FDA Poised to Approve Depuy Orthopaedics First Ceramic-On-Metal Hip Replacement for U.S. Market
Appears in Print As: First Ceramic-On-Metal Hip Implant to Hit the U.S.?
| Depuy Orthopaedics, www.depuy.com |
An FDA advisory panel has recommended approval of a ceramic-on-metal hip replacement from Depuy Orthopaedics, Warsaw, Ind. It is believed the FDA will approve the new implant, the Pinnacle CoMplete Acetabular Hip System, by next month, making it the first such hip implant in the U.S.
Until now, American hip replacements had a ball-and-socket design that involved metal-on-metal contact. The problem has been that this contact puts wear on the metal components and metal ions end up in the patient’s blood stream. Pregnant women and people with kidney disease, among other potential implant candidates, have been advised against metal-on-metal artificial hips because of concerns about metal ions.
In two years of testing, the new hip replacement showed 90% less wear than metal-on-metal designs under normal walking conditions. The reduction in wear went to 80% among patients who ran or put “more than normal” stress on their hips.
The Pinnacle implant is already available in 40 countries outside the U.S., according to Depuy.
© 2012 Penton Media Inc.

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What are Stem Cells?
Stem cells are “non-specialized” cells that have the potential to form into other types of specific cells, such as blood, muscles or nerves. They are unlike "differentiated" cells which have already become whatever organ or structure they are in the body. Stem cells are present throughout our body, but more abundant in a fetus.
Medical researchers and scientists believe that stem cell therapy will, in the near future, advance medicine dramatically and change the course of disease treatment. This is because stem cells have the ability to grow into any kind of cell and, if transplanted into the body, will relocate to the damaged tissue, replacing it. For example, neural cells in the spinal cord, brain, optic nerves, or other parts of the central nervous system that have been injured can be replaced by injected stem cells. Various stem cell therapies are already practiced, a popular one being bone marrow transplants that are used to treat leukemia. In theory and in fact, lifeless cells anywhere in the body, no matter what the cause of the disease or injury, can be replaced with vigorous new cells because of the remarkable plasticity of stem cells. Biomed companies predict that with all of the research activity in stem cell therapy currently being directed toward the technology, a wider range of disease types including cancer, diabetes, spinal cord injury, and even multiple sclerosis will be effectively treated in the future. Recently announced trials are now underway to study both safety and efficacy of autologous stem cell transplantation in MS patients because of promising early results from previous trials.
History
Research into stem cells grew out of the findings of two Canadian researchers, Dr’s James Till and Ernest McCulloch at the University of Toronto in 1961. They were the first to publish their experimental results into the existence of stem cells in a scientific journal. Till and McCulloch documented the way in which embryonic stem cells differentiate themselves to become mature cell tissue. Their discovery opened the door for others to develop the first medical use of stem cells in bone marrow transplantation for leukemia. Over the next 50 years their early work has led to our current state of medical practice where modern science believes that new treatments for chronic diseases including MS, diabetes, spinal cord injuries and many more disease conditions are just around the corner.
There are a number of sources of stem cells, namely, adult cells generally extracted from bone marrow, cord cells, extracted during pregnancy and cryogenically stored, and embryonic cells, extracted from an embryo before the cells start to differentiate. As to source and method of acquiring stem cells, harvesting autologous adult cells entails the least risk and controversy.
Autologous stem cells are obtained from the patient’s own body; and since they are the patient’s own, autologous cells are better than both cord and embryonic sources as they perfectly match the patient’s own DNA, meaning that they will never be rejected by the patient’s immune system. Autologous transplantation is now happening therapeutically at several major sites world-wide and more studies on both safety and efficacy are finally being announced. With so many unrealized expectations of stem cell therapy, results to date have been both significant and hopeful, if taking longer than anticipated.
What’s been the Holdup?
Up until recently, there have been intense ethical debates about stem cells and even the studies that researchers have been allowed to do. This is because research methodology was primarily concerned with embryonic stem cells, which until recently required an aborted fetus as a source of stem cells. The topic became very much a moral dilemma and research was held up for many years in the US and Canada while political debates turned into restrictive legislation. Other countries were not as inflexible and many important research studies have been taking place elsewhere. Thankfully embryonic stem cells no longer have to be used as much more advanced and preferred methods have superseded the older technologies. While the length of time that promising research has been on hold has led many to wonder if stem cell therapy will ever be a reality for many disease types, the disputes have led to a number of important improvements in the medical technology that in the end, have satisfied both sides of the ethical issue.
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Hip Implant Recall
The scary thing about it is that most folks don't know about the symptoms, which can be from severe pain to implant loosening to implant dislocation. Some patients have required a second surgery to replace the defective DePuy implant. Even if you are not experiencing problems at this time, it is likely that the system could cause hip pain, difficulty walking, damage to the hip joint, and loss of bone cells. Thus, it may be necessary for you to have the system removed and replaced by another hip replacement system to avoid future problems.
ceramic on metal
Has it been approved as of 11/04/10? I am scheduled for hip surgery 11/15/10 with metal on metal -- Based in this research I would rather go with metal on metal.
A good question for the manufacturer
John:
I'd advise dropping the manufactuerer an email and asking them this question.
Thanks.
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