Free Hernia Mesh Report

free hernia mesh report
Overview of post-surgery complications experienced from different types of hernia mesh medical devices and legal actions being taken against manufacturers of these products.

To download a pdf version of this report, click here.

What You Need to Know About Hernia Mesh Litigation

Thousands of patients whose hernias were repaired with mesh have experienced debilitating pain. After years of being told by their doctors that nothing is wrong with them, many now know what they’ve suspected all along — that the mesh devices were faulty.

The U.S. Food and Drug Administration (FDA) now admits that hernia mesh devices are creating serious adverse side effects. This summary is listed on the FDA website:

“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market.

Pain, infection, recurrence, adhesion, obstruction, and perforation

are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.”

In a lawsuit brought against the makers of the Bard Composix Kugel Mesh Patch, a jury found the device was defective and unreasonably dangerous. One plaintiff who had a sepsis infection and internal injuries was awarded $1.5 million in damages. This result is not necessarily a prediction of what an average patient might be awarded in a claim – each case is unique, depending on the claims proven against the manufacturer and the extent of the damages suffered by the patient. But it does show that when juries are presented with the same facts that the FDA had, juries are concluding these products were known to be dangerous, or that the makers should have known of the risks and acted earlier.

While the FDA now admits to the serious problems with hernia mesh, the website notice suggests that the danger only lies with products taken off the market. But thousands of patients suffering from devices that remain on the market know otherwise. Where the FDA is slow to act, or won’t act at all, many patients are taking matters into their own hands by filing private lawsuits against the manufacturers.

Kugel Mesh Patch Patients Get $70,000 Each in Settlement

In 2011, 2,600 patients who suffered complications from the Composix Kugel Mesh Patch, settled a case against the manufacturers. The device was made by Davol, Inc., a subsidiary of C.R. Bard, Inc. Bard paid out $184 million to settle the case, which worked out to about $70,000 per plaintiff.

While each case is unique, the problems with the Kugel Mesh Patch are similar to problems with other hernia mesh devices. The company got the product was “approved” by the FDA through a quickie approval process that does not require any reviews into the product’s safety or effectiveness. Adverse events were reported by doctors and surgeons whose patients had complications from the device, and sometime later the company issued a variety of recalls.

The Kugel Mesh Patch went on the market in 2000, and doctors were reporting adverse events to the FDA as soon as 2002. When public realization of the problems first surfaced, the company denied the problems. Instead, the company asserted that the doctors and surgeons were the problem, because they had not implanted the devices correctly.

Then, Davol’s own testing showed the mesh device was faulty. The FDA finally investigated and found numerous safety violations at the plant. Bard recalled more than 137,000 of its hernia mesh products.

Which Hernia Mesh Makers Are Being Sued?

The Kugel Mesh Patch is a variation of the many types of hernia mesh devices used. There are many hernia mesh products that have been shown to cause serious side effects and are the subject of lawsuits.

Three manufacturers that have been sued by hundreds of patients are Atrium Medical Corp., maker of the C-QUR Mesh, Ethicon (a division of Johnson & Johnson) the maker of Physiomesh and several polypropylene hernia mesh devices, and Davol, Inc., a subsidiary of C.R. Bard, Inc. the maker of many Polypropylene hernia mesh products.

C-QUR Mesh Made by Atrium

Allegations

Hundreds of plaintiffs have alleged that:

  1. The C-QUR hernia mesh was defectively designed or manufactured;
  2. The manufacturers knew or should have known about allergic and inflammatory responses that patients suffered; and
  3. The company failed to provide adequate instructions and/or warnings.

Common Types of Injuries Suffered:

  • Serious pain
  • Bowel obstruction
  • Infection (high rates)
  • Need for secondary surgeries
  • Perforation of organs

Sample Hernia Mesh Plaintiffs:

Nicole Young, Charlotte, N.C. Age 34 – Suing Atrium

Ms. Young had hernia mesh implanted in her umbilical region in 2010. Three years later, she had serious pain, but her doctors said they couldn’t do anything. Finally, in 2015, the device actually protruded, and she was sent for surgery. She needed a third surgery three months later, when doctors removed the rest of the mesh. One of the pieces had adhered to her bowel.

William Dalton, Hancock, NH, Age 73 – Suing Atriu

Surgeons used the C-QUR mesh to repair Mr. Dalton’s belly hernia in December 2013. The device curled up and essentially failed. Six months later, Mr. Dalton needed a second surgery for a replacement mesh. Six weeks after the second surgery, that device became infected inside his body.

Source: New Hampshire Business Review

Ethicon Polypropylene Hernia Mesh Devices

Allegations

Hundreds of plaintiffs have alleged that:

  1. Ethicon, a division of Johnson & Johnson, failed to warn people about the risks of its hernia mesh products;
  2. The manufacturers were negligent in putting a defective product on the market.
  3. The devices are defective and unsafe for their designed and intended use.

Common Types of Injuries Suffered:

  • Pain
  • Inflammatory reactions
  • Mesh folding or bunching up
  • Adhesions
  • Failure of the mesh to incorporate into the body
  • Recurrence of the hernia

Ethicon has five hernia mesh devices that have been tied to patient injuries. They are all multi-layered hernia mesh products made from polypropylene:

The multi-layered hernia mesh devices are different than the uncoated, two-dimensional type of polypropylene mesh design, in two important ways: (i) Their design increases the rate and severity of serious complications and (ii) They were intended to increase the company’s sales by making implantation procedures go faster; they were focused on speed and profits, rather than safety or effectiveness for the patients.

1. Physiomesh Flexible Composite

In May 2016, Ethicon issued a “Field Safety Notice” about Physiomesh, advising hospitals and medical providers that the company was conducting “a voluntary product recall.”

The Physiomesh was marketed for its supposed anti-adhesion properties. The barrier layer that was supposed to prevent scar tissue from forming actually hindered the mesh from incorporating into the abdominal wall, and instead, it caused the mesh to buckle, fold and even migrate into the body, endangering other vital organs.

Lawsuits also allege that Ethicon knew that a chemical used in the device, Poliglecaprone, can cause inflammation, and thus creating potentially serious problems. Plaintiffs allege that Ethicon know about this problem before it put the product on the market and promoted its use.

When Ethicon issued the Safety Notice in 2016, it admitted that there was a higher recurrence rate of hernias after laparoscopic ventral hernia repair using the Physiomesh than for other meshes.

2. Proceed Surgical Mesh
3. Proceed Ventral Patch

The Proceed Surgical Mesh and the Proceed Ventral Patch both have a high rate of mechanical failure, which surgeons have started calling “Proceed rupture”. Each product has design defects that have been shown to contribute to the formation of adhesions in patients implanted with the mesh. In lawsuits, plaintiffs allege that Ethicon knew or should have known the products did not prevent adhesions and, instead, contributed to adhesions forming.

4. Proleme Hernia System

The Prolene Hernia System is a three-dimensional mesh. It was marketed for both inguinal and ventral hernia repairs. It was intended to reduce the chance of a hernia recurrence, but in many patients, it triggered a foreign body response that caused inflammation. This inflammation caused serious complications, that included serious pain, movement of the mesh into other parts of the body, and into other vital organs.

5. Prolene 3D Polypropylene Patch

The Prolene 3D Polypropylene Patch is three-dimensional. This design was created especially for hernias in the inner groin area (“inguinal”). The shape acts as a plug into the abdominal cavity. Many patients had serious inflammatory responses after being implanted with this device.

Bard Davol Hernia Mesh Devices

Many of the Bard Davol hernia mesh products made of polypropylene have been named in lawsuits.

Allegations

Suits have alleged that the devices contain defects that have caused injurious complications.

Common Types of Injuries Suffered:

  • Infections
  • Adhesions
  • Damage to organs
  • Inflammatory and allergic responses
  • Rejection of the mesh
  • Unintended movement of the mesh

Here is a list of some of the Davol hernia mesh devices. Not all of them have as yet been named in lawsuits. Consult with an attorney to find out if the device used for your procedure has been shown to be defective:

  • AlloMaxBard Soft Mesh
  • Bard Mesh Sheets
  • Composix
  • Dulex
  • MK Patch
  • OnFlex
  • PerFix Plug
  • Phasix Mesh
  • Sepramesh IP Composite
  • 3DMax
  • Ventralex
  • Ventralight
  • Ventrio
  • Visilex
  • XenMatrix Surgical Graft

Why Were Hernia Meshes Approved in the First Place?

A key factor in the whole problem behind the defective mesh scandal is the fact that the FDA never reviewed any of the products for their effectiveness or efficiency. The makers could put them on the market based on their own promises about the product, sight unseen.

For most of the hernia mesh devices, the companies received what’s often called a “quickie 510 k review.” This process allows drug companies to get around the clinical

trial approval system if the company simply claims that the device is substantially like a product already approved and on the market. The “510(k)” term refers to a federal regulation that allows this premarket submission, if the company can show that the new product is at least as safe and effective as a legally marketed device.

A 2011 report by the Institute of Medicine made the following findings about the quickie 510(k) process:

“The 510(k) program did not provide adequate assurances of safety and effectiveness nor did it provide sufficient information for healthcare providers and patients to make well-informed treatment or diagnostic decisions.”
The FDA approved the Ethicon Physiomesh hernia mesh repair product in 2010 using the same quickie 510k approval process as the other flawed meshes.

Hernias are a very common problem, and in most cases, surgery is the only means for repair. Companies promising faster and better outcomes have been able to push all sorts of products out to the market without testing that might easily have predicted the problems to come.

According to the FDA website, a “hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue.” Some hernias can be seen, for example, if they strain muscles in the area; others are unseen.

Up to 80% of hernias are “inguinal” which means they occur in the inner groin area. The only actual treatment for a hernia is through surgery. A doctor might suggest the patient hold off on surgery in some cases, if a patient is not having pain or other complications. There are two surgical approaches to repairing a hernia:

  • Open repair surgery- A surgeon makes an incision, conducts repair with or without surgical mesh.
  • Laparoscopic surgery – A surgeon makes a small incision, and repairs with or without surgical mesh

What Hernia Mesh Is Supposed To Do

Each year in the U.S., over one million patients with hernias will have their hernias repaired surgically. Over 90% of those repairs now will include a hernia mesh device.

The FDA classifies surgical mesh as a “medical device”. Surgical mesh is essentially used to support weak or damaged tissue. Most of the mesh used is made of synthetic materials. The idea behind the hernia mesh devices is, in theory, a good one. Once a surgeon has essentially pushed the protruding tissue back where it’s supposed to be, the mesh is designed to secure the pushed in tissue, with a kind of temporary wall. Over time, the body is supposed to grow through and around the mesh and eventually strengthen the weakened spot.

Once mesh became more widely used with hernia surgeries, the manufacturers experimented with techniques for surgeons to use them even in laparoscopic procedures. Again – good idea in theory, but tragically many of these experiments were not adequately tested.

The Bard Composix Kugel Mesh Patch was intended to improve the success of the less intrusive laparoscopic procedures. The device contained a “memory recoil ring” that was designed to spring open after it was inserted. It seemed like a great idea — with just a small incision, the mesh could be folded into a tiny ball, which the surgeon could easily position exactly where needed behind the hernia, and then, after insertion, the mesh would spread out flat.

Serious problems happened when the memory ring came apart. Often the ring literally poked into the patient’s body and damaged sensitive organs and tissues. Some doctors reported that broken rings had caused their patients serious abdominal injuries.
Davol’s own testing of the product showed the memory ring to be weakened at sites it was welded together. In its 2006 recall, Davol acknowledged that the “Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula [abnormal connection of intestinal body parts]”.

While the makers have not admitted to much in the FDA reviews and lawsuits pending so far, Atrium, the makers of the C-QUR mesh, did admit in a court of law that they never tested the C- QUR on humans – only rabbits and rats. The C-QUR’s supposedly unique design, was to use an Omega 3 gel coating, which Atrium claimed would prevent many common prior hernia mesh problems. Instead, the Omega 3 coating caused a higher rate of infections and other serious complications. It turned out that the gel coating prevented fluid from escaping, which caused fluid to collect and allowed bacteria to grow.

Studies now show as much as 10-15% of those implanted with hernia mesh can experience chronic pain. Other studies estimate chronic problems are experienced in up to 50% of patients with hernia mesh implants. Those numbers mean tens of thousands of people may be suffering now, or will suffer, from the use of hernia mesh devices.

Am I eligible to file a lawsuit?

The best first step is to hire a personal injury law firm that has experience with mesh cases. Skilled lawyers will walk you through the steps in determining if your case makes you eligible to file a lawsuit. Once of the first issues to know is the maker and type of device used. This can require some research into your medical files.

The type of mesh used should be shown on what is called the “device tag.” The tag should show the catalog number, lot number, manufacturer, and expiration date. However, some hospitals will use only generic descriptions on their reports, and not identify the device details. In those cases, so you might need to contact your surgeon’s office, because they usually keep more detailed records.

You will also need to document your symptoms. It’s not enough just to show that you had a device implanted that has been shown to be defective (or that will be shown to be defective); you also must show that you suffered damages because of the device. As an example, here are some of the symptoms listed in the complaint by one of the patients who sued the makers of the Physiomesh. This patient had a laparoscopic ventral incisional hernia repair using mesh in 2010.

The symptoms he listed in his complaint include:

  • Following surgery, a noticeable bulge appeared that never went away.
  • The bulge was combined with pain that was constant and worsening
  • He experienced weakness, loss of strength, and a reduction in his daily activities
  • Bouts of nausea
  • Seven years later, his symptoms were so severe he went to the Emergency Room where a CT scan showed his intestinal tract was blocked by the mesh.
  • He had a second surgery to remove the mesh in 2017. During that removal surgery, it was shown that the mesh did not adhere to the muscle as it was intended to.
  • His pain did not go away until the mesh was removed in that second surgery.

Of course, the idea of filing a lawsuit might seem overwhelming, if you’re dealing with chronic pain and undergoing test after test. The good news is that we will evaluate your case for no charge. If you are eligible to file a lawsuit, we will work on a contingency payment basis – which means no upfront costs for you. We only get paid if you win a settlement. If you are eligible for a lawsuit, we will evaluate whether it’s best to file your claim in state or federal court, whether we should have you join other mass suits underway, and we will calculate what your financial award ideally should be.

Contact Us Anytime for a Free Consultation

Slater & Zurz LLP is a unique team of attorneys and legal professionals dedicated to helping our clients prevail in all types of legal matters. To help you win, we offer you our extensive experience, our wealth of knowledge, our vast resources, our aggressive pursuit of justice and our unwavering support.

Please feel free to contact us anytime day or night for a free and private consultation by calling 1-800-297-9191, emailing [email protected], or chat with a 24 hour live representative by visiting our website dedicated to helping people who have experienced complications from the hernia mesh medical devices: HerniaMeshHelp.com

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