People are filing thousands of lawsuits against hernia mesh manufacturers, alleging design and manufacturing defects and failure to warn of serious side effects.
Hernias are extremely common injuries that can be caused by a myriad of medical issues, including prior surgical incisions and congenital defects. While a person who develops a hernia typically displays obvious symptoms such as a protrusion out of the abdominal wall, some hernias are asymptomatic, and the person is unaware of the hernia.
The most common treatment for a hernia is a surgical repair using synthetic polypropylene mesh.
Polypropylene is a petroleum by-product that is manufactured in strands akin to fishing lines. These strands are weaved together to form a patch which is essentially a flat piece of mesh. After the mesh is placed over the weak spot in the abdominal musculature, the pores in the mesh are designed to allow the tissue to grow into the mesh. This theoretically results in the mesh securing or strengthening the weak spot.
Unfortunately, over the years, we have learned of a cascade of serious injuries that the mesh can cause. This includes the mesh becoming embedded in nearby organs or bowels, causing serious medical issues such as perforations. Infections are another extremely common injury. As are issues resulting from the inflammatory reaction the mesh implant creates in your body.
These serious injuries have resulted in a large number of personal injury lawsuits alleging the failure to warn patients of the risks of these serious complications. Particularly in comparison to surgical repairs using native tissue or biologic mesh products.
What is a Hernia?
Hernias are basically fissures in the abdominal wall. Hernias can occur almost anywhere in the abdominal musculature. Some common types of hernias include epigastric hernias right below the sternum. Umbilical hernias pop out around the belly button. Inguinal hernias, the most common type, show up in the lower abdomen. Femoral hernias occur high on the thigh near the groin.
Once a weak spot in the abdominal wall has occurred, your intestines or even your stomach may start to protrude through this weak spot. Once a hernia occurs, they rarely go away without surgical intervention. And once an individual suffers from a hernia, the chances of suffering from another increase substantially.
How Do You Treat a Hernia?
Although hernias rarely go away without surgery, it is possible for a small hernia to become asymptomatic through non-surgical approaches like exercise and weight loss which can strengthen the abdominal wall and decrease the pressure on the abdomen. However, this is rare and is not a cure. Hernia will not go away and, in all likelihood, will get larger.
If a hernia is not treated properly, it can result in life-threatening and serious injuries such as an incarcerated hernia which is when the contents of the hernia become trapped in the weak spot of the abdominal wall resulting in the bowel becoming obstructed. In essence, this is akin to the creation of a folded knot in your bowels which prevents bowel movements and can cause severe pain.
Strangulation is when the incarcerated hernia cuts off the blood flow to the intestines leading to the death of the intestinal tissue deprived of blood flow. Strangulation is a life-threatening medical emergency and usually requires a bowel resection where the “dead” part of the intestines is removed, and the living pieces are then resected back together.
What Is Hernia Mesh?
The most common way to fix a hernia is through surgery to repair the hole in the abdominal wall. Many hernia surgeries help repair that hole by using a synthetic patch or mesh. The mesh can be made from polypropylene or other materials. Typically, it looks like a small gauze circle or like a circle of wire screen with a wide strip of ribbon tacked to the top.
Hernia mesh is intended to provide support for the weakened abdominal wall not just from the points where the mesh is sewn or attached to the musculature but from allowing the abdominal tissue to grow into pores in the mesh, anchoring it into place.
How Is Hernia Mesh Used?
In one type of hernia repair, the surgeon opens the patient’s abdomen and eases the herniated tissue back into place. Then, the surgeon folds the mesh patch in half and inserts it into the cavity between the organs and the abdominal wall. The surgeon then unfolds the mesh creating a flat piece of mesh that is usually circular. The surgeon stitches the mesh into place and sews the layers of the abdomen back together.
Theoretically, over time the abdominal tissue will grow into the pores of the mesh, securing it firmly into place. The patch strengthens the weak spot in the abdominal wall preventing the intestines or stomach from protruding through.
Does Hernia Mesh Always Work?
In short, no. Not only is a hernia mesh now associated with serious complications, but frequently this results in the hernia recurring and the mesh needing to be removed. Intestinal perforations, perforated intestines, adhesions of the mesh to the bowel, or abdominal organ punctures are the most common problems.
Infections, including peritonitis or sepsis, are also common complications that can result in mesh removal or other surgeries to treat the infection. It is also possible that your abdominal tissue may not grow into the mesh as intended.
If your hernia mesh has failed, you may feel heat and soreness or a lump around the area of the hernia. You may feel nauseated and sick or not be able to pass a stool. You may have a fever, which is often a symptom of infection. You may need another operation, and you almost certainly will need medical treatment. You may need costly emergency treatment.
The Flawed FDA Approval Process
Part of the problem lies in the FDA’s approval process. Even though many medical devices must undergo randomized clinical trials to prove the device is safe and efficacious, hernia mesh manufacturers bypassed these requirements through a loophole and were approved under the FDA’s 510(k) process.
The 510(k) process does not require rigorous safety studies and instead grants manufacturers approval to market and sell a new device if it is “substantially equivalent” to another medical device already on the market. In other words, the FDA will give its approval if a medical device is close enough to one already out on the market.
Medical device manufacturers have taken advantage of the FDA and the 510(k) process, often selecting existing devices that were not always similar to the device seeking approval. And without having undergone studies to show safety and efficacy, using a predicate device that is not “substantially equivalent” means corporations place a completely new and unproven device on the market using patients as their test subjects.
Hernia Mesh Failure and Injuries
Some hernia meshes fail to allow tissue in-growth and may degrade or shrink, creating further medical issues. Hernia mesh can also become embedded into nearby bowels or organs, causing serious injuries such as perforations.
Perhaps the most common complication relates to the coating that is frequently placed on one side of the mesh. The coating is supposed to prevent the hernia mesh from becoming embedded into nearby organs or bowels. However, the coating can degrade or be damaged by the sterilization process causing infection or allowing the mesh to become embedded into nearby organs.
How Are Patients Informed?
When a car is recalled, the auto manufacturer has to inform the car dealership or the car owners about the recall. However, unlike car recalls, this same process of warning generally does not exist with defective medical devices.
Neither the device manufacturer nor the doctor usually tells patients that there’s been a problem with a medical device. Surgeons might stop using a faulty hernia mesh patch if they hear about a persistent issue with it. Unfortunately, many patients only find out about their defective mesh after they begin to experience severe medical complications and side effects.
Although patients can check the FDA’s website for medical device recalls, they may not know which device was used in their surgery. Medical device manufacturers will also “voluntarily” and quietly discontinued or stop selling defective products before a formal FDA recall. While the medical device manufacturer avoids a recall and bad publicity, the patient suffers.
Hernia Mesh Recalls
Some hernia mesh manufacturers have already been subject to FDA warnings or recalls. These warnings and recalls have addressed two main areas: faulty devices and poor quality control.
For example, the FDA warned the device manufacturer Atrium in 2012 to work on the quality control problem with its C-Qur mesh. Specifically, surgeons and others had found human hair in the mesh — a serious sterility issue.
Ultimately, the FDA ended up filing suit to compel the manufacturer to stop producing the C-Qur mesh. As a result, Atrium issued a recall of more than 95,000 meshes.
C-Qur’s problems did not end there, though. Not only did its polypropylene material deteriorate over time, but the C-Qur mesh is coated in fish oil. This fish oil coating caused several patients to experience serious allergic reactions. Worse, these hernia mesh devices caused an alarming number of adhesions, or scar tissue cobwebbing and tangling around tissues and organs. If Atrium had tested C-Qur over time, they might have known about these effects before using unsuspecting patients as test subjects.
Moreover, Ethicon, a subsidiary of Johnson and Johnson, encountered difficulty with its hernia patch devices. The coating used for Physiomesh, the Ethicon brand, is allegedly incompatible with many patients’ bodies. Physiomesh was recalled in July 2016.
Unsurprisingly, both C-Qur and Physiomesh got approved through the fast-track FDA 510(k) process. The 510(k) requires only that a device be similar enough to one that has already gotten the official thumbs-up. Neither device received extensive clinical trials. In other words, no one really took the time to figure out the long-term effects of the materials.
Hernia Mesh Lawsuits
To date, thousands of lawsuits have been filed against hernia mesh manufacturers like Ethicon, Atrium, and Covidien, among others.
Most of these lawsuits allege the hernia mesh manufacturers failed to warn doctors and patients of the serious complications associated with their products. Some also allege design and manufacturing defects exist in these devices resulting in serious injuries to the implant recipients. The FDA’s 510(k) approval allowed these companies to fast-track these devices to the market without taking reasonable time to research the potential complications.
The device manufacturers’ negligence, the lawsuits allege, has caused needless pain and suffering. Many patients have had to endure repeated surgeries, suffer dangerous infections, perforated organs or bowels, and experience serious, life-altering pain.
Federal and State Court Hernia Lawsuits
Most of these hernia mesh lawsuits are consolidated either at the federal level or state level. At the federal level, the consolidation of lawsuits against a manufacturer is called multi-district legislation (MDL).
Multi-district litigation, or MDL, consolidates many similar individual lawsuits for pretrial purposes to save judicial resources as well as the resources of the attorneys for the plaintiffs and defendants. A large part of the discovery has focused on issues that apply to all of the lawsuits. Once the general discovery portion has been completed, the cases are then tried individually rather than jointly.
The largest hernia mesh lawsuits have been organized under several MDLs. One of the consolidated hernia mesh lawsuits, MDL 2782, focuses on Ethicon’s Physiomesh product. This MDL involves over 1,000 hernia mesh lawsuits.
MDL 2753 consolidated thirty lawsuits against Atrium Medical Corporation’s C-Qur mesh.
Suffering From Hernia Mesh Complications?
If you or a family member have been injured by a hernia mesh product, you may have the legal right to seek compensation. This compensation is in the form of medical bills (both past and future), pain and suffering, and lost income (both past and future).
The medical costs to treat complications from hernia mesh products can add up. Frequently, multiple surgeries are required. This includes doctor and hospital bills, rehabilitation, and prescription drugs. And it’s almost impossible to compensate someone for the pain and suffering they have endured and may continue to endure in the future.
A lawsuit is the only mechanism to hold medical device manufacturers responsible for the suffering they cause. Manufacturers rarely (if ever) compensate patients injured by their medical devices without being forced to do so by litigation.
If you or a family member has experienced complications related to faulty hernia mesh, it’s helpful to speak to an experienced medical device attorney. Hernia mesh cases can be complex. They require a solid understanding of medical procedures, manufacturing issues, and FDA regulations.