Attorneys Committed to Holding Manufacturers Responsible for Hernia Mesh Complications
Medical device manufacturers have long known of the dangers of a hernia mesh implant used in abdominal hernia repair surgical procedures. Even so, they continue to sell their products to an unsuspecting population although they knew or should have known that the materials used have been proven not to be safe in humans.
Studies have revealed that the polypropylene material used to manufacture many popular hernia mesh devices and patches have been directly linked to severe pain, internal bleeding, infections, and the need for revision surgery.
High Failure Rate
For years, medical malpractice and product liability attorneys have filed thousands of Hernia Mesh Lawsuits because of defective designs and faulty medical device materials. The failure rate for hernia mesh materials is significantly higher than expected when these devices were first approved by the Food and Drug Administration (FDA). Patients requiring abdominal muscle repair usually have one or more severe side effects including bowel obstruction, infection, chronic pain, scar tissue, and organ damage.
Are You at Risk?
Any individual 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 may be entitled to receive significant financial compensation. Our legal team has assisted numerous clients to ensure they receive the recompense they deserve.
However, it is essential to file a legal claim against the manufacturer of the dangerous medical device before the state statute of limitations expires. Currently, claims are being filed against numerous hernia mesh device manufacturers for their failure to warn patients and doctors of the health risks associated with defective hernia mesh implants.
What is Hernia Mesh?
Hernia Mesh is a prosthetic material used to repair muscle tears in the abdominal wall that has usually taken many years to develop. 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.
For decades, surgeons understood that they could simply sew the torn area back together in a tension (primarily) repair. 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 create a small hernia with an intestinal bulge to develop into a large hernia were loops of the intestine were pushed through the muscle. In some severe cases, the intestines would become pinched in the muscle wall.
Over time, surgeons realized that they needed better options to stabilize a weakening muscle and minimize hernia recurrence. Mesh material was invented to support weakened muscle around a hernia that could be inserted an implanted in the patient during a surgical procedure. Recent studies have shown a much lower recurrence rate of 1% in hernia operations using mesh compared to a 4%-20% recurrence rate of hernias in surgical procedures using sutures only.
What Type of Mesh is Best?
According to the National Institutes of Health (NIH) publishing under the National Library of Medicine, the types of materials and methods used to repair a hernia can determine the patient’s outcome. In 2010, NIH published an article after extensive research of medical literature spanning back to the 1950s, when using mesh to repair abdominal walls was first introduced. The article reveals that “mesh repairs that are now standard in most countries and widely accepted is superior to primary suture repair. As a result, there has been a rapid growth in the variety of mesh available and choosing the appropriate device can be difficult.”
The NIH states that the properties of the mesh device are crucial to its success in repairing torn abdominal walls. These properties include the material’s tensile strength, the type of filament, and porosity (the size of pores or voided areas inside the material). In recent years, the lightweight material with increased flexibility has decreased discomfort and minimized the potential risk of shrinkage and infection.
By 1998, lightweight mesh material with large pores was introduced in the medical marketplace. This innovative design was thought to stimulate a reduced reaction that led to inflammation while providing greater flexibility and elasticity. The new material also shrunk less and created minimal pain especially after undergoing a Lichtenstein inguinal torn abdominal wall repair. However, most major mesh material brands are fabricated out of polypropylene, polyester, or ePTFE that are implanted using a combination of other materials including titanium, PVDF, monocryl, and hyaluronate that have shown significant disadvantages. Some hernia mesh materials are made from biologics including porcine (pig) tissue, pig skin, human cadaver skin, and human tissue.
The underlying process of using mesh during a surgical procedure will eventually “allow soft tissue to infiltrate the mesh, which eventually becomes integrated into the body by process of remodeling. Unfortunately, this process also appears to lead to a rapid reduction in [the material’s] mechanical strength.” The authors of the article state that they have concerns regarding the reduced strength and how it “restricted their use to infected environments.” The researchers argued that “it is clear that the evolution of mesh is not yet complete, and the ideal mesh has not yet been found.”
The article claims that when surgeons choose a mesh, they must consider all factors and look for a device that is manufactured with a minimal surface area, and large pores in a lightweight material. The researchers believe that “ideally, [the material] should consist of a monofilament” that will be “more comfortable and have a lower risk of infection.” The authors also stated that “if the mesh is to be used inside the perineal cavity, an attempt should be made to minimize adhesions by choosing a hybrid mesh with an absorbable surface.”
Surgical and Nonsurgical Options
About 800,000 hernia surgical procedures are performed every year in the US. According to the Food and Drug Administration (FDA), there are two general treatment options for correcting hernias – non-surgical and surgical.
- Non-Surgical Option – The patient, following their doctor’s recommendation, can wait and see if the problem exacerbates over time. Typically, the physician will maintain a watchful eye on the hernia to ensure it does not become a significant health issue. In many cases, the patient can forego a hernia repair if there are no life-threatening health problems or dangerous complications that could occur during surgery.
- Surgical Options – The doctor might recommend one surgical procedure over another based on the patient’s health and the severity of the abdominal tear. These options include:
- Laparoscopy – The patient will undergo several small incisions in the abdominal area where the surgeon can insert tools to open the area and repair the damaged abdominal wall. Surgeons can perform Laparoscopic procedures using a hernia mesh, or not.
- Open Surgical Repair – The surgeon can make a much larger incision in the skin above a hernia to repair the weakened muscle. Much like laparoscopic procedures, “opened” hernia surgeries can repair the abdominal wall using mesh with sutures, or only sutures (primary closure). This type of procedure is often the first choice in repairing small hernias, inguinal hernias in newborns, or infected and strangulated hernias that are common in adults.
The use of abdominal mesh material for repairing hernias became popular in the 1980s. By the turn of the millennium, ‘mesh with sutures’ repairs represented more than 90% of all abdominal wall surgeries using groin hernia repair techniques.
Surgeons often chose hernia mesh materials because studies have shown a significant improvement in patient outcome, decreased surgery time and minimal recovery time. However, there are still significant problems with choosing the wrong surgical approach. Surgeons who choose to use medical device mesh material known to be defective in some patients can prove devastating to those who suffer serious side effects after the operation.
The Food and Drug Administration has received many serious complication reports from doctors and patients who have undergone hernia repair using surgical mesh. The FDA has analyzed many of these reports on adverse medical events and has either recalled some medical mesh devices directly or encouraged the manufacturer to recall or pull their product from the medical marketplace.
Why is a Hernia Mesh Used?
Many surgeons believe that there are significant benefits to using hernia mesh material instead of just sutures alone, including the lower potential of hernia recurrence at the same site. Many doctors understand that there is a high potential risk of needing additional repair surgery if a hernia was corrected using sutures alone. However, the FDA acknowledged in February 2018 that there are problems with hernia surgical mesh implants. The agency stated that:
“Despite reduce rates of recurrence, there are situations where the use of surgical mesh for hernia repair may not be recommended. Patients should talk to their surgeons about their specific circumstances and their best options and alternatives for hernia repair.”
According to an article in JAMA (The Journal of the American Medical Association), surgeons use a prosthetic mesh on nearly 200,000 patients every year undergoing elective incisional hernia repair (2012). However, the journal states that “the benefits of mesh for reducing the risk of hernia recurrence for the long-term risks of mesh-related complications are not known.” The author of the article states that:
“Mesh implantation prevented the need for subsequent reoperation in relatively few patients, suggesting that the benefits associated with the use of mesh are partially offset by long-term complications associated with its use. This observation, however, should be interpreted with caution because of the risk of selection bias. Larger, more complicated hernias are likely to be repaired with mesh, and small, simple hernias with little likelihood of long-term problems tend to be repaired without mesh.”
While the type of material is crucial to the outcome of the surgical procedure, so too is the way the hernia repair 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?
Many surgeons push the health benefits of using a mesh product to repair specific types of hernias because of the quick results and shorter-term recovery time when compared to other surgical techniques. Traditionally, most hernias were repaired using stitches only. In recent years, medical device makers have manufactured mesh products that are held in place with sutures. Unfortunately, over time, the suture or mesh product can shrink or move, leading to organ damage, bowel perforations, or obstructions that all require revision surgery.
Surgeons will elect to use hernia mesh materials to repair a variety of abdominal tears including:
- Incisional – A hernia will develop at an old surgery site or incision.
- Umbilical – This type of abdominal tear occurs near or inside the belly button (navel).
- Femoral – A femoral hernia develops high in the leg area and usually inside or at the front of the thigh.
- Bilateral – Bilateral hernias develop on both the right and left side of the abdominal wall.
- Inguinal – Many men, women and newborns develop these hernias in the groin area.
- Recurrent – When the original repaired abdominal wall tears again in the same location.
There have been significant failure issues with the polypropylene coating used during the manufacturing process. This failure is especially hazardous to the patient’s health if the mesh perforates organs, tissue, veins or arteries that lead to sepsis (life-threatening blood infection).
For years, patients have reported serious problems after undergoing hernia mesh surgical procedures. The most common signs and symptoms that something is wrong with the device include:
- Chronic pain and discomfort at the surgical site.
- Mesh material erosion that can occur quickly or over time.
- Painful and swollen infection developing at the surgical site.
- Recurrence of an original hernia usually because of weakening abdominal muscles or defective medical mesh device.
- Allergic reaction to the synthetic properties of the medical mesh device.
- Organ puncture or perforation that typically develops when the mesh can move on the underside of the abdominal wall.
- Problems that are obvious to the surgeon who recommends corrective or revision surgery.
- The development of abscesses or life-threatening infections at the surgical site.
- An autoimmune disorder that developed as a reaction to antibodies attacking the synthetic mesh material.
- Bowel obstructions that are the result of adhesion formation where the patient is unable to defecate or has significant negative changes in their bowel habits.
- Adhesions where the hernia mesh adheres to the bowel.
- Rashes that develop as a reaction to specific hernia mesh material including Ventralex and V-Patch.
- Dyspareunia (pain during sex) that is usually the body’s response occurring after an inguinal hernia repair when the mesh unexpectedly attaches to the spermatic cord that might require testicle removal.
- A fistula that develops from a severe hernia repair-associated infection.
- Fever associated with an infection or other severe mesh-associated problem.
- Neurological changes that have been identified through CT scans.
- Seroma with or without infections when a thick capsule filled with fluid develops around the implanted mesh.
- Constipation or diarrhea that might be the result of bowel obstruction or mesh attachment to the bowel.
- Debilitating pain that occurs in the testes, groin or leg area.
- Abdominal pain that develops from nerve damage, infection, bowel obstruction, or adhesion formation.
- Renal failure the tends to occur in patients who underwent procedures with large coated mesh material implantation.
- Severe headaches that are often associated with infections.
- Dental issues caused by serious, life-threatening infections.
- Meshoma where the mesh migrates, bunches up, or contracts and develops 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.
In many cases, the mesh device degrades over time and can cause serious complications and severe immune responses. Biological implants and polypropylene mesh fibers can become intertwined around the body’s organs and surrounding tissue that can cause catastrophic injuries and permanent disability.
Who Manufacturers Hernia Mesh Patches?
Using hernia mesh materials to repair abdominal tears is nothing new. However, over the years, the materials have changed significantly. That said, medical device manufacturers have yet to create the ideal product with the safest materials that can eliminate complications. The leading manufacturers of hernia mesh patches and devices that now sell and 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 had significant legal issues concerning the complications associated with patient reaction to their products. Recently, both Johnson & Johnson and Atrium have recalled their devices because of patient complications.
A List of Recalls and FDA Actions
The Food and Drug Administration (FDA) and mesh device manufacturers have recalled numerous hernia mesh products in recent years. In 2016, Johnson & Johnson subsidiary Ethicon, Inc. launched its Physiomesh Flexible Composite Mesh used by surgeons in laparoscopic hernia repairs. However, since then, there has been a significantly unacceptable increased rate of life-threatening complications in patients who underwent surgical procedures with this medical device. Many of the patients have required revision surgeries.
Maquet Holdings subsidiary Atrium Medical Corporation sold their C-QUR Hernia Mesh between 2006 and 2015 in the medical marketplace. It was only a few years ago that FDA regulators required the manufacturing facility to shut down under a court order. The federal agency noted the company’s repeated failures to correct major sterilization problems that violated patient safety. While their recalled products are no longer available in the medical marketplace, many patients who underwent hernia repair surgery still have the implanted Vpatch, FXpatch, Mosaic Mesh, Texshield, and Film Mesh that have been recalled.
In many cases, the patient will not experience any severe injury or serious complications for years or decades after the mesh implantation procedure.
Common Questions About Mesh Lawsuits
Lawsuits involving defective medical mesh devices in the past have been resolved through the payout of millions of dollars to victims through jury trial awards, and court-ordered settlements. Many of the recent cases were based on common questions about resolving a claim or lawsuit. Some of these questions include:
- How much can I expect to receive through a hernia mesh claim or lawsuit?
- I was diagnosed with a hernia recurrence, does that mean I can sue the manufacturer and my surgeon?
- How much financial compensation should I expect to receive through a successfully resolved hernia mesh lawsuit?
- What are the common payouts through a jury trial award’s a negotiated out-of-court settlement involving hernia mesh cases?
Many of the lawsuits that have been won or negotiated have resulted in millions of dollars in monetary recovery to be placed in a compensation fund. Some of these lawsuits required the fund to be divided up and paid out to multiple plaintiffs. That said, there are still individual lawsuits and claims where one plaintiff faces the medical mesh device manufacturer to resolve their case quickly.
Why Filing a Lawsuit is Often Necessary
If you have undergone a severely painful secondary replacement surgery required to repair or exchange your defective hernia mesh, you have legal rights to seek compensation for your preventable harm. You did not make a choice to use the original mesh to correct your abdominal hernia but are suffering the consequences of someone else’s decision. Your surgeon decided to use a medical device that the manufacturer likely knew was defective.
Filing a claim or lawsuit against those responsible for your injuries can now provide you funds to deal with your mounting medical expenses in the time you will need to recover fully. Our team of dedicated attorneys can ensure that you receive the monetary recovery you deserve. Rosenfeld Injury Lawyers can:
- Fight on Your Behalf – Our team of attorneys understands that many device manufacturers place profits ahead of patient safety. With our lawyers on your side, we can fight for you and your family to ensure your rights are protected in a court of law to obtain financial compensation.
- Get Your Life and Health Back on Track – You looked to medical device manufacturers and surgeons to fix your original hernia injury and have been blindsided and sidetracked after the device began to fail. Our lawyers can assist you to get your life back through compensation and ensure you recover with access to better medical care.
- Hold Those Responsible Legally Accountable – The defect in your hernia mesh device likely forced you to undergo a revision (second) surgical procedure or will soon. Our attorneys have handled many cases just like yours and can ensure we will successfully resolve your case by holding those legally responsible for your harm financially accountable.
- Receive Compensation without Upfront Fees – Filing the necessary documentation in the appropriate county courtroom before the statute of limitations expires is the first step in ensuring that your case will be successfully resolved. We never ask our clients to pay upfront fees to file their claim, build their case, gather evidence, speak to witnesses, and prepare for a jury trial or out of court settlement. Instead, we make our no fee promise meaning you pay our legal team only after we have successfully resolved your case or lawsuit.
Remember, others are responsible for your harm. Let us deal directly with the insurance company. Handling personal injury product liability, medical malpractice, and wrongful death cases are all we do.
Hernia Mesh Financial Verdicts and Settlements
Many patients who have undergone hernia repairs using medical mesh devices have filed lawsuits against the manufacturer after suffering complications. Hernia mesh lawsuits are usually resolved in a negotiated monetary out-of-court settlement, especially after plaintiffs in similar cases have obtained a large verdict. In recent years, hernia mesh claims and lawsuits resulting in large verdicts have included:
- August 2010: C. R. Bard: U.S. District Court jurors awarded married plaintiffs $1.5 million due to the suffering caused by a hernia repair patch. The couple Laure and Christopher Thorpe were awarded $1.3 million to recover their personal injury damages and an additional $200,000 for spousal damages (loss of consortium). This lawsuit was the second case tried in open court involving Composix Kugel Hernia Mesh Patch manufactured by DaVol, Inc. a subsidiary of C. R. Bard. Federal jurors found the defendants negligent in the product’s design.
The plaintiff’s attorneys argued that Christopher had suffered severe internal injuries caused by a broken plastic ring on the mesh device after undergoing hernia repair. The plaintiff required multiple revision surgeries. Jurors concluded that the defendants’ defective design and failure to provide adequate instructions or warning concerning their product identified their liability in the case. The jury also identified negligence by the defendants that led to emotional and physical suffering by Christopher’s wife, which led to a loss of consortium.
- 2011 – C. R. Bard: The surgical mesh manufacturer C. R. Bard settled more than 3000 lawsuits involving its Composix Kugel Hernia Mesh Patch for $184 million. The Food and Drug Administration (FDA) recalled the popular medical device in 2005, 2006, and 2007. Even after the recalls, many plaintiffs continue to file lawsuits against the company and its subsidiary DaVol, Inc. citing serious complications.
The mesh medical device manufacturer continues to face additional lawsuits over its defective product along with their vaginal mesh medical devices, surgically implanted for the treatment of incontinence. Unfortunately, many women have suffered mesh erosion that led to revision surgeries, organ damage and chronic pain.
How Much is my Case Worth?
Nearly every potential client will ask the initial question “how much is my hernia mesh injury case worth?” However, the answer can be as broad as the types of problems every injured potential plaintiff can experience. Predicting the amount of the financial settlement or a jury trial award can be difficult. Our law firm will look at a range of factors to determine the value of the case and explain your legal options. Some of these factors include:
- The Hernia Mesh Device Material Used – Our team of attorneys will need to determine if your device was recalled voluntarily by the manufacturer or mandated by the FDA. Even if the manufacturer still sells the device like yours in the medical marketplace, you still have a case for compensation.
- The Level of Your Injury – Defective, malfunctioning or poorly designed hernia mesh devices can cause an array of debilitating health problems that can reduce a patient’s quality of life. Our attorneys can better calculate the value of your case by reviewing the extent of your surgeries, the length of time you stayed in the hospital, and the permanency of your physical, mental, emotional and financial damages.
- Your Medical Expenses – As a part of calculating the value of your case, our law firm will review your diagnostic tests, the number of doctor visits, the requirement for hospitalization, the need for revision surgery, the cost of your medications, if you require assisted medical devices, and the number of surgeries. When the case is won at trial or settled out of court, you can be assured you will have enough money to cover all your bills along with additional funds for your pain-and-suffering.
- How Complications and Injuries Impact Your Daily Living – Extensive chronic infections, major complications, bowel problems or other issues can have a serious negative impact on your daily life. In building your case, we will determine how your life has changed for the worse since you underwent your initial surgery.
- Pain and Suffering – Dealing with a chronic infection, bowel issues, allergic reactions, renal failure, or other serious health issue associated with your hernia repair can lead to a variety of non-economic damages. Some of these damages include pain, suffering, mental anguish, loss of consortium, loss of companionship and the emotions associated with a diminished quality of life. Those responsible for causing your harm should be held financially accountable for your intangible damages. Our team of attorneys uses a proven calculation to determine how much these damages are worth during your settlement or when seeking a financial award from a trial verdict.
- Other Losses – In all likelihood, the extent of your injuries have resulted in a loss of wages and the loss of any potential future earnings that could be temporary or permanent. You may not be able to return to work for a while or ever or continue working in your previous employment because of the severity of your permanent disability.
The legal consequences of nearly every mesh device recalled by the Food and Drug Administration are initially resolved through bellwether trials. In these cases, the lawsuits will be consolidated in multidistrict litigation courts to help judges, defendants, and plaintiffs better understand the value of similar cases.
The complications that arise out of a hernia mesh problem can undermine your daily enjoyment and leave you grappling with chronic pain, discomfort, inflammation, scarring, bowel problems and injury to your kidneys. The level of incapacitation has led many to file a claim or lawsuit against the manufacturer and surgeon to hold them financially accountable for causing harm.
Take the First Step
You are likely wondering what the first step is to seek compensation for your injuries. It is not a problem if you do not know what hernia repair mesh device was used during your surgical procedure. Our attorneys working on your behalf can find out all the information we need to build a solid case for compensation. You deserve to hire an experienced legal firm that specializes in cases involving wrongful death, personal injury, medical malpractice, product liability and health problems with adverse side effects.
Rosenfeld Injury Lawyers represent clients injured through medical procedures. We provide a free injury discussion and case consultation and invite you to call us at (888) 424-5757 today. Our lawyers have fought hard for our 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 that involve transvaginal mesh, hernia patches, hernia mesh, and pelvic mesh products. We do not charge any fee until we resolve your case through a jury trial verdict or a negotiated out-of-court settlement. If we do not win your lawsuit or negotiate an acceptable settlement on your behalf, you owe us nothing for our services.