I would like to thank both Benita Rollis and Shelly Davis for the wonderful job that they have done for me. They made it easy and helped through the hard times. Thank you both. Steven Lubowsky
Steven Lubowsky
a year ago
Medical devices long only considered for use in the elderly are being embraced by younger generations; however, some are concerned about device safety and oversight and the long-term potential for problems with these products. In fact, many key players in the medical device industry such as Medtronic, St. Jude Medical, and Boston Scientific, are seeing […]
Medical devices long only considered for use in the elderly are being embraced by younger generations; however, some are concerned about device safety and oversight and the long-term potential for problems with these products.
In fact, many key players in the medical device industry such as Medtronic, St. Jude Medical, and Boston Scientific, are seeing their devices used in younger patients, according to the Star Tribune. In particular, middle aged Americans are being implanted with the devices in an effort to stave off the effects of old age, with the number of patients 45-64 years of age undergoing hip replacement more than doubling from 2000 to 2010, according to a Star Tribune analysis of data from the U.S. Department of Health and Human Services. Knee replacements saw the largest increase, at 213 percent.
Meanwhile, some devices have been tied to premature failure including defective defibrillator wires, artificial hips and knees, and leaky drug pumps, according to the Star Tribune. Lawsuits and injury reports continue to mount over these devices and patients and their families allege complications, life-changing adverse reactions, severe pain, and even death. What’s worse, 25-40 medical devices are recalled annually over high risk, a classification that means that use of the device puts patients’ lives at risk.
Despite mounting litigation and reports of patient injury, device makers are spending large to tout products to doctors and patients and are also seeking simplification of government reviews of their products so that more devices can make it to market sooner, according to the Star Tribune. “We’re not talking about computers or cars or toasters,” said Lisa McGiffert, director of the Consumers Union’s Safe Patient Project, a group that campaigns for improved medical practices. “We’re talking about things that go inside people’s bodies,” she told the Star Tribune.
In 2000, one-third of about 157,000 Americans who underwent hip or knee replacements were under the age of 65. In 2010, that figure just about tripled to 430,000—nearly half of the procedures were performed on the non-elderly. Patients implanted with devices typically must replace those devices more frequently, which calls for costly, complex, risker surgery and significant rehabilitation work, the Star Tribune pointed out.
Typically, hip devices are meant to last 15-20 years. Meanwhile, DePuy Orthopaedics—a unit of Johnson & Johnson—created the ASR, a metal-on-metal hip device. The device maker recalled 93,000 ASRs in a global recall in 2010; to date, more than 11,000 lawsuits have been brought against the device maker. Law 360 pointed out that Johnson & Johnson stated that 37 percent of the implants will fail earlier than expected; however, other estimates indicate that the premature failure rate exceeds 60 percent.
Metal-on-metal hip implants, as a class, have become the subject of safety concerns. These devices received clearance using the fast-tracked 510(k) route, which bypassed clinical testing. Now, studies reveal that metal hip replacements tend to fail more often than other implants, although the devices were created for greater durability and longevity and with the intention that the seemingly stronger components would be far superior over their more traditional counterparts constructed with plastic or ceramic elements. In recent years, the metal devices have come under fire for failing at unexpectedly high rates and leaving patients with significant and, often, life long injuries.
Lawsuits are also being filed against St Jude Medical Inc., the device maker that manufactures the controversial Riata defibrillator leads. The cardiac devices have been associated with numerous reports of deaths and injuries. The Riata was removed from the market in 2010 following reports of defects and high failure rates, which, as well as emerging lawsuits, allege that the Riata’s conductive ends break free. When this happens, the device either delivers excessive shocks, insufficient shocks, or shocks at the wrong time. The problem stems from the Riata’s exposed ends, which have been linked with internal injury reports that include reports of lacerations. An inferior Riata lead housing was blamed for many of the reported defects and was ultimately changed to a silicone material, called Optim, and released as the Durata lead.