When used in hip replacement surgeries, metal-on-metal hip implants can cause serious complications. Complications include infection, dislocation, and metallosis. Many Patients have sought legal action against hip implant manufactures, and settlements are expected to average $250,000.
Many experts believe that hip replacement surgery is the most important medical device innovation of the last 40 years. Millions of people have overcome crippling arthritis and recovered from hip fractures because of hip replacement surgery. Patients experience an improved quality of life after surgery.
However, hip implant surgery is not without complications. Recently, a growing number of patients have experienced severe complications because of defective devices.
In the past, the use of hip implants was limited to older patients and patients that had suffered hip fractures. These patients tend to be less active in their day-to-day lives, and suffered from other ailments such as arthritis that caused loss of mobility and discomfort. Advances in materials and design of hip implants and the techniques used to install them, have increasingly lead surgeons to recommend hip replacement to younger, more active patients. These patients received implants to correct a variety of conditions that would not have previously been considered severe enough to merit hip replacement.
As younger, more active patients received implants, the devices were pushed to the limits of their design. New implants made from stronger and more durable materials were developed. These new implants imitated the natural hip joints motion more accurately. These new designs, and the materials the are constructed of, caused unforeseen complications in many patients.
Total hip replacement, partial hip replacement, and hip resurfacing are the three types of hip replacement surgeries. In a total hip replacement the hip socket, ball and femoral stem are replaced. A partial hip replacement requires only the femoral head (the ball) to be replaced. Hip resurfacing replaces the cup or socket and the ball is reshaped and covered with a metal cap.
Each procedure share the same goal and achieves its goal in a slightly different manner. Each procedure also shares similar complications. These shared complications are cause by the materials in the components used in each procedure.
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Hip Implants and Particle Debris
Through the course of normal use, implant components rub against each other. Friction and wear between components cause debris and microscopic particles to be produced. The particles can cause major complications and lead to eventual implant failure. Estimates place the number of particles created for every step between 100,000 and 1 million.
The type of debris depends on the material make-up of the implant itself. Different materials cause different complications. Metal-on-metal hip implants, for example, create particles of cobalt and titanium which can cause a form of blood poisoning called metallosis. Implants made from other materials like plastic can cause an equally severe side effect called osteolysis.
Metallosis is a form of blood poisoning caused by metal ions in the blood and soft tissue of the body. In the case of metal-on-metal hip implants, the soft tissue most affected is in and around the hip joint.
Metallosis is most often seen in hip resurfacing patients because they tend to be younger and lead more active lifestyles. Increased wear and tear causes premature device failure and higher instances of metallosis. Also, because a larger ball is typically used in hip resurfacing procedures, there is a tendency for more aggressive wear from friction causing an increase in metal particles released into the bloodstream.
Total hip replacement patients can also suffer from metallosis. This usually occurs when the plastic insert separating the metal components on the femur from the metal component in the socket fails.
The build up of metal particles in the tissue surrounding the implant causes a gray discoloration indicating that the tissue is not getting enough oxygen and is dying. Patients with metal sensitivity are particularly effected by metallosis, and can suffer from a metal poisoning as a result.
The total impact of metallosis is not completely known but it is believed to cause the following side effects:
- Severe joint pain
- Implant failure
- Implant loosening
- Local tissue necrosis (tissue around the implant dies)
- Deterioration of the bone around the implant
- Formation of cysts or pseudotumors
If metal particles build-up in the bloodstream more extreme side effect can occur including emotional imbalance, cognitive problems, severe headaches, and nervous system problems.
Osteolysis is bone loss around the hip implant. It occurs when the body tries to rid itself of built up debris in the tissue surrounding the hip replacement. Osteolysis is the most common side effect of hip replacement surgery, and is also the most common reason for implant failure.
Osteolysis is a reaction to the body’s natural desire to rid itself of material it sees as foreign. The body attempts to expel the unwanted material by releasing enzymes, cytokines, and other cellular reactions. The result is chronic inflammation.
The body also releases cells called macrophages, which in turn cause bone reabsorption. Because hip implants constantly create a stream of foreign particles, the body is continually trying to remove the debris. Since the body responds only with cells that absorb bone, no new bone is grown. Over time this can lead to significant bone loss, loosening of the device, and eventual failure of the implant.
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Implant Failure and Other Complications
More than 450,000 hip replacements are performed in the U.S. every year. While metallosis and osteolysis are two of the more dangerous side effects, other side effects from what is commonly thought of as a routine surgery, can be very serious and even deadly.
In a 2003 study, researches found that the mortality rate for first time hip replacement patients was 1%. The study discovered that the mortality rate for patients that required revision surgery jumped significantly to 2.5%. Finally, the study revealed that patients over 70 were three times more likely to die from complications than younger patients.
Proper placement of the hip replacement components is crucial for the implant to remain in place. The natural hip is held together by dense tissue and a large ligament. During replacement surgery, the tissue is removed, and although not common, dislocation can occur.
Revision surgery increases the risk of dislocation by as much as 20%.
Also known as soft tissue calcification, heterotopic ossification is the process of bone forming outside of the skeleton. Heterotopic ossification usually occurs where severe trauma was suffered. In the case of hip replacement surgery, the muscles and tissue around the hip joint calcify and stiffen.
Heterotopic ossification is one of the most common side effects of hip replacement. Nearly 50& of patients suffer from some heterotopic ossification. Luckily, only 10% of patients suffer from symptoms of the condition. These symptoms include tenderness, swelling and a decreased range of motion.
Heterotopic ossification can be treated with low-dose radiation and anti-inflammatory drugs. Severe cases may require surgery to remove affected tissue.
Infections are not common after hip replacement surgery. If infection is detected early enough surgeons can treat it by re-opening the incisions, cleaning the affected area and injecting antibiotics. If not caught early, the implant may have to be removed and re-implanted after the infection is dealt with. In extreme cases, amputation may be necessary to stop the infection from spreading and save the patient.
While infection is one of the most feared complication after surgery, it only occurs in about 1% of procedures.
Because it is most likely to lead to a revision surgery, implant component loosening is considered one of the most serious long-term hip replacement complications. Common causes for component loosening are normal wear and tear of the implant, or failure of the cement used to hold the components in place. However, loosening of implant component can also be caused by more serious conditions such as metallosis or osteolysis.
A series of x-rays taken over a period of time is the best tool doctors have to detect movement and loosening of implant components.
Periprosthetic fractures are breaks in the bone near the implant. Periprosthetic fractures can cause implant failure. These breaks usually occur because of existing conditions like osteoporosis that weakens the bone, medications, or undue stress placed on the implant.
Periprosthetic fractures are rare in first-time hip replacement surgeries, effecting about 1% of patients. About 4% of revision surgery patients will suffer periprosthetic fractures.