Many people who have had hernias needed surgery to fix the problem using a hernia mesh. These products come with side effects, including infection, adhesion and a reaction to the mesh. However, some products have a defective design which causes them to not function properly. When this is the case, the injury often turns into a lawsuit.
Defects in the Devices
When a lawsuit is filed, the attorneys for the plaintiffs argue that the devices were designed incorrectly or not tested to ensure safety. The main issues with the hernia mesh includes using the wrong material. The materials used often:
- Migrate
- Shrink or contract
- Harden
- Adhere
- Fail
The results from a defective mesh can include damage to the bowels or abdominal wall, damage to other organs and nerve damage. Often additional surgeries are necessary to correct the problem.
Another issue with hernia mesh devices is they have been marketed for uses for which they aren’t necessary. For example, they may be used in small hernias that would otherwise use laparoscopic treatment or stitches.
The challenge of the court is to determine if the injuries that occurred would not have occurred with a substitute product or another treatment option.
Injuries and Side Effects from Hernia Mesh
When the hernia is located in the abdominal wall, surgery is often necessary to correct the condition. Smaller hernias in this area can often be repaired with a different material for the mesh or without the use of a mesh device.
Synthetic mesh products pose a higher risk than biologic devices, and many of these products are taken to market quickly through a clearance process by the Food and Drug Administration called 510K. Numerous devices have been recalled.
There are hidden results that many patients aren’t aware of. They include the following:
- Coatings which are used on the mesh device and may cause a reaction in the patient or infection
- The mesh shrinks or hardens
- The mesh may detach and migrate to a different area
- Reaction to a foreign body or rejection of the device
Common side effects for patients who receive a hernia mesh include:
- Infections
- Obstructions in the intestines
- Adhesions to tissue
- Permanent nerve damage
- Recurrence of the hernia
Many times, the patient must undergo revision surgery to correct the resulting conditions and remove the mesh or replace it.
Risks of Using Hernia Mesh over Stitches
A hernia mesh is often used in surgery where stitches would work as well. The risk of choosing the mesh is the device can shrink or move over time. This situation can lead to perforations in the bowel or other organs as well as obstruction in the bowel. The risks increase if the device is faulty or if it uses polypropylene as a coating.
If the bowel is perforated, bacteria can seep into the bloodstream or other areas and cause sepsis, which can be a fatal disease.
Symptoms of complications from a hernia mesh include:
- Fatigue
- Fever
- Irritable bowels
- Constipation
- Severe pain
- Urinary problems
- Nausea
- Vomiting
- Abdominal pain
Complications can occur immediately following the procedure or within a few days. They can also take years to show up when the mesh device falls apart or causes a problem.
While there is risk involved with hernia surgery and complications can arise, they are often increased with a defective device. The product should be labeled properly with the risks and warnings clearly stated.
Multiple Devices Recalled
Numerous mesh devices from different manufacturers have been recalled. For instance, Johnson & Johnson recalled the Physiomesh, manufactured by the subsidiary Ethicon. Studies revealed a higher rate for revision surgeries with the use of this device for minor hernia repairs.
Covidien is another manufacturer that has been involved in settlement discussions for its products. One issue was with the Parietex product, which used polyester as the material instead of polypropylene. Tests were not conducted to test the safety of the product before it went on the market.
Bard has also been involved in hernia mesh issues with the Sepramesh IP Composite product, which is used in deficiency of soft tissue. It has been associated with bowel obstruction and adhesions.
Atrium C-QUR is another device that was used in small hernia repairs but has had some issues. There are two products in this line. One was for pre-peritoneal hernias and the other was for intra-abdominal repairs.
Hernia mesh products have not always been effective and may even cause more problems than what they were intended to cure. Numerous patients have suffered pain and required multiple surgeries to fix the problem caused by defective products.