Dr. Nargol's description of what he sees in a Depuy surgery was of particular interest to me. It is almost a verbatim description of what my orthopedic surgeon saw with my revision except for the fact that the tone of concern and descriptive from Dr. Nargol was much more pronounced. It is a fantastic description of what you can expect to see in a Depuy revision...
- "horrendous amount of metal debris"
- "lots of damage"
- "We were astounded"
- "holes deep inside the pelvis through to the bladder.."
- "holes requiring reconstruction with bone grafts" (as was the case with my revision surgery...)
Dr. Joyce raises the question of "Who does the testing?"
Meet that team and appreciate the content of the videos. Quite informative indeed and great work on the part of this team to unveil this as a world wide problem. It always amazes me as what a few people with conviction can do!
Dr. Tony Nargol-Orthopedic Surgeon
Video length: 15 minutes (speaks to the surgical experience when revising a Depuy hip)
Dr. Dave Langton-Orthopedic Surgeon and also studying for a PhD in metal on metal hip devices.
Video length: 7:17 minutes. (Speaks to the issues with the device itself and effects of the metals)
Dr. Tom Joyce- PhD is a biomedical engineer specialising in the design, testing, analysis and evaluation of artificial joints including hips, knees, shoulders and fingers and is on the Faculty of New Castle University in England.
Video length: 8.26 minutes (Speaks to the regulation of testing these devices.)
Excerpt from the New York Times article in 2010 that broke the story... after interviewing these folks:
It also was in 2007, ........ that an orthopedic surgeon in northeastern Britain, Dr. Antoni Nargol, would start seeing a few A.S.R. patients complaining of groin pain. But two years later when Dr. Nargol and a colleague say they told DePuy officials they had found an explanation for why the A.S.R. was failing in patients, the company did not stop selling it or issue a warning.
Instead, the men said they were met with a response similar to one that other orthopedic surgeons who have tried to sound alarms encountered — a claim that the fault was not related to a particular device but to a doctor’s surgical technique.
“They basically said that the problem was me,” said Dr. Nargol, who practices at a hospital in Stockton-on-Tees, a small industrial city south of Newcastle.
Dr. Nargol started as a believer in the A.S.R., not a critic; today both he and a colleague, Dr. David Langton, are consultants to lawyers suing the company.
Dr. Nargol’s involvement with the A.S.R. started in 2004, he said, when DePuy asked him to be one of its investigators on the study of the A.S.R. resurfacing device it submitted in 2007 to the F.D.A. The 45-year-old surgeon said DePuy had shown him data to persuade him that the A.S.R. was superior to a competing resurfacing implant he was using called the Birmingham hip.
One DePuy video, he recalled, resembled a product face-off: An A.S.R. and a Birmingham were mounted on mechanical simulators that replicated years of use; soon, the oil used to lubricate the Birmingham turned black while the A.S.R.’s stayed clear.
“Their data indicated that the A.S.R. was going to last longer than the Birmingham,” he said recently. Smith & Nephew, the Birmingham’s marketer, would later assert that DePuy had doctored that test; DePuy declined to comment.
Dr. Nargol said he was not overly concerned in 2007 when a few of his A.S.R. patients developed pain because he first thought the problem was related to his implant technique. For example, an improperly positioned hip cup can cause so-called edge-loading, a situation where the joint’s ball strikes against the cup’s edge, chiseling off debris. And tests of those patients showed that they had elevated levels of cobalt and chromium ions, the A.S.R.’s constituent metals, in their blood, a sign of edge-loading.
“At first, I blamed myself,” Dr. Nargol said.
But Dr. Langton, an orthopedic resident working with Dr. Nargol, was not so sure because Dr. Nargol’s patients with the Birmingham hip seemed to be doing fine. So he began to take blood samples from Birmingham patients as well as A.S.R. patients not experiencing pain.
That study, which was presented in mid-2008 to a medical meeting, showed that many A.S.R. patients had elevated blood levels of cobalt and chromium. It also soon became apparent to Dr. Nargol that well-positioned cups were failing.
By 2008, the Australian registry was also showing that the A.S.R. was failing early at a fast growing rate. And as doctors operated on patients to remove and replace the device, they discovered that the metallic debris shed by the device had set off a reaction that was destroying muscle and bone.
Working with an engineer at Newcastle University[Dr Tom Joyce], Dr. Nargol and Dr. Langton concluded by early 2009 that the design of the A.S.R. cup — the very component that the F.D.A. had allowed to be sold without clinical testing — was at the heart of the problem. Its interior surface was so shallow, the researchers asserted, that it was particularly vulnerable to edge-loading and shedding debris. In February 2009, the two British physicians met with DePuy officials at a company facility in Leeds, where the A.S.R. was then being produced.
Dr. Nargol said he expressed his grave concerns to the company about the A.S.R.’s safety. He said DePuy officials told him that they had confidence in the device because many other doctors had used it successfully and that they were not aware of similar complaints.
“I told them I was done,” he said.
Full Disclosure: I sent my explant to Dr. Tom Joyce's lab for analysis at New Castle University in England. I found they have had years of experience looking at these hips vs many labs in the US that are just starting to look at the hips as result of the litigation. Also, they have a different protocol for analyzing the hips than the protocol issued by the MDL litigation committee (which I reviewed) and I found the Lab at NewCastle to have a more comprehensive approach specifically addressing the taper/stem which has now become the area of concern for the metal sloughing.
The results have not been returned yet but will be happy to share the excepts with you as I have with all of my tests. I am hoping this test can provide another data point which my medical team can use to rule out the hip as being causative or contributory to my current condition which has been discussed in previous posts. http://www.mydepuyhiprecall.com/2012/02/connies-status-with-her-investigation.html
For those of you who have lawyers, this explant analysis is something that is done as part of preparing their case for you. You might ask to see the results of your report though if you have not already. I have not retained counsel and ran into these medical issues so I approached this team without a lawyer.