Just as for prescription drugs, the U.S. Food and Drug Administration (FDA) is charged with regulating medical devices and ensuring they are safe for consumers. However, the medical device industry is a billion dollar business, and has increasingly gained power over the FDA in recent years. Companies are eager to get new devices onto the market as quickly as possible, and the FDA is under increased pressure from manufacturers to speed up the approval process and lessen regulation of these devices.
In order to sell their products to patients and hospitals as soon as possible, medical device manufacturers may skip crucial testing procedures that can identify safety risks. Doctors are often misled into thinking that these devices are safe to use, while consumers who receive the devices unwittingly become test subjects. It may take months or even years for the full effects of a failed device to become known—and during this time the manufacturer will continue to profit as patients suffer.
If a medical device is discovered to cause injury, the FDA can issue a recall and prevent doctors from using the product in the future. However, FDA-ordered recalls are rare, and are usually done only after hundreds or thousands of patients have been harmed by the device. Many may be unable to earn a living, some are placed under a severe financial strain due to medical bills, and still more will be forced to endure chronic pain for the rest of their lives.