Recent critics of the FDA have called into question its process for reviewing medical products. They state that the FDA's use of the 510(k) review process, which allows products to pass as long as the manufacturer can show that the product is significantly similar to another product that has already been approved. It has been estimated that 71% of products are approved in this way.
The number of recalled medical products are proof, say the critics, that this process of review is not working. Devices such as insulin pumps, neurological devices like shunts, and anesthesiology devices make up a huge portion of products recalled each year. Defective products such as these are extremely dangerous and can cause serious harm, and even death, to patients.
The FDA, as well as the Institute of Medicine, are currently evaluating the 510(k) process to prevent future faulty devices from being approved.
If you or someone you love has suffered injuries from a defective medical device, please contact the Kenosha defective medical product attorneys of Habush Habush & Rottier S.C. ® at 800-242-2874.