As baby boomers age, medical device manufacturers are experiencing a significant demand for products to treat the ailments of an aging generation of unprecedented size. Older people, however, are not the only ones who may need medical devices to improve their condition.
Any defective medical device lawyer in Miami knows that there has been a major shift in recent years in the people who are seeking joint implants and other similar medical procedures. Now, instead of just older people needing hip or knee replacements, younger people are making use of these devices as well. This could be great news for medical device manufacturers, except these manufacturers made serious mistakes with some of the products targeting the young: hip and knee replacements.
Defective Medical Devices Could Endanger Younger People
There is no question that the demographic makeup of individuals undergoing joint replacement surgery has change. As the Bulletin reports, between 2000 and 2010, the number of patients between the ages of 45 and 64 undergoing hip replacement surgery has more than doubled. During the same period, there was a 213 percent increase in the number of patients between ages 45 and 64 undergoing knee replacements.
The number of younger people undergoing joint replacements is spurred by two competing causes. Many younger people are undergoing these procedures because they are healthy and want to stay active longer, continuing to exercise or play sports that they like. The rising epidemic of obesity is also a leading cause of an increase in joint surgeries among younger patients, since being overweight tends to break down the joints in the body.
The trend of younger patients seeking joint replacements has not gone unnoticed and medical device manufacturers have been targeting this new market aggressively. An effort to attract younger customers was one of the prime reasons why medical device manufacturers released metal-on-metal hip and knee replacement products.
The metal-on-metal products were an alternative to the traditional joint replacements in which a ceramic stem was placed inside of the femur bone with a ceramic head on top to replace the hip joint and fit into the femoral cup. The ceramic could break, while metal-on-metal hip replacements were promoted as longer-lasting and more durable. Some companies, such as Stryker, also created products designed to offer more customization among replacement joints in order to provide greater flexibility for more active patients.
Medical device manufactures that brought these metal-on-metal products to the market largely did so under special 501(K) clearance rules with the FDA that allow for products to be sold to the public with minimal testing and few clinical trials as long as they are substantially similar to existing medical devices on the market.
Unfortunately, it turned out that manufacturers should have done a lot more to make their metal-on-metal products safe. The products began to cause serious complications including metallosis as the metal parts broke down in the body. Metal hip and knee replacement joints had to be recalled because of a very high failure rate, and lawsuits have been filed by thousands of people who had defective hip and knee joints implanted.
More mistakes like this one are likely to be made as device manufacturers try to take advantage of new markets, unless these manufacturers get serious about their obligation to the public to ensure the safety of medical devices they bring to the market.
If you or a loved one has been injured as a result of metal joint implants or other defective medical devices, contact the Law Office of Jeffrey D. DeCarlo, P.A. today at (305) 572-0065 for a free case consultation.