A hernia is the protrusion of bodily tissue, such as part of an intestine, another organ, or fat tissue, through a weak spot in the muscle or other tissue that ordinarily holds it in place, usually as a result of some type of straining or pressure, such as coughing, sneezing, constipation or diarrhea or lifting a heavy object.
A Common Condition and Commonly Performed Surgery
Hernias are quite common and can be repaired surgically. More than a million hernia repair procedures are performed annually in the United States. About three-quarters of these are inguinal hernias, which are located in the groin area. An “innovation” in hernia repair, beginning in the 1980s, is the use of a product called surgical mesh, inserted into the body where it is meant to provide reinforcement at the site of the hernia. The mesh can be derived from animal tissue, or it may be made of synthetic material. Animal tissue mesh is absorbed by the body, but some types of synthetic mesh remains in the body indefinitely. This type of “patch” is considered a permanent medical implant. Synthetic surgical mesh has been marketed for hernia repairs for several decades, but it is a potentially dangerous product, which has caused untold amounts of suffering.
Symptoms of Surgical Mesh Gone Bad
A patient who has had surgery to repair an inguinal, ventral, umbilical or other types of hernia in which the surgeon used a mesh product may have serious complications, some not appearing for several years after the mesh was inserted, causing some nasty and potentially life-threatening symptoms, including:
- Nausea and vomiting
- Organ perforation
- Internal bleeding
- Recurrence of hernia at the repair site
- A lump or hematoma forming around the site of the surgery
- Adhesions and scar tissue
- Damage to tissues surrounding the mesh implant
- Burning sensation at the repair site
- Intestinal kinks
- Severe constipation
- Total blockage of the intestine
- Erosion through the intestinal wall, causing bowel contents to leak out
- Liver damage
- Neurological problems
- Dental problems
- Body rash
When these symptoms occur, it may be necessary to undergo more surgery to remove the mesh.
The Manufacturer’s Duty to Do No Harm
When a manufacturer designs and manufactures a medical device, they have a moral and legal responsibility to test it thoroughly to determine that it is safe for use in humans before it is placed on the market. Although in theory the U.S. Food and Drug Administration is charged with oversight, they often rely on the data provided by the manufacturer when approving a device or drug. The clinical studies are typically done in a fairly short period of time, often not long enough for dangerous defects to appear, resulting in premature approval of an unsafe product. There have even been cases where research data regarding a medical device was falsified in order to get quick approval. Some of the hazardous mesh products were approved through the FDA’s controversial 510(k) approval system, which allowed some medical devices to be put on the market without first requiring rigorous clinical research to determine their safety.
Inadequate Testing is Often to Blame
If clinical trials are adequate in length and performed ethically and honestly, a manufacturer will typically have some indication of a potential problem; however, the longer they take getting their product to market, the longer it takes for the profits to start rolling in, so overlooking potential problems or terminating trials after a matter of months may appear to be in the company’s best interest. To put it bluntly, greed for profits may supersede concern for patients’ well-being.
Thus, defective and dangerous medical devices are released on a trusting and unsuspecting public, who may suffer serious consequences as a result. Victims of this unconscionable corporate greed may be able to recover money as compensation for their damages in a product liability lawsuit against the manufacturer and others along the chain of distribution.
Specific Products that May Have Caused Your Illness and Pain
These and other mesh products used in hernia surgery could be responsible for your post-surgical illness and suffering include:
- Atrium C-Qur® Hernia Mesh
- Ethicon Physiomesh® (a subsidiary of Johnson & Johnson)
- Novus Scientific TIGR® Matrix Surgical Mesh
- Bard Ventralex® Hernia Mesh
- Bard 3DMax® Hernia Mesh
- Davol Sepramesh® Hernia Mesh
Contaminated Counterfeit Mesh Distributors
Another cause of patient complications related to surgical mesh was not caused by the manufacturer. but by certain distributors of mesh products who distributed counterfeit mesh that was not sterile and therefore unfit for use. Those distributors include:
- Q-Med Corporation
- Amerimed Corporation
- Marathon Medical Corporation
- Medline Industries
- MMS-A Medical Supply Company
- RAM Medical
What You and Your Attorney Will Need to Prove
Product liability cases involving medical devices are often difficult and complex. You will need an attorney with significant experience in pursuing these demanding legal cases. With your attorney, you will try to show that the designer, manufacturer, or distributor of the mesh:
- Failed to do sufficient or adequate research before marketing their hernia mesh patch
- Failed to investigate reports of problems experienced by mesh implant patients
- Failed to promptly recall a hernia mesh product after problems materialized
- Failed to warn doctors, patients, and the public about the dangers of the product
- Misrepresented the safety of the mesh product
In addition, you will need to show that you suffered damages to your health and wellbeing as a result of your surgeon implanting the mesh, in the condition it was purchased, as a part of your hernia repair, and that the mesh was the actual and proximate cause of your damages. If you are going to have surgery to remove the mesh, make sure the surgeon does not dispose of it and returns it to you as evidence in support of your claim.
Get the Legal Help You Need when Suffering from a Mesh Implant
If you or a member of your family underwent hernia surgery in which a surgical mesh product was used, you may have a claim to recover compensation for your economic (medical bills, lost earnings, etc.) and non-economic damages (pains, suffering, disability loss of enjoyment of your life, etc.).
Join Others Suffering Similar Harm
You are not alone in your suffering. Mesh products have harmed many unsuspecting surgical patients. For this reason, they are usually best pursued as mass tort cases involving multiple claimants who have suffered from problems similar to yours.
At Rosenberg & Gluck, LLP, our attorneys have substantial experience in handling mass tort cases that involve dangerous medical devices, hazardous pharmaceutical drugs, and other defective products. These complex and labor-intensive litigations require commitment, diligence, and access to top medical and other professionals to provide analysis and offer expert testimony in support of these demanding cases. Contact our office today and tell us your story. We will give you honest and straightforward answers to all of your questions and discuss your legal options with you. It costs you nothing upfront and nothing out-of-pocket until you win money. You have nothing to lose, but you have much to potentially gain. You will pay no legal fees or expenses until the case has been settled in your favor. Hold greedy medical device manufacturers accountable for the suffering they have caused. Call Rosenberg & Gluck today.