What year was hernia mesh used?


Hernia mesh has been around since the late 1950s. It was patented in 1959 which was 17 years before the FDA required rigorously testing of medical devices and products. In 1976 the Medical Device Amendments were passed giving the FDA authority to require testing and ensure the safety of medical devices before releasing them to the market. New products that were substantially similar to a product already on the market before 1976 are released to the market without additional safety testing. Modern mesh products are released to the market in this way without the FDA's requirement for rigorous safety testing. Although it was availeble long before there was not to much interest in mesh until the early 1990's. This was around the time of the birth of moderm laparoscopic surgery. There was a sudden and dramatic surge in the interest in technology advances in surgery. Mesh was swept up in this fever, was heavily promoted by manufacturers and caught on big time. But this new mesh was the same as the old mesh. It was released to the market by the FDA with out additional rigourous safety testing. Currently it is implanted in about 1 million hernia patients in the US every year.



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