There are hundreds of devices that have been deemed “defective” throughout the years. These devices range from breast implants and birth control patches to artificial hips and heart stents.
The makers of medical devices are expected to conduct rigorous testing on the products they sell. The testing performed by medical device manufacturers as well as independent doctors and scientists in clinical trials is used to determine if a device is safe enough to be used in medical procedures.
Unfortunately, there are loopholes in the system that make it possible for some medical devices to come to the market with limited testing and with no evidence that the products are safe. The problem typically stems from the 510(k) approval process that the Food and Drug Administration (FDA) allows.
The 510(k) approval process permits a medical device to be approved with minimal testing through a fast-tracked process, as long as there is a substantially similar product with approval. The approval process can occur even if the similar product has caused problems, provided that the product has not been the subject of an official recall.
The 510(k) medical device approval process may allow dangerous medical devices, such as transvaginal mesh implants as well as hernia mesh implants, into our marketplaces.