What is a hernia?
Very simply, a hernia is a situation in which an internal organ or a portion of tissue protrudes through the space in which it is supposed to reside. Hernias are quite common, and can be brought on by diet, obesity, strenuous labor, and chronic or genetic conditions.
The reason that hernias can be serious is that, when the organ bulges into an “off-limits” area, the blood supply to that organ can get choked off. That can lead to tissue necrosis, disease, or even, in serious cases, death.
In principle, a hernia mesh device can hold a bulging organ or tissue back into its proper place.
Types Of HerniasThe most common types of hernias are:
• Inguinal: occurs in the inner groin
• Femoral: occurs in the upper thigh/outer groin
• Incisional: occurs through an incision or scar in the abdomen
• Ventral: occurs in the general abdominal/ventral wall
• Umbilical: occurs at the belly button
• Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm
What is Hernia Mesh?
Hernia mesh is a surgical “patch” that is woven from stringlike strands of a versatile, lightweight plastic called polypropylene – the same plastic used to make fishing line, carpet fibers, and a wide variety of other consumer products.
Many of the world’s largest manufacturers of medical devices, surgical devices, and/or pharmaceuticals manufacture or have manufactured hernia mesh products. You may recognize the names of the companies and/or the products in the list below.
Mesh Device Manufacturers• Atrium C-QUR (manufactured by Atrium Medical Corporation)
• Visilex (manufactured by Bard Davol)
• Supramesh (manufactured by Bard Davol)
• Physiomesh (manufactured by Ethicon, a subsidiary of Johnson & Johnson)
• PerFix Plug (manufactured by Bard Davol)
• Parietex (manufactured by Covidien)
• Kugel (manufactured by Bard Davol)
• Composix and Composix EX (manufactured by Bard Davol)
• 3DMax (manufactured by Bard Davol)
The purpose of a hernia mesh is to strengthen the walls of internal tissues that, under typical circumstances, hold our organs in place. When someone “has a hernia,” it means that tissue walls have weakened or become porous in such a way that an organ (or portion of an organ) becomes displaced from its usual space inside the body and pokes through into another body cavity.
Hernias can be exceedingly painful.
Think of a hernia mesh as a woven patch that is intended to keep your internal organs where they belong. The idea is sound, but, in application, hernia mesh products have proven problematic, to say the least.
Hernia Mesh Devices
Every hernia mesh device is designed along the same principle: A fine mesh screen is surgically implanted at the site of a hernia for the purpose of keeping the bulging organ or tissue in place.
There are many different hernia mesh devices on the market (see the previous paragraph), and each of them differs from the others in small but significant ways. In the case of the Bard Composix and Bard Composix EX hernia mesh devices, the distinguishing characteristic is very simple: they have two layers of material.
One layer of all types of Composix hernia mesh is polypropylene – the same kind of plastic used to make fishing line and synthetic carpets. According to Bard Davol, the maker of the Composix hernia meshes, the polypropylene side of the mesh promotes tissue growth at the site of the surgical incision over which it is placed.
The other side of the Composix hernia mesh contains a “permanent submicronic ePTFE barrier.” OK, so what’s ePTFE? You mean you didn’t know? ePTFE is an abbreviation for “expanded polytetrafluoroethylene,” which is a polymer that has extremely tiny pores. You may know it as the key component of Gore-Tex, a substance that’s now in everything from ski jackets to dental floss to NASA equipment. The purpose of the ePTFE layer of the Composix hernia mesh is to minimize the possibility that the mesh will adhere to the incision.
All of that sounds like a great idea. Except that it doesn’t always work.
What are health risks that have been associated with hernia mesh?
Photo Credit: https://commons.wikimedia.org
The problem with hernia mesh devices lies in the nature of the material from which they are made: polypropylene. Initially, polypropylene promised to reduce the rates of complication and infection that had risen to alarmingly high rates with biologically derived hernia mesh devices. But polypropylene turned out to cause more problems than it solved.
In fact, polypropylene hernia mesh devices have been shown to fail more frequently than hernia mesh patches made from biological materials (such as cow intestine or pig skin), and they have been implicated in a great many health risks, some of them quite serious.
Injuries Attributed To Mesh Devices
• The spiky ends of a hernia mesh’s polypropylene fibers have been found to poke through tissues and organs, causing pain and infection. This is called organ perforation, and it is a very serious condition.
• Body tissue has been shown to grow around and through the perforations in polypropylene hernia mesh devices, such that the patches “melt into” living tissue. When this happens, they can cause pain and infection. The devices can thus become inseparable from body tissue, resisting multiple surgical attempts to remove them.
• Nerve tissue can push through the tiny gaps in a hernia mesh device, and then become twisted and pinched, causing immense pain. In the most serious cases, this type of complication can cause permanent nerve damage.
• Elements of the male reproductive system, too, can become tangled in a hernia mesh device, causing pain and even infertility. In the most serious cases, the nerves and/or blood vessels that supply the testicles can be pinched closed by the warping hernia mesh device, a situation that can necessitate the surgical removal of one or both testicles.
• The polypropylene that comprises hernia mesh has been implicated in a great many types of inflammation, pain, and infection. In the very worst cases, these devices can cause blood poisoning and death.
• Sometimes, the complications connected with hernia mesh devices may be remedied by one or more additional (or “revision”) surgeries. But surgery is complicated, expensive, and risky – and, if the products worked properly, it would be unnecessary.
Product recalls of hernia mesh devices
In the United States, where hernia mesh devices have been used in greated numbers than in Canada, several brands of mesh have been recalled by the U.S. Food and Drug Administration (FDA).
So far, Health Canada has recalled just one hernia mesh device: the Physiomesh flexible composite mesh device, which is manufactured by Ethicon, a subsidiary of Johnson & Johnson. Health Canada issued this recall in May 2016.
Indeed, the Ethicon Physiomesh has been recalled worldwide, not just in Canada.
The reason for the worldwide recall of this particular hernia mesh device is that it had been associated with higher-than-average recurrence and reoperations rates. That is, people who had been surgically implanted with the Ethicon Physiomesh experienced unusually high rates of the reappearance of hernia-related health problems, and they also experienced unusually high rates of corrective surgery to fix problems related to the devices.
As lawsuits continue to mount against the manufacturers of hernia mesh devices, the attorneys at TheLawFirm.com believe that more such devices will eventually be recalled. To check whether your hernia mesh device has been recalled, contact TheLawFirm.com.
Hernia Mesh Lawsuits
How are hernia mesh lawsuits filed?
Most lawsuits concerning hernia mesh devices are filed as part of a mass tort, a particular type of lawsuit that is related to but distinct from a class action lawsuit.
Class action suits are filed by multiple plaintiffs acting as one party. A plaintiff group can number hundreds or thousands of people. If the plaintiffs win their case, each individual plaintiff receives an equal share of any damages that are awarded. In a class action case with a plaintiff group of 50,000 and an award of $5 million, each plaintiff receives $1000, less legal expenses.
A mass tort – the category of legal action under which most hernia mesh lawsuits are likely to fall – differs significantly from a class action suit. In a mass tort, courts hear a small number of representative cases, which they then use as a basis for settlements in a larger number of nearly identical cases.
Settlements and damages in mass tort cases are not distributed equally, but are determined individually, according to the details of each particular case.
How do I know if I’m qualified to join a hernia mesh mass tort lawsuit?
The first step in determining if you should participate in a hernia mesh mass tort lawsuit is to consult an attorney who has expertise in the areas of product liability law and personal injury law.
Not all hernia mesh devices cause health problems. Some cause no problems at all. If you have a hernia mesh device, and you are concerned that it may be causing or will soon cause health problems for you, consult your physician.
If you have a hernia mesh device, and if you believe it has been the cause of your health or medical problems, you may be entitled to join an existing hernia mesh lawsuit. Typically, if you meet one or more of the following criteria, you are likely to qualify to join an existing lawsuit:
You have experienced one or more of the following complications, which you believe to have resulted from a defective hernia mesh implant:
Post Hernia Surgery Complications• chronic pain for more than three months
• recurrence of your hernia
• mesh migration (the device has moved to another part of your body)
• mesh adhesion (the device has become permanently stuck to a part of your body)
• obstruction (the mesh blocks a normal body process from occurring)
• fistula formation (a fistula is an abnormal “passageway” between two organs)
• organ perforation
In many cases, you will need a doctor to confirm that you are afflicted by these complications.
• The type or brand of mesh that has been implanted in your body has been recalled by the company that made it. If you do not know the exact name or model of the mesh with which you have been implanted, consult the surgeon who performed your operation.
• You have had or will need to have additional surgery or surgeries to treat a recurrent hernia, or to treat any complications (such as infection) that are related to your hernia mesh device.
• You require, will require, or have required surgery to remove your hernia mesh device.
Certain exceptions do apply. Your attorney will be able to explain these to you.
Hernia mesh lawyers offer legal advice
The attorneys at TheLawFirm.com are not doctors. However, as we talk to the hundreds of patients who are calling us for legal advice following hernia mesh surgery, we are often asked for our advice. First, talk to your doctor. Second, from speaking to many hernia mesh patients, it seems to us that there is treatment for hernia mesh pain and most patients getting the right treatment recover.
Many of the patients who call TheLawFirm.com with hernia mesh call because they have developed chronic pain. We have learned through our research that hernia recurrence is a small risk. A patient with hernia mesh and chronic pain usually means that the hernia mesh is the cause of the pain. So we usually tell our hernia mesh pain clients to refuse to be told that the hernia mesh is not responsible.
The reason that hernia mesh causes pain is because your body sees the hernia mesh as foreign and your body responds with chronic inflammation. Chronic inflammation causes pain. The pain could be from an error in surgical technique or because the mesh has moved but we have found from our clients that the mesh is probably responsible.
Imaging studies such as CT scan, MRI and ultrasound are for the most part worthless for evaluating a patient with hernia mesh pain. Imaging studies typically show nothing wrong with the mesh if in fact the mesh is visualized. However, on most imaging studies the mesh is invisible.
We highly recommend a second opinion if your doctor tells you that a hernia recurrence is causing your pain. Patients with chronic pain after mesh hernia surgery need to find doctors who have experience taking care of this condition.
Again, we are not offering medical advice. But call the hernia mesh attorneys at TheLawFirm.com if you got a hernia mesh implanted and it is now causing you additional medical problems.
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18.5 Million people suffered from hernia injury in 2015