Over the year since I set up Earlsview as part of my “anger management” the site has had nearly 200,000 visits so I guess I was not alone!!!
I have recently been approached by Dr Steve Tower who has a unique perspective as a surgeon and a sufferer of the DePuy ASR – and via Earlsview we would like to see if we can help more people get the answers they need, from a medical perspective.
Here is Steve’s story
Shortly he will will have his own page to add to and answer questions direct.
Saturday, July 14, 2012
I am an accidental authority on metal-metal complications. I observed my first hip replacement in 1979, started assisting on the procedure in 1982, and performed my first as primary surgeon in about 1985.
I started practice in Alaska in 1992. I was the first up here that had interest in revising failed hips. That interest drove a collaboration with Dartmouth Biomedical Engineering Center (DBEC). DBEC analyses hip explants, I have sent them about a hundred over the years (including my own). They are likely as independent of industry as any academic lab that does this work. They are best known for work that was seminal to the improvements in the polyethylene use in the “Gold Standard” metal-on-plastic and ceramic-on-plastic hips. This work will likely be eclipsed by their evolving analysis of the mechanisms of failure of metal-metal hips.
I have been captured by why hips fail since training. My first publication was about femoral fractures around hip replacements (periprosthetic fractures), this was my training research topic. It won the big prize at a regional US orthopedic meeting in 1992 and saw print about then in CORR.
Early in my Alaskan hip revision experience I stumbled over four catastrophic failures of thin XLPE acetabular liners of one design (Zimmer, Longevity, Trilogy). The analysis of those liners by DBEC lead to a podium presentation at the Annual AAOS meeting in 2006 and publication later that year in JBJS-American. Ironically, this experience lead to my selection of the ASR XL as my primary THA several months later. This JBJS paper likely influenced the redesign of the implant systems that use XPLE and relatively large femoral heads (32 mm and greater). This technology, either as Metal-on-Plastic or Ceramic-on-Plastic (CoP) is what I exclusively use now in both primary and revision hip replacement.
I will not dwell here on my own ASR XL experience as it is well described in my JBJS-American (December 2010) publication that you have a link to on your site. I was the index case and the author of this paper that found that and approximate million metal-metal hip implantees are at risk for cobaltism (systemic cobalt poisoning). The collaboration of DBEC was critical to this work.
Once I realized at the end of 2009 that I had been poisoned by my ASR it was clear that many others might be baffling their surgeons and primary medical providers with a litany of unexplained mental, neurologic, cardiovascular, and thyroid maladies that might be falsely attributed to normal aging or just madness.
This realization stimulated a collaboration with the Alaska State Epidemiologist (Dr. Joseph McLaughlin) that resulted in a May 2010 publication in the Alaska State Epidemiology Bulletin, “Arthroprosthetic Cobaltism (APC) in two Alaskan men.” The June 2010 edition of “Alaska Medicine” featured a paper on the description and diagnosis of Arthroprosthetic Cobaltism (APC) that predated my JBJS publication by 6 months.
The Ak Epi BULL attracted the attention of CDC Atlanta that wished to summarize it for their Weekly Morbidity and Mortality Report. This was nixed by the FDA because a turf issue. The WMMR has national circulation, publication there the summer of 2010 might have saved thousands the grief of metal-metal implantation and tens of thousands the delay in the diagnosis of a progressive multi-organ-system illness.
I was surprised by the FDA’s response. I was naive, I believed the primary mission of the FDA was to protect the public. I started a campaign to educated the FDA about the perils of metal-metal.
At a certain point I was curtly dismissed by the physician in charge of the FDA investigation, “Dr. Tower you do not understand, when the FDA thinks their may be a problem with a device we gather representatives of industry to define the problem, you are not affiliated with industry, you have no standing with us.”
This occurred in the fall of 2010 just before my JBJS publication. Fortunately, to its credit, two years later the FDA is showing interest in metal-metal complications.
My ASR was implanted in March of 2006, within a year it was clear that something about the hip was not right. I had my first metal levels drawn.
My blood cobalt and chromium levels were about 200 times mean normal and 40 times the Biologic Exposure Index (BEI).
The BEI is used as a marker for industrial hygiene, levels below the BEI and thought not likely to be harmful. This peaked my curiosity.
I started to call DePuy design surgeons, distributors, and engineers. I was reassured not to be alarmed, they asserted that such levels were not known to be a problem. I also made inquires to my surgeon and other prominent American hip surgeon authorities on arthroprosthetic design and technique, same story, no worries. I was naive, I believed them, they were the authorities on the topic, they ought to know.
Water over the bridge, but seven years later I am still have difficulties in getting the topic addressed at the annual meeting of the American Academy of Orthopedic Surgeons. The officers of the Academy and the officials that control the Academy’s educational efforts have been closely tied to industry. I was allowed an editorial piece in the AAOS’s monthly newsletter a year ago, “Bad Bearings.” It was sadly prescient.
Frustrated in my efforts to educate surgeons, the FDA, and industry about the risks of the metal-metal hip technology I allowed an interview with Consumer Reports hoping to educate patients directly. Since then I have been contacted by patients from all corners of the world that believe that they might be in trouble. Many have a plausible story for Adverse Local Tissue Response (ALTR) or Arthroprosthetic Cobaltism (APC) but many of those concerned are not at risk (they do not have metal-metal hips).
Getting Dr Steve’s help:
In order for me to make sense of the case history of a concerned individual I need to know the following.
What is the brand and type of hip. This information can be acquired from the surgeon or the hospital, it is best to get the actual implant inventory. All hip components come with duplicate stickers that are placed in the hospital record, copies are often given to the surgeon for the clinic chart. If this is not available the critical factor is the materials of the opposing sides of the hip bearing. If the material mating with the head is plastic their is no risk of cobaltism a long as the hip was not a revision operation for a fractured ceramic socket or head.
If your hip is known to be a metal-metal (all “resurfacings” done over the past decade are metal-metal) the next most important information is a serum or whole blood cobalt level. Your GP can organize that if your surgeon is reluctant.
Your problems at the hip and any decline in mental or general health then needs to be known.The case reports of cobaltism to date suggest that serious mental or general health decline are unlikely if your serum cobalt level is less than 10 micrograms/Liter (mcg/L). Parts per Billion (ppb) are equivalent to mcg/L. If your report returns in nano-moles per liter (nm/Liter) a bit of math will be required to convert to mcg/L. Your metal levels is less helpful in excluding an ALTR problem. Some individuals react to minute levels of chrome-cobalt debris based on an immune mechanism. Several to the most severe cases of tissue destruction that I have seen at revision surgery were in patients with serum or whole blood cobalt levels of less than 1 mcg/L.
If you are concerned that you may have a metal-metal hip related problem contact Earl with the following information.
The brand, model, and bearing type of your hip.
The date of implantation.
Your serum or whole blood cobalt level.
Any problems that you might be having at the hip.
Any decline that you have experienced in your mental or general health since your hip replacement.
JPEG or DICOM copies of the x-rays of your hip. It is helpful to have those that were done after the operation and the most recent.
Earl will pass that information along to me I will help as best I can. It is important to realize that my advice will be general and should supplement but not supplant the recommendations of your treating physicians.
If your surgeon seems indifferent to your concerns you might be better served by involvement of your primary medical provider.
If you do require revision of your metal-metal hip request that your surgeon send the explants to DBEC for analysis. This is the path to understanding the metal-metal hip debacle and it is this understanding that will prevent future arthroprosthetic misadventures.
- MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA (earlsview.com)
- Early Clinical Experience With the Use of the Birmingham Hip Resurfacing System | Orthopedics (earlsview.com)
- FiDA Failed Implant Device Alliance (earlsview.com)
- Pennsylvania woman to address FDA panel on husband’s hip-replacement recall – Philly.com (earlsview.com)
- Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit (earlsview.com)
- FDA panel sees little use for metal-on-metal hips – SFGate (earlsview.com)
- FDA Probes Safety Issues Associated with Metal Hip Implants | Qmed (earlsview.com)
- FDA probes safety issues with metal hip implants (earlsview.com)
- Stryker recalls two metal-on-metal hip products for fear of corrosion (earlsview.com)
- FDA panel sees little use for metal-on-metal hips | CTVNews (earlsview.com)
- The US Drug Watchdog Now Offers To Find The Best Possible Attorneys For All Recipients Of The Recalled DePuy ASR Hip Metal on Metal Hip Implant-Before Time Runs Out (prweb.com)
- US Drug Watchdog Now Calls All Metal Hip Implant Failures the Biggest Disaster Ever for up to 500,000 U.S. Citizens and Offers the Names of the Best Attorneys for Victims (prweb.com)
- Metal on Metal Hip Disaster – F.D.A. Hearing to Focus on Replacement Hips (earlsview.com)
- US Drug Watchdog Now Offers To Provide The Contacts For the Best Possible Law Firms For Recipients Of The Recalled DePuy ASR Hip Implant-No One Gets Left Behind (prweb.com)
- Justice for Hip Failures: DePuy ASR Recall: Nearly 16,800 adverse events reported for metal-on-metal hips, including DePuy ASR and Biomet Magnum (earlsview.com)
- Thousands Must Have Second Operation to Replace Defective DePuy Hip (blogs.lawyers.com)
- Insight: As lawsuits climb, J&J may have new hip trauma (oddonion.com)
- Replacement Hips Focus of F.D.A. Hearing (nytimes.com)