What Is a Hernia?
A hernia occurs when an organ or fatty tissue moves through a weakened location in a muscle or connective tissue. Hernias are usually seen in the abdominal wall. In some cases, a hernia is visible as an external bulge, which occurs when bearing down or straining. Hernias are typically caused by both pressure and a weakness of the muscle or connective tissue. Being overweight, lifting heavy objects, having diarrhea or constipation, and chronic coughing or sneezing may lead to an increase in abdominal pressure. Poor nutrition, smoking, and overexertion may weaken muscles.
Surgery is the only option available to repair a hernia. Laparoscopic surgery involves small incisions in the abdomen; open repair surgery involves a larger incision near the hernia. Hernia mesh may or may not be used in either procedure. When sutures fail and the hernia recurs, the hernia is usually re-stitched. But when mesh fails and the hernia recurs, severe complications can occur.
What Is Surgical Mesh?
Surgical mesh is a medical device used to give support to weakened or damaged tissue. The mesh, usually made from synthetic materials, is implanted to provide permanent reinforcement. The larger a hernia is, the likelier it is that mesh will be needed for repair. There are more than 50 different hernia mesh products on the market today.
However, mounting lawsuits allege that hernia mesh does not work as intended and is often associated with serious complications, including attaching to and damaging surrounding tissues and organs. The hernia mesh lawyers at Parker Waichman LLP are here to support those who have suffered injuries due to hernia mesh, offering experienced representation at no out-of-pocket cost to clients. If you’ve been harmed by hernia mesh side effects, call us today for a free consultation.
What Are the Symptoms of Hernia Mesh Failure?
Symptoms of hernia mesh complications include:
- Abdominal pain, which may signal adhesion formation, bowel obstruction, infection or nerve damage
- Abnormal sweating, a symptom of an autoimmune response or an infection
- Autoimmune disorders
- Constipation, a symptom of bowel obstruction
- Dental problems, including tooth loss
- Diarrhea
- Dyspareunia (painful sex), typically caused when the mesh attaches to the spermatic cord
- Fever
- Fistula, an abnormal tunnel between two body structures
- Hernia recurrence
- Infection
- Joint pain caused by inflammation due to infection
- Leg, groin, and testicular pain
- Liver abnormalities
- Meshoma, a migration, contracture or bunching of the mesh that may become a hard, tumor-like mass
- Nausea
- Neurological changes
- Rashes
- Seroma, a fluid capsule surrounding the mesh
- Renal failure
- Severe headache
Hernia mesh often leads to life-threatening complications, including erosion of the bowel, an injury that requires multiple additional surgeries, weeks of hospitalization, partial bowel removal, and colostomies. Mesh failure also often causes patients to experience systemic infection that include high rates of dental infections. Many patients report that all of their teeth abruptly rotted.
FDA Fails to Act
An FDA review of medical adverse event reports revealed that pain, infection, hernia recurrence, adhesion, obstruction, and perforation are the most common complications associated with hernia mesh. Yet despite these all-too-common risks, it is the opinion of many that the FDA continues to approve more hernia mesh products without adequate testing.
Many hernia mesh products have been found to be defective, significantly harming thousands of people nationwide, this has led some to criticize the FDA for being slow to take action. Manufacturers of hernia mesh are aware of the life-threatening complications the mesh may cause, but have been accused of not warning the public or surgeons. And many of what are considered the most dangerous hernia meshes remain on the market and have not been recalled by the FDA. In many cases, only a hernia mesh class-action lawsuit can push manufacturers into pulling these dangerous medical devices from the market.
Manufacturers Skirt Safety Rules With Materials
Many hernia mesh products contain a type of plastic called polypropylene. Polypropylene is used to make many non-medical devices, like fishing line and soda bottles, and it’s also used to make many types of implantable products, such as pelvic mesh and bladder slings. It’s an inexpensive material, but it can lead to damage on the surface of any bodily organ it reaches. In fact, the material safety data sheet for this material cautions against permanently implanting it into the body.
When a hernia is repaired with mesh in a laparoscopic procedure, the mesh may be implanted deeper into the abdominal cavity than it should be, which causes the mesh to come in contact with the bowel. When polypropylene comes in direct contact with the bowel, severe complications often occur.
To gain FDA pre-market approval (PMA), which could help a device maker protect itself from lawsuits, manufacturers would have to conduct studies to prove that the hernia mesh was safe. Instead, manufacturers began applying different coatings to the mesh to create a layer between the bowel and the polypropylene, creating what is known as a composite mesh. The FDA requires barrier-type medical devices such as these to undergo studies to ensure device safety, too. But instead of conducting safety studies, the coated hernia mesh makers advised the agency that they would not promote their mesh as a barrier, skirting this requirement.
But manufacturers of hernia mesh products have funded studies to show a lower rate of hernia recurrence when hernia mesh is used. However, the studies did not discuss the length of time that patients were monitored following mesh implantation and what were considered normal complications.
Most types of mesh used in hernia repairs today are untested composite meshes that have been on the market for only a few years and have little or no reliable safety data. Mesh products are now one of the most profitable medical devices manufacturers make, with many netting more than $100 million annually. Composite mesh also sells for about 15-20 times more than uncoated polypropylene mesh. Many device manufacturers have rushed to bring composite mesh onto the market, often selling several different types of composite hernia mesh simultaneously; therefore, if one type of composite mesh caused too many side effects, the company would simply stop making that particular product.
Hernia Mesh Injury Reports: Which Products Have Been Recalled or Prompted Lawsuits?
Many different hernia mesh products manufactured by different medical device companies have been the subject of lawsuits and/or been recalled by their manufacturer. Hernia mesh devices that have been the focus of a large number of complaints include:
Covidien/Medtronic
- Parietex
- Parietex Composite Mesh
- Parietex ProGrip/Parietex Plug and Patch System
Atrium/Maquet/Getinge Group
- C-Qur Hernia Mesh
Davol/C.R. Bard
- Kugel Hernia Mesh
- 3DMax
- PerFix Plug
- Ventralex ST Hernia Mesh (Sepramesh)
Do I Qualify for a Hernia Mesh Lawsuit?
Common complications after hernia mesh surgery include excruciating pain, infection, organ puncture, bowel perforation, and mesh migration: If you have experienced any of these serious complications after a hernia mesh surgery, a lawsuit may be able to help you recover damages. Experienced hernia mesh attorneys with our firm can help you find out if you’re entitled to compensation.
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