Medical Device Recalls In The U.S. According to data from the Food and Drug Administration (FDA), between 13 and 75 medical devices are now recalled in the U.S. every day.
Tens of millions of Americans have medical devices implanted in their bodies, but some of those devices are faulty, including devices that have been on the market for years, The Motley Fool (fool.com) reports, and the process for approving devices that is often to blame.
Johnson & Johnson’s metal-on-metal hip implants – articular surface replacement (ASR) systems – were on the market for many years before being recalled. The devices’ high failure rate meant that many recipients needed further costly and painful surgeries, according to Motley Fool. Metal-on-metal hips were intended to provide more flexibility and range of motion but instead many users suffered pain and crippling injuries including joint loosening, hip dislocation, and metallosis. (metal poisoning).
Defective products on the market are often the result of shoddy materials or manufacturing but for medical devices, often, manufacturing is not to blame. Instead, the rush to bring a product to the market quickly can compromise safety, Motley Fool reports. Testing can often be bypassed if the manufacturer can demonstrate the product is “substantially equivalent” to one already on the market. In the case of metal-on-metal hips, the devices did not prove as safe and durable as hip devices made of a combination of materials. Johnson & Johnson phased out ASR hips and started recalling the devices in 2010. By then, more than 37,000 in the U.S. and 93,000 people worldwide had the devices implanted and were at risk for metal poisoning and the need for additional surgery. J&J faced more than 7,500 lawsuits for its recalled hips and the company paid billions in settlements. Stryker, Zimmer Holdings and other manufacturers of metal hips have also been sued.
Medical device manufacturers often make small changes to a device to improve the product. But when unapproved components are introduced into an existing design, and the device does not undergo thorough testing, this can cause major problems for recipient, problems that may not happen with older versions of a device. And now, as an increasing number of devices rely on software, the recipient is at risk if there is a software design problem or system failure. It is essential, Motley Fool says, to reformulate procedures so that safe medical devices can reach the market in timely fashion.