Tags
Biomet, DePuy, Hip Replacement, Hospital for Special Surgery, joint replacement, Medicine, NEW YORK, New York TImes, surgery, UNited States
More comments made in response to this article was published in the New York Times:
Hip Implant Complaints Surge, Even as the Dangers Are Studied
By BARRY MEIER and JANET ROBERTS Source: The New York TImes
Published: August 22, 2011 Tim Shaffer for The New York Times
KB
Denver, CO
August 25th, 2011
1:55 am
Thankful
Northport NY
August 25th, 2011
1:50 am
onykagan
ny, ny
August 25th, 2011
12:50 am
miriamhyde54
Salt Lake City, UT
August 24th, 2011
7:30 pm
I am a “lifer” for physical therapy (when I can afford it!). I will always need something like a forearm crutch. I need something like a Jazzy if I want to be out and about…I don’t have one due to the expense. My life has been changed in so many ways, I lose count. I’ve adapted as many things, and my mindset, as much as I can. I am filing a suit against Biomet, but the truth is, no amount of money will ever replace what I can never again do’ not that I won’t try to get every cent I can. I have a long lifetime of medical expenses ahead of me! My 3-year old granddaughter brings me my crutch, but can’t understand why I can’t chase after her. She doesn’t understand why “Mee-Mee” won’t pick her up. Oh! I’ve developed Carpal-Tunnel from using the forearm crutch.
Months after my first contact with my attorney, I was asked to have a blood test for chromium and cobalt. No one expected positive results because it had been so many months; but there it was.
I do not blame my surgeon; he gave me what he believed was the best possible replacement. However, I do hold Biomet 100% responsible. They manufactured the replacement, and took the chance of pushing it to doctors, who then put it in patients. Untold numbers of patients.
BTW, one of the commentators asked if a recipient would have preferred to not have the original surgery(ies). Of course not! I think I can safely say that no one would undergo any kind of surgery unless you came out of it better. I questioned the third surgery, but I knew that if there was any chance of pain relief, it was only by having the surgery.
A long, sad story, but at the same time, I hope to encourage and inspire others. They may been in situations worse or better than mine, but most have learned to be grateful for what we do have; acceptance for what we don’t; and never giving up the fight to keep going, and doing more.
Gudrun
Independence, NY
August 24th, 2011
12:55 pm
At age 52 for unknown reasons I required a hip replacement in 1992. Every year I got an Xray and in 2001 I was informed that the plastic on the femur was shredding against the metal at the hip and the shredding was spilled over the pelvis bone and by autoimmune reaction it caused holes in the bone in several spaces in the pelvis. I needed a revision or total hip replacement in 2002 and they were going to stuff cadaver bone (irradiated so it was not possibly transmitting the HIV virus) into those holes. I have been doing well since then– the holes in the pelvis are repaired from the cadaver bone transplant and I continue to get an annual Xray of the new hip.
I agree we need a computer registry of all hip replacements – good use of the computer…. I also think we need the same for other diseases to learn more: Example I had a foster child that died of a brain tumor- nobody was keeping track of who was getting that disease and nobody was learning enough how to understand brain tumor– we are simply not using the computer for good uses like that just because there are people out there that profit from suffering and from illness and even death and they seem to have a superior lobby going. The rest of us need to speak up!- political will is what is required- we need a lobby too.
Thanks to the excellent surgeons that operated on me – one that needed the most skill to do the revision – he got only $2000 from Medicare (lucky for me I was 62 ) and he is contemplating not accepting Medicare in the future and it is understandable.
Patty
Palmdale, Calif.
August 24th, 2011
12:27 pm
My father is 92 years old & can barely walk. He’s too frail to go through another surgery to fix his hip again. He had a tough time the 1st surgery. This is a man who never had a sick day in his life. Now he has to live the rest of his life (what’s left of it) in pain hardly being able to walk & feeling useless? . What is this business? Job security for the manufactures & surgeons? That’s elder abuse in my book – knowing what they know about these hip replacements.
hb
fairfax, va
August 24th, 2011
7:40 am
Pattygirl
Los Angeles, CA
August 23rd, 2011
6:48 pm
consumerx
Wisconsin
August 23rd, 2011
5:19 pm
Metal on metal is a problem period! A high school kid metal shop student knows this.
Rolland Norman
Canada
August 23rd, 2011
5:18 pm
This is second, a bit polished version, of my initial a stronger
comment.
Since in our good America any “business” which “makes”
money is a good, and, by extension, a legitimate business,
the hip replacement fraud is perpetrated under stewardship
of the state, with approval of a pro-business agency
the FDA.
FDA should be abolished by the voice of the people as
an unsocial agency. That’s simple like this.
Being a consulting engineer, when asked, post factum,
by my friend (a literature professor ) if METAL to METAL
DEVICE can work, my answer was – VERY IMPROBABLY – …
The metal to metal joint without lubrication, this an
engineering nonsense. Since human body is not producing
on its own a lubricant, this concept from its inception
was a FRAUD. Now, 500,000 people are at risk of
re – replacement.
But MONEY HAS BEEN MADE…
That’s the most corrupted outcome any society can
experience.
Rolland Norman
Barbara
Virginia
August 23rd, 2011
4:20 pm
Those who are chiding the NYT because not all metal on metal devices are alike need to stop and think things through.
1. In many cases a single device will be what you might refer to as the canary in the coal mine — in fact, it just gets noticed first, but other devices bear the same risks.
2. It is OFTEN the case that manufacturers will, as some comments here have, blame doctors for being poor performers. Well, sure, this is probably a risk factor, but to the degree that surgical skill must be higher for a given device to be installed properly, that is a risk associated with the device as well as the surgeon. A consumer is still justified in assessing the risk of that device, particularly if they do not have access to a large number of surgeons.
3. In many cases, the FDA comes under tremendous pressure from manufacturers to talk in terms of types of devices rather than specific devices. In order to avoid being leaned on by the Congressman for the district where a device is made, the FDA will avoid singling out the specific poor performers and look at the class more generally, and, as I pointed out above, often enough it will be more of a generalized issue. It is certainly prudent to assume that it might or could be on the part of the FDA, once it gets past good manufacturing practice issues.
4. It just should not be the consumer’s job to worry about which specific metal on metal devices are problematic. In most cases, the consumer has no basis for differentiating the device and no input into its selection.
Martha R.
Washington
August 23rd, 2011
2:35 pm
miriamhyde54
Salt Lake City, UT
August 23rd, 2011
1:05 pm
I am now 57 years old. I had my right hip replaced with a Biomet full metal in 2004. It failed, and was redone after 6 weeks.
Almost to the day, a year later, I had my left hip done; also a Biomet model. I was constantly in pain. In 2008, something was horribly wrong. I kept at the physical therapy, but wound up in a wheelchair. I had to have a massive bursitis aspirated under a CAT scan. After that procedure, the medical team told me there was still about 25% of the nasty liquid in me, but in an area they couldn’t get to.
Towards the end of 2008, and into early 2009, the pain intensified. I saw a doctor because I felt an odd, very hard lump in my lower pelvis area. Unfortunately, I saw a very bad doctor, who told me it was scar tissue. I complained to the clinic manager; explaining that it couldn’t be scar tissue because I’d never had any surgery in that area. Happy to say, he didn’t last long. As the pain continued, I was referred back to physical therapy. Thank whatever for my physical therapist. On his first exam, he, too, noticed the lump. He treated me for several months, all the while keeping note of the “bump”. It grew, exponentially, over those few months. As did the pain. I started doing the “doctor-go-round” in October, and by the end of December (Merry Christmas!), I was back at my orthopedic surgeon’s office. He informed me, with a great deal of distress) that there had been reports of non-cancerous tumor growth caused by the metal-on-metal replacements. Interestingly, predominantly in women; and the left hip. We scheduled my “replace-the-replacement” surgery for 2/2/10.
Barbara
Virginia
August 23rd, 2011
12:50 pm
People talk about the change in ethics at manufacturers, but changes in medical practice have also left patients at higher risk — the FDA used to be able to count on doctors to be skeptical of newer products when effective products already existed. Hence, it took longer for new drugs and devices to scale up, so that if problems arose there was a good chance it would be confined to a relatively small number of people — more than had gone through any clinical trial, but not, as with this device, hundreds of thousands.
That has changed — aggressive marketing (sometimes containing improper financial incentives) that is aimed at a receptive audience (doctors) that willfully refuses to understand the limits and flaws of the regulatory framework governing products that only doctors can order has resulted in a much faster adoption of the latest products — and put many more patients at risk of experiencing the as yet unknown and unstudied complications of that product.
A medical culture that reinforces caution and skepticism that a “new” product is likely to be any better than a current product that is performing well could limit patient injuries — this is the Kaiser model, and Kaiser is often the only source of research on drugs and devices that is not explicitly funded by manufacturers.
Eric B
Oxnard, CA
August 23rd, 2011
12:30 pm
ScubaDuck
Oregon
August 23rd, 2011
10:45 am
Three weeks ago I received a metal-on-metal implant. Why would I do such a foolish thing?
I am a very active 50 year old who has lived with arthritis pain for over 10 years. Each year despite trying practically every method to manage the pain it became debilitating. My first surgeon recommended that I wait for 10 years then get a total hip replacement. But I couldn’t stand choking down enough ibuprofen for that long and cause other damage.
So I researched the internet and found out about hip resurfacing. I read about the successes of athletes returning to high level competition. I read about the problems that have occurred with these devices. I read scientific and medical research papers. I read the great statistics kept by the UK and Australian health services.
The studies concluded that with an experienced surgeon and a proven implant that there is a very high (98%) success rate at 10 years. So I found a surgeon that was very experienced (over 2600 hip resurfacings) and an implant with the best track record, Birmingham Hip Resurfacing by Smith and Nephew. Furthermore if my device wears out I still have a femur that will accept a total hip replacement. I have no reservations.
Yes, there are problems with some metal-on-metal implants. In some cases it is the design of the device and in others it is the poor placement of the device. In either case there are not “metal shavings” created but rather metal ions released by improper wear. This is not dissimilar from the plastic particles created by total hip replacement implants. There does need to be greater oversight by the FDA but the patient can do their own research as well.
There are great links at www.surfacehippy.info and www.hipresurfacingsite.com Including research and studies.
Dave Cohen
New York
August 23rd, 2011
10:40 am
JenofNJ
NJ
August 23rd, 2011
9:15 am
I am a rehabilitation nurse, and I see what patients must endure as they undergo rehab after a single or double hip replacement. It horrifies me that not only might their effort and suffering be for nought, but that they might end up with more pain, complications and further surgery. Many of my patients are elderly and frail. Their bodies cannot tolerate repeated surgeries.
As for the lack of a patient registry, that has me scratching my head. When I buy a new car, the manufacturer immediately has my vehicle identification number, my contact information, etc. In the event of a recall, they contact me. Why on earth wouldn’t a simple registry have been put in place long ago? Answer: because the companies were not required to. The creation of a registry should become law, pronto.
Michael
Nashua, MT
August 23rd, 2011
9:10 am
Related articles
- Complaints Surge About Crumbling Artificial Hips (earlsview.com)
- Hip Replacement Loosening (earlsview.com)
- Hip Implant Complaints Surge, Even as the Dangers Are Studied (earlsview.com)
- MUSC Reconstruction Experts Address Metal-on-Metal Joint Replacement Device Controversy (earlsview.com)
- Biomet Receives FDA Clearance for Active Articulation(TM) E1(R) Dual Mobility Hip System (earlsview.com)
- How to Choose a Hip Or Knee Replacement Surgeon & Prosthesis (earlsview.com)
- Australian TGA Response to Recall of DePuy ASR Hip Replacement (earlsview.com)
- Hip Implants – from American Academy of Orthopaedic Surgeons (earlsview.com)
- UK – Advice for GP’s – Hip Joint Replacements (earlsview.com)
- Replacing your joint replacement (earlsview.com)
Annie said:
Yes, there is an industry out there to replace joints. There’s another group of MDs who make it their mission to spare the body’s natural joint if and whenever possible.
There are also times when there are medications that are life-saving, but have the unfortunate (and VERY unfortunate side effect) of killing the bone; which cause the need for a joint replacement. This is no day at the beach, but it is a real scenario.
There are also medical conditions which cause the need for a joint replacement. It’s not all nutrient depleted soil which causes the brittle bones and therefore the need to replace them.
earlstevens58 said:
Yes – good way to put it.
Either an industry in pain killers and NSAID’s or joint replacement.
If we had some better prevention – like not “over gyming” like I did, or were less obese or… then we would save a lot of money and pain!
Earl
Pingback: Groundswell of Grievances Against Manufacturers of Defective, Dangerous Hip Replacement Devices « Earl's View
Pingback: Hip revision surgery « Earl's View
Pingback: 6 Points on Patient-Specific Knee Replacement Using Stryker’s ShapeMatch Technology « Earl's View
Pingback: Why do surgeons avoid the obvious when patients complain??? « Earl's View
Pingback: Generic Orthopedic Implants’ Time Has Come « Earl's View
Pingback: Howard Sadwin’s Story – a lesson in perserverance… « Earl's View
Pingback: Fast Track Hip Replacement – Study by Dr Bryan Nestor « Earl's View
Pingback: Patient’s Agony – The importance of the Surgeon and Level of Care « Earl's View
Pingback: The regulatory standards for the approval of medical devices in Australia – Senate Inquiry « Earl's View
Pingback: Jackie – a typical story repeats again & again – Patient Fear and Distress « Earl's View