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Birmingham, chest x ray, Cobalt chrome, Cobalt poisoning, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, depuy hip recall, FDA, Food & Drug Administration, Health, Hip recall, Hip Replacement, hip resurfacing, hip revision, Hospital for Special Surgery, Magnetic resonance imaging, Medicine, Mental Health, Nephew, NephewSmith, New York City, pericardial effusion, rapid heart rate, Smith, Smith & Nephew
In August of 2008 at the age of 49 I had a Birmingham Resurfacing of my right hip. This hip had been arthroscopically debrided in 2004 for an acetabular labrum tear. I was told at that time that I would likely need a total hip replacement at some point because of the cartilege damage that found.
I had an uneventful recovery from the Birmingham, (it was done by a very experienced surgeon at the Hospital for Special Surgery in New York City). I returned to my regular activities including working as a registered nurse first assistant in the operating room at 6 weeks post-op.
About 11 months (the fall of 2009) after the resurfacing, I started having all sorts of “strange” symptoms. First I developed tachycardia (rapid heart rate) with chest pain. I went to a cardiologist that investigated everything thoroughly and the only thing that she could find that was abnormal was that I had a small pericardial effusion (fluid around the heart) that she felt may have caused the abnormal rhythm.
Shortly thereafter, I developed a flu-like syndrome that lasted close to six weeks. I was short of breath, exhausted and generally felt awful. I saw my internest, he did a chest x-ray and sent me for pulmonary function testing. I recall asking if my hip could have anything to do with this, but he said it was unlikely. They couldn’t really find anything to explain the symptoms.
Along with all this I started having swelling and cold intolerence in my fingers and pain in my feet when I walked. This prompted a trip to a rheumatologist who I again asked if he thought the hip could be the culprit…again he said no. Again, all the tests he ran came back normal. But I know I am not CRAZY!
In time we are about 15months (spring of 2010) out from the operation at this point. The hip is still seemingly functioning well. I am not having any unusual symptoms that I feel are coming from the prosthetic joint.
Over the summer of 2010 I start noticing that the hip is popping and clunking at times. I think this is strange but I don’t have any pain so I continue about my life.
In the fall of 2010 I start noticing pain in the resurface hip when I am walking my dog. I pay relative attention to this, but don’t actually address it until the spring of 2011 when I am having almost constant pain in the hip and I am eating anti-inflammatory drugs like candy. So I have my metal ion levels checked. It is February of 2011. My levels are elevated, but not super elevated. The cobalt is 2.7 and the Chromium is 3.3.
In March of 2011 I make an appointment to see my surgeon to have him go over all this with me. Unfortunately, the surgeons attitude at the time was that the x-ray was perfect, I had good range of motion and he doubted the “pain” was coming from my hip. He though my pain was coming from my back. Also, he felt that the labs were not useful as they had not been done by the proper lab. At my insistence he repeated the blood work and ordered an MRI of my hip and back.
The blood work came back with the cobalt at 2.8 and the chromium at 5.7 (this is about 3 weeks after the first blood test). The MRI of my hip showed inflammation and metal debris in the tissue. I never had the MRI of my back. The surgeon called me and told me this was going to have to b watched, but likely the prosthesis would have to be replaced.
In August of 2011 (almost exactly 3 years to the day) I had a revision and conversion to a titanium on plastic total hip.
I have also since been diagnosed with hypothyroidsm (Hashimoto’s disease) which is an autoimmune disorder that I think was precipitated by the immune reaction to the metal on metal hip.
Hopefully this will be helpful for others when looking at what is going on with their bodies after a metal on metal hip implant.
I know there are many people out there with Birmingham resurfacing devices in similar situations. It seems that Smith & Nephew is immune to trouble because of the PMA approval that they received for this particular device, but I feel if enough of us could get organized we might be able to impact them somehow.
Sincerely,
Laurel Mengarelli
Related articles
- FDA Action on Metal on Metal Hips – too little, too late… (earlsview.com)
- Anon. UK – Smith & Nephew BHR hip failure heartache… (earlsview.com)
- David’s BHR Horror Story – Smith & Nephew Floodgate will open soon… (earlsview.com)
- Ed Confirms that S&N BHR MoM’s are Ticking Bombs… (earlsview.com)
- Come out front Smith & Nephew – we have had your medicine – time for yours… (earlsview.com)
- San Diego Chargers team doctor sues Smith & Nephew over botched hip implant | MassDevice – Medical Device Industry News (earlsview.com)
- Howard Sadwin – Video of Howard’s battle with the damage from Smith & Nephew BHR hip (earlsview.com)
- More Smith & Nephew THR Spectron/BHR metal on metal Horror – Anna’s Story (earlsview.com)
- UK – Gayle makes valuable discoveries about MoM hips post revision (earlsview.com)
- Metal-on-metal hip implant risks ‘unique’ – Health – CBC News (earlsview.com)
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Hi Laurel,
So much of your story is mine.
I too was 49 when I had a Birmingham hip resurfacing and over the first couple of years nothing really to worry about. But then I experienced the grinding and clicking. Not much pain and I figured I was better off than before surgery.
After the J&J recall I decided to test my metal levels even though I had a S& N and guess what……Chromium 1477 nmoL (86 ugL) more than 15 times normal and cobalt 3724 nmol/L (219 ug/L) more than 150 times the norm !!
I had immediate revision surgery which involved scraping the destroyed tissue from the hip area and removing as much metal as possible, a bone graft as my pelvis was disintegrating, and a metal plate and pins inserted to keep everything together. I still experience nerve damage in my feet and some pain in the joint but am so reluctant to do anything more about it as I cant stand the idea of more surgery. Such a bitch !!!
Please keep me updated with anything happening with S&N….Cheers from Oz
I’ve had 4 hip replacements, starting with Smith and Nephew. I have a lawyer who is looking for others like us, to do a MDL (Multi-District-Litigation, meaning any state) (a couple of firms with a few clients pool their resources. I don’t pay anything whether they win or lose. United we must stand!
Attorney Joseph Lyon
The Lyon Firm
22 W. 9th St.
Cincinnati, OH 45202
513-381-2333
http://www.TheLyonFirm.com
I have very similar symptoms following my Mitch Stryker resurfacing in 2008 here in sunny Melbourne [which particular combination has not been recalled] – chest pains, fatigue, feeling very hot, – not to mention a bloody sore hip and I too know I’m not crazy.
My ‘problem’ is that my MRI is ok and my blood metals are not elevated – in fact they have gone down “after the wear in phase” . Whenever I read one of these accounts I am saying to myself “that’s exactly what’s happened to me but then I get to the part where the unfortunate person talks about blood levels and MRI results and the non functioning hip is conclusively and objectively demonstrated.
Are there any cases of bad hips not showing up on MRI or with elevated blood levels? Can symptoms occur before tests reveal them.
Regards
Andrew
Hi Andrew
The answer is yes. Mine hurt from day one. The metal levels were never as elevated as others and for a few years until the stem came loose and the bone shrunk away (died), all looked relatively normal. But I had all the various symptoms well before it was finally accepted as needing revision. Did you watch the Tony Nargol video?
Earl
Thanks Earl – I haven’t seen that video – can you direct me to it please ?- how are you getting on ? – I’m so petrified of revision surgery – mine too hurt from day one – it has simply never worked – I can feel the hip is strong but has always been painful. My surgeon has the same one in his hip and says it’s great !! Figure that out.
It is the featured post on the home page of my blog. https://earlsview.com/2012/11/27/important-surgeon-talks-about-the-silent-mom-dangers/
Thanks Earl – I have watched that now. My situation is the reverse ie I have all the symptoms but no pathology. Tony Nargol describes people who had no – or very little – symptoms but once they got to the blood test metal ions very high. My hip was scoped a few months ago so I have asked my surgeon if tissue damage/metal debris can be detected when performing a ‘scope. Regards Andrew
Yes. I understand but the body is more sensitive than the tests as I found out. In my experience the symptoms won’t get better and eventually the pathology will be evident. Hang in there and grit your teeth which is what I do most days, for various reasons!!!
Earl
PS. Hips keep me honest. Revised hip is good but not perfect! Left hip is worn out but I am in denial until it stops me walking and sleeping!!!
Earl
Laurel,
Thanks for rehashing your (miserable) well-written thoughts on the Smith & Nephew issue. I have had 4 hip replacements since late 2007 which came with a list of ailments I won’t bore you with.
The point is, when I saw Earl’s posting of the video of Dr. Tower and MoM implants, I was enraged. My last op was 8-14-11. A wonderful knowledgeable compassionate lawyer, Joseph Lyon of The Lyon Firm, took on my double case; I pay not a cent. However, he is doing an MDL (Multi-district Litigation), where he collaborates with other firm(s), even in other states, who have clients with the same complaint. The last I spoke to him, the other firm had backed out. Joe said it “wasn’t going well”. I couldn’t believe it! How could I, just above poverty-level, hold Smith & Nephew accountable for huge amounts of metal shards in yellow liquid came spurting(!) out of my agonized right hip.
The film’s link is here on Earl’s blog. Yes, there must be a way to do this, but from my place, I am only one . . . if all the Smith & Nephew victims could ask their lawyers if they are interested in joining The Lyon Firm on this case. There are many of us! But no organization yet to redress in any way the 4 years of my life I’ve lost and the hundreds of combined years of quality life lived by thousands.
Please pass this around so we all can have our voice. Contact:
Joseph Lyon
The Lyon Firm
22 W. 9th St.
Cincinnati, OH 45202
513-381-2333
http://www.TheLyonFirm.com
I signed up with a lawyer too but have not heard anything much from them. I think we need a lawyer with balls to take on S&N. I keep thinking we’re a little step closer to a recall but it doesn’t seem to be happening.
I’ve had 5 surgeries since 2008 by the way and now have recalled Stryker hips!!!
Laurel and all make sure you get your implanted hip that is removed and put it in a safety deposit box or such.
Attorney’s take this type of case on a contingency basis: they pay all out of pocket expenses ( in this case expenses will run into millions of dollars )
It may behoove attorneys handling Smith & Nephew cases to work and talk to each other in order to share in the discovery expenses and two minds are better than one sometimes.
I sent a quick e-mail to Joseph Lyons, he was polite enough to respond right away, I have my own attorney. My understanding from all I have read is the pre-emption laws leave little room for legal actions against the manufacturer Smith and Nephew, however that is not to say it is impossible, so don’t get discouraged.
I believe there exist enough reasonable doubt that this device was approved under questionable data submitted by the manufacturer and the inventor himself.
The inventor and company received 66 million pounds for a company that had a highest grossing years of 23 million pounds ( how is that worth 66 million pounds )
then a bonus of 33 million pounds was paid to the inventor once the FDA approved the pma on the bhr.
NOW if this isn’t a conflict of interest ?????
I strongly suggest read the story about the bhr from Midland Technical (original company of the bhr) to the approval by the FDA in a special hearing called on September 5, 2005 held in Washington, DC to approve this device.
Read the citizen’s letter submitted to the FDA by Wright manufacture by Roberts asking the FDA to deny approval and why ( this will get your blood bubbling)
there was correspondence back and forth between the FDA, S&N and Wright on this
matter. My opinion on the citizens letter to deny may have been looked upon ( with a little help $$$$) as one company ( Wright ) vs Smith & Nephew.
Had the letter requesting denial been taken for it’s content and not for a rock throwing
contest, there is no way this device should have been implanted in my body or yours.
Smith & Nephew new about problems with their R3 ace tabular hip and their stem problem in the bhmr hip, yet they never said anything to the USA. and these problems were apparent during same timeframe the bhr was going through the approval process in the USA.
You may not feel up to it but read this material, you will have a better understanding of what is going on, why, and you may even come up with ideas to help your attorneys.
This will tell you what happened, why it happened, how it happened and what can I do about it.
This is not easy on victims, at times I get physically ill dealing with the bhr Smith & Nephew hip debacle, but I regroup and continue, if not, justice, accountability, reform and folks in need of help will not happen and this type of nightmare will only happen again-may be to my grand child.
The pma approval by the FDA is law. However the FDA is not perfect they were influenced to approve this device knowing it may have serious repercussions due to the unknown, METAL PARTICLES FROM FRICTION OF THE MATERIALS USED IN THE BHR MOVING IN THE HUMAN BODY, AND WHAT WOULD THESE PARTICLES DO TO THE HUIMAN BODY ONCE THEY ENTER OUR BLOOD.
WELL NOW THE FDA HAS ALL THE DATA IT NEEDS TO SEE THESE DEVICES HAVE NO BUSINESS BEING ON THE MARKET.
YET THE FDA CAN’T-WON’T MAKE THE RIGHT DECISION CORRUPTION-CORRUPTION PREVAILS.
I WOULD STRONGLY SUGGEST YOU WRITE TO THE FOIA ( FREEDOM OF INFORMATION -FDA ) ASK FOR ALL CORRESPONDENCE BETWEEN THE FDA AND SMITH & NEPHEW RE: BIRMINGHAM HIP AND WRITE TO YOU POLITICIANS
TELLNG THEM YOUR STORY AND THEN ASK THEM WHY NO ONE IS DOING THE RIGHT THING HERE- TAKE THE MEWTAL ON METAL DEVICES OFF THE MARKET.
I hope this may be of help, I know some of this is repetitious but you must go beyond the point of anger in order to move forward.
Remember ” David and Goliath ” Smith & Nephew may employ 90,000 people and be all over the world, but that DOESN’T GIVE THE RIGHT NOR A FREE PASS TO HURT US IF THEIR HIP DEVICE MALFUNCTIONS.
respectfully
HOWARD SADWIN
thank you for your encouraging words Howard. This also makes me sick to my stomach (I’m a victim of the BHR) to see how they slipped themsleves behind the FDA for protection (and I think it is the only hip that is protected this way?). I feel like it is the sames feeling a non-guilty person must feel being in prison and there’s nothing they can do about it. No lawyers want to go up against the FDA. I absolutely can’t believe it. Even if just one of us had problems with the mom device that should be enough to take it off the market and look how many of us are left disabled (and there are many with the mom that are silently suffering but don’t even know!). I am also baffeled why the doctor’s putting in these devices (like mine) are not warning their patients. This is a story for the show “20/20″ or “John Stossel”!! I am finding encouragement from people like you.
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My husband had a BHR hip reserfucing when he was 28 in December ’07. When he awoke from surgery, he had a new pain in his hip, but this was dismissed by the doctors. By February he started developing flu-like symptoms, we thought it had to do with the implant. We called his ortho doc (who was several hundred miles away), he told us to go to the local emergency room. We did, they said he had an infection (blood work was elevated) from the surgery and we needed to go back to the ortho surgeon. We did. That doctor said everything was fine and sent us home.
Over the next few months, everything went downhill rapidly. He lost 60 lbs and could barely function. He could barely move from the chair to the bed. He was unable to work or even have a life. During the summer, he was hospitalized for a week. The doctor was not able to diagnose him with anything and said maybe he was depressed! We knew the problem was not in his head, but no doctor seem to think he had to do with his hip. By the following September, we were at a infectious disease doctor. He did diagnose him with Q fever but that was treated and he was still not better. They ran a full body scan and all problems areas pointed to the hip but all we got is “that’s odd” and “that is not my area”. No doctor seemed to take us seriously. We went to several orthopedics and even an oncologist orthopedic surgeon and no decision could be made. For a year my husband could not spend time with his children or have a life or work, all the while doctors were clueless or did not care. We went back to the orthopedic who put in the implant. He did check out at the BHR and said and everything was fine with it. He suggested it could be sciatic nerve (surprise), and that it should be fused. But first he sent my husband to a rhuematologist, she diagnosed him with Ankylosing Spondylitis, RA, and SA. It has been a long hard battle and several different medicines to fight the chronic pain. He still lives everyday with the debilitating pain but is on medication that puts him at risk for serious infection just he can live a semi-normal life. And now to find out that it could all be tied to the hip! We still do not know. We are looking for a new orthopedic in our area to look at the hip and possible options.
Hi Sherra
that is dreadful – I would be very dubious about the “diagnosis” from the rheumatologist. I had one prescribe me a drug called Salazapyrin which just about killed me – I lost 20kg and my liver was nearly destroyed.
Another orthopaedic surgeon sounds like a very good idea – where are you located?
Earl
We are located in West Texas but more than willing to travel for a good doctor! Any suggestions are greatly appreciated and needed.
He seemed to respond to this last medicine but we are closely watching his liver.
Thanks
Sherra, it is so obvious that the problem is the BHR hip!! This makes me sick just reading about it. He needs to get it out ASAP!! There is a Dr. at Mass General in Boston that specializes in “revision” hip surgery’s (i had the godawful BHR and he got it out for me!). It amazes me how many orthopedic surgeons don’t even know what they are doing – do they not have any common sense? The one that put my “refurfaced” hip in had no idea eithor – he said he had never seen a psydo-tumor and I was full of them. I just have to respond to your comment because I really do think that these hips are going to kill people. Everyday I ask myself why I was stupid enough to let some idiot put a metal device in me! I actually think if I was that stupid to let someone do it (because I wanted to keep running and stay active – like the orthopedic said!) then I deserve this (disabled)!! You have to take your own life in your own hands and ASSUME they know nothing because they don’t! You were right from the very beginning – IT IS THE HIP!! So glad you found this blog (thanks Earl).
Thanks Connie, you put it far better than I could. I sat in front of TV watching an action movie gritting my teeth with the pain from the left hip that should have been replaced 18 months ago but got bumped as the useless S&N mom THR had to be revised. The revision has been good most days but not for the last few days. Falling down some stairs did not agree with it. But at least I a still walking and I am grateful for that. Keep fighting! Earl
Laurel, there are no words to describe you and your husbands nightmares,
you are very brave writing you story and then sharing it.
You are not alone, as you can see from other folks that have had the BHR implanted.
I to, My name is Howard Sadwin, my BHR was implanted in 2007 the rest of my story is on Earl’s View ( Earl is also a victim of a metal on metal hip ).
All I can suggest is try to take any of your frustrations-angers and direct that same energy into getting well.
In 2010 when my BHR implant was removed there was no protocol, BHR patients (victims-lab rats ) were now having to similar or same symptoms of ill health etc.etc
Surgeons were only aware of what the manufacturer released to them.
Surgeons only became aware of these problems as more and more patients were having issues and doctors started conversing with other doctors. They were in a quandary looking for information on treating these symptoms. There were none, the manufacturer never provide one that I am aware of or I can find evidence, or then again it maybe Smith & Nephew has it listed under CLASSIFIED or they neglected to tell the doctors as they were becoming aware.
There is a trial just started July 25,2013 in Los Angeles, California, re: another device manufacturer of a metal on metal hip resurfacing device.
The LA Times wrote about the opening statements on the case.
This could be landmark, if the victims prevail over the manufacturer, this could be the beginning of eliminating the CORRUPTION in the medical device world.
If the well being and safety of a human being prevails over the rate of return to the investor and MARKET SHARE justice will have been served, accountability, etc. etc
The victims will never get what they have lost, no one can fully understand unless you have been through a nightmare like this.
There will be more and more Smith & Nephew BHR victims coming forward, don’t think it is you if experiencing problems with your metal on metal hip see your surgeon. The FDA RECOMMENDED recently metal on metal hip patients should ask their doctors about having blood checked for chromium and cobalt levels and have an MRI taken on your hip.
Had this information on symptoms been available to others perhaps we would not have suffered as much or as badly.
Stay strong and believe in yourself and know you are not alone their are many folks with malfunctioning BHR’S. in the USA and ABROAD
Respectfully
Howard Sadwin
Laurel, I repeatedly had x-rays on my BHR hip and repeatedly my original surgeon
said x-rays looked fine. It wasn’t until I made an appointment with another surgeon who specializes in such problems that he suspected a build up of fluids around the hip area. He ordered an MRI, unfortunately, one hour after I left his office I had my 3rd hip dislocation re: BHR.
In defense of most surgeons information they were in the dark, these symptoms as you, I and others were experiencing were just publically surfacing.
THE MANUFACTURER SMITH AND NEPHEW SURELY WERE NOT SHARING THIS INFORMATION, IT WOULD HURT THEIR RATE OF RETURN TO INVESTORS AND MARKET SHARE.
THEY STILL ARE TOUTING THEIR METAL ON METAL HIP RESURFACING
DEVICE THE BIRMINGHAM HIP IS THE BEST ON THE MARKET AND IT OUT PERFORMS ALL OF THE OTHER COMPETITION.—–what other competition
they are it, so naturally their hip statistically out performs on paper.
HOW MANY HIPS DID THEY SELL IN THE USA SINCE 2006 APPROVAL AND HOW MANY REVISIONS IS THE QUESTION AND WHEN ANSWERED WE
WILL SEE REAL NUMBERS OF FAILURES.
A VIDEO A FRIEND OF MINE BOB NESS, JUST POSTED ON ” YOU TUBE ”
THEN TYPE MY NAME HOWARD SADWIN AND YOU SHOULD SEE THE VIDEO.
ALL BHR VICTIMS BE PATIENT MORE AND MORE VICTIMS ARE COMING FORWARD AND HOPEFULLY WILL CONTINUE. THE PRE-EMPTION LAWS THAT PROTECT PMA APPROVED DEVICES SUCH AS THE BHR WILL HAVE TO BE DEALT WITH AS THEY ARE IN DIRECT CONFLICT WITH “ENSURING THE SAFETY AND WELL BEING OF HUMAN LIFE ”
respectfully
Howard Sadwin (hbs924@verizon.net)
Check out the video and comment on it THANKS
Go to ” YOU TUBE ” then type Howard Sadwin
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Dear Laurel (and all of you who are suffering, or have loved ones suffering0,
I am so sorry you have gone through this agony. I well understand. I had a BHR implanted in 2005, and it failed last year (actually, my surgeon said it had been failing for a long time) but, it was revised last year. My surgery was also at HSS–in fact, I bet we had the same surgeon. My revision was a failure as well. I live with a cane or a crutch, on daily pain meds and anti-inflammatories, and still have awful, chronic pain–and very acute if I do too much. Both of my new doctors, one at NYU Langone, and another at HSS, are afraid to meddle with it, and want me to go on living in such pain for as long as I can endure it. Much of my massive bone graft was reabsorbed, and there was just too much pelvic bone loss and tissue damage. Also, my revision surgeon didn’t do the best job for me, structurally–it has been inferred by teams of the top orthopods in NYC, I should have had a cage, or a plate, and many more screws–more bone grafting material, as well. I may have had a successful revision had my surgeon not been so odious and cocky. He is a BIG Smith and Nephew man–and one of the top promoters of the BHR in our country. That is why I think we had the same surgeon, he is one of a few at Hospital for Special Surgery doing the BHR (well, not anymore, I would gather!)
I would love to talk to you. If you have the time, can you write to me at my e-mail address, and I shall give you my contact info?
Thanks So Much. I hope you are feeling better. Most Sincerely Yours, Camille Petrillo