A recent study published in the Journal of the American Medical Association found that hernia mesh surgery patients could be at risk for complications they would not otherwise have had, including abscesses, bleeding, bowel obstruction and bowel perforation.
The study looked at records from more than 3,200 patients who underwent hernia repair surgery in Denmark from 2007 to 2010. Some of the surgeries used hernia mesh while others did not. Researchers found a number of mesh complications five years post-surgery in 5.6 percent of the patients. For the patients who had non-mesh repair surgery, just 0.8 percent experienced any complication from the procedure.
The study noted that all the risks and benefits of hernia mesh surgery are not known because of an expedited FDA process known as the 510(k) process, which fast-tracks approval for new products that are similar to other products already on the market. Under the expedited process, FDA approval is granted without rigorous clinical trials that could unveil potential risks.
In 2016, an expedited approval product from Johnson & Johnson’s Ethicon unit called Physiomesh Flexible Composite Mesh was withdrawn from the market after a high number of reports of complications from the product. It had been on the market for six years prior to its voluntary removal.
Among the complaints from patients implanted with the Ethicon mesh were reports of bacterial infections, pain, swelling, adhesions and migration of the mesh to other parts of the body. In some instances, patients had to undergo a second surgery to repair the complications or the recurrence of their hernias.
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