Tags
BHR, Cobalt chrome, Cobalt poisoning, FDA, Food & Drug Administration, Hip Replacement, hip replacement failure, hip resurfacing, metal, metal-on-metal hips, metallosis, NephewSmith, science, Smith, Smith & Nephew, surgery
by Ed Larsen
When I first became aware of “Earls View” and contributed to the Blog regarding my personal experience with the BHR and elevated cobalt/chromium levels, I had no idea this would only be the beginning of my problems and not my road to the remedy!
Following the removal of the BHR on Dec 11th after its original implant in Aug of 2009, my hip was revised with a Zimmer metal on plastic device. My surgery went well, accelerated recuperation and my extremely elevated chromium / cobalt levels already dropped over 60% in a matter of weeks after the device removal.
Unfortunately, on Dec 28 th while eating dinner and sitting in a chair my hip dislocated and after an 8 hr ordeal in the emergency room my hip was relocated under sedation and I was sent home.
Over the next 3 weeks recuperation from the dislocation was more akin to the original recovery challenge from the original BHR implant. I subsequently developed a serious infection in the hip area and had to be admitted for emergency surgery.
The infection was such that the incision had to be reclosed after cleansing the device and hip area to wait for the bacteria cultures to be developed and schedule a subsequent surgery in a matter of days to extract the device, implant a concrete spacer impregnated with the targeted antibiotic and then be treated with the same antibiotics by IV over the next 6-8 weeks until hopefully the infection is eliminated.
At that time, the now 5th surgery will be scheduled to remove the spacer and put in place a new metal on plastic hip replacement. This is exactly what I feared most after being affected by the BHR metal ion toxicity and having to have the original device removed.
Obviously one never wants to test the odds of multiple surgeries inviting variables such as blood clots or infections which you escaped the first go around!
So I take a day at a time in this journey to remedy these problems but emphasize the seriousness of the BHR issues out there, FDA ‘s ignoring the need to address Smith & Nephew ‘s responsibilities to the patients , the absurdity of the current Insulation S &N has enjoyed from litigation and most importantly how far off practical reality our chief justices of the Supreme Court have been in misinterpreting the FDA guidelines and their mutual responsibility to protect the consumer !
Ed Larsen
Related articles
- Ed Confirms that S&N BHR MoM’s are Ticking Bombs… (earlsview.com)
- Laurel’s Story – Smith & Nephew BHR Hip Resurfacing Ruins Another Life (earlsview.com)
- Anon. UK – Smith & Nephew BHR hip failure heartache… (earlsview.com)
- More Smith & Nephew THR Spectron/BHR metal on metal Horror – Anna’s Story (earlsview.com)
- FDA Action on Metal on Metal Hips – too little, too late… (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)
- Come out front Smith & Nephew – we have had your medicine – time for yours… (earlsview.com)
- UK – Gayle makes valuable discoveries about MoM hips post revision (earlsview.com)
- Calling all Smith & Nephew victims (earlsview.com)
Taking nothing away from Ed Larsen’s post, a situation that seems to be to be as bad as it gets, the FDA’s protection of manufacturers of faulty MOM hips extends beyond manufacturer Smith and Nephew. Others (Corin / Cormet for one) made and profited from these devices too, and enjoy the benefit of PMA while patients endure revisions, infections and a lifetime of fear that something as simple as shifting in a chair could dislocate their hip.
How do we get our elected officials to break from their partisan intransigence to take the time to address the infrastructure of our laws and regulations that put profits before people?
Good question. There are at least 243 millionaires in congress I have read. A wise man once said ” you cannot get a pig to slaughter itself”.
I don’t think elected officials have any interest in rocking the boat.
Earl
Ed, all I can say is ouch! It is a disgrace that this has happened to you and I can feel the pain, literally! Please, would you be interested in filling in the form on my site to help provide a louder voice? You can find the info under ‘calling all S&N victims’ it’s not just for the UK regarding the form and there is no conflict with Earl.
Earl is accurate in his comments; try to discuss this nightmare from hell with your local
politicians, the men and women we elected, and the taxes we pay to provide assurance that we will be protected first above and beyond the manufacturer, especially when their approved devices fail or malfunction causing harm to 100′s of THOUSANDS of innocent patients. KEEP WRITING, CALLING, WHATEVER TO GET YOUR LOCAL POLITICIANS TO ADDRESS THIS DEBACLE. K EEP WRITING AND TELLING YOUR STORIES IN EARL’S View or other publications, but do not stop
communicating, in the long run it will pay off.
I think trying to discuss poison ivy would be easier. It seems several Senators attempted to persuade the FDA to do something about the MOM hip debacle, but to no avail. It appears the powers to be including the manufacturers think this will just blow over and every one will forget about this disaster, at least until the next.
Tenacity is what we all must put forth in our efforts to make the FDA see the light and tenacity on our part is what it may take to make the FDA stand up and admit they did not do a good job on this issue and the metal on metal hips should never have been approved to begin with.
A child would know metal on metal continuously rubbing against each other ( components of the device ) causing friction and eventually shedding particles of metal that would enter the human blood stream causing more harm than good in the long run. For those that have these MOM hip devices and are experiencing no problems I pray you will continue to have no problems, however be AWARE.
The FDA dropped the ball, the manufacturers withheld adverse information or even lacked pertinent information when they sought approval of their devices, now this data and results are surfacing. Which MAKES US THE LAB RATS.
I don’t know about you but I never received any notification that I was to be a lab rat victim of a metal on metal hip resurfacing device: SMITH & NEPHEW’S BIRMINGHAM HIP RESURFACING DEVICE.
Respectfully
Howard Sadwin
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