Side effects of this medical innovation include:
- fluid buildup at the surgery site
- organ perforation
- nerve damage
- mesh migration and/or rejection
- bowel obstruction
Over 100,000 hernia meshes are implanted in the United States on an annual basis. Unbelievably, some of the most popular meshes used in hernia repair remain on the market despite known adverse reactions. The cause of these complications varies widely depending on the particular product used in each surgery. Many of these products are made from polypropylene plastic, which is not suitable for permanent implantation because it causes adhesion, inflammation, infections, and erosion. This is the same material that caused so many problems when used for transvaginal mesh implants. In fact, the Polypropylene Material Data Safety Sheet classifies permanent implantation into the human body as a prohibited use of this material.
Why are meshes made with this plastic still on the market? Why are they in continued use? Instead of creating better hernia meshes, pharmaceutical device manufacturers tried coating the polypropylene. And rather than conduct extensive testing, research, and clinical trials for Pre-Market Approval, manufacturers were able to use the FDA’s 501(k) process, whereby a new medical device is excused from the rigors of pre-market testing by virtue of its similarity to products already on the market. Many of the above-mentioned side effects could have been avoided had doctors and patients been properly informed of the complications associated with hernia mesh, particularly those made from polypropylene plastic.
Defective devices like these are why we challenge pharmaceutical companies and seek to hold them accountable for the life-changing harm their products can cause. We do this with expertise and confidence that produces results. If you underwent a hernia repair and continue to suffer from the mesh that was supposed to be the solution to your suffering, there is help available for you. If you experienced any of the side effects listed, consult your physician right away. For help with your legal options, call Baron & Budd at 866-829-0176 or complete our contact form.