As Younger Patients Embrace Implanted Devices, Questions, Concerns AriseSep 24, 2013
With hundreds of thousands of Americans receiving medical devices—particularly joint implants—that were once almost exclusively the province of the elderly, device manufacturers have seen a major expansion in their market, but not without concerns about safety and oversight of the products.
This dramatic increase in the use of medical devices results from the desire of middle-aged Americans to remain physically active, the Minneapolis Star Tribune reports. Hip replacements in patients ages 45 to 64 more than doubled from 2000 to 2010, according to a Star Tribune analysis of data from the U.S. Department of Health and Human Services. Knee replacements rose 213 percent.
But the success of the devices—particularly implanted ones—has been overshadowed by reports of problems and failure: defective wires in defibrillators, failing artificial hips, leaky drug pumps. Patients have suffered complications, pain, injuries, and even death. Device companies face thousands of patient lawsuits challenging the safety of devices. Federal regulators are under pressure to intensify oversight while device makers seek simplified approval procedures to hasten new products to market, according to the Star Tribune.
Two contradictory forces push patients toward joint replacement. Obesity has caused hip and knee deterioration for many people, while others suffer wear and tear on their joints from sports and exercise. Joint replacement at a younger age usually means the patient will need to replace the joint again, once if not twice or more often. And each replacement means expensive surgery, possible complications, and significant rehabilitation.
Most artificial hips have a life span of 15 to 20 years, depending on the patient’s weight and activity level. Companies including Stryker, Zimmer, Johnson & Johnsons’ DePuy Orthopaedics division, and Biomet developed all-metal hips, believing implants made totally out of metal would prove more durable, but the design has not met expectations.
In fact, thousands of metal-on-metal hip recipients have filed lawsuits alleging pain, swelling; bone and tissue damage; early failure of the implant; high levels of metal ions in the blood; and difficulty walking. Many of the lawsuits also question whether the U.S. Food and Drug Administration (FDA) adequately tested the devices before they were allowed on the market. The FDA is now reviewing the device-approval process.