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DePuy, Earl, FDA, Food & Drug Administration, hip, Patient, Smith & Nephew, Stryker
Why don’t we hear more from those with defective Smith & Nephew Hips?
Earl, you are right, are people afraid of speaking up re: Smith & Nephew problems?
In reading reports on the BHR, referrences of data from Smith & Nephew’s BHR are taken from the same controlled group of 2385 patients that McMinn seems to control. Then there is reference from 140 surgeons who supposedily were responsible for 3800 hip implants.
The first attempt by Smith & Nephew to get their hip device approved by the FDA was denied in 2004, by a 3/2 vote. One of the major concerns expressed by the FDA was the data used in reporting results came from the ( I believe ) same 2385 patients, and McMinn the inventor of the BHR, worked for Smith & Nephew at the time, and he had a huge pay day for his BHR, supposedly over $100,000,000.
In 2006 the FDA through their 510k plan approved the device by 3/2 vote and the company used the same basic information; once used for denial, now used for approval.
Well here we are years later, and I still see reference to the same 2385 patient test group being used for statistics?
Questions:
if a study were done taking the history of hip devices;
- when they were approved?
- how approved?
- If the good and bad results taken randomly, would we discover company A says we are introducing xyz hip device, then company B says we are introducing 123 hip etc?
- Would we see a pattern that may lead one to suspect market control of pricing these devices?
Where are the skeletons?
I have not found Smith & Nephew’s “be aware of problems” list, other than articles you have to dig for, however your site has brought some of us that have suffered using the BHR.
Their name doesn’t appear as having potential problems.
Isn’t Cobalt Chrome the same in all hips?
Their product was metal on metal same materials used in other devices by DePuy, Stryker, etc. there aren’t as many people suffering from the BHR as with other manufacturers, however just because there hasn’t been a recall on the BHR, fact remains metal on metal present issues that affect the quality of our lives.
Is the data real or not?
The continuous use of the same 2385 BHR patients is absolute Bull Sh-t, don’t you think?
So BHR victims speak up if it is justice you seek.
Respectfully
Howard Sadwin
Related articles
- History – Smith & Nephew Receives US FDA Approval For Ceramic-On-Ceramic Hip (earlsview.com)
- Mr. Michael Solomon, Sydney Australia Surgeon Gives Advice on Hip Replacement (earlsview.com)
- Smith & Nephew turns attention to emerging economies to counteract tough European market (independent.co.uk)
- ‘Metal on metal’ hip implants leave some recipients in pain, at risk (earlsview.com)
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The question should be what CAUSED the failures? Was it REALLY a defective BHR device? If so, then why are we not finding a ton of patients with failed hips like with the ASR after only 7 years? ALL devices have failures, no matter what they are made out of. So the real question should be WHY did your device fail? Was it positioned right? The only way to know that for a fact is to get opinions from some of the top hip experts in the world and do it anonymously, no name, no mention of device, no mention of your doc.
I have helped thousands of patients through my volunteer work and believe me, I am a PATIENT ADVOCATE first and foremost, not a doctor advocate, not a device advocate, but a PATIENT advocate. I want to see successful happy endings for everyone out there. The majority of the failures that I have dealt with had their own surgeons as well as one or two other “specialists” that really did not know much about hip resurfacing, examine their x-rays and tell those patients that the device was placed fine and they must be allergic to the metal or have a metal ion problem. When those patients finally got in touch with me, I sent their x-rays to a group of top surgeons to get their opinions for free. And again, the majority of those patients had poorly placed components. A couple of them had their cups placed so deep that they had holes through their pelvis, no wonder they were in pain after they had surgery!!!
When your cup angle is placed wrong, it can cause excess metal wear. Reading Howard’s story, it sounds to me like he just got a really bad deep infection and I am sorry but with ANY major surgery, infection is a risk, that is just a fact. Metal ions do NOT cause infections that need to be treated with antibiotics, it just does not. All the cases I have worked with, the patients that were revised to THR’s, many are now living happy pain free lives and their metal levels are back to normal once the implant was removed.
I have never heard of one single case of a patient that had high metal levels that needed their hip removed and heavy duty antibiotics. That just makes no sense to me at all. Did you check to see what the infection rates have been at the hospital you had surgery in?
If in fact the BHR device was defective, then the failure rates would be through the roof by now (after 14 years on the market) the way they are with the ASR device (after only about 7 years). After all, the BHR has been around the longest, for 14 years exactly designed the way it still is today as it was 14 years ago, but if you count the first prototypes, it has been over 20 years now. But they are not failing like crazy. They are lower than most THR’s out there. I see WAY more failures of THR’s happening all the time, just go on any THR only support group, you will read stories of patients having their 3rd, 4th or 5th revision in a matter of a few years sometimes. Are they running out and blaming the device? No, most patients just accept that THR’s come with leg length discrepancies and multiple dislocations and end up getting revisions.
The BHR is a proven device, believe me, I did my research because I had my first one done almost 6 years ago and right in the middle of all the negative press out there, I went back and got my other hip done with a BHR. I personally have NO interest, not paid one cent for my volunteer work, do NOT get any kick backs from any manufacturers or doctors, I am 100% neutral. I certainly would not risk my life and run out and get another BHR if I thought for one second anything was wrong with the device. I also would not get any other device other than a BHR, because I do believe it is proven. Both hips are doing fantastic and I couldn’t be happier.
If anyone on here wants to really find out what the root of your problems were that ended up causing your BHR to fail, then please, email me your x-rays and I would be happy to anonymously send them to several top surgeons from around the world, including many that don’t even implant the BHR if you like, but use the C+ device most of the time, so unbiased surgeons.
I am happy to help anyone that would like my help or wants help. Even if you already got a revision, get your old x-rays and we will find out what really was the reason for your failure.
PLEASE, let’s not spread FALSE information out there, it really does the public no good. What facts do you have that your component was placed perfectly? Your own surgeon telling you it was perfect is NOT reliable, it is biased, pure and simple. Especially inexperienced surgeons that have not done a lot of BHR’s, most do NOT get the positioning right and are quick to blame it on metal allergy or anything other than their own skills. Please feel free to contact me, anyone that wishes to and would really like to know what happened to you. This is an incredible procedure that really does and can give you your full active life back. I have met with SO many very happy ecstatic patients, some going on well over 10 years with their BHR’s. Even some of the earlier first prototypes of the BHR that are now going on 20 years post op, thrilled with their results. Feel free to contact me at vicky@ vmarlow.com, just delete the space after the @ symbol.
I just believe in putting the TRUTH out there backed with FACTUAL data. Get some opinions from unbiased world class surgeons anonymously. Then and only then can you really know if your failure was caused by a malpositioned component or a true metal allergy. But again, in Howard’s case, I am sorry but I have never heard of one single other patient that ever had to go on antibiotics due to a metal implant. What happened to him where they remove the hip and place a spacer and the patient is on antibiotics and the hip is flushed out with antibiotics is due to infection, and that has happened with a lot of THR patients as well, but it had nothing to do with the DEVICE, the patient just got a deep infection. It sounds like Howard got a deep infection that possibly went untreated for way too long and that can happen even with a knee implant. I know of one guy that lost his leg due to a deep infection after knee surgery and he didn’t even have an implant.
Let’s get the facts right, there is enough misinformation out there being spread by the press with half truths. I am really sorry for all of you that have had to face such a horrible experience, but if it were me, I know I certainly would want to get to the bottom of it and find out what the REAL problem was and not just listen to my own doc and one other doc that probably hasn’t done many resurfacings at all. I am here to help, so email me if you would like my help to find out what really happened to you, find out what the REAL problem was and what really went wrong.
Vicky
Vicky
Thank you for your very sensible advice. I too question whether there is any relation between the BHR and the infection. There was no infection prior to the removal. So I would be questioning whether it was a “dirty hospital” environment that was the real cause.
Howard – have you worked through this as an option? I am sure you have? What are your thoughts?
Earl
So a question for you Howard, if you don’t believe in Derek McMinn’s numbers, have you looked at all the Joint Registry data? They all show the BHR device has a great success rate. Derek McMinn comments on his own series because he keeps very detailed follow up on ALL of his patients. But if you don’t believe his numbers, look at all the National Joint Registries that are out there, that is as unbiased info as you can get because it is every single hip ever implanted in that particular country.
Vicky
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I am just wondering why Howard that you have no interest in finding out what happened in your case? I offered to send your x-rays out to several of the world’s top surgeons anonymously for their opinions and yet you refused. I mean yes, it is very sad what happened to you. But what are you going to do now? You can not live with a spacer in your hip the rest of your life. You WILL have to choose a THR device and what happens if you get another deep infection? Will you then blame the manufacturer of THAT device whatever it is? I’m sorry but I am not getting your point here. FDA aside, as far as the BHR is concerned, maybe you don’t see the failures coming out of the woodwork like you do with the defective ASR device because they just aren’t there? I mean of course every device will have a few failures here and there, it is impossible for a device to have 100% success rate. But WHY did it fail? Surgeon error? Defective implant? Again, I am not sure what your motive is behind all of this anger when you are offered to actually find out the real reason behind your failure, FREE of charge AND anonymously and yet you refused to from me. So what is your REAL reason behind attacking what to me has been a perfectly successful device TWICE in my hips and gave me my full life back as well as MANY other very happy patients. Again, I am very sorry for your problems that you have had to deal with, but at the same time, I know if it were me, I would want to know why? Unless you have some other motive behind this? I’m sorry to say it, but if you refuse to send your x-rays out to find out the true reason for your failure, are you doing what many others are accusing some docs of doing? Just going after money? Because from the past 6 years of experience I have had on all the support groups and helping tons of patients, I have found the BHR to be the best and most proven device out there. Look at the track records of the BHR compared to any other resurfacing device on the Australian registry, the UK registry, etc. It hands down beats them all. I am very confused at your refusal of assistance especially since it is free to you.
The FDA, well that is a different story and I am not even going to get into that on here, it is senseless. Is your beef with the FDA or S&N? Or do you even know? I just think it is only fair to show all sides to the story and get to the bottom of it. Every single device out there is going to have failures, but the BHR is the most proven after over 14 years around and if you count the first prototypes, over 20 years and still going strong. Why would you badmouth a device that can help SO many young active patients when you yourself are not willing to find out what really happened to you? Am I missing something here? Vicky Marlow
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