies. Resolving personal injury, product liability, medical malpractice, and wrongful death cases are all we do.
What Financial Payouts (Settlements) Have Resulted From Hernia Mesh Lawsuits?
Hernia mesh patients usually ask their attorneys how much financial compensation they can expect to receive from a successful lawsuit and what the typical payouts are in hernia mesh settlements and jury awards.
Many patients who have suffered complications after undergoing hernia repairs using mesh devices have filed lawsuits against the manufacturers. Hernia mesh lawsuits are usually resolved in a negotiated out-of-court settlement, especially after plaintiffs in similar cases have obtained a large monetary jury verdict.
Litigation associated with nearly every mesh device recalled by the FDA is initially resolved through what are called “bellwether” trials. In these cases, the lawsuits will be consolidated in multidistrict litigation in a single court to help judges, defendants, and plaintiffs better understand the value of similar cases. Many of these lawsuits have resulted in millions of dollars in monetary recovery placed in a compensation fund, which is then divided up and paid out to multiple plaintiffs. That said, there are still individual cases where one plaintiff sues the mesh device manufacturer to resolve their case more quickly.
The mesh manufacturer C. R. Bard has settled more than 3,000 lawsuits involving its Composix Kugel Hernia Mesh Patch for $184 million. The FDA recalled the popular device in 2005, 2006, and 2007. Even after the recalls, Bard continues to face additional lawsuits over the defective product, along with its vaginal mesh devices which are implanted for the treatment of female incontinence.
How Much is my Case Worth?
Nearly every client wants to know how much their hernia mesh injury case is worth. The answer can be as broad as the types of problems every injured plaintiff can experience. Predicting the financial settlement or jury trial award in a specific case can be difficult. Our firm will look at a range of factors to determine the value of your case:
- The material used in your hernia mesh device and if it was recalled voluntarily by the manufacturer or by the FDA
- The nature and extent of your injuries
- Your medical expenses
- How the complications from your injuries impact your daily quality of life
- The pain and suffering you have experienced
- Other damages including lost wages and lost future income if you have been unable to return to work
How do I Take the First Step Towards Getting Compensation?
The complications that arise out of a hernia mesh repair can undermine your quality of life and leave you grappling with chronic pain, discomfort, inflammation, and other physical problems.
Don’t worry if you don’t know what type of hernia mesh device was used in your surgical procedure. Our attorneys can obtain all the information we need to build a solid case for you. You deserve to hire an experienced legal firm that specializes in cases involving personal injury, medical malpractice, product liability and adverse health effects from medical devices.
Rosenfeld Injury Lawyers represents people injured by hernia mesh and other defective medical products. We provide a free case consultation and urge you to call us today at (888) 424-5757. Our lawyers have fought hard for clients who have been harmed by medical devices and have won millions to ensure their families are protected. We work on a variety of product liability cases including those involving transvaginal mesh, hernia patches, hernia mesh, and pelvic mesh products. We never ask our clients to pay upfront fees. Instead, you pay our legal team only after we have successfully resolved your lawsuit. If we do not win your case or negotiate an acceptable settlement on your behalf, you owe us nothing for our services.