As we age as a society, as “Baby Boomers” reach their golden years and as medical device technology continues to make advances, more and more individuals are undergoing joint replacement surgery, including the implementation of artificial hips.
What many don’t know, is just how often these medical devices fail, especially artificial hips that use metal components.
It is now better understood that these so called “metal-on-metal hips” have been linked to neurological and heart problems, due to a condition called metallosis. Additionally these hips can have complete failure requiring the immediate removal and replacement of the hip.
When a metal on metal hip fails, the individual must undergo necessary revision surgery to completely cut the defective hip out and to replace the hip with a different artificial hip, nonmetal. The hip revision surgery is extremely painful and causes great discomfort for patients.
The medical condition known as metallosis can occur when ions within the metal of the metal on metal hips, begins to leach into the patient’s body, specifically their soft tissue, bones and/or bloodstream.
Two specific ions chromium and cobalt can be very damaging to the human body.
Chromium and cobalt ions, which can leach out from metal on metal hips, can cause damage to the lymph nodes, spleen, liver, and kidneys.
Metallosis can cause necrosis, or premature death, in surrounding tissue at the implant site. Healthy pink tissues eventually becomes gray or black and dies. The longer the metal debris is present, the worse the soft tissue damage may be.
It has been documented on numerous cases that affected patients may notice the growth of lumps, or pseudo tumors, under their skin.
Medical data has shown a significantly higher failure rate than other models with stemmed metal-on-metal hips and an above average failure rate with hip resurfacing.
Unfortunately, even after hip replacement revision surgery, metal particles disseminated throughout the body and can be found in many organs including marrow, blood, liver, kidneys, and bladder.
The British Medical Journal reported that high exposure to metal ions is associated with an increased incidence of certain cancers. A 2006 study cited in the same journal found higher rates of prostate cancer and melanomas in patients after hip replacement than among the wider population.
In 2011 the New York Times reported that metal on metal implants accounted for nearly one-third of the estimated 250,000 hip replacements performed each year in the United States. A study pointed to in the piece found that no new artificial hip or knee introduced during a recent five-year period—implants that included some of the all-metal hips—were more durable than older devices, and 30% were worse.
Approval by the FDA. Unfortunately, many artificial hip implants—and many other medical devices—have been approved by the FDA under an abbreviated procedure known as the 510(k) approval process, which rests on the notion that if one device has been cleared by the FDA, then similar devices need little or no testing on actual human patients. If a new medical device is "substantially equivalent" to an already marketed design, then clinical testing is not required.
And while the design of the metal on metal hips is similar in layout, measurements, etc, the introduction of metal in the construction of the hip, changed everything.
Many now believe that more regulations are needed. The fast track process of the FDA is placing too many at risk of harm.
If you have an artificial hip but aren't sure if you have a model that might be harmful to your health, consult your physician soon, as complications can develop down the road. And call our Law Firm, day or night, we may be able to assist you with your claim.