The Food and Drug Administration has received reports of many complications following hernia repair with surgical mesh associated with recalled hernia mesh products. These complaints involve pain, infection, recurrence, adhesion, obstruction, and perforation related to hernia repairs. For decades, surgical mesh has been used by surgeons to repair hernias, but many of the devices have been recalled due to defective design and manufacturing that has led to serious injuries and complications. As a result, people who have suffered injuries because of hernia mesh products are pursuing legal claims against the manufacturers.
If you or a loved one received a hernia mesh implant and experienced serious complications, you may be eligible to file a hernia mesh lawsuit. The lawsuits claim that the medical devices are defectively designed and manufactured, and the manufacturers failed to properly warn medical providers of the serious adverse complications and device failures.
Gerling Law is accepting clients who received a hernia mesh and experienced injuries and complications. We invite you to call us today so that our experienced hernia mesh lawyers can ensure that you get paid the full compensation you deserve. Contact our team of knowledgeable, dedicated attorneys to schedule a free consultation today and allow us to explain how we can help to maximize the compensation that may be available to you.
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Experienced hernia mesh lawyers will work on a contingency basis, which means there are no upfront costs. We only get paid if you receive money.
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What is Hernia Mesh?
In the most basic terms, a hernia is a hole in the abdominal wall or a weak spot in the surrounding muscles or connecting tissue (fascia) that allows the contents of the abdomen to protrude outside the abdominal cavity. This forms a lump which causes discomfort and pain. As a hernia enlarges, levels of pain can reach excruciating thresholds. The amount of discomfort a victim may feel is directly related to the hernia’s location and whether it is causing damage inside the body. The most common type of hernias is located in the groin area. The second most common type is located in the abdomen.
Mesh is a Type of Treatment for Hernias
Most hernias require surgical repair. More than one million hernia repair surgeries are performed each year, making it one of the most common surgical procedures in the United States. Generally, there are two types of surgical options to treat hernias: 1) native tissue repairs; and 2) surgical mesh repairs. Native tissue repairs involve several different procedures using the body’s own tissue. There are also multiple mesh-based hernia repairs where mesh is surgically implanted to treat a hernia. Mesh products are net-like patches made of sterile, woven material that surgeons use to act as a flexible scaffold in hernia repair to shore up and support distended muscles and tissues.
Originally, to repair a hernia, a surgeon simply pushed the bulging tissue back into place and stitched the muscles closed. Decades of research, however, showed that this type of repair was likely to lead to a recurrence of the hernia. The rationale was that the surgeons were using already weakened, thinned and damaged muscles around the hernia to repair it, so the resulting repair was not very strong.
Pursuant to a 2010 study, the concept of using a mesh product to repair hernias was introduced over 50 years ago, but it was in the late 1980s that the procedure started to gain widespread acceptance. Though early studies seemed to suggest that repair with mesh was superior to repair without it, later studies have produced mixed results. In 2016, the scientific journal JAMA< published a study that followed 3,242 patients who went through hernia repairs from 2007 to 2010 and compared outcomes with and without hernia mesh. Results showed that, though the use of mesh was associated with a lower risk of hernia recurrence, the benefits were offset by other mesh-related complications, many requiring additional surgeries.
Types of Surgeries Used to Repair Hernias
There are four types of surgeries used to repair hernias:
- Laparoscopic extraperitoneal repair
- Laparoscopic transabdominal preperitoneal patch repair
- Open tension-free mesh repair
- Open primary tissue approximation repair
The first three all require the use of surgical mesh to repair a hernia. The hernia meshes implanted to repair a hernia can vary by brand and type.
Manufacturers of Common Types of Hernia Mesh Implants
Atrium Medical Corporation C-QUR, C-QUR hernia mesh is made from the same synthetic plastic material as that used in Physiomesh, but it has a different coating on it. The product was recalled in 2013 after reports indicated it could stick to the inner packaging liner during shipping and storage, particularly when exposed to high humidity. A total of about 32,000 products were removed from the market worldwide. Though this recall has not been connected to patient injuries, other studies have shown that C-QUR was associated with an increase in adhesions and infections. In 2015, the District Court of New Hampshire entered a permanent injunction against Atrium, preventing it from manufacturing and distributing C-QUR, but Atrium has produced other variations of the product that are still on the market.
Covidien – Parietex, manufactured by Covidien, a Medtronic company, Parietex is made of polyester rather than polypropylene. There were several problems with the initial product, so the company has put it through a number of revisionary designs. It is extremely lightweight, however, which has made it difficult for surgeons to place it correctly. It has unsealed edges, which can perforate the bowel and other organs, and may lead to fraying and tearing. The mesh also tends to contract and shrink. Though there has been no Parietex recall, the product is the subject of lawsuits in which patients seek to hold the company liable for serious injuries.
C.R. Bard – Kugel, manufactured by Davol, a C. R. Bard company, Kugel mesh was initially recalled because of problems back in 2005 because it was associated with complications like pain, infection, hernia recurrence, and adhesion. The company updated the design but was recalled again in 2006 and 2007 because of breakage and bowel perforations. Thousands of lawsuits were filed nationwide, and the company has paid out millions of dollars in lawsuit settlements and verdicts. Other brands of Bard mesh linked with complications include the 3DMax, Sepramesh, and PerFix.
Ethicon–Physiomesh, this mesh was initially advertised as being superior to other meshes because of its unique 5-layer design, which was supposed to encourage incorporation into the body. Instead, it caused fluid buildup that increased the risk of infections and was also prone to migration and shrinkage. In May 2016, Ethicon released an urgent field safety notice telling doctors and hospitals to stop using thePhysiomesh because recurrences and reoperation rates after laparoscopic hernia repair were higher than the average rates of comparative mesh products. Proceed, another Ethicon mesh device was also recalled in 2005. Johnson & Johnson issued a voluntary hernia mesh recall of the products in 2016.
W.L. Gore & Associates – Gore-Tex DualMesh, is made by the company well-known for making waterproof, breathable material called Gore-Tex. Gore-Tex DualMesh is still on the market and still causing serious complications in patients.
Although Ethicon’s Physiomesh Composite Mesh product was voluntarily recalled in 2016 by Johnson & Johnson, all other products are currently still available for hernia mesh repairs in the United States.
What’s Wrong With Hernia Mesh?
Patients who have been implanted with hernia mesh products and then experienced problems have reported injuries including the following:
- Adhesion, where the mesh sticks to internal tissue (more common with meshes that are coated),
- Erosion of the implant device, which can cause fever, infection, pain, and nausea,
- Abdominal pain, which is often accompanied by nausea and associated with adhesion to the abdominal wall, bowel obstruction, nerve damage, and infection,
- Bowel or intestinal obstruction, where the mesh has migrated and/or adhered to the tissue, preventing proper use of the bowels and leading to subsequent diarrhea or constipation,
- Infections, which is often accompanied by severe headaches, fever and sweating, and can lead to sepsis (more common with meshes that are coated),
- Migration, where the mesh moves from its original site of implantation,
- Perforation of organs or tissues, which often occurs after the mesh erodes, shrinks, or otherwise gains the ability to migrate – some patients need to get colostomies or partial removal of their bowels,
- Seromas, where fluid collects under the surface of the skin and can be accompanied by an infection,
- Chronic pain throughout bodily tissues and joints, which can be associated with many other complications caused by mesh failure and ensuing inflammation,
- Mesh failure, where it overall fails to do what it was intended to do and requires mesh removal,
- Recurrence of the hernia following mesh surgery, which often requires additional intraperitoneal or inguinal surgery,
- Groin and testicular pain, which could also lead to testicle removal from damage to the spermatic cord,
- Delayed and/or long-term consequences, which can surface many years after the implant, far longer than any hernia mesh studies or clinical trials took into account,
- Cancer, which can develop from infected mesh (learn more about hernia mesh and cancer),
- Hernia mesh revision surgery made necessary by the failure of the original implant at the incision site,
- Fistula formation, and
- Many other complications and injuries, including a rash, renal failure, liver problems, autoimmune disorders, neurological changes, dental problems, or dyspareunia (painful sex), depending on your specific case
Hernia Mesh Lawsuits
Plaintiffs claim that hernia mesh manufacturers knew about the problems associated with their products, including the inflammatory properties of the materials, yet failed to provide adequate risk warnings on the labeling or in related product materials. They also claim the companies failed to adequately test the products in clinical trials before releasing them on the market. Hernia mesh lawsuits claim the devices caused injuries or complications so severe that people had to have additional surgeries.
As of October 2020, there were 14,900 hernia mesh lawsuits pending against Ethicon, Atrium and Bard Davol in three separate multidistrict litigations, or MDLs. None of those cases had gone to trial. Individual lawsuits not currently in an MDL include cases against the manufacturer Covidien over its Parietex mesh. Medtronic is also a named defendant in these cases because it bought Covidien in 2015.
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Contact a Lawyer at Gerling Law Today to get Help with your Hernia Mesh Case
The number of lawsuits concerning hernia mesh products continues to grow. If you or a loved one was implanted with hernia mesh and experienced serious complications, you may be eligible to file a hernia mesh lawsuit. Gerling Law is now investigating these cases and invites you to call today. When you call, we will ask you to provide the following information:
- The date of your hernia surgery and any revision surgeries,
- A list of your symptoms and complications, and
- If you know it, the manufacturer and model of your mesh device. If you are unsure about the specific mesh manufacturer and brand used in your surgery and have questions about your hernia repair, contact your surgeon or the facility where your surgery was performed to obtain the information from your medical record.
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