Table of Contents
- 1 Overview
- 2 Role of Surgical Mesh in Inguinal Hernia Surgery
- 3 Types of Hernia Mesh
- 4 Pros and Cons of Surgical Mesh in Inguinal Hernia Repair
- 5 Causes of Hernia Mesh Failure
- 6 Complications of Hernia Mesh Failure
- 7 Hernia Mesh Lawsuits
- 8 Damages covered in the Lawsuit
- 9 FDA Regulations in Hernia Mesh
- 10 Final Thoughts
A soft lump in your belly or groin. It may go away when you press on it or lie down. It may leave you in pain when you cough, stoop or lift something heavy. That’s a hernia in a layman’s term.
An organ, intestine, or fatty tissue when shoved through a hole or weak area in the surrounding muscle or connective tissue, is called a hernia.
- Indirect Inguinal Hernia
- Direct Inguinal Hernia
- Incarcerated Inguinal Hernia
- Strangulated Inguinal Hernia
Hernias occur due to weakened muscles that may be congenital or repeated physical strains on the abdominal and groin areas. Obesity, pregnancy, frequent coughing, or constipation may cause exertion.
When left untreated, inguinal hernias may enlarge and may even cause death of the individual. There are many strategies of hernia management like watchful waiting, muscle strengthening exercises and surgical repair. The choice of treatment relies on the type, severity and location of the hernia and the general health of the individual.
Surgical repair is the most followed and effective method in hernia treatment. Surgery may be performed through an Open Inguinal Herniorrhaphy, Laparoscopic Inguinal Herniorrhaphy or Robotic-Assisted Inguinal Hernia Repair. These approaches of hernia surgery vary in the type of incision made in the surgical site and the mode of repair.
Role of Surgical Mesh in Inguinal Hernia Surgery
A hernia mesh is a flat sheet of prosthetic material used in hernia surgery. This mesh to repair hernia is incorporated into the surgical site and later attached by stitches, surgical glue or staples. There are minute pores in the mesh which allows the tissues to grow into it. This condition creates scar tissues, thereby providing either temporary or permanent support to the damaged tissue around the hernia.
Surgical mesh in hernia surgeries has become more common since the 1980s. Over 1-million hernia surgeries are performed every year in the United States. According to U.S. Food and Drug Administration (FDA), more than 90% of the hernia surgeries in the US make use of hernia mesh.
Types of Hernia Mesh
Based on the type of origin, two types of hernia mesh devices are currently available in the market.
Nylon was the first synthetic material used in hernia mesh. Nylon loses strength over time and it is very susceptible to infections. This led to the usage of other synthetic materials like Polypropylene (PP), polytetrafluorethylene (PTFE), and Polyester (POL)
Synthetic hernia mesh may be in the form of a knitted or non-knitted sheet. It may be absorbable, non-absorbable, or a combination of both. It may be permanent inside the body or may be designed to degrade over time.
It is also called as animal-derived hernia mesh as it is produced from the intestine or skin of pigs and cows. Biological meshes undergo a series of disinfection and processing before they are used for hernia repair.
Based on its nature, hernia mesh are of two types
Absorbable meshes are temporary and lose its strength over a period of time. By the time the mesh degrades, new tissue growth provides strength to the surgical area. Animal-derived meshes are absorbable in nature.
Non-Absorbable meshes are permanent and do not degrade. It provides lasting support to the repair spot. Some types of synthetic hernia meshes are non-absorbable in nature.
Based on the design, hernia mesh may be classified as follows
Patches are designed to go over or under the weakened tissue
Plugs are designed to fit precisely inside the incision in the damaged tissue
Sheets can be customized to fit a patient’s hernia site.
Pros and Cons of Surgical Mesh in Inguinal Hernia Repair
According to the FDA, hernia surgeries implanting surgical meshes are reported to have the following advantages and disadvantages.
- A reduced hernia recurrence rate
- Decreased operative time
- Minimized recovery time
- Pain and infection
- Recurrence of hernia
- Bowel obstruction
- Mesh migration
- Mesh shrinkage
Causes of Hernia Mesh Failure
- When the material used in the hernia mesh is too heavy with large pores, it would easily cause infection after it is implanted into the site of hernia.
- Due to defects in product design, hernia mesh may shrink or migrate which makes the surgical site weak and causes recurrence of the hernia.
- In some cases, the hernia mesh may not support tissue growth after implantation which may make the surgery a failure.
- Poor quality of the hernia mesh may make it break after implantation which in turn may lead to complications in the patient.
- Some manufacturers use low-quality material in hernia mesh which triggers an immune response in the patient causing pain and inflammation.
Complications of Hernia Mesh Failure
The consequences of a hernia mesh failure are often catastrophic for the patient. Hernia mesh failure may lead to severe pain, inflammation and swelling of the surgical site in the patient. Imaging studies like MRI scans and X-rays could help in diagnosing a hernia mesh failure. The complications may occur immediately or few days after the surgery.
In some instances, the complications of the hernia mesh failure would be more devastating for the individual than the hernia itself. Complications caused by a defective hernia mesh often lead to surgical removal of the mesh through a procedure called hernia mesh revision surgery.
Hernia Mesh Lawsuits
One of the most effective ways to hold a negligent manufacturer liable for hernia mesh failure is to bring a hernia mesh lawsuit. The claim could be pursued through the legal opportunities for product liability. Product liability claims for hernia mesh may involve factors like citing defective design, manufacturing defect, or failure to warn.
The lawsuits would establish that the implant devices were defectively designed by the manufacturer. The manufacturer had failed to warn patients about the known and foreseeable risks and side effects of the product.
A hernia mesh lawsuit is usually filed as part of multi-district litigation (MDL) where similar victims sue the same defendant in a federal court. In a mass tort MDL, each plaintiff files an individual claim against the defendant.
Damages covered in the Lawsuit
The below-mentioned damages are covered for hernia mesh failure lawsuits.
- Economic damages:
- Current medical expenses
- Future medical expenses
- Loss of income
- Loss of future earnings
There is no cap on economic damages for hernia mesh failure lawsuits. It should be noted that the total sum of your economic damages is the total sum of the compensation owed under this type of damages.
- Non-economic damages:
- Loss of quality of life
- Pain and suffering
- Emotional distress
- Mental anguish
- Loss of consortium
The compensation for non-economic damages is usually determined by the severity and the extent of damage caused to the individual, the extent of disability, time for recovery and the medical prognosis.
- Punitive damages
Punitive damages are obtained when the manufacturer is found to be negligent and in such damages prevent the manufacturer from committing further negligent actions.
The highest settlement in a hernia mesh lawsuit would be given to individuals who have undergone a hernia mesh revision surgery.
There are two types of settlements in a hernia mesh lawsuit. They are
- Global settlement – where the hernia mesh manufacturer gathers all the plaintiffs’ law firms together and provides a collective settlement.
- Inventory settlement- where the manufacturer reaches each plaintiff and individual deals are given.
Companies like Bard/Davol, Ethicon/Johnson & Johnson, Atrium, and Covidien are the main hernia mesh manufacturers facing lawsuits over their hernia mesh products. C.R. Bard paid $184 million in 2011 to settle over 3,000 hernia mesh lawsuits, making it the highest hernia mesh litigation settlement to date.
FDA Regulations in Hernia Mesh
FDA approves and monitors all the hernia mesh products reaching the US market. For hernia mesh, FDA follows the 510(k) clearance process. The manufacturer has to prove that there is another equivalent device on the market and their product is safe to the consumers.
FDA has monitoring strategies like the adverse event reporting system to identify issues associated with a hernia mesh. If a particular product is reported to have failure reports, it is recalled. If the manufacturer rectifies the issue, the recall is removed and the device returns to the market. However, the device is permanently recalled if the error is unfixable.
Some of the serious complications due to hernia meshes have often caused recalling of many hernia mesh brands from the market. From 2005 to March 2018, hernia mesh manufacturers recalled about 211,000 units of faulty mesh. In May 2016, Ethicon’s Physiomesh Flexible Composite Mesh was removed from the market after it was studied to have higher than usual rates of reoperation and hernia recurrence.
In the state courts in Georgia, New Hampshire, and Ohio, there were 17,134 cases pending against Ethicon, Atrium Medical Corp., and Davol Inc. /C.R. Bard as of March 15, 2021. This is just the tip of the iceberg of the existing hernia mesh failures.
In case of any symptoms or discomfort after hernia surgery, the individual should immediately seek medical care. This may help him in any claims that may be filed if the problem is due to a defective hernia mesh.
However, some complications like testicular torsion post hernia repair surgery are mistakenly associated with the hernia mesh. A detailed medical record review of the plaintiff would reflect if the complications are hernia mesh dependent or independent.