Earl's View » hip resurfacing

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants

earlstevens58 — Thu, 14 Nov 2013 09:05:42 +0000

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants

A faulty Articular Surface Replacement, or A.S.R., removed from a patient in 2010.

Published: November 12, 2013

Johnson & Johnson has tentatively agreed to a settlement that could reach up to $4 billion to resolve thousands of lawsuits filed by patients injured by a flawed all-metal replacement hip, said two lawyers briefed on the plan.

The tentative plan, which must win court approval, represents one of the largest payouts for product liability claims involving a medical device.

A spokeswoman for the company’s DePuy Orthopaedics unit declined to comment on the possibility of a settlement. An announcement about the plan is expected in the coming days, the lawyers said.

The agreement will include those patients who have already been forced to have the device, known as the Articular Surface Replacement, or A.S.R., removed and replaced with another artificial hip, said the lawyers who spoke about the agreement only on the condition of anonymity.

Under the deal, each patient would receive about $350,000 on average in compensation, though that figure will vary depending on factors like a patient’s age and medical condition.

The precise value of the settlement is unclear because lawyers for patients are still trying to estimate how many of the 12,000 related lawsuits involve patients who had a replacement. Lawyers believe that number may be 7,000 to 8,000 cases.

The final cost of the deal to Johnson & Johnson could rise, depending on how many claimants who received the device undergo replacement operations in the future, the lawyers said. Under the plan, patients who have not had a replacement would not receive compensation, the lawyers said.

Read the full article here – New York Times

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants (nytimes.com)
J&J Said to Reach $4 Billion Deal to Settle Hip Lawsuits (bloomberg.com)
Johnson & Johnson DePuy hip implant settlement reported (lawprofessors.typepad.com)
Johnson & Johnson said to reach settlement for hip-implant suits (denverpost.com)
Johnson & Johnson Reaches $4 Billion Settlement Over Hip Implants (theatlanticwire.com)
Johnson & Johnson Investors Sweat, but the Dow Bounces Back (fool.com)
Johnson & Johnson Offer Two Settlement Deals for the DePuy ASR Hip Replacements (prweb.com)
Johnson & Johnson said to reach $4 billion accord to settle hip-implant claims (nj.com)
Johnson & Johnson to pay $4 billion settlement over metal-on-metal hip implants: Report (cbsnews.com)
DePuy ASR Settlement Update: Rottenstein Law Group LLP Comments on $4 Billion DePuy Hip Settlement News (businesslawdaily.net)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, Food & Drug Administration, Health, Hip Replacement, hip replacement failure, hip resurfacing, Human settlement, Johnson, Johnson & Johnson, Medical device, New York TImes, Patient, Product Liability

Stuart Cain speaks out re DePuy Hell – Meet The Press, Episode 22, Sunday July 21 | News.com.au

earlstevens58 — Thu, 25 Jul 2013 20:43:07 +0000

Meet The Press, Episode 22, Sunday July 21 | News.com.au.

Stuart Cain talks about his horrific time post DePuy ASR revision.

Click here

Here is his interview/article from the SUnday Telegraph too.

Click on this link below:

Stuart Cain Sunday Telegraph Article

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Barack Obama, Cobalt chrome, Cobalt poisoning, David Gregory, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, depuy hip recall, hip resurfacing, Johnson, Meet the Press, Music and Audio, Press, Tavis Smiley, UNited States

GOOD NEWS —- Smith & Nephew Hip Lawsuit News: Illinois Federal Judge Rejects Preemption in Smith & Nephew Hip Replacement Case, Bernstein Liebhard LLP Reports – Watch List News

earlstevens58 — Thu, 25 Jul 2013 12:46:45 +0000

Smith & Nephew Hip Lawsuit News: Illinois Federal Judge Rejects Preemption in Smith & Nephew Hip Replacement Case, Bernstein Liebhard LLP Reports – Watch List News.

Smith & Nephew Hip Lawsuit News: Illinois Federal Judge Rejects Preemption in Smith & Nephew Hip Replacement Case, Bernstein Liebhard LLP Reports

July 24th, 2013

The Firm is currently investigating Smith & Nephew hip recall lawsuits on behalf of individuals who suffered metallosis, premature device failure and other complications allegedly associated with Smith & Nephew’s optional metal liner component for its R3 Acetabular Hip Replacement System.

New York, New York (PRWEB) July 24, 2013

A federal judge in Illinois presiding over a Smith & Nephew hip lawsuit has ruled that the Plaintiff’s claims of negligence and strict liability involving alleged quality control issues in the Birmingham Hip Resurfacing System may go forward, Bernstein Liebhard LLP reports. In an Order dated July 22nd, Judge Joan H. Lefkow of the U.S. District Court for the Northern District of Illinois rejected Smith & Nephew’s assertions that the claims were preempted by federal law. The Birmingham Hip Resurfacing System may be used with the optional metal liner component for the R3 Acetabular Hip Replacement System, which was the subject of a Smith & Nephew hip recall in June 2012.* (Tillman v. Smith & Nephew Inc., No. 1:12-cv-04977 (N.D. Ill.))

“We continue to hear from individuals who have suffered serious complications, allegedly due to Smith & Nephew hip replacements. We are encouraged by the decision in this case,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm is currently offering free Smith & Nephew hip lawsuit evaluations to patients who suffered serious complications, including metallosis and premature device failure, allegedly due to the recalled R3 metal liner component.

Smith & Nephew Hip Recall

The Smith & Nephew hip recall was announced in June 2012, due to the high failure rates associated with the optional metal liner component for the R3 Acetabular System. According to the Food & Drug Administration (FDA), the R3 metal liner is not cleared for use with the R3 Acetabular System, a total hip replacement system, but has been approved for use with the Birmingham Hip Resurfacing System.*

According to a report from Reuters, yearly revision rates among recipients of the recalled Smith & Nephew hip replacement device were above the rate Britain’s National Institute for Health and Clinical Evidence deems acceptable. Patients fitted with the device may be at risk for numerous complications, including infections, fractures and dislocations. However, Smith & Nephew has maintained that there is no evidence that the metal liner has caused metallosis, or increased metal debris in the body.**

Victims of serious complications allegedly associated with the Smith & Nephew hip recall may be entitled to compensation for their medical care, pain and suffering, and other damages. Additional information about filing a Smith & Nephew hip lawsuit is available at Bernstein Liebhard’s website. To arrange for a free, no obligation legal review of your case, please call 800-511-5092 today.

*fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241770.htm, FDA, June 1, 2012

**reuters.com/article/2012/06/01/us-smithnephew-hip-idUSBRE85010J20120601, Reuters, June 1, 2012

About Bernstein Liebhard LLP

Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.

Bernstein Liebhard LLP

10 East 40th Street

New York, New York 10016

800-511-5092

ATTORNEY ADVERTISING. © 2013 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.

###

Contact Information:

Felecia L. Stern, Esq.

Bernstein Liebhard LLP

info(at)consumerinjurylawyers(dot)com

http://www.consumerinjurylawyers.com

For the original version on PRWeb visit: http://www.prweb.com/releases/smith-nephew-hip-recall/smith-nephew-hip-lawsuit/prweb10960667.htm

Smith & Nephew Hip Lawsuit News: Illinois Federal Judge Rejects Preemption in Smith & Nephew Hip Replacement Case, Bernstein Liebhard LLP Reports (prweb.com)
Smith & Nephew Letter (earlsview.com)
Biomet Hip Implants Alleged Poor Design Lead to Serious Problems (defectivehips.wordpress.com)
Stryker Hip Recall Claims Move Forward With Issuance of New Case Management Order in New Jersey Litigation, Bernstein Liebhard LLP Reports (prweb.com)
Smith And Nephew Unveils New Hip Device (smithnephewhip.wordpress.com)
$20 Million Lawsuit on Damages from Hip Replacement: Now, AttorneyOne… (prweb.com)
Increasing Number of Lawsuits for Smith & Nephew (debooramoore.wordpress.com)
Hip Resurfacing an Alternative to Hip Replacement (hothealthnews.wordpress.com)
Hip Replacement Recall (ehipreplacementrecall.wordpress.com)

Filed under: Birmingham Hip Resurfacing, Cobalt chrome, Cobalt Poisoning, Hip Replacement, Hip Revisions, Metal on metal hip, Smith & Nephew, Smith & Nephew BHR Problems, Smith & Nephew Hip Recall, Smith & Nephew R3 Hip Liner Recall, Total Hip Replacement Tagged: arthritis, Cobalt chrome, Cobalt poisoning, Food & Drug Administration, Hip Replacement, hip resurfacing, Illinois, Limited liability partnership, Nephew, Smith, Smith & Nephew

Data show hip replacement revision rate low, though higher with metal-on-metal – Winnipeg Free Press

earlstevens58 — Fri, 19 Jul 2013 22:01:33 +0000

Data show hip replacement revision rate low, though higher with metal-on-metal – Winnipeg Free Press.

Data show hip replacement revision rate low, though higher with metal-on-metal

By: Helen Branswell, The Canadian Press

Posted: 07/18/2013 2:51 PM |

TORONTO – New Canadian data suggest that people who have a type of metal-on-metal hip replacement are more likely to need a revision within five years, but even then, the rate of revisions is low.

The data show that people who had large-diameter modular metal-on-metal implants had a 5.9 per cent chance of needing to have the implant replaced within five years, compared to a rate of 2.7 per cent among people who received the more common metal-on-plastic implant.

The data, released by the Canadian Institutes for Health Information, show that nearly three out of every four hip replacements logged into the Canadian joint replacement registry were metal-on-plastic units.

Metal-on-metal hip replacements made up only nine per cent of the procedures recorded in the registry.

Metal-on-metal units were introduced with great optimism a few years ago; the thinking was the replacement hips would be more durable and better for younger patients than the metal-on-plastic type.

But data from a number of countries have shown that hasn’t been the case for a small subset of people who received the units.

Canadian orthopedic surgeons took a more conservative approach to the metal-on-metal implants and it turned out to be the way to go, says Dr. Michael Dunbar, an orthopedic surgeon from Halifax and co-chair of the joint replacement registry.

“It was the right side of the street to be on, for sure,” Dunbar says.

“It was the fact of the matter that in the United States in the late 2000s almost 45 per cent of every male in the country (who got a hip replacement) got metal-on-metal. So this is why it’s such a big issue in the United States.”

Dunbar says the differences between the U.S. and Canadian situations underscore why it’s important to gather information on joint replacements. Currently the joint replacement registry is a voluntary one, and only captures a portion of the procedures done in the country.

Two provinces — British Columbia and Ontario — are moving to make it mandatory for these procedures to be recorded in the registry. But Dunbar wishes others would follow suit.

“We have a voluntary system and until recently we’ve been down around 50 per cent. We think that all implants should be registered because this is important. We’re spending the nation’s treasure on this stuff. This is a top health-care priority in Canada,” Dunbar says.

“We want to make sure we can deliver the very best product to the patients in our country. And we want to make sure that the money that we’re spending … is best spent for the most appropriate implant for the most appropriate patient.”

The report is based on nearly 60,000 hip replacements done across Canada between 2003 and 2011. Data from Quebec were not included.

Data show hip replacement revision rate low, though higher with metal-on-metal (globalnews.ca)
Metal on Metal Long Term Risks Confirmed (earlsview.com)
Products Included in the Ceramic Hip Replacement Recall (arthritis.answers.com)
Risks, Benefits and Recovery From Birmingham Hip Procedures (arthritis.answers.com)
Metal-on-metal hip implants more likely to need replacement (cbc.ca)
Risks and Rewards of Cemented Hip Replacements (arthritis.answers.com)
Hip Resurfacing an Alternative to Hip Replacement (hothealthnews.wordpress.com)
Understanding Hip Revision Surgery: A Medical Overview (orthopedics.answers.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Business, Cobalt chrome, Cobalt poisoning, DePuy, Health, hip, Hip Replacement, hip resurfacing, joint replacement, Medicine, science, Smith & Nephew, surgery, Technology, UNited States, Winnipeg Free Press

Hillary’s Story – Resurfacing Nightmare

earlstevens58 — Sun, 26 May 2013 09:50:56 +0000

The following is a statement from Hilary Dingwall-Fordyce regarding the hip resurfacing she underwent in May 2007

In May of 2007 at the age of 55, I underwent a hip resurfacing procedure in the right hip with fitment of a Smith and Nephew BHR metal prosthesis at Claremont Surgical in Cape Town, South Africa. I had extensive and expensive rehabilitation and physiotherapy however I never fully recovered and have suffered endless problems as follow:

• In 2008, my leg became swollen and the doctor fearing a thrombosis injected me with blood thinning medication. I had a CAT scan which showed a bursar in the hip area which was collapsing the main vein – I then had a procedure to remove the liquid from the bursar but one week later the swelling returned. I was advised to see a vascular surgeon who admitted me to hospital and inserted 2 stents, the first one collapsing under pressure from the bursar.

• In 2009 my leg again became swollen another scan showed the bursar had become tumerous and was pushing the vascular bundle against my pelvic bone and the stent had collapsed. I was admitted to hospital where both orthopaedic and vascular surgeons operated – the stent being repaired and the tumerous mass being removed and the area around the prosthesis cleaned of debris. The tissue was found to contain metal debris and I was found to be suffering from metallosis and an infection around the prosthesis. I was put on a course of strong antibiotics to which I had a severe allergic reaction. I was told no further operation on my hip was possible until this infection was cleared. Since I can no longer afford the operation anyway I have not returned.

• From 2008, I was suffering from acute anxiety and depression which required hospitalisation and medication for several years.

• My one leg now being shorter than the other I have had stability and balance problems – unable to walk any distance because of pain and discomfort. I believe this instability also contributed to a fall in 2010 and a second fall in 2011 – this time breaking my ankle.

• Lately I have noticed a marked deterioration in my sight as well as short term memory lapses and confusion with time lines.

I had no idea that all my problems mentioned above must clearly stem from the BHR metal prosthesis in my body, until reading an article in a magazine.

I would like to point out that besides the pain, discomfort and constant worry about what would happen next to my hip and the constant reminder because of the “clunk-clunk” when I move in certain ways, the time and the expense has taken its toll and today I have been unable to find a job and have neither pension nor savings nor medical aid as I am effectively destitute all being used to pay for the endless medical bills since my hip replacement. I am now relying on my son for a living and am currently homeless, moving between various friends.

I approached a firm in South Africa who are involved in a class action against Du Puy. They agreed to add me to the action as I did not realise there were a number of manufacturers of these prostheses – however on investigation they discovered I was not fitted with a Dupuy prosthesis but a Smith and Nephew “Birmingham” prosthesis. I subsequently went on line to find out what was being done to assist people who are suffering from the failure and after effects of this prosthesis in a case against this manufacturer as is being conducted against Du Puy and Johnson and Johnson. I don’t see any cases being handled in South Africa and would like to ask your advice as to my next steps.

Smith and Nephew Hip Replacement LawyersSmith and Nephew Hip Replacement Lawyers (earlsview.com)
Hanna’s Story – another Smith & Nephew BHR tale of disaster (earlsview.com)
Reasons to Choose the Birmingham Hip Resurfacing Procedure (arthritis.answers.com)
Risks, Benefits and Recovery From Birmingham Hip Procedures (arthritis.answers.com)
Smith and Nephew: Motion to Consolidate | Smith and Nephew Hip Replacement LawyersSmith and Nephew Hip Replacement Lawyers (earlsview.com)
Daily Maintenance of Breast Prosthesis (breastcancer.answers.com)
Why Smith and Nephew Could be Culpable in the Courts (smithnephewhip.wordpress.com)
Smith and Nephew Hip Replacement Newsletter (earlsview.com)
Avascular Treatment: Preventing Further Bone Loss (arthritis.answers.com)

Filed under: Hip Replacement Tagged: anxiety and depression, blood thinning medication, Cape Town, cape town south africa, Cobalt chrome, Cobalt poisoning, Hip Replacement, hip resurfacing, Johnson, May 2007, metal debris, NephewSmith, Prosthesis, Smith & Nephew, Smith and Nephew, South Africa

Hanna’s Story – another Smith & Nephew BHR tale of disaster

earlstevens58 — Sat, 04 May 2013 01:12:42 +0000

My name is Hanna Viner, I am 61 years old and I live in Sydney, Australia. I had recently a left hip revision surgery from MoM BHR to ceramic THR. After subscribing to your blog and reading your very interesting articles and stories I have decided to share my experience with you. I have bilateral artificial hips. Left is ceramic THR, MoM BHR on the right side.

In October 2000 I had my first right hip MoM BHR put in due to severe osteoarthritis and 3 months after had developed a limp in the left leg and pain in the left hip. My surgeon, who was trained in BHR 6 months before my first operation, had gone to Birmingham to learn how to use Derek McMinn‘s BHR prosthesis and I was one of the first patient to receive this BHR prosthesis in Australia. Anyhow this operation was successful and help me enormously with the pain, which I had suffered for at least 3 years, I was 48 years old when I had my first operation.

Two years later in September 2002 I went and had left hip BHR inserted and this operation was not as successful as the first one. My surgeon has told me that the damage in the left acetabulum and femur head was not as great as in the right one therefore they have to insert a bigger socket and force it into the acetabulum, I think they maybe did not have the right size of the socket for damage I had there. The future CT Scan had showed an old healed fracture in my pelvis next to the left prosthesis. Anyhow i was happy to have the new hip resurfacing in and did not pay much attention to the details then.

From the beginning the left prosthesis was squeaking and made all sorts of noises while I was moving or bending, but I had a little pain and considered that ok. When I attended numerous check up visits with my surgeon I have told him about the problems but he dismissed them as normal. Over the years the noises and occasional pain were more disturbing and in 2007 my X-ray showed the lucency next to the left BHR, which again my doctor has dismissed and said that there is nothing to worry about.

So life was going on and I started having gait problem and developed excessive pronation in my feet, more severe on the left foot. I also developed bunions on both feet and I had to do something because due mainly to left foot drop I was falling while walking even on leveled ground and my feet were killing me, being very painful while walking or standing for prolonged periods.

After numerous fallings I have researched the cause for it and decided to go and see podiatrist, which of course diagnosed me with severe pronation of my feet, especially the left one. I was given orthotics and felt better immediately. I also stared to notice that the left leg was kind of weaker than the right one, but I did not pay too much attention and was living my life as normal.

Mean while this leg problems had affected my thoracic skoliosis and my shoulders were very uneven, more than ever before, the right one was now much lower than the left one. So I started paying attention to my posture. I work in the office and had to be aware the way I was sitting and using computer. My right knee developed Bakers cyst and was and is quite painful especially when I walk up the hill or up and down the stairs.

I also started being very fatigued and developed some chronic aches and pains all over my body, I had digestive problems, loss of vision especially at night and could not hear so well with my left ear. I also have done a comprehensive stool analysis test learning from it that i had some bacterias, amoebas and parasites, my immune system was already compromised and i did not know why. I was a healthy eater, non smoker and non drinker, I use to do lots of sport activities and i was very miserable, irritable and unhappy, thinking that all of this is due to menopause.

In 2009 I had an Idiopathic hemorrage in the back of my left eye,which disappeared after 4 months. My blood pressure was playing up, hot flushes and night sweets were there even I had finished menopause few years before (by the way that period of my life was a miserable one too) and I felt overall very sick. I started Chinese herbs and acupuncture treatment which somehow helped because it made my body stronger but many of my symptoms had never disappear.

Than in June 2012 I went to see my orthopedic surgeon for a check up, which was 5.5 years overdue, i should attend this check up 4 years after my las check up, it was 1.5 years overdue due to some family commitments in Poland, had to look after my elderly mother for 15 months there.

In winter 2011 in Poland I already realize that my left leg is getting weaker and weaker as I was not able to do long walks on the snow the way I was able to do it in winter 2010, but did not worry too much about it blaming the old age, I also developed thyroid problems, my TSH was climbing up and overall I looked terrible, I was swollen especially my face at the chin and neck and my hands and feet and started putting lots of weight.

When I came back to Australia I went and had all necessary blood tests including thyroid tests and tests showed a Hashimoto disease, all thyroid tests were at the normal range, but my thyroid antibodies were elevated to 208IU/mL and my cholesterol was slightly elevated and some of the liver functions as ALT GGT and ALP were elevated. This started to worry me a bit. I did hip X-rays and went for a check up. I have already read the description written by radiologist, which showed that I have some overgrowth on the femur near the left prosthesis. I had showed that o my surgeon and he decided that we need to investigate this further, he had send me for a CT scan and a nuclear bone scan and I had also requested the metal ions blood test.

We did all of that and, o boy, I had a big pseudo tumor next to my left hip, bone and surrounding tissues eaten away by metal debris and metal ions in thousands in my blood, I had no option but to have surgery ASAP so we have scheduled this surgery for hip revision for 25 October 2012. I was speechless and angry and I had no option but to go for this operation.

The operation was successfull but it was done at the lasy moment as the damage to my bone and surrounded tissue was so extensive that if I would left it unattended for a bit longer I wouldn’t have any hip left there.

My surgeon had to remove about a litter of fluid with metal debris and repair all surrounded tissue damage. I was given THR made out of ceramic with ceramic liner to last longer and with titanium stem, also he did a bone graft from my own bone scraps from the femur onto acetabulum and fix the socket there with 2 titanium screws. I was doing pretty ok after the op and after 5 days in hospital I went to rehab hospital for 2 weeks for further rehabilitation ( isometric exercises in the morning and hydrotherapy in the afternoon), this was a great help. When I got back home I have continued hydrotherapy every day of the week and it felt great. It has been over 5 months now after the operation, I do continue hydrotherapy attending sessions at least twice a week.

I went back to work 2.5 months after the operation and I am taking systemic enzymes which are helping enormously with my scar tissue and swelling, they are great, I also detox with chlorella and am taking lots of supplements to keep me going, but I am still tired and the left leg is not fully healed yet, still getting a bit painful if I will overuse it. But the range of movement is great.

I have been back to see my surgeon with new xrays on 8/3/2013, the bone has healed terrifically well and my metal ions are substantially down: chromium from 1200 nmol/l to 574 nmol/l and cobalt from 1860 to 68, still high but much, much better. During this check up I have requested a removal of my right BHR prosthesis and my surgeon was surprised by my decision asking me – why do you want to remove a perfectly good device, I had answered that this is a ticking bomb an it could be blowing up at any rime, he answered yes potentially it can. We had scheduled another revision surgery for 26/6/13. Since then I had enough time to think about it and considering the fact that my left leg is still quite weak I have realized that I may not be well enough to perform the second revision so soon, besides my lower back is playing up since the last operation which is quite normal. I have requested an MRI scan for hips and lower back and measurement of metal ions in blood every three months and if all will be good and metal ions will gradually come down (I know it is a long process, sometimes up to 2 years) than I won’t rush to have another revision surgery. So this is my story.

Dear Earl, what do you think about my decision, do you think I have to do some other checking ups in regards to my problem. I will be glad to sue Smith and Nephew for producing such a horrible device, I have made enquiries in Australia and in one law firm in America but they refused to help me because there is not class action against S&N. So I will wait until many people will come forward and do the same as I want to do. If you know about any possible law suit against Smith and Nephew please let me know.

Looking forward to hear from you soon

Kind regards

Hanna Viner

Hip Resurfacing Procedures: A Viable Alternative to Hip Replacements (orthopedics.answers.com)
Study: Metal Hip Pain and Tissue Damage – Stryker Rejuvenate Hip Implant (earlsview.com)
Walking Better: Rehab After Hip Joint Prosthesis Surgery (orthopedics.answers.com)
Hip Hip Hooray! – Austin, TX (travelpod.com)
Surgeon Says Recalled Stryker Metal Hip Implant May Fail Half the Time (earlsview.com)
Mike’s Stryker problems ruin his life (earlsview.com)
Introducing Hip Resurfacing: A Minimally-Invasive Alternative to Hip Replacements (prweb.com)
Am I Too Old? Too Young for a Hip Replacement? (stpaulhip.wordpress.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Total Hip Replacement Tagged: Acetabulum, artificial hips, Australia, BHR, Derek McMinn, Health, hip, Hip Replacement, hip resurfacing, hip revision, Medicine, metal, surgery, Sydney

Conflict of Interest of “industry experts” – Open letter from Dr Steve to Dr Frick…

earlstevens58 — Sun, 24 Mar 2013 02:26:47 +0000

Friday, March 8, 2013

Steven L. Frick, MD

Central Program Commitee Chair, 2013 Annual meeting AAOS

Dear Dr. Frick,

Please consider this an open letter. Sunshine remains the best disinfectant and I remain concerned that unless the faculty of the panel that will address the complications of metal-metal hips at the rapidly approaching annual meeting of the AAOS is changed hundreds of thousands of patients implanted with metal-metal hips might suffer harm from the delayed diagnosis and treatment of the local and systemic complications of chrome-cobalt metallosis.

Figure 1: Symposium at AAOS 2013 addressing metal-metal hip complications.

Table 1: Membership of 2013 panel, their arthroprosthetic company allegiances and their intrarelationships.

Panelist	Arthroprosthetic Company	Nature of compensation	Notes
AV Lombardi (moderator)	Biomet	Royalties, employee or consultant, speaker’s bureau.	President of the Hip Society, metal-‐on-‐metal modular hip advocate. Chair of the annual meeting hip program committee. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-‐ metal hips.
MA Mont	Stryker, Wright Medical	Royalties, employee or consultant.	Hip Resurfacing Advocate has resurfaced 1600 hips. Hired gun by Stryker to promote the Corin metal-‐metal hip resurfacing. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-‐metal hips.
TP Schmalzried	DePuy, Stryker, Wright Medical	Royalties, employee or consultant.	Hip Resurfacing Advocate and design surgeon of the ASR. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-‐metal hips.
JJ Jacobs	Zimmer, Medtronic, Implant Protection	Stock options, employee or consultant.	Wrote some of the foundational literature supporting metal-‐on-‐ metal technology with Dr. Schmalzried. President of the AAOS. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-‐metal hips.
Young Min Kwon	None declared.	Past research work supported by multiple arthroprosthetic companies.	Foundational researcher on the periprosthetic complications of chrome cobalt metallosis. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-‐metal hips. Least conXlicted of the faculty.
SJ MacDonald	DePuy, Stryker	Royalties, employee or consultant, research support.	Wrote some of the foundational literature supporting metal-‐on-‐ metal technology with JJ Jacobs.

I sincerely apologize for mistaking Dr. Fehring’s arthroprosthetic company allegiance as being Biomet rather than DePuy. DePuy as well as Biomet has a large metal-metal hip liability. DePuy’s ASR has been formally recalled from the market and was implanted in 92,000 patients. DePuy’s Ultramet modular metal-on-metal product is still on the market and is part of DePuy’s popular “Pinnacle” acetabular system. Dr. Fehring has likely assisted DePuy with the development of this product line although he is not the “thought leader” on the metal- metal bearing option. His work with DePuy has likely brought him into close collaboration with Dr. Schmalzried who also consulted on the “Pinnacle” system and was the primary design surgeon of the ill fated ASR. DePuy has already placed a 5 billion dollar down payment on the ASR remediation.The metal-metal option for the “Pinnacle” system appears to have the same problems as the “ASR” and many more have likely been implanted.

I appreciate that Dr. Fehring has recognized and published on the complications of the “ASR” and has also contributed to publications addressing monitoring protocols for patients implanted with metal-metal hips.The Alaskan experience indicates that monitoring criteria developed by Dr. Fehring in collaboration with the other symposium panel members may be more protective of the arthroprosthetic companies from which these surgeons have received millions of dollars than the patients that been implanted with those companies metal-metal hip products.

Experts on Conflict of Interest (COI) in the professions might conclude that only Dr. Kwon is qualified to objectively address the complications of metal-metal hips. He is but one of six, his influence is likely to be muted by the “group-think” of the five more conflicted members.

The weakness of the proposed monitoring criteria of the publications that you reference is that blood cobalt determinations are recommended only for patients with notable symptoms at the hip and the possiblity of the systemic complications of unidentified cobaltemia is minimized. Our experience indicates that all patients with metal-metal hips should be contacted and their blood cobalt levels determined. Patients with blood cobalt levels above10 mcg/L merit a through neurologic and cardiac evaluation. The neurologic and cardiac complications of cobaltemia are insidious, progressive, and potentially disabling. Patients can develop these complications without sentinel hip symptoms.

Most of our severely cobaltemic patients, incuding five with disabling neurologic toxicity, had minimal symptoms at the hip. Two of our toxic patients had no hip symptoms although both had severe periprosthetic tissue damage.

I am concerned that the 2013 symposium on metal-metal hip complications will be a repeat of last year’s. I witnessed that event and found the panel to be hopelessly entangled with industry and unable to adequately recognize or disclose those entanglements.

Table 2: Membership of 2012 panel, their arthroprosthetic company allegiances.

Panelist	Arthroprosthetic Company	Nature of compensation	Notes
WJ Maloney (moderator)	Wright Medical, Zimmer	Royalties from Wright Medical Received $423,412 from Zimmer in 2007	Also does medical legal surgeon and industry defense work.
JJ Jacobs	Zimmer, Medtronic, Implant Protection	Stock options, consulting fees.	Wrote some of the foundational literature supporting metal-‐on-‐ metal technology, Vice President of the AAOS.
CA Engh	DePuy	Royalty income in 2010-‐11 > $ 350,00 Consulting income 2010-‐11 > $ 27,000	Has resurfaced > 500 hips and did studies initially supportive of DePuy’s modular metal-‐on-‐ metal hip.
TP Schmalzried	Design Surgeon ASR, DePuy, Stryker	Royalties from ASR 2010-‐11 $3.4 million	Has resurfaced > 600 hips. Wrote some of the foundational literature supporting metal-‐on-‐ metal technology with JJ Jacobs.
DW Murray	Biomet, DePuy, Smith & Nephew, Stryker, Wright Medical, Zimmer	Royalties from Biomet and Smith &Nephew Research support from all listed	Believes that metal levels are of academic interest and only indicates revision of metal-‐on-‐ metal hips for those with major symptoms at the hip.
BL Penenberg	Wright Medical	Consulting fees and Royalties	Involved in the design of Wright Medical’s modular metal-‐on-‐ metal

I must disagree with your statement that the present process for determining the CME content at the annual meeting is acceptable. The choice of such a commercially conflicted panel to address the largest medical device failure in history points to the contrary. The inclusion of Dr. Schmalzried on multiple panels at this year’s and last year’s meetings seems inappropriate. He is the design surgeon of the ASR and continues to promote and perform metal-metal hip resurfacing. It is extraordinarily unlikely that Dr. Schmalzried could either recognize or reconcile the true frequency, severity, and cost of the periprosthetic and systemic complications of chrome-cobalt metallosis. Placing Dr. Schmalzried on any panel at an orthopedic meeting is akin to a mariners convention featuring the captain of the Costa Concordia as the keynote speaker on the topic of inter-island navigation.

I have similar concerns about the inclusion of Dr. Mont. It seems that much of the purpose of the symposia at the 2012 and 2013 meetings is to reassure surgeons that hip resurfacing remains a viable and safe arthroplasty option. There is no Level 1 evidence that hip resurfacing has advantage over a stemmed metal-on-plastic one that is proven safer, more durable, and less expensive. For the hip program committee to continue to place hip resurfacing advocates at the podium of AAOS CME events is a disservice to marketable surgeons, arthroplasty candidate patients, society, and the million patients already implanted with metal-on-metal hip arthroplasties.

Why would the hip program commitee place commercially conflicted hip resurfacing advocates at the podiums of the world’s most influential orthopedic meeting where they are likely to minimize the periprosthetic and systemic complications of chrome-cobalt metallosis?

Table 3: Membership of 2013 hip program commitee and their arthroprosthetic company allegiances.

Surgeon Committee Member	Arthroprosthetic Company	Nature of compensation	Notes
AV Lombardi (chair)	Biomet	Consulting fees, royalties, and speaker’s bureau.	Also President of the Hip Society, Fellow of GA Engh and TH Mallory. Has published studied supportive of modular metal-‐on-‐metal hips with large heads.
KL Garvin	Biomet	Royalties
DW Manning	Biomet	Consulting fees and royalties.
JB Meding	Biomet	Royalties
JW Mesko	Stryker	Consulting fees
DE Padgett	Stryker, Mako	Royalties, consulting fees, stock or stock options.
JC Kudrna	DePuy, Innomed, Convatex	Royalties, consulting fees, stock or stock options.
WB Macaulay	Wright Medical	Research Support	Vocal hip resurfacing advocate has performed > 100 hip resurfacing.
AH Glassman	Zimmer, Stryker, Exatech, Innomed	Royalties, consulting fees, stock or stock options, speakers bureau	Has coauthored multiple papers with CA Engh.
MJ Archibeck	Zimmer		Not declared but DOJ disclosure notes he received 14K from Zimmer in 2006 trained by or is colleague of JJ Jacobs
PE DiCesare			None declared but is on the faculty at HSS and a colleague of Dr. Su a major advocate for Smith and Nephew’s BHR resurfacing.
AJ Ayers
JF Fetto
RH Gonzales
JM Passick

It is notable that two-thirds of the hip program committee panel members are financially entangled with arthroprosthetic companies with huge metal-metal hip liabilities.

This committe not only controls the content at hip replacement related symposia and instructional course lectures, it also controls the content of the hip replacement related scientific program.

I submitted applications for the symposium on metal-metal hip complications, an instructional course lecture of the management of the metal-metal hip implanted patient, and three scientific papers on the systemic complications of chrome-cobalt metallosis, the histopathology about failed metal-metal hips, and on the explant analysis of failed metal-metal bearings. These submissions were rejected

by a hip program committee rife with Surgeon Industry Conflict of Interest. I wonder how many other submissions addressing the underappreciated complications of the metal-metal hips might have also be excluded from the program of the 2013 meeting.

I spoke with Dr. David Langton at last years annual meeting. He is arguably the World’s foremost authority on the periprosthetic complications of metal-metal hips. He has also had great difficulty in getting any of his many submissions on metal-metal hip complications accepted for presentation at AAOS annual meetings.

I am worried as much about what will not be presented at this year’s meeting as what will be presented. I agree that not all the members of the selected symposium are dyed in the wool metal-metal hip advocates but they are all entangled with surgeons that are, or with arthroprosthetic companies that might be bankrupted by their metal-metal hip liabilities.

Please forgive my passion in attempting to advocate for the million patients implanted with metal-metal hips and those that might unwittingly be placed at risk due to ongoing hip resurfacing. I am troubled that the million metal-on-metal hip implanted patients that are at risk for asymptomatic periprosthetic tissue loss and an insidious, reversible, and potentially disabling neurologic illness are not being appropriately monitored by their surgeons. This equates to patient abandonment.

Please accept my sincere apology for misindentifing Dr. Fehring’s commercial arthroprosthetic affiliation. It is difficult to keep straight who works for who.

Dr. Jacob’s has generously offered to present my work on arthroprosthetic cobaltism in my stead in two weeks. If this communication seems rushed or contains minor inaccuracies, I apologize, I am preoccupied with interviewing the 24 patients of my series to assertain their present status so that I can supply Dr. Jacobs with a current manuscript on the incidence of cobaltemia and cobaltism in 24 Alaskan patients with 26 revised metal-on- metal hip arthroplasties.

Sincerely,

Stephen S. Tower, MD

Fellow AAOS, Affiliate Professor, UAA, WWAMI School or Medicine

Letter from Dr Frick

Dear Dr. Tower,

As Central Program Committee Chair for this year’s AAOS Annual Meeting, I have appreciated your concerns about the processes used to construct our program. Our committee and organization are taking your concerns seriously to strengthen and improve what I believe is already an excellent system, one that produces an annual meeting that provides the best educational experiences in the world for orthopaedic surgeons.

While President Tongue and the Presidential Line speak for the organization, I am responding personally and on behalf of the Program Committee about some of the inaccuracies in your recent letters. Like many passionate individuals trying to effect change, if your message contains information stated as fact that is not true, the rest of your message loses its intended effect.

First, you question the qualifications of Dr. Fehring to speak on the complications of metal-metal THA, and list him as a consultant for Biomet. As a pediatric orthopaedic surgeon, I am not as familiar with the literature on THA as you are, but as I was the program director for the residency program in Charlotte and Dr. Fehring served on our faculty, I know him well and am very familiar with his practice and academic work. He does in fact have potential conflicts of interest, but as a consultant for DePuy, not Biomet, and his work for them involves metal- polyethylene THA (thus perhaps his conflict is that he would like for metal-metal THA to fail). He does not have any design or consulting involvement with metal-metal THA, has not advocated for metal-metal THA, or clinically used metal-metal THA, and his published and presented works (including at AAOS) involve the complications associated with metal-metal THA. I performed a brief literature search and quickly found the 5 publications listed below by Dr Fehring on complications of Metal-metal THA in the past two years. It is thus difficult for me to see how his presence on the symposium panel does not “balance” it to provide a perspective on the possible complications of metal-metal THA.

1. Beaver WB, Jr., Fehring TK. Abductor dysfunction and related sciatic nerve palsy, a new complication of metal-on-metal arthroplasty. The Journal of arthroplasty. Aug 2012;27(7):1414 e1413-1415.

2. Kwon YM, Jacobs JJ, MacDonald SJ, Potter HG, Fehring TK, Lombardi AV. Evidence- based understanding of management perils for metal-on-metal hip arthroplasty patients. The Journal of arthroplasty. Sep 2012;27(8 Suppl):20-25.

3. Steele GD, Fehring TK, Odum SM, Dennos AC, Nadaud MC. Early failure of articular surface replacement XL total hip arthroplasty. The Journal of arthroplasty. Sep 2011;26(6 Suppl):14-18.

4. Fehring TK, Fehring K, Springer BD, Masonis JL, Dennos AC. Comparative analysis of periarticular osteolysis in modern total hip bearings: a minimum 5-year study. The Orthopedic clinics of North America. Nov 2012;43(5):e14-16.

5. Griffin WL, Fehring TK, Kudrna JC, et al. Are metal ion levels a useful trigger for surgical intervention? The Journal of arthroplasty. Sep 2012;27(8 Suppl):32-36.

The third surgeon you questioned in your letter is Dr Lombardi. I do not know Dr. Lombardi personally, but see that he is listed as a coauthor on a paper on the “perils” of metal-metal THA (article #2 above)

Last, you question whether the potential complications of metal-metal THA will be covered in the symposium, and complain that the AAOS is somehow suppressing information about these potential complications to the detriment of patients. Below is the application for the the symposium on metal-metal THA that was selected for presentation at the 2013 Annual Meeting. Reading this, it is difficult for me to see how this presentation will not address the potential local and systemic complications of metal-metal THA. Also for your information, your symposium on metal-metal THA was not the only other symposium on metal-metal THA that was not selected by the program committee. In fact, President- elect Jacobs also submitted a symposium on metal-metal THA that was not graded as highly as the symposium below, and thus it also was not selected.

Basic Science Consideration: This symposium addresses important issues such as understanding metal-on-metal failure mechanisms, current recommendations, clinical presentation of adverse soft tissue reactions, a systematic diagnostic algorithm, and utility of specialized tests including metal ion levels and cross-sectional imaging studies. Integration of clinical expertise from national faculty with best available clinical evidence from research and national joint registry data into the decision making process to address clinical challenges relevant to every day practice and identify areas for future research.

Learning Objective 1: Understand the spectrum of clinical presentations of adverse soft tissue reactions (symptomatic and asymptomatic), reflecting a complex interplay of implant, surgical and patient factors.

Learning Objective 2: Comprehend the various intrinsic and extrinsic causes of a painful metal-on-metal hip arthroplasty as well as a systematic treatment approach to optimize management based on currently available data.

Learning Objective 3: Recognize a low threshold to perform a systematic evaluation of metal-on-metal patients as early recognition and diagnosis will facilitate initiation of appropriate treatment prior to significant adverse biological reactions.

Learning Objectives All: For Report: Understand the spectrum of clinical presentations of adverse soft tissue reactions (symptomatic and asymptomatic), reflecting a complex interplay of implant, surgical and patient factors; Comprehend the various intrinsic and extrinsic causes of a painful metal-on-metal hip arthroplasty as well as a systematic treatment approach to optimize management based on currently available data; Recognize a low threshold to perform a systematic evaluation of metal-on- metal patients as early recognition and diagnosis will facilitate initiation of appropriate treatment prior to significant adverse biological reactions.

In conclusion, I strongly disagree with you about the symposium that will be held on metal-metal THA in Chicago. It has a highly knowledgeable and qualified faculty, and they will address the learning objectives noted above. As educating members of the AAOS about the potential adverse effects of metal-metal THA seems to be your primary objective, it is difficult for me to see how that objective is not met by the above symposium.

Sincerely,

Steven L. Frick, MD

2013 AAOS Annual Meeting Central Program Committee Chair

Open Letter – Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications. (earlsview.com)
J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)
DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable (earlsview.com)
Some Surgeons Do Speak & Shout – but Those that Should Listen Don’t Hear… (earlsview.com)
What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com (earlsview.com)
J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg (earlsview.com)
DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
DePuy Pinnacle Hip Replacement Lawsuits: Bernstein Liebhard LLP Comments on New Study Finding that Hip Replacement Failure More Likely in Women (earlsview.com)
DePuy Pinnacle Hip Lawsuits: Bernstein Liebhard LLP Notes New Order in Federal DePuy Pinnacle Litigation (earlsview.com)
Stuart Cain Reports – A Warning for all MOM Patients – It is NEVER over, and your health is never, ever going to be the same! (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: best disinfectant, Biomet, chrome cobalt, Cobalt chrome, Conflict of interest, DePuy, Dr. Fehring, hip, hip resurfacing, jacobs zimmer, Medtronic, Research, science

Stuart Cain Reports – A Warning for all MOM Patients – It is NEVER over, and your health is never, ever going to be the same!

earlstevens58 — Sun, 17 Mar 2013 21:09:53 +0000

A Warning for all MOM Patients – It is NEVER over, and your health is never, ever going to be the same!

My apologies for not writing for some time! I have been following the progress of the many brave people who have been using Earl’s awesome blog and I continue to admire every one of you who have been able to speak up and even more so, those of you who are unable to share but use the site as a communication tool and information gathering service! I implore all of you to continue to speak out and seek answers, as I have found out (as has Howard, Bob, Brooks, Earl, Meg, Anna, Connie and so many others) these answers are often not there to be discovered, but if we all continue to push the medical world, the device manufacturers, governments and regulators, they may actually realise the importance of this and provide the funding to the researchers who are crying out for the opportunity to look into this terrible situation. My best wishes for 2013 to all, mine hasn’t started very well but I hope that the following will give each of you renewed vigour and the strength not to accept mediocrity in your treatment by the device manufacturers or the medical world!

Thanks to Johnson and Johnson/DePuy, Smith and Nephew and all the other companies that pushed MOM (Metal-on Metal) technology into the market place our lives will never be the same. Not only for the current issues that each and every one of us is experiencing, but for those that are going to continue to develop until we all die. I wanted to share with you my latest ‘issue’ and let it be a warning that there are darker days ahead for many of us who are yet to find out the true impact of what these implants and their associated ‘side-effects’ are doing to us.

I don’t know what each person was told, but I was assured that this ‘Rolls Royce’ of implants would allow me as a young person (37 at the time of implantation), to go back to my previous level of activity (with some obvious limitations) and that it would last longer than the alternatives. This was probably where the biggest mistake was made (apart from using the bloody thing in the first place). After 3 revisions of the hip, the insertion of a plate and 9 screws to hold my femur together and of course the painful rehab associated with this, I am now in a worse condition than I was before the initial implant. I know many of you will relate to this (30 operations now isn’t it Howard!). I almost wish the suspected infection that they thought was in my bone actually was there this week as even though it would suck, the treatment was possible! Unlike the ‘holding pattern’ I have been placed in whilst the medical world try to come up with why my health has deteriorated to the point that it has!

My ‘ASR experience’, as Johnson and Johnson/DePuy like to refer to it as, has come crashing down on me in the last week. After a rapid deterioration in my health over the last 2 months I had an x-ray which showed that not only had my 15 month-old fracture in my femur not healed (as it previously appeared to finally be), but it has now increased in size and ‘crossed’ over 2 of the screws in my femur. This has occurred during a month where I was virtually chair and bed bound as I had incredible pain, increasing fatigue without actually being able to sleep and couldn’t weight bear without a great deal of assistance. I had also developed intense pain in the foot on the opposite side to the implant, pain in my opposite shoulder and lower back. After a series of blood tests (to rule out infection), Nuclear Bone Scans and CT Scans, it is confirmed that I have ‘stress fractures’ in my foot and signs of developing fractures in my shoulder and lower back. No, I wasn’t in a car crash, these ‘fractures’ have developed ‘spontaneously’ as described by my surgeon. In his words: “how can an otherwise healthy individual (not counting my destroyed hip of course) develop stress fractures, especially when you haven’t been doing anything”.

In the absence of research and evidence (as no-one either has the funding or genuine interest, or if it has been done is too damning for us to see!) on the effects of Cobalt and Chromium toxicity on the body, my surgeon after seeing ‘some very interesting side effects’ in his other patients firmly believes that we are now starting to see the true effects of Cobalt and Chromium toxicity in the human body. He also notes that it is an interesting correlation between the higher levels of side effects in those people who were more ‘active’ after being implanted with a MOM device. I should note that my surgeon has never used any MOM technology as he felt when it was released that it wasn’t tested and investigated enough for not only its long term sustainability but also for the possible side effects that it may create. This was on the basis of research in the 1990’s and early 2000’s into the ‘wear’ of such devices and how there was little evidence of what this ‘wear’ might do to the patient. It is amazing that the very small number of surgeons, such as him, are now given almost ‘charlatan’ status now if they have the courage to speak out amongst their own colleagues about MOM implants, I am sure that Dr Steve may well appreciate this!

So now as I enter a new week of more doctors and tests, the ever-present company of pain, not being able to walk without crutches and the mental anguish of not only ‘not knowing’ where to turn from here, let alone what effect this is having on my wonderful wife and amazing family, I want all of you to be aware that there is so much more that none of us are aware of about the effects of MOM implants and as I have now experienced, the medical world have even fewer answers when it does happen! I even approached Johnson and Johnson/DePuy direct to see what they are doing about research into the effects of these devices, surprisingly they were more concerned about the multitude of pending legal cases than what these wonderful devices will continue to do to us patients as long as we live! I implore each and every one of you who have had a MOM implant (or your loved ones) to monitor your health with diligence, as I found out it isn’t just the area of concern (your implanted hip/s) that you need to consider, this poison can hit you anywhere! I should have known as part of my ‘initial’ raft of side effects was a very rare form of anaemia caused by of all things “heavy metal poisoning”, this is a systemic problem we all need to be aware of now. Please also remember, the removal of the offending device is not the ‘end of the road’ as far as your problems go, if you had a recognised toxicity to Cobalt or Chromium, or even one that wasn’t investigated, the damage has been done, we are all just waiting to see now how that damage presents to us all!

I would be very interested to hear from anyone else, who has had problems with either poor fracture healing after Cobalt/Chromium toxicity or of course the development of ‘random fractures’, I also encourage anyone who has had any as yet ‘unexplained’ side effects to please let us know as I would like to try to develop a data base of any side effects that have or may be attributed to Cobalt or Chromium toxicity. I have tried to see if such a list exists and I am yet to find one (please let me know if I have had a ‘boy look’ and missed it if it does indeed exist), although I suspect that as many of these effects are only now coming to prominence that a list would be inaccurate anyway. I would be very interested to hear if anyone has had any luck with any sorts of treatments (western or eastern medical, alternative or otherwise) to do with their complications from their MOM implant so that these can be shared to the wider group.

I hope that everyone has a better week! I am going to fight to get to the bottom of this in my circumstance as to be honest I am truly scared of where this might lead and I think my family have suffered enough through all of this without having to sit back and watch me slide even further into the mire of declining health! I am very aware that there are many of you out there in a worse position than me so please don’t think I am in any way diminishing your experiences, I can only imagine what you are going through and lend my support in any way I can! I am also determined that regardless of compensation payouts and court cases, that Johnson and Johnson/DePuy, Smith and Nephew and any other ethically challenged medical device manufacturer is truly held to account for what has happened to each of us and apparently what is continuing to happen to each of us! I encourage you to keep up the fight, share your experiences with us or at the very least seek answers to any questions regardless of what people (especially doctors who may have a reason (financial or conscience) to keep you in the dark) try to tell you, if you don’t believe them or have doubts about the answer/s you have been given look elsewhere until you are satisfied!

One final thought: “Hope is the essence of life, no-one can live without hope!”, this Buddhist quote is one that I wear (literally) around my neck every day, I think that we can all draw some strength from it as I believe it is vital to us all getting through this (although it has been sorely tested in the last couple of weeks!! J).

Take Care, Stuart Cain

Metal-on-metal hip replacement toxicity | NPS MedicineWise (earlsview.com)
FDA cracks down on all-metal hip replacements (earlsview.com)
Biomet M2a Metal Hip destroys 46 year olds life… (earlsview.com)
J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg (earlsview.com)
Metal Debris in Patients’ Bloodstream is “Harmless,” J&J Toxicologists Say (earlsview.com)
J&J metal hip failed because of toxic debris -expert at trial | Reuters (earlsview.com)
Expert Witness Says Hip Implant Harmless (polymersolutions.com)
Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury (earlsview.com)
Bullshit-R-Us …. J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg (earlsview.com)
J&J metal hip failed because of toxic debris – expert at trial | Reuters (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: chromium, chromium toxicity, Cobalt, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, Earl, Health, Hip Replacement, hip resurfacing, hip revision, Johnson, Johnson & Johnson, metal, Metal on metal hip, Smith & Nephew

Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants

earlstevens58 — Tue, 05 Mar 2013 10:07:33 +0000

Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants.

FDA Safety Communication: Metal-on-Metal Hip Implants

Date Issued: Jan. 17, 2013

Audience:

Orthopaedic surgeons
Health care providers responsible for the ongoing care of patients with metal-on-metal hip implants
Patients who are considering or have received a metal-on-metal hip implant

Medical Specialties: Orthopaedics, General Medicine, Family Practice, Radiology, Radiologic Technology, Clinical Laboratory Managers and Directors

Device:

Metal-on-metal hip implants consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys.

There are two types of metal-on-metal hip implants:

Traditional total hip replacement systems
Resurfacing hip systems

Purpose: In February 2011, the FDA launched a metal-on-metal hip implant webpage. The FDA is providing updated safety information and recommendations to patients and health care providers. This new information is based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.

Summary of Problem and Scope:

Metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.

In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).”

Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions).

Presently, the FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects. In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.

Recommendations for Orthopaedic Surgeons:

Before Surgery

Select a metal-on-metal hip implant for your patient only after determining that the benefit-risk profile of using a metal-on-metal hip implant outweighs that of using an alternative hip system (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic or ceramic-on-metal). Factors to consider include the patient’s age, sex, weight, diagnosis, and activity level.
- Note that a 2012 FDA advisory panel of experts identified young males with larger femoral heads as the best candidates for hip resurfacing systems.
Inform patients about the benefits and risks of metal-on-metal hip implants, including the risk that the hip implant may need to be replaced. Also discuss the patient’s expectations and review the potential complications of surgery with a metal-on-metal hip implant.
Pay close attention to patient populations for which metal-on-metal hip systems are contraindicated. Be aware of the risk factors that may predispose a device to excess wear and early failure.

Additional information on the FDA’s recommendations for orthopaedic surgeons before, during and immediately following metal-on-metal hip replacement surgery can be found in Information for Orthopaedic Surgeons.

Patient Follow-Up

Follow-up of asymptomatic patients with metal-on-metal hip implants, including physical examinations and routine radiographs, should occur periodically (typically every 1 to 2 years). If the hip is functioning properly, the FDA does not believe there is a clear need to routinely perform additional soft tissue imaging or assess metal ion levels in the blood.
Be aware that there are certain patients who are at risk for increased device wear and/or adverse local tissue reactions (ALTR) and should be followed more closely. They may include:
- Patients with bilateral implants
- Patients with resurfacing systems with small femoral heads (44mm or smaller)
- Female patients
- Patients receiving high doses of corticosteroids
- Patients with evidence of renal insufficiency
- Patients with suppressed immune systems
- Patients with suboptimal alignment of device components
- Patients with suspected metal sensitivity (e.g. cobalt, chromium, nickel)
- Patients who are severely overweight
- Patients with high levels of physical activity.
Pay close attention to signs and symptoms that may be associated with metal-on-metal hip implants. Please see the website for a list of common ALTRs and systemic symptoms/complications.
Conduct a thorough evaluation if a patient with a metal-on-metal hip experiences local symptoms such as pain or swelling at or near the hip, a change in walking ability or a noise from the hip joint more than three months after metal-on-metal hip implant surgery.
Follow symptomatic patients with metal-on-metal hip implants at least every 6 months.

Additional information on the FDA’s recommendations for patient follow-up can be found in Information for Orthopaedic Surgeons.

For additional information regarding soft tissue imaging or assessing metal ion levels, please review the FDA’s recommendations below.

Imaging

For some symptomatic patients with metal-on-metal hip implants, additional diagnostic imaging is required to assess and diagnose soft tissue findings surrounding the implant. Please be aware of the FDA’s recommendations:

Consider the benefits and risks of using different types of diagnostic imaging procedures (e.g. MRI with metal artifact reduction, CT, or ultrasound) as well as the availability of specialized radiology expertise when determining the most appropriate imaging modality for each patient.

If you determine that an MRI of a metal-on-metal hip implant patient is appropriate, the FDA recommends the following:

Consult with the radiologist to evaluate the benefits and risks of utilizing MRI with metal artifact reduction;
Review the available device-specific labeling from manufacturers for MRI Conditions; and
Inform the MRI site that the patient has a metal-on-metal hip implant.

For additional information on the FDA’s recommendations about imaging a patient with a metal-on-metal hip implant, please see Imaging Evaluation.

Assessing Metal Ion Levels

Some patients with a metal-on-metal hip implant may have elevated metal ion levels (e.g. cobalt and/or chromium) in their bloodstream. Several factors can impact the accuracy, reproducibility, and clinical interpretation of metal ion test results. Please be aware of the FDA’s recommendations:

The FDA does not believe there is a clear need to routinely check metal ion levels in the blood if the orthopaedic surgeon feels the hip is functioning properly and the patient is asymptomatic.
Patients with metal-on-metal hip implants who develop any symptoms or physical findings that indicate their device may not be functioning properly, should be considered for metal ion testing.
If measuring metal ions, consider obtaining and following serial measurements (using the same sample type, the same measurement method, and preferably the same laboratory) in determining metal ion levels in symptomatic patients.
At this time, the FDA is not recommending a specific metal ion level as a trigger for revision or other medical intervention. The metal ion concentration values, including increases in metal ion levels over time, should be considered in addition to the overall clinical scenario including symptoms, physical findings, and other diagnostic results when determining further actions.

For additional information on the FDA’s recommendations on metal ion test methods, selecting a test lab and interpreting test results, please see Metal Ion Testing.

Device Revision

The decision to revise a metal-on-metal hip implant should be made in response to the overall clinical scenario. In case of adverse local tissue reactions (ALTR), revision of a metal-on-metal hip implant may have a worse prognosis than revision of other types of bearing surfaces.

In selecting components for revision:

Consider the benefits and risks of all bearing surfaces for each patient.
Check the specific device labeling for compatibility of device components.
If a patient is suspected to have developed metal sensitivity, carefully select the materials of the revision components (potentially avoiding materials with nickel or chromium).

For additional information, please review the FDA’s considerations on device revisions, which includes our recommendation for a retrieval analysis of every failed metal-on-metal hip implant.

Summary of FDA Recommendations for Orthopaedic Surgeons

	Symptomatic Patients	Asymptomatic Patients
Regular Clinical Evaluation	At least every six months	Typically at least once every 1 to 2 years
Soft Tissue Imaging	Consider the benefits and risks of MRI, CT and ultrasound for each patient.	Not necessary if you feel the hip is functioning properly.
Metal Ion Testing	Consider monitoring serial metal ion levels. Currently, the most reliable test results are available for cobalt in EDTA-anticoagulated blood*. In repeat tests, use same sample type, measurement method and preferably the same laboratory.	Not necessary if you feel the hip is functioning properly.

*For chromium testing, a validated method that resolves potential interferences must be used. Please reviewFDA’s recommendations for chromium testing.

Recommendations for Health Care Providers:

Metal-on-metal implant patients with systemic symptoms are more likely to visit their primary care practitioner than their orthopaedic surgeon, which makes it important for all health care providers to be aware of metal ion adverse events that may occur in metal-on-metal hip implant patients. Based on case reports, these events may include:

General hypersensitivity reaction (skin rash)
Cardiomyopathy
Neurological changes including sensory changes (auditory, or visual impairments)
Psychological status change (including depression)
Renal function impairment
Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold.

Patients with systemic findings that are thought to be related to a metal-on-metal hip implant should be advised to follow-up with his or her orthopaedic surgeon to determine the appropriate course of action.

For additional information, please review the FDA’s considerations to Health Care Professionals.

Recommendations for Patients Considering Hip Implants:

Be aware that every hip implant has benefits and risks.
Discuss your options for hip surgery with your surgeon.

A list of some questions to ask your orthopaedic surgeon can be found in Patients Considering a Metal-on-Metal Hip Implant.

Recommendations for Patients with Metal-on-Metal Hip Implants:

If you are not having any symptoms and your orthopaedic surgeon believes your implant is functioning appropriately, you should continue to routinely follow-up with the surgeon every 1 to 2 years.
If you develop new or worsening problems such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or change in your ability to walk, contact your orthopaedic surgeon right away.
If you experience changes in your general health, including new or worsening symptoms outside your hip, let your physician know you have a metal-on-metal hip implant.

Additional information for patients with a metal-on-metal hip can be found in Patients who have a Metal-on-Metal Hip Implant.

FDA Activities:

The FDA is committed to providing reliable safety recommendations to patients and health care providers about the utilization of these devices. Recent activities include:

On May 6, 2011, the FDA instructed manufacturers of metal-on-metal total hip replacement (THR) systems to conduct postmarket surveillance study of these devices. Five manufacturers currently market metal-on-metal hip implants in the U.S. and all five have approved postmarket surveillance study plans. Data from these studies will provide patients and health care providers with additional information about the safety profiles of the implants, including the effect of metal ion concentrations in the bloodstream.
On June 27-28, 2012, the FDA convened the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion on the benefits and risks of metal-on-metal hip systems. Information from this panel meeting has helped form these recommendations.
On January 17, 2013 the FDA issued a proposed order requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval (PMA) applications. Metal-on-metal total hip replacement systems were evaluated under the 510(k) premarket notification program. Metal-on-metal total hip replacement systems were marketed in the U.S. prior to 1976 legislation that gave the agency premarket authority over medical devices. As “preamendment devices,” they were designated as Class III (higher risk) devices but were regulated under the 510(k) premarket notification program.

Additional information on FDA ongoing activities are provided in FDA’s Role and Activities.

Other Resources:

For additional resources, see Metal-on-Metal Hip Implants: Other Resources.

Reporting Problems to the FDA:

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with a metal-on-metal device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

Reports to the FDA about adverse events related to metal-on-metal hip systems include, but are not limited to: pain, malposition, adverse local tissue reaction, metallosis, hypersensitivity (allergy), loosening, and dislocation.

To help us learn as much as possible about the adverse events associated with metal-on-metal hip implants, please include the following information in your reports, if available:

Date of implantation
Date of implant removal (if applicable)
Clinical cause for revision (if available)
System components affected by the adverse event.

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) via e-mail at DSMICA@FDA.HHS.GOV or by phone: 800-638-2041 or 301-796-7100.

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Total Hip Replacement Tagged: Cobalt chrome, Cobalt poisoning, DePuy, FDA, Food & Drug Administration, Health, Hip implants, Hip recall, Hip Replacement, hip replacement failure, hip resurfacing, hip revision, Johnson & Johnson, joint replacement, Medicine, Metal on metal hip, metal-on-metal hips, metallosis, Patient, Radiology, Research, science, Smith & Nephew, soft tissue damage, Specialty, UNited States

DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable

earlstevens58 — Tue, 05 Mar 2013 09:56:43 +0000

Trial plaintiff says J&J hips defective, company says not liable.

Trial plaintiff says J&J hips defective, company says not liable

3/1/2013

By Deena Beasley

(Reuters) – Johnson & Johnson‘s DePuy unit was well aware of defects in its all-metal hips when plaintiff Loren Kransky was implanted with one of the devices in 2007, lawyers for the 65-year-old man said in closing trial arguments.

The lawsuit filed by the retired Montana prison guard is the first to reach court out of more than 10,000 filed against J&J in the wake of its 2010 recall of the ASR artificial hips.

Kransky attorney Brian Panish told Los Angeles Superior Court jurors that J&J should be ordered to pay around $5 million for Kransky’s pain and suffering, and as much as $179 million in punitive damages. The proceedings were monitored over the Courtroom View Network.

J&J recalled 93,000 of its ASR metal hips after determining that they were failing at a higher-than-expected rate.

Kransky’s attorneys argued that the design of the hip was defective, leading to the shedding of metal debris that caused tissue poisoning and pain as well as the need for the plaintiff to undergo hip revision surgery.

“Any compensation should not be reduced simply because the plaintiff was more susceptible to injury than a normally healthy person,” Panish said.

Both sides in the case agreed that Kransky’s medical problems, including diabetes, cancer, kidney disease, heart disease and vascular disease, were not related to the ASR hip implant.

J&J attorney Michael Zellers argued that Kransky’s ASR hip was implanted at an incline that was steeper than company guidelines advised. He also said the plaintiff’s need for revision surgery was caused by an infection.

Testimony in the trial included DePuy executives explaining that the ASR hip was tested in the laboratory at a single angle of implantation. Plaintiffs’ lawyers contend that they should have tested it using multiple angles.

“We know there is no perfect hip design. There are always trade-offs,” Zellers said, adding that the company designed the all-metal device with the aim of developing a longer-lasting hip that would show less wear than existing devices.

The J&J attorney argued that there is no medical consensus on what levels of chromium and cobalt, the metals shed by ASR hips, could cause harm to patients.

“Ultimately the product did not perform as DePuy wanted it to perform or expected it to perform,” he said.

All-metal hip implants were developed to be more durable than traditional implants with ceramic or plastic components, but have been shown to fail at a higher rate than traditional implants.

Michael Kelly, another Kransky attorney, told jurors the evidence shows that J&J’s DePuy unit was primarily focused on making money from the all-metal ASR hips at the expense of patient safety.

DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg (earlsview.com)
J&J gambled on hip implant safety, lawyer alleges – latimes.com (earlsview.com)
Parker Waichman LLP Reviews Closing Arguments of DePuy ASR Trial and Discusses Risks of Metal-on-Metal Hip Implant (prweb.com)
J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)
When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
DePuy ASR Hip Lawsuit News: Plaintiff’s Attorney Alleges J&J Pursued Profits Over Safety; Asks for as Much as $180 Million in Damages (prweb.com)
US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
Trial underway in hip implant lawsuit – latimes.com (earlsview.com)
Business: Washington Post Business Page, Business News (earlsview.com)

Filed under: 510k process, Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Cobalt chrome, Cobalt poisoning, Courtroom View Network, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Food & Drug Administration, Hip recall, Hip Replacement, hip replacement failure, hip resurfacing, hip revision, Johnson, Johnson & Johnson, joint replacement, Kransky, Medicine, metal, Metal on metal hip, metal-on-metal hips, Plaintiff, Reuters, Smith & Nephew, Zellers

Earl's View » hip resurfacing

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants

Published: November 12, 2013

The tentative plan, which must win court approval, represents one of the largest payouts for product liability claims involving a medical device.

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Figure 1: Symposium at AAOS 2013 addressing metal-metal hip complications.

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Table 2: Membership of 2012 panel, their arthroprosthetic company allegiances.

Table 3: Membership of 2013 hip program commitee and their arthroprosthetic company allegiances.

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FDA Safety Communication: Metal-on-Metal Hip Implants

Audience:

Device:

Summary of Problem and Scope:

Recommendations for Orthopaedic Surgeons:

Before Surgery

Patient Follow-Up

Imaging

Assessing Metal Ion Levels

Device Revision

Recommendations for Health Care Providers:

Recommendations for Patients Considering Hip Implants:

Recommendations for Patients with Metal-on-Metal Hip Implants:

FDA Activities:

Other Resources:

Reporting Problems to the FDA:

Contact Information:

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