American Academy of Orthopaedic Surgeons, American Academy of Orthopedic Surgeons, arthritis, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, depuy hip recall, DePuy Hip Recall Litigation, FDA, Food & Drug Administration, Health, Hip Replacement, Johnson & Johnson, Medicine, Mental Health, metal-on-metal hips, metallosis, Nargol, Orthopedic surgery, Research, science, Smith & Nephew, UNited States
By Stephen Tower
Affiliated Professor UAA WWAMI School of Medicine
Barry Meier’s recent article in the NYT about surgeons not speaking up about the metal-metal hip failures that they are witnessing is largely correct but the problem is also that those surgeons that do speak up, even if they shout, might not be heard because those listening are deaf or are pretending to be.
I began inquires to DePuy design surgeons, engineers, sales staff, and executives about my ASR and that of one of my patients in the spring of 2007. My cobalt levels were off the chart and my hip pain was reoccurring. “No worries Dr. Tower, nobody is reporting problems.” We now know that Drs Langton and Nargol had been lighting up DePuy’s switchboard at this time.
I continued to express my concerns to the same parties several times a year until my ASR was explanted in November of 2009. By that time I had experienced a partially disabling neurologic illness (mood changes, cognitive decline, tinnitus, high frequency deafness, and early blindness) and a cardiac illness (stiffening of the heart). Always the same answer, “Dr. Tower, cobalt poisoning has never been reported.”
Once my ASR was explanted my suspicions were confirmed, my neurologic and cardiac illness resolved in step with my declining cobalt levels. I wrote up my experience and that of my patient and submitted it to an Orthopedic journal and to DePuy by early 2010. A reviewer nixed the paper, he had published favorably on metal-metal hips. DePuy did not comment on the manuscript. A brief report was published in the spring of 2010 in the Alaska State Epi Bull, it was noticed by CDC Atlanta who wished to publish the report nationally. The FDA nixed the CDC, “our turf, back off, we are studying the issue.”
At the end of 2010 my paper was published in JBJS but I had to do an end run around the section editor who was a DePuy consultant. I attempted to present a the Annual Meeting of the American Academy of Orthopedic Surgeons in 2011, 2012, and 2013 my applications were rejected by a hip program committee, the majority of which were consultants for arthroprosthetic companies vested in metal-metal hip technology. In my stead design or consultant surgeons for companies with a strake in metal-metal hip were selected to address the poorly understood complications of chrome-cobalt metallosis.
I appealed to the Presidental Line of the AAOS starting at the end of 2010 to be given a chance to present the “Alaskan” experience with the local and systemic complications of chrome-cobalt metallosis in AAOS publications, “Webinars,” and meetings. The President and Vice President were DePuy consultants, another VP was a Zimmer consulted and had stock options in a company vested in metal-metal technology, only one member of the AAOS Presidental line was without obvious direct Conflict of Interest concerning metal-metal hips.
I did not fair better in attempting to influence the FDA. “Dr. Tower, you do not understand, when we believe their is a problem with a medical devices we sit down with experts forwarded by your professional organizations and industry to determine whether a problem exists, you have not been recognized as an expert by either, you have no standing with us.”
The underlying problem is surgeon-industry COI. The orthopedic literature, the committees that determine who presents “science” and opinion at meetings, the governance of the AAOS, and those that advice the FDA are a Cabal of orthopedic surgeons that work with arthroprosthetic companies vested in metal-metal hips. Their influence is so prevalent that it seems unlikely that internal reform of either the AAOS or the FDA is possible.
Your local orthopedic surgeon might not know about the frequency, nature, and severity of the metal-metal hip complications because the material that is published in the orthopedic literature and that presented at meetings, and to the FDA fails to recognize or underestimates these problems.
Your “Blog” is a critical resource to educate patients and physicians about the nature, frequency, and severity of the metal-metal hip complications. It is necessary to do an end run around organized American Orthopedics and the FDA.
Stephen Tower, MD
- Dr Tower writes to Senator re concerns about the regulatory malfeasance at the FDA – Metal-on-Metal hip replacement debacle (earlsview.com)
- Patients victims of untested medical devices – SFGate (earlsview.com)
- “What a Mistake,” says DePuy Hip Recipient (earlsview.com)
- Tim’s Horror Story – DePuy has more Problems with Ceramic on Metal Pinnacle Hip – and another Surgeon shows no concern … (earlsview.com)
- Hip Implant’s Risks Inadequately Assessed, DePuy Report Found in 2010 – NYTimes.com (earlsview.com)
- Arizona Orthopedic Surgeon Dr. Sumit Dewanjee Now Offering Innovative Surgery to Repair Cartilage Defects (prweb.com)
- DePuy Defective Hip Implant Claims | eLocal (elocallawyers.com)
- J&J Feared Metal Backlash Would Hurt Hip Sales, Jury Told – Bloomberg (earlsview.com)
- When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
- J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg (earlsview.com)