05/23/2013 // Concord, CA, USA // LifeCare123 // Greg A. Vigna, M.D., J.D. // (press release)

Medical Perspective:

Growing up with a father who was a history major at Stanford developed my interest in history. Whenever I could squeeze in a history class in my biochemistry curriculum I did. I nearly earned a minor in history but simply ran out of time and graduated. The benefits of going to University of the Pacific, a small private college, could not be more evident when I sat down in a class of fifteen students when taking American history and the professor took polaroid’s of each student and by the next class was referring to us by name. My analysis of the history of western civilization is the history unfortunately repeats itself. The wars, the religious battles, the rise in nationalism, and the discourse between the rich and poor are cyclic events that reflect human nature.

Science is very much opposite to the cyclic changes in western civilization. Science builds on itself, one thing leads to another. General chemistry builds on organic chemistry. Understanding organic chemistry makes the understanding of biochemistry easy. One scientific study that is validated builds on the next. One question that is answered, leads to another question that is investigated. Just an endless process to the understanding of the physical matter that we create and physical matter that we live in.

Here, lays may frustration and dismay with current pharmaceutical and medical device companies that are producing metal-on-metal disc replacements for an alternative to fusions in the lumbar and cervical spine. Since 1975 it has been recognized that hip surfaces that have metal surfaces and the “ball” and metal surfaces at the “socket” increase both the local and systemic concentration metal ions in the order of ten times greater than in metal-on-plastic surfaces and the “ball” and “socket”. In 1975 an author recommended the use of metal-on-plastic because of the unknown effects of increased concentration and the hypersensitivity reactions associated with it that included rashes. Despite these recommendations and unknown effects of metallic ions on local and distant structures the metal-on-metal design hip replacement continued in practice. In 2005 it was reported by Dr. Davies that an inflammatory mass adjacent to metal-on-metal hips was very different than tissue adjacent to metal-on-plastic hips. In 2007, problems were identified and reported by Dr. Pandit in an article where he noted a soft-tissue mass which he called a pseudotumor that consistent of metallic debris, inflammatory cells, which made up a soft tissue mass adjacent to and in continuity with the hip joint. He reported that this soft tissue mass caused problems that included ‘spontaneous dislocation, nerve palsy, and a rash. He estimated that within five years 1% of all patients develop pseudotumor and long-term rates were unknown.

In January 2010, the FDA noted clamped down on the manufacturers of the metal-on-metal hips requiring them to prove that they are safe after reviewing over 100 studies, which showed unacceptable risks of problems in women, and patients who receive larger implants. The FDA has concerns both with the local effects caused by the pseudotumor and the potential for distant effects on other organ systems including heart, kidney, skin, and nervous system from increased systemic levels of metallic ions. This is obviously a design problem with the device that requires the device to be taken off the market.

The FDA has approved several total disc replacement devices since 2004 that offer patients ‘preserved’ motion at the segment in the spine as opposed to the surgical option of fusing the spine at the level of the diseased disc. This offers a hypothetical decreased wear at the spinal levels immediately above and below the level of the fusion. There are two designs of total disc replacement devices available one of which includes metal-on-metal.

Here we go again, similar design related problems this time with metal-on-metal discs. In 2009, Dr. Cavanaugh at the Spine Institute of Louisiana reported the first recognized case of a soft tissue mass that was causing a reoccurrence of symptoms nine months following a cervical disc replacement with a metal-on-metal device. Dr. Guyer reported in a case series of four patients, three of which were lumbar disc replacement and another was cervical disc replacement that there was a large soft tissue mass causing nerve impingement with no evidence on re-operation that there was loosening of the device. This mass on laboratory analysis revealed similar findings of metallic debris and pathologic findings as the hip metal-on-metal. There is a report of a patient following lumbar disc replacement with a metal-on-metal device suffered from cauda equina compression.

Medical devices are based on science, not human behavior. The first lawsuit related to the metal-on-metal hip and its complications awarded the plaintiff $8.3 million which included punitive damages against Johnson & Johnson for a design defect and a failure to remedy the problem in reasonable time after being made aware of the problem. It appears that the continued use of metal-on-metal total disc replacement design is not based on science but on human behavior. History has shown human behavior is flawed. This metal-on-metal design is simply flawed.

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