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Earl : Thankyou for providing me with your great site. Your information has helped me tremendously, I have communicated with other people that have had problems with the same manufacturer that made mine.
There is a tremendous amount of information regarding hips and knees.
Here are a few questions I have:
1.) Is plastic on plastic better than metal on metal ?
2.)Can friction of these components create plastic shavings?
3.)Have the newest hips been tested adequately: providing realistic data?
4.)Do the manufactures of the newest and gretest hip devices have 1 year,2year,3,4,5,6 years results? (Data taken from a random sample of hospitals, orthopaedic surgeons, US, and rest of the world) and does this data include the best to the absolute worse patient results, including rashes,nausea, low grade fevers, back pains, limping,sleepless nights caused from pain, groin pain etc.
5.) Have these devices been tested by any family members of the ceo’s of these large companies?
I hope all of you that have suffered from surgery with any of the various devices provided for us. Remember in belief in yourself, good medical support, belief in your God, friends and family including your pets, That something inside you is greater than any obstacle.
Respectfully
Howard Sadwin
Hi Howard,
you are such an inspiration and incredibly humble – considering all you have been through I wonder at times how you keep going!
The site is part of my “anger management” – an old boss of mine once said – “don’t get mad, just get even”!!!
I am trying to figure out the answers you are after too. Here are my current thoughts after having read hundreds of articles:
Question 1: Is plastic on plastic better than metal on metal ?
Metal on Plastic doesn’t seem to have the same toxicity issues as the plastic, not the metal is eroded. The plastic particles are much larger than the metal particles and do cause osteolysis. However, it seems that these stay localized and there is not the same issue as with MoM.
Metal on Ceramic – I think this will end in heart ache for a number of people – the cobalt chrome is still ground away and looking at the data on the new ones on the market, cobalt levels are elevated. The new DePuy one is reviewed here https://earlsview.com/2011/06/25/ceramic-on-metal-total-hip-replacement/ on the Blog
When it comes to the Smith and Nephew Oxinium & metal, I think you have the same potential for problem & if you search under Oxinium on my blog you will see that it is oxidized Zirconium metal – i.e., zirconia – which even in very small amounts is very “osteolytic”, if there is such a word – i.e., will cause marked osteolysis – tissue and bone breakdown. Look at my Blog article here https://earlsview.com/2011/06/24/is-oxinium-going-to-be-safer-maybe/
Ceramic on ceramic has its own issues too – squeaking, fracture etc.
Question 2: Can friction of these components create plastic shavings?
Absolutely and without a doubt in the world. Friction is well proven in the scientific literature to cause plastic “shavings” in metal on plastic hip joints – and osteolysis is the predictable result.
Question 3: Have the newest hips been tested adequately: providing realistic data?
The newest hips on the market seem to be a reinvention of materials that have been around for ages – the new DePuy ceramic on metal – the ceramic component has been around for ages and is made by a third party… or a DePuy subsidiary with another name! The DePuy device has only been tested for two years on a small same of about 400 from memory and I think it is way to early to say this is safe – it may take 4 – 6 years to evidence the same problems as their infamous ASR & Pinnacle hips.
The Oxinium material Smith and Nephew are touting in their new hip replacements has been used in their knee implants for about 10 years – and it has had its share of troubles.
There seems to be a lot less of complaints in the press and scientific literature with the hip replacements from other companies and I suspect that it is because of a couple of things – the first is that they are not the market leaders and so the volumes are less – hence given the percentages that apply, there are less absolute sufferers if something goes wrong – if DePuy had not been a market leader then it may have taken much longer to come to the attention of the general population – that is why you and I with Smith & Nephew devices don’t get the same press – there are less of us!
The bottom line is that most new hips are a variation on a theme, like another mouse trap, and so they are “grandfathered” into use by the 510k process or something similar, depending what country you are in.
No the data is NOT adequate from a patient’s perspective, but statistically, the good outweighs the bad as long as those affected is lower than 10% – and they get to hide behind the fact that with age, we all have problems and some of these can be used to rule out data that would potentially make them look bad.
Question 4: Do the manufactures of the newest and gretest hip devices have 1 year,2year,3,4,5,6 years results? (Data taken from a random sample of hospitals, orthopaedic surgeons, US, and rest of the world) and does this data include the best to the absolute worse patient results, including rashes,nausea, low grade fevers, back pains, limping,sleepless nights caused from pain, groin pain etc.
In a word – NO!!! All companies are required to undertake post-market studies – and now that DePuy has made just a mess of people’s lives, the requirements are becoming more stringent. But they try to measure as few as possible and keep the data collection as tight as possible.
Last night I blogged the FDA info about metal on metal hips onto my site – they are a bunch of conservative statistical fence-sitters; there is clear evidence that the cobalt chrome levels are unsafe and toxic in many of these cases and yet they waffle on about no definitive studies to prove this is the case – what about the 93,000 people suffering all around the world… duh…
Like most commercial ventures, none of these companies likes to take the heat and so they always try to explain it away – like Stryker’s Trident & DePuy – blame the surgeon and the positioning of the acetabular cup.
None of the data you would expect to be collected – or sensibly should be collected, is collected – there is rough attempt at this with the scoring they use (forget the name) but it is very narrow and “outliers like you and me” get missed or excluded.
Question 5: Have these devices been tested by any family members of the ceo’s of these large companies?
I suspect – yes and no – but we will never know as that would be classified. If DePuy had done this, then there would have been a lot less harm done – but then they have their problems too – it is not politic to experiment on your own employees – but it seems OK to experiment on the general “hip replacement public” at large!
Your advice is well received – it is our faith, friends and family which keeps us going each day – otherwise we would quickly tire of the great experiment of biological existence!
Earl
I too have a smith and nephew hip resurfacing ,my pain level on a scale of 10 is a bout a 9 .it was done in february of 2008 ,I am scheduled for hip revision surgery this february first 2012. I just had to have my right hip aspirated as build up with fluids. my original surgeon wants nothing to do with me ,so I am being referred to a revision specialist.my colbalt level is around 60,in my chromium level is around 50.according to the cat scans and the MRI’s I have severe bone deteriation and muscle deteriation. I think we should get a hold of our congressmen or representatives bring is the issue to their attention. I have a lawyer out a new york that is been collecting my paperwork. There company is called Parker/Watchman/Also LLP. There phone number is 516-466-6500. call them they took down all my information and send me a packet ,we have to stand together and do something about this ,we can’t let smith a nap to get away with this.please feel free to email me at
Hi Billy
I published your story on the Blog and by now you should have had a few people in touch – there are lots of S&N recipients coming out of the woodwork and I image S&N will start to feel the heat sooner rather than later. Metal on metal has worked for many but for those of us affected, it has been I real nightmare – I have had 5 years of hell so far, start to finish & two right hips. Next of the rank will be my left hip and I can assure you it won’t be S&N and it won’t be metal on metal – it will be Zimmer ceramic on ceramic. I know there has been bad press about most Orthopaedic devices but the latest version of ceramic on ceramic and metal or ceramic on plastic seem way better than the metal ones. Sure plastic wear particles can lead to osteolysis too but over a much longer period and without the systemic toxicity of the metal ions. And they seem to be able to replace the plastic cups without taking the whole hip apart.
All the best – let me know how you go.
Earl
Hi Earl,
I hope all is well with you, I was worried about you a week or so ago, I hope all is ok for you at home!! I am going to step up the correspondance with the site as I think it is an excellent forum and I have met some remarkable people through this! I would like to catch up with you soon to discuss some further methods of ‘getting our joint, pardon the pun, message out there’. I hope you are not going too bad, is your left hip up for a ‘grease and oil’ as well, make sure they don’t use second hand parts and keep up the pain killers! I have to decide in the coming weeks if I am going to yet again let them open me up as you may have seen I have a few ‘metal fatigue’ issues going on! Please talk soon, keep up this awesome site and I hope you aren’t suffering too much.
Cheers, Stuart
I am looking for individuals in the New york area who have had, have, problems with metal on metal implants- namely smith and nephew BHR systems. I am supposed to get a revision of the surgery I had in 2009-different surgeon and hospital-original surgery at Hss in NY-left hip replacement-all types of problems and now I need to correspond wiith like individuals.NEED HELP WITH INFO- THanks Larry
Larry, I’m on the other coast, but when I just Googled Smith and Nephew BHR MOM this link came up:
http://www.ennislaw.com/smith-&-nephew-metal-on-metal-hip-implant-metallosis-lawsuit-lawyer.html
It looks like these people may now want to talk with people like you and other S&N MOM victims, and it appears more and more firms nationwide (And I’m sure eventually worldwide) are now ready to speak truth to S&N power.
I hope it helps, and good luck with the revision.
thank you for your input- i will try and contact them in the next week-i am now seeing a different surgeon and have had multiple tests which confirm the revision path-surgery was at ny hospital for special surgery, smith and nephew products; three years hence back to pain, limping, sleepless nights, no physical activity-i really do not know what to do-i struggle with all of it-i am very concerned about doing a revision
No problem, just trying to help. I was thinking if your product has actually been recalled by the manufacturer perhaps the statute of limitations would not apply, so there’s always hope. Always hope.
Most people who post here are going through the same thing as you are right now, and the main thing for me was not to panic and worry about the whole thing constantly. (That way lies madness). It’s an ongoing struggle such that people who haven’t experienced it know nothing about it. That is why it is good to ‘vent’ here, or just talk about your ordeal or write about it on the site. Nobody in my house wanted to here about it anymore, nor anyone I know for that matter.
And I just had a revision, and while it was real tough and hurt again, I’m now back in rehab and have moved from the walker to the cane! (Got to have some element of humor)! I feel good about just that amount of progession, and so I just keep on keepin’ on. I mean I try to stay focused on recovery and just exist in the moment, or I don’t sleep too well either. And I can’t stay angry around the clock, even though I — we — were terribly wronged. Angry makes me feel worse, and may even slow down my recovery. I don’t know for sure, of course, I just have opinions like everybody else.
Lastly, Larry, call that attorney or two ASAP (they’re all listed on the left side of the blog).
Hang tough now
thanks again for the correspondence-from like individuals with similar problems- Its like AA for the physically impaired-a listening voice. Do you have the address and title of where to send these letters(fda). I want to make sure it goes to right set of eyes. Larry
I like helping, as it gives me something to do while I’m trapped in my house recovering from my revision last month! Plus I’m really pissed off now, so coming here and writing helps with the depression as it feels empowering.
At this point I would just email a few pages describing your problems — and it only has to be an outline, with dates, manufacturers, revisions and damage to your body (metalosis, blood poisoning, etc.), because we have to have something in before May 9th and ‘snail mail’ won’t make it (unless you were to overnight something).
“Submit electronic or written comments regarding this meeting. Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. (It is only necessary to send one set of comments). The window in which to comment will be closing on May 9, 2012.
I just emailed a few pages in, my original operation page from my THA on this hip in 2009, my procedure page from my revision last month, that details how they had to cut pseudotumors out of me, etc. Both of those pages I just scanned in and ‘attached’ as files to the email, because I got them from the hospital and it’s all on their letterhead which I think helps our case(s) It just summarizes doctors describing what they put in, why the MoM failed, what they had to do when they revised it, and new materials in the components used to replace it (I now have a polyethylene liner in my cup and a much smaller ball [44mm compared to the old 52mm one] which rotates [they like to say 'articulates'] against that liner) For some unexplainable reason my doctor does not use any metal on metal devices whatsoever any longer — wow, I can’t understand why! Then I wrote a few paragraphs in the body of the email to tie it all together, and talked of how unfair it was to be used as a guinea pig, how they had damaged me for life and so forth.
So most of what I gave them was written by the hospital and adds another Smith and Nephew MoM to their statistical pile of junk.
Let ‘em know, Larry, because the more of us that do the closer we’ll get to a S&N recall, which in my mind is imminent but will be accelerated by the FDA’s recognizing the trend of these increasing failure rates. We have to do everything we can to ensure these people don’t get away with this uncontrolled experiment, of which we are a part but never volunteered for. I think all MoM THAs will eventually be recalled, and it may be the biggest worldwide medical device recall in history.
Don’t give up the fight
The Banking Industry just settled their robo signing Lawsuit for 8.5 Billion dollars,yet Depuy can’t settle it’s case with us,nobody died or got poisoned in the banking lawsuit,people lost their homes but you can always get another house,we’ll never get our Lives back like they were,I just don’t understand the Justice system at all
The key to changing our systems that Govern the medical device world is by me, you
standing up for our rights as human beings and demanding these device manufacturers to be held accountable if their device fails beyond an acceptable rate 1.1% and causes harm.
Unless we take it upon ourselves, this requires patience and tenacity, nothing will change to better protect and ensure the quality of human life.
The FDA has heard repeated opinions and recommendations that metal on metal hips should be shelved not used. Yet the FDA wants to gather more information as they had requested repeatedly, yet nothing seems to happen other than excuses to delay any actions such as removal of a device that has hurt 1000′s of people throughout the world.
Politicians don’t want to deal with this matter, why I ask myself again and again, what takes precedence rate of return to the investor or safety and ensure the well being of a human being : answer HUMANS lose.
Hello Earl – hope you and your family had a great xmas and let’s hope 2013 is a better year for all the MOM sufferers – glad to hear Stuart has also gone on a well earned holiday with his family, and hopefully this last operation was successful. I have just visited my surgeon and we have now decided not to put a “spacer” in my left hip as this will only give me half of the 1.8cm difference I am now left with between my two leg lenghts, plus the operation is just as invasive as normal hip surgery, I think I will wait a few years to see if any new technology might evolve plus I still have an ASR hip in my right hip which still may have to come out. I also now officially cannot do my old job which I miss terribly as a medical sales rep. I met a lady the other day who is going through these same issues as the rest of us and she has joined the class action with a lawyer in Queensland and she told me they were going to charge her 40% as there fee in whatever funds she might end up with, my lawyer hasn’t discussed fees but I thought this sounds a lot, do you know or have you heard of this, or am I kidding myself and this is the norm. I would appreciate any feedback you may have.
Many thanks for you wonderful site and support.
Rosita
Rosita, be strong, get well first and foremost and remember you are not alone.
Attorneys charge a percentage of monies awarded in such a case. They pay all the out of pocket expenses to litigate and in some instances the hip debacle lawsuit will run into the millions.
Be satisfied with your attorney, make sure they walk the walk and talk the talk in this metal on metal hip debacle.
Interview the attorney not the paralegal, ask if they are financially big enough to defend your case or are they going to refer your case out to a larger firm ?
Ask what medical device litigation they have been involved with and were they successful ( read the case)
Are they politically active as an advocate in matters of such, in favor of human rights over the manufacturers.
What is their game plan
If you aren’t satisfied with answers, find other attorneys folks may be using in the mom hip debacle.
What ever you do don’t give in or nothing will be done to improve current systems of devices being approved and implanted.
This requires you to be amongst the brave and strong.
So you know from my personal experience this is as hard as being sick all over again at times for me, but I keep telling myself it must be done or nothing will improve and worse – suppose this happened to my grandchildren.
The bottom line is the medical device world is disgustingly CORRUPT – CORRUPT – CORRUPT and that is wrong, we need to see justice is properly served and we the human being are not used as lab rats and that these manufacturers are held accountable. Last the people involved in approving these devices, ceo’s of manufacturers and Government officials should be charged with criminal offenses and put in jail if guilty. I am willing to wager if some of these people were threatened with jail time they would be happy to tell the TRUTH.
Respectfully
Howard Sadwin
Hello Howard –
Thankyou for your reply – I think I will ask more questions of my lawyer as there seems to be quiet a few variances between them. I too like you believe in staying strong and hope that the medical device industry has many more checks and they are held more responsible for there actions, obviously things have been very loose and corrupt as you said. Lets hope everyone gets what they deserve, the guilty parties held accountable and the victims compensated for what they have been throught.
Take Care.
Rosita