Hip and Knee Prostheses – An Insight
Hip and knee replacement is an effective treatment for osteoarthritis, a degenerative disease that breakdowns the joint’s cartilage. Like all other medical devices or products, it is important that the United States Food and Drug Administration clears or approves the prostheses. This means that the new medical device have to undergo several clinical trials. Improvement in the construction of prostheses and advancement in surgery have made hip and knee replacement more successful, effective and common. However, there are many risks associated wit this procedure. Past incidents showed that the potential risks, problems and complications associated with new prostheses are not discovered during their clinical trial. There is high possibility that these prostheses may cause joint dislocation, wearing and breaking out or loosening of the joints over a period and nerve damage.
Hip and Knee on Rise
Over the past few years, there has been rapid advancement in prostheses and surgery. Due to the lack of medicines and other therapies to treat osteoarthritis, surgeons have to perform more knee and hip replacement surgeries. Although, doctors still perform this procedure on the people above sixty years of age, there is a growing population of individuals between the age group of 35 and 57 who are opting for prostheses or hip and knee implants. According to the American Academy of Orthopedic Surgeons, individuals between the age group of mid thirties and late fifties underwent 20 percent of the total hip replacement procedures in the year 2003 or had 36,000 hip replacements. That is an increase of 27 percent all the procedures in 1997. In addition, people in this age group 50,000 knee replacements or 16 percent of the total 2003, an increase from 24 percent in 1997.
According to a large no. of doctors, more than 90 percent of joint replacement procedures occur because of osteoarthritis, which affects approximately 20 million people and is one of the most common types of arthritis. Osteoarthritis is a degenerative disease, which is characterized by the breakdown of joint cartilage. It occurs due to variety of factors like obesity, injuries and genetics. Due to the breakdown, bones rub against each other causing loss of movement and pain. The incidence of arthritis increases with the increasing age of an individual.
According to the statistics of the year 2002, the United States Centers for Disease Control and Prevention (CDC) estimated that doctors told approximately 45 million adults that they suffered from some kind of arthritis, gout, fibromyalgia, rheumatoid arthritis, or lupus. Another, 22 million reported of several chronic joint symptoms bur were not diagnosed with arthritis. One in four or 20 percent of the adults reported of suffering from arthritis. Over all, 51 percent of the adults’ above50 years of age reported of arthritis. According to the CDC, by the year 2030, approximately 65 million of Americans aged 18 years or above will have physicians’ diagnosed arthritis.
Approximately, a decade or so ago, patients and health care professionals chose to avoid implants as long as possible replacement surgery becomes more dangerous and less effective each time it is performed and prostheses would last only for about ten years. Due to the advancement in science and technology, some prostheses lasts for 25 years, however, still there risks associated with the surgery and implants in general.
Prostheses or artificial joints are medical devices, thus, it is important to get them cleared or approved from the FDA before marketing them in the United States. Additionally, a company should seek the permission of FDA before testing redesigned or new prostheses in human studies. These studies are conducted in specific hospital, therefore, the data collected from these studies and research may be used to support a firm’s application for manufacturing its prosthesis to hospitals and surgeons. However, it is mandatory that a medical device or product must prove effective and safe. The FDA assures the effectiveness and safety through different ways depending upon the risks associated with a particular medical device or product and the technology that it presents. For the devices having a history of effective and safe use, using established technology, the Food and Drug Administration relies upon a set of general controls to establish which medical devices can be deployed. The FDA augments general controls with special controls such as standard test methods.
However, the FDA requires demonstration of all those devices that use a new or advanced technology in order to determine the effectiveness and safety of those devices. As proven in the past also, some clinical trials fail to identify the potential risks associated with a new type of knee or hip prostheses.
In addition, just like any other surgery, knee and hip joint replacement surgery carries some life threatening risks such as blood clots, complications from anesthesia and infections. Few other complications include breakage or dislocation after surgery, nerve damage and loosening or wearing of the joint over a certain period. After undergoing a hip replacement surgery, there is high possibility that the one leg may be shorter than the other leg. Infection is one of the ongoing risks for the patients with joint replacements. It cannot only occur in the hospital but also years after the surgery if bacteria travel through the blood stream to the area of replacement. However, it is only in rare cases that an infection spreads to new joints and does not cure with antibiotic treatment, the joints have to be replaced. Usually, this type of joint replacement requires two surgeries, one to take out the infected joints and another to insert the new joints.
An individual’s choice of surgeon and medical device to repair a knee or hip injury is important to avoid any serious complication in the future. If the problems associated with the prostheses exist then the patient should immediately seek legal assistance.