Is The FDA Appropriately Addressing Hernia Mesh Problems?
Hernia mesh problems are gaining more visibility as more adverse event reports are being submitted to the FDA and lawsuits are beginning to stack up. The safety of these products is under question, and it has patients and physicians wondering if the FDA is doing enough to address these problems to prevent further issues from occurring.
What is Hernia Mesh?
Hernia mesh is a medical device designed essentially as a patch to repair a hernia, which occurs when organs bulge through the weak spot in muscles or tissue. Hernias may appear in a number of locations in the body, such as in the abdomen, above the belly button, in the groin, the upper thigh or at an incision site.
The mesh is made of a number of materials but the most common is a polypropylene, which according to its MSDS (Material Safety Data Sheet) may be the source of some of these issues. The MDSD states under “Prohibited Uses” it should not be used in “Applications involving permanent implantation into the body.” Some of the mesh products also have a gel coating that is supposed to help but may actually be contributing to issues.
Common Hernia Mesh Problems
A number of problems have been reported, including, but not limited to the following:
- Abdominal pain
- Autoimmune conditions
- Bowel obstruction
- Mesh contraction
- Mesh migration
- Mesh shrinkage
- Organ perforation
- Painful intercourse
Hernia Mesh Problems and the FDA
Last year, the FDA issued a statement about hernia mesh and reported the following about hernia repair surgery complications:
“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.”
While a number of the mesh products have been recalled, or withdrawn from the market without a recall in some cases, reports continue to be submitted to the FDA about products that are still currently in use, and hernia mesh problems have not ended with the recalls that have already taken place.
Each time a lawsuit is filed over hernia mesh problems, the manufacturer of the hernia mesh must notify the FDA that a lawsuit was filed and note the basis for filing. If a surgeon notifies the hernia mesh manufacturer, the manufacturer has some discretion as to what is reported to the FDA, so these incidents may be underreported. The process for surgeons to report to the FDA is reportedly quite time-consuming and it is also suspected that this kind of fling is underreported.
Filing a lawsuit that triggers an FDA report regarding hernia mesh problems or filing a MedWatch report are the only ways that reports are directly made from patients to the FDA. Filing a lawsuit over hernia mesh problems also serves to send a strong message to the manufacturer that patients demand safety and transparency in medical products, and can help bring about justice apart from waiting for the FDA to intervene.
If you’ve suffered from hernia mesh problems, contact the attorneys at McDonald Worley for a FREE case evaluation.