What Does This Mean for the Future of Medical Innovation in the U.S.?
Dr. Isador Lieberman, an expert on spine surgery at Texas Back Institute, did not hesitate when he was asked if the news of the first 3-D printed vertebra occurring in China surprised him. “Absolutely not,” he said. “China has great doctors, outstanding technology and their regulations do not stifle innovation.”
His response was based on a CBS News report in September which noted surgeons in Beijing, China successfully implanted an artificial vertebra replacement in a young boy with bone cancer. This medical feat was even more remarkable when it was learned the titanium vertebra was produced by 3-D printing.
“As far as I know, this is the first time such a procedure has been done,” said Dr. Lieberman. “This represents an important new trend in medicine.”
Why is China Leading the Way in Medical Research?
According to the network news report, during the five-hour operation, doctors first removed the tumor which was located in the second vertebra of the 12-year old boy’s neck and replaced it with the 3-D printed implant between the first and third vertebrae.
Dr. Liu Zhongjun, director of orthopedics at #3 Hospital, Peking University, who performed the surgery, reiterated Dr. Lieberman opinion. “This is the first use of a 3-D printed vertebra as an implant for orthopedic spine surgery in the world,” he said.
While many feel the United States has the most advanced healthcare in the world, breakthrough procedures such as this 3-D printing of a vertebra are becoming less likely to occur in this country due to the expensive investments required for testing and getting approval for new medical devices. Hence, Dr. Lieberman’s lack of surprise when he heard a Chinese physician performed this advanced procedure.
“The approval process of the U.S. Food & Drug Administration (FDA), which regulates medical devices, has always been conservative in its due diligence,” said Dr. Lieberman. “While this keeps unproven or potentially dangerous drugs and devices from being used in procedures, it also inhibits research of viable advances.”
“The employees at the FDA are civil servants,” he said. “While there is nothing wrong with this, they have much less urgency than a gravely ill patient or a concerned physician. By and large, they are engineers with very little experience in an operating room and they move very slowly.”
“Would they approve this type of 3-D printing of an artificial vertebra? Maybe. But it will be way down the road when some medical device company agrees to spend the dollars necessary to test it and get regulatory approval,” he said.
The Break-Through’s from Texas Back Institute
Texas Back Institute is internationally recognized for pioneering many break-through procedures and man-made devices for surgical implants. Dr. Lieberman noted several of these advances, including: endoscopic surgery, artificial disc replacements, alternative implant material and robotic surgery.
Given its history with managing FDA trials and developing cutting edge procedures, is this 3-D printing of vertebrae something Texas Back Institute would be interested in researching? Again, no hesitation from Dr. Lieberman. “Absolutely,” he said.
What might be the challenges this type of futuristic vertebra construction?
“The materials used to fabricate these implants would require extensive research and testing,” he said. “The titanium vertebra used in the Chinese procedure might work for every age and situation, but it might not. Plus, 3-D printing equipment is enormously expensive and until that technology becomes more wide-spread, the cost for these devices would be out of reach for almost anyone. Since it would be deemed ‘experimental,’ health insurance would not cover it,” he noted.
The Future: Miracles and Wonder
The future of medicine, specifically that which is associated with spine injuries or disease is fascinating to consider. As physicians on the forefront of these advances, Dr. Lieberman and the other specialists at Texas Back Institute will play important roles.
While no one has a crystal ball to predict the future of spinal medicine, Dr. Lieberman believes the breakthroughs will come from uncovering the secrets of nature.
“In the very near future, we are going to be able to regenerate the spinal cord,” he said. “Instead of implanting artificial devices, we will be able to apply genetic knowledge, combined with biologic materials to stimulate cell growth. This material won’t be metal or plastic. It will be composed of the patient’s own cells,” he said.
“Perhaps 3-D printing techniques could be used to ‘print’ the soft tissue scaffolding on which biologic material could be encouraged to grow,” Dr. Lieberman noted.
“Another exciting area for spine surgery in the future involves using robotics to integrate the brain with the nervous system,” he said. “With these types of advances, there will come a time in the future when no one will be paralyzed. We will be able to biologically or robotically correct this condition.”
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