A hernia, which occurs when tissue pokes through a hole in a weakened spot in the body, is a serious condition. It can vary from a slight inconvenience to a nearly debilitating injury, resulting in pain and discomfort.
Hernia mesh products are not required to have labels on their packaging. Manufacturers use their own discretion to decide what’s on the labels, which can result in insufficient information that varies by product.
What are the main issues with labeling for hernia mesh repair?
In some cases, the mesh may be necessary to patch a hernia and provide support for the hole in the tissue. While meshes are effective when used correctly, surgeons and doctors run into trouble when it comes to picking the right mesh.
There is no standard of labeling on mesh packaging, which means many key details are not included in the Instructions for Use (IFU). Most products require opening the mesh to see the details, which is highly impractical when making a health care decision.
In addition to poor labeling, doctors also have a limited amount of choice in their mesh that they use since meshes are selected contractually by hospital. They’re also consistently under-educated about mesh types and options through a mix of ignorance and lack of options.
Why is it important for doctors to understand hernia mesh types?
A study, published in the General Surgery News report, conducted by Dr. Jeff Blatnik and Brown University student Lindsey G Kahan found that information such as pore size, the most important characteristics of meshes, was rarely mentioned on the packaging, although it was found on the IFU. This information is vital to know whether the synthetic mesh has a barrier (a component that helps prevent adhesion) or if the mesh has inappropriate pores for the surgery.
In fact, in Blatnik and Kahan’s study, it was found that some meshes were even classified as “macroporous” or having a mesh with pores too large to even be called a mesh according to the European Hernia Society.
Doctors recommend including specific information on the exterior of packaging, such as:
- Pore Size
- Barrier Presence
- Biomechanical Properties
What are the main hernia mesh complications?
Some doctors feel there is no excuse to choose a mesh that harms patients. “They still should be aware of the basic properties of what they are putting into a patient” says Dr. Ajita Prabhu, a practitioner at Cleveland Clinic in Ohio.
Hernia mesh side effects can be very serious, especially if you notice these five signs that you may be having hernia mesh complications. There are a number of side effects from failed mesh, including:
- Pain in and around the area
- Infection of surrounding tissue
- Returning Hernia
- Adhesion of the mesh to intestines
- Bowel Obstruction
- Intestinal Perforation
Although a simple step, labeling meshes may spark standardization and labeling requirements for meshes across the medical field. Unfortunately, many companies want meshes unstandardized for fear that standardizing may prove their product inferior to others.
If this movement does gain strength, Food and Drug Administration oversight may be implemented to hold companies accountable for providing a measurable standard of effectiveness and reliability, protecting the consumer and ensuring there are fewer complications in the future.