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Hip Study: Smith & Nephew touts study results for new metal-on-metal implants | MassDevice – Medical Device Industry News.
Hip Study: Smith & Nephew touts study results for new metal-on-metal implants
March 13, 2012 by MassDevice staff
Smith & Nephew unveils the results of its FDA-requested metal-on-metal hip resurfacing implant study, finding that 99% of participants were either satisfied or extremely satisfied with their implants at 10 years.
British orthopedic titan Smith & Nephew (NYSE:SNN) touted the results of a 10-year study of its metal-on-metal hip resurfacing implants, hoping to differentiate its implants from the high-profile recall of rival DePuy‘s ASR device.
Smith & Nephew, one of the largest metal-on-metal hip implant makers, is looking to limit the collateral damage to its Birmingham hip resurfacing system from the Johnson & Johnson (NYSE:JNJ) subsidiary’s ASR recall. J&J is facing down a slew of patient injury lawsuits, not to mention scientists warning of possible toxicity and bone destruction related to the implants and researchers urging the FDA to ban the devices entirely.
Smith & Nephew’s latest data, from a study it ran at the request of the FDA, found that 99% of the U.K. 400 patients followed were either satisfied or extremely satisfied with their Birmingham hip after 10 years, according to a press release.
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Hi Earl,
Thanks so much for forwarding along this press release data. Here is an excerpt regarding study design:
“The 10-year study sample, carried out at the request of the FDA, was comprised of patients implanted by the primary investigator and BHR design surgeon Derek McMinn, MD FRCS of The McMinn Centre in Birmingham, England. The study included 258 males and 142 females who were implanted either unilaterally or bilaterally and had an average age of 53.2 years (range: 23-84 years).”
A first blush, I see several issues with this study and have a few thoughts I’d like to share.
1) it appears to be a convenience sample selected from an “enriched” population, which introduces a selection bias.. In this instance it appears that a more positive outcome is gamed because patient selection was from an elite clinical trial group whose procedures were done by the BHR design surgeon and the primary investigator. This group IS NOT representative of the overall BHR recipient population as scientifically it is well accepted that clinical trial participants are very different that the general populations for many, many reasons. These surgeons would originally only accept patients considered to be “ideal” candidates for the procedure, who have a high likliehood of success for one.
2) Who are these 400 patients? Are they the first 400 patients who received hips at the McMinn Center? Or more appropriately;
-We’re they RANDOMLY selected? Most appropriate would be to randomly select from the universe of patients (across the UK/EU/AUS/USA) who have been implanted, or some acceptable surrogate scenario, as such.
-What about patients who have had revisions? Were their satisfaction scores captured?
-Why were twice as many men than women enrolled when we now know that women are experiencing more frequent issues to the point of not being recommended that resurface occur in women? Statistically this can skew results.
3) As an industry insider, patient satisfaction surveys are typically a crock of BS. They are the go-to when industry doesn’t want to do research having teeth. In survey research it is necessary to perform psychometric validation on an instrument for it to be considered reliable/reproducible. I would lay money that this did not occur.
Where is the TEN YEAR Outcomes data?
- serial measurements of serum Co/Cr?
- correlation of pain scores/satisfaction/revision rates to those ion levels?
- predictors of revision at 2, 5 and 10 years perhaps, to help gain understanding in who are (if any) the best candidates for the procedure….this should have been done during development, of course.
- funding provided to independent investigators to evaluate specific toxicities of long term/high concentration exposure to metal ions in question….
We know this list could go on and on as there are so many unanswered questions.
It would be great to be able to review the protocol to this study. I could really pick it apart then–
Best,
Connie
As I understand it, they are hand picked to feed us BS. There are plenty of papers showing major failure rates but they ignore these and push out their little pet family of data, thinking we are deaf, dumb and blind.
Earl
Amen..Thats how they are treating my Husband ..his levels we just found out after our dr. didn’t let us know we went to another dr.and his levels are very high,,and so far nothing is being done..he has had 2 total hip replacements both hips….and we don’t have that kind of money…its sick how we all are being treated..the dr. we went to acted like it wasn’t a big deal , he now been told he has diabets..hes be feeling sick alot ..foods not tasting right..headaches…high blood pressre…he was so health until he got hurt and ignore by his first pcare dr. and months later found out his hips have been frature and the one uncared for until that one gave out and he fell and frature the othe rtrying to catch his fall to the right then to the left and now hes been in pain from day one never stops..on disability we can’t do anything hardly…and pray every day they don’t take the disability away..so yes theses DR’s are hidning everything and being told what to tell the patient like robot sessions… worried wife!!
That is terrible. They treat us like idiots. His symptoms sound identical to those I had.
What part of the US are you in?
Earl
Great comments, I hope this keeps the fire going in other victims of the BHR.
Connie you may want to read the Citizen’s petition submitted to the FDA by Wright medical ( Roberts ) asking the pma on the Birmingham Hip Resurfacing Device be denied.
The petition was denied by the FDA, perhaps due to politics or CORRUPTION or some one of authority looked upon this petition as one company trying to shine over another, a pissing contest you might say.
However the petition illustrates how the FDA deviated from the written rules and regulations in it’s own manuals as to approving a pma (pre-market approval ) device such as the Birmingham Hip.
A perfect example is conflict of interest rules as stated in the FDA manual for approving such a device.
Originally The inventor worked for Smith & Nephew, Midland Medical was aquiured by S&N, the bhr inventor happened to own this company, it sold for 66 million pounds ( the best reported annual earnings reported a 23 million dollar gross revenue. How is this company worth almost 3 times it’s best annual gross revenue.
Then the inventor received a bonus of 33 million pounds once the FDA approve the pma on the BHR.
During the approval process of the bhr, the inventor distant himself from Smith & Nephew by becoming a consultant. ( perhaps this would make the monies received ok in the eye of the FDA. I hope not, but possibly so. If this isn’t a conflict of interest ????
The post approval reports made by Smith and Nephew indicated their patient group used in the data reports were 18-21 years of age. Smith & Nephew touts about the results of the BHR being so successful when comparing them to the competition, there is no metal on metal hip resurfacing competition, they were the forerunner in this field and the others followed for approval of their mom hip resurfacing devices through the 510 K approval. ( my hip is similar to the BHR that is the requirement in a nut shell in order to gain 510 K approval on a device.) Smith and Nephew spouts out statistics and data that is BULLSHIT.
When I spoke in front of the FDA panel this summer on MOM hips, there were enough questions raised and re-raised by manufacturers and their doctors, inventors and consultants it could take a 1000 years to reach any conclusion, and along the way there would be more questions.
Enough, pertinent information and data is available to the FDA today to reach the conclusion Metal on Metal hips are hazardous to human health and should be removed from the market.
They have been collecting data for years on mom hips, WHAT do they do with it???
I guess wait until the manufacturers say release this but not that information this way we can continue with our sales on the mom devices.
Rate of return to the investor and market share–the cost–a few 100 thousand victims.
Respectfully
Howard Sadwin
B S aint the word to use, f#@&ing B S is more like it. I have posted my story on earls view.I had mine put in in February of 2008. I still have it in me, I was supposed to have it taken out over a year ago, I have been hospitalized a couple times with severe pain. my last cobalt level was over 150, and my chromium level was almost 200. The only reason why I have been putting off to surgery is due to work. I don’t work, I don’t survive. Who is going to pay my bills why I am laid up again.I have a lawyer working on it, but not much can be done until Smith and Nephew admits what they have done to us.I am going to go after them for poisoning, until a recall from Smith and Nephew or the FDA grow some balls and goes after them. They should do a study on everyone that is on earl’s view here.I’m sure just us alone would be enough to find a ruling. why can’t they contact us and add us to that list of people, and make a ruling on that. I wonder how that would affect the percentage rates
William
I have to agree. Their BS is one of the reasons I started the blog. They are masters of spin.
Sorry to hear that you still have that thing poisoning you. They have to cough up. Their actions, BS, and silence is going to be their doing.
Earl
100% agree then what would be there reasons not to help us…They would be BROKE..and thats why they aren’t looking at real PATIENTS…I also have comment on this Blog many a time….
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