Tags
FDA, Finance, Food & Drug Administration, Hip Replacement, Medical device, Medicine, Queens, UNited States
For those of you who have been following this blog for some time, you will recall the story of Howard Sadwin who had a major problem with his hip replacement – a S&N BHR Device – which led on to a major hip infection and nearly a year in hospital fighting for his life.
Howard recently underwent surgery to put a new hip in after about 18 months with no hip, confined to a wheel chair.
Howard, wrote to me recently and here is his report:
After not having a hip for over a year and half on 10/10/2011 I had a new total hip put into me. I am learning to walk, by use of a walker. Prior to surgery my right leg was 9 inches shorter than my left leg. Atrophy from not having a right hip for so long was the cause of the length difference. Now after my new hip has been in for a month, there is a 2 ½ inch difference. To compensate the difference a custom device will be made for me, to offset the difference.
Back to the importance of my information for all of you that have questions or are suffering from your hip, one of the biggest obstacles you will encounter in court could be the following:
- Back in 1976 a law giving the FDA authority to regulate medical devices immunizes manufacturers of the riskiest devices from liabilities for injuries and deaths caused by their products. This removed protection for patients-
- The ability to hold medical device makers responsible for design defects and for failures to warn about hazards associated with their products. No other industry I know of is so free from accountability to consumers.
- There was a publication from “ Citizen “ (public citizen) written August 4, 2009. Addressing this matter.
- Congress had an opportunity to pass the Medical Device Safety Act of 2009 (S.540, H.R. 1346) Without this legislation, patients, me you etc. ability to seek compensation from medical device manufacturers for injuries caused by the most risky devices is severely limited.
- In lay words a judge could throw hip cases out based on these laws. Absurd, yes but real.
- Congress ignored the passing of this act. Why, I,you need to ask anyone you know involved in politics.
In discussions I have had with some attorneys, it seems if this matter is discussed its taboo, dropped like a hot potato. The only thing that comes to my mind is we, us human beings are second to the importance of Market Share and Finances.
Don’t get angry as I did when first reading this, I need each and every one that is affected by this to get involved with people you know in politics, put a big bug in their ears or this law will never change And that is definitely wrong, wrong, wrong.
Information can be read on the FDA site under product liability exemption laws. Take the little time it will take you and educate yourselves.
In other countries the laws are day and night compared to ours. My thoughts are if you are from Australia,England etc. and the tort systems are similar, it would behoove you to gather in numbers and submit your grievances as 100+ rather than 1, if that doesn’t work I wouldn’t stop until I got an audience with Kings or Queens to hear me.
However I will continue to see if there is a possibility to get representation, if the USA can approve devices solely on European data involving patient studies to approve a device, then the laws should have some similarities in protecting we the people over these medical giants.
Respectfully
Howard Sadwin
wow! First, glad to hear that Howard finally got his hip! And secondly, if banning in numbers for ANY CAUSE is a good thing, what’s happening to the peaceful numbers that are protesting wall street is an indication of what may happen to those who do ban together.. there is a great deal of unrest all over the world and people are dissatisfied with many things that are wrong. The world was brought closer together by the internet, and is being torn apart by the very people who were ienlightened. I don’t have an answer to it all except that I will continue to monitor things as I too heal from a hip replacement. Be well dear Howard, fight for your health with all your strength… and at the very least, let your voice be heard….
And again, I have to comment that I absolutely believe in you finding out what REALLY happened to you, but IMO you are burying your head in the sand if you think it is only the fault of the device. I offered my help to you several times, to help you get some expert opinions on the placement of your BHR and you refused? My question to you as it should be to everyone else is WHY would you refuse that?
I have no idea why anyone in your position would not want to obtain ALL of the information they possibly could to get to the root of the problem. My heart goes out to you for this nightmare that you have been through. But there ARE hundreds of thousands of us out here that have BHR’s and are extremely satisfied even ecstatic with our outcomes. I had my first BHR put in almost six years ago and went back and got another BHR only 11 months ago. I was down to one crutch at 6 days post op, no walking aids by 3 weeks and by 4 weeks I was practically running up and down my stairs. By 3 months post op, I could touch my nose to my knee. Here are actual photos taken just a few days after three months post op, just scroll down below the video
http://www.hipresurfacingsite.com/VM-s-Live-Surgery-Video/VM-s-Live-Surgery-Video/menu-id-118.html
ANY device no matter what it is made out of, if a surgeon places it inside a patient WRONG, the patient is going to suffer with problems, that is just a fact. But I guess you are willing to just take your original surgeons word for it that he placed your component right. I am still extremely puzzled at your refusal to actually get FREE opinions from some of the best surgeons in the world as to how your BHR was placed. I just want people to read the FACTS and not go by blind anger from someone that justifiably has a right to be angry. But, Howard, why don’t you find out what really caused all of your problems and point the blame where the blame belongs? There will never be ANY device that has 100% success rate. There just is no such thing. If your surgeon placed your component completely wrong, then do you honestly think he is going to admit to that? I again, can offer you ANONYMOUS FREE opinions from some of the best surgeons in the world, but you apparently have no interest in finding out what really caused you all of this grief.
But I can definitely say this, if I thought for one second that I was putting anything that was poison in my body do you honestly think I would have gone back less than a year ago and had another BHR placed in me? I absolutely love my BHR’s and I am still not even one year post op on my new hip. Surgeon selection is a key. If you had had a THR placed completely wrong and problems with that and when the surgeon removed that and you ended up with a deep infection that they failed to recognize, you would still be in the same boat. I think it is insane to put all this misinformation out on the internet when you refuse to gather ALL the facts. That just makes absolutely NO logical sense to me whatsoever.
AND still my offer stands if you ever want to get those free opinions Howard. I am really confused as to WHY you refuse that? Unless maybe monetary reasons are your real motive here? Because anyone that went through the horror you did, I would definitely want to get to the bottom of the CAUSE of it and not just blindly blame a perfectly good device that has helped give back full active lives to SO many of us out here. I mean doesn’t that just make logical sense? Did your surgeon horribly place your component? Did he use lack of care in cleanliness when you were revised, therefore you got a deep infection and then they did not notice it, again, lack of care on the physicians part, leaving it to get so bad to the point that you almost lost your life? Where in the world does that equate to a bad device? A metal on metal implant does NOT cause deep infection, lack of care DOES.
Vicky
ECSTATIC with my TWO BHR’s and would do both hips with a BHR again tomorrow if I needed them done right now.
Oh and here is a new study that just came out on a top surgeons results for his series of metal on metal hip resurfacings, a 1.3% failure rate! That is a 98.7% SUCCESS rate.
http://www.orthosupersite.com/view.aspx?rid=89618
Vicky
I agree that the S&N has the best track record of any of them and nothing is perfect.
However, I believe that every individual has the right to test their “complaint” through due process, even if the weight of evidence is against it. It is hard being one of the “few percent” that don’t work – the one time in your life, you don’t want to be special!!!
And I do think that the hospital has some major responsibility when it comes to deep infections – I personally cannot link deep infections to anything other than surgical and aseptic technique.
Earl
Agree with you Earl-and more and more information is coming forth AND ‘UNDER REVIEW currently-that is pointing to the technique and performance of surgical Team, in my own Replacement surgery. God did not desert me.
I could clog up the courtroom with ‘The before and after’ in my life. Dont want to get on the wrong side of our biased in ACC favour-dsrl dipute tribunal,Preparing submissions now for this all important review. Thanks for all your info, studies, and assistance.
I agree completely with you Earl, of course he is angry and had every right to be, but it just puzzles me as to why he refuses to find out the facts? I mean it just makes no logical sense to me that a patient would not find out the infection rates of that hospital, and ask WHY they did not find his infection sooner so he would not have had to suffer and IF his component was placed wrong.
My heart genuinely goes out to all of those that did not have good outcomes and I am doing everything I can to help many patients in this situation, and the majority of the time, what they thought to be so, was not so. But they got to the bottom of the problems they were having and now they know the TRUTH, the FACTS. Some surgeons were blaming the patients for their failures, etc. NOT a good thing for someone already suffering to also have to go through unfair guilt for something that was not their fault.
I work 7 days a week many hours a day helping patients, both to find good surgeons to begin with so that they are not faced with these problems as well as those unfortunate ones that are facing these problems and not getting the needed answers they are seeking. I am here to help, so I want to make sure the patient community knows that there IS a resource out here, and I am willing and able to help you find out the truth of what your issues are and the right direction to point the blame. Spreading false information or incomplete information doesn’t do anyone any good, facts are important IMO. Again, my heart goes out to all of those suffering that did not end up with their happy outcomes they had hoped, but don’t blame a perfectly good device when you do not have all of your facts and are unwilling to obtain them when it has been offered to you. That is my only point.
Vicky
Here in small NZ-It is hard to completely be sure of ‘The right Surgeon’ even more baffling when x-rays
indicated MILD oesteo changes-early degeneration-but surgeon insisted my right hip was urgent/advanced and require IMMEDIATE replacement. Even attempted to set down proceedure for less than a month after one and ony consult. Shifting at the time-no time to check with any other surgeon,so tried TWICE to go back-whilst extending hopital admission date to two months.
This was denied, as was donating my own bloods DENIED, As I suffer from an anaesthitic phobia, and re=action -attempted to set up an appointment with the unknown Anaethitist. DENIED. My sole reasons for undergoing the surgery were-Was going to drop my Southern Cross policy after nearly 30 years of little use. Thoughts were -if this does NEED doing, maybe best to undergo this now. MY BIGGEST MISTAKE (See Jills 7 years of hell’ on this sight. Have spent seven years fighting the afermath of the mind bogglig, full of mistakes surgery-in a haste and speed proceedure at the wrong end of the day. I have never been able to walk or drive very far, and 10 out of 10 pain was immediate-Lots of other strange happenngs, and worst of all-knowing I was not well informed, ready to sign out BEFORE surgery and waas waiting for my lift home.Surgeom-then anaethitist (first time I had seen this team, since initial consult two months before (surgeon only) used dollar signs blackmail, to keep me there- ie. You cant come back next month-would be 5 months later-in another private-much more expensive hospital on the other side of town, and you cant afford me there.””(This to a by then extremely anxious patient-who needed consultation time, re-assurance, not blackmail.Even as I was wheeled down to theatre at 5.30pm-instead of lunctime proposed surgery (had also requested early in the day”)Had grave misgivings. My biggest lesson learnt that day-I am NOT assertive enough, as their pre-op performance was disgusting, and have the protection of our ACC Corporation-based on American Law. (The rest of my story)is on Earls view-and on two ocassions. Attempting to bring this to outside interest My story is on global medical website’s and have had wonderful advice, that I have followed through on, and as self represented, with yet another Review in 3 weeks, I need to plow ahead with what knowledge -and tests-that I have gleaned from o;seas experts, including Zimmer-Look to surgeon tecnique,disintergration of liner, (toxicollogy levels are high) heat stroke=from cement process (Stated on form and verbally (no cement) the screws-only knew of 3 screw few months ago, and infected Bone. Filled out mega forms for Bone Donation, but have knowledge NONE was ussed or taken from me. Apparently lot and batch no, are NOT suspect. Have had 72 assesment, and recognized so far-is all the nerve damage, (Not just femoral) but orthopaedic world makng the most of my immediateweakened leg-could not walk to toilet, painful left heel would not hold me, and sustained a thunderos backward fall in hosptal bathroom. Eceryone tryin to pass the blame”and the victim remains as was 7 years ago,The desire for truth and facts has seen me-research worldwide. Mistakes were made by both Surgeon and anaethitist, but prooving their mistakes is like hitting a brick wall, and all have closed ranks. Earl has been enormously helpful,as was Sadwin in those bad times-when my story was noticed by Earl-Just adding I was healthy, active-lifetime dancer, and swimmer (never to be again) and had more minor known arthritis that did not bother me, at that stage. Bp always excellent, sent me into immediate hypotensive state, and only controlled with medication. Kidneys went from grade 1 to grade 5 in short space of time, and just returned to grade 4-I am demanding my stolen life back, and the fact that I suffered at one man’s mistake”was known to have difficulty affixing the Duron Cup-hence screws, and cement in haste and speed surgery at wrong end of day-where many mistakes were made (negligence-and this should never have happened) The bitterness is not as acute-with more positive attitude. Still remains 7 years of my life were stolen overnight. Feel for Sadwin and all others-but it does become a fight of personal integrity in the end result.I believe that in time (new discoveries every day) Justice will be seen to be done. Good Luck Sadwin, and thanks Earl
Hi Jill
it seems to be the same every where.
I was talking to someone in the US a few days a go – their husband’s surgeon had died and the other 3 partners wouldn’t deal with him.
Seems all the doctors don’t want to take another surgeon’s mistake on – up there they are forever being sued by their patients.
So in some ways no better off than under the ACC system which protects NZ surgeons.
Seems to be a mates club – take the money off the patients and run is how some of them operate.
Thankfully not all surgeons ascribe to this behavior. Just a matter of finding the good ones.
Earl
If your hip implant is causing you pain, you may be entitled to financial compensation.
Contact us now to get a free and confidential evaluation.
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