The first Trans vaginal mesh recall took place in 1999, due to the safety concerns and adverse effects of ProtoGen. ProtoGen was first manufactured by Boston Scientific in 1996. After the release of ProtoGen in the market, other companies started manufacturing similar products by relying on section 510(k) that is part of the Food, Drug and Cosmetic Act. This act allows a product in the market, which is similar to an already approved product.