Earl's View » Cobalt chrome

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

Paige’s Hunger Strike – cancelled on legal advice

earlstevens58 — Wed, 17 Apr 2013 13:01:36 +0000

Hi everyone

I took down Paige’s page earlier today at the request of her son as he advised that Paige had discontinued her hungers strike on legal advice.

Hopefully there is a solution in sight?

Cheers

Earl

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Cobalt chrome, Cobalt poisoning, Hip Replacement, metal-on-metal hips, Smith & Nephew

The Challenge of Corrosion in Orthopaedic Implants

earlstevens58 — Sat, 06 Apr 2013 23:11:29 +0000

The Challenge of Corrosion in Orthopaedic Implants.

The Challenge of Corrosion in Orthopaedic Implants

Kenneth L. Urish, MD, PhD; Paul A. Anderson, MD; William M. Mihalko, MD, PhD; and the AAOS Biomedical Engineering Committee

Corrosion has been a persistent challenge in orthopaedics. Even Sir John Charnley noted the critical challenges of corrosion in the design of trauma and arthroplasty implants. The idea that different metals cannot be used in the same implant secondary to galvanic corrosion is a basic scientific concept in orthopaedic residency education.

But in actual practice, multiple different metals are combined to improve overall implant design. In hip arthroplasty, for example, cobalt-chrome heads fitted to titanium stems are the industry standard. Where is the disconnect between standard practice and textbooks?

Galvanic corrosion

Galvanic corrosion is the electrochemical potential difference between two dissimilar metals. In theory, one metal becomes the anode and the other the cathode. The active metal, the anode, is under attack from the more resistant metal, resulting in the corrosion. Given this basic knowledge that a circuit established between two different metals leads to aggressive corrosion, common sense would dictate not using multiple metals in an orthopaedic implant.

The passivation layer is the essential component that enables implants composed of multiple alloys to avoid galvanic corrosion. Metals are not inert. Oxide layers that develop in vivo or as a consequence of surface treatments protect implants from corrosion. In essence, the metal oxide film becomes an insulator, protecting the metal from direct exposure with the electrochemical milieu.

Not all metals can form a stable passivation film. Classic stable “passive” metals include titanium, chromium, and molybdenum alloys.

Corrosion in orthopaedic implants is really about the breakdown of this passivation film. Chemistry and mechanical wear erode the dynamic oxide film that insulates the implant and are key to both wear and corrosion. In essence, wear and corrosion become intertwined, each dependent on the other, and accelerate component breakdown.

Passivation layers

Passivation layer dynamics is the key concept behind three types of corrosion: pitting, crevice, and fretting. In pitting, localized dissolution of the metal oxide film and formation of cavities occur at rates faster than the build-up of the metal oxide layer. Crevice corrosion is based on a similar mechanism, but occurs in stagnant areas where fluid diffusion is limited.

In crevice corrosion, an increase in the concentration of chloride ions, low pH, and low oxygen tension accelerates breakdown of the passivation layer by creating conditions that increase the solubility of the metal oxide film. Fretting is mechanically assisted crevice corrosion, in which mechanical destruction of the passive film allows crevice corrosion to predominate. The combination with the highest potential for corrosion is stainless steel and cobalt-chrome; this combination has the weakest passivation layer, resulting in a lower threshold for corrosion.

Galvanic corrosion can potentially be avoided when a stable passive film develops on metal components and motion and local chemistry that can cause crevice and fretting wear are eliminated. When these criteria—a stable passive layer and elimination of motion between metals—are met, different metal alloys can be used in the same implant.

Hip arthroplasty implants

A classic example of mixing metals can be seen in total hip arthroplasty (THA) designs. Mixing metals first became advantageous after the introduction of porous-coated cementless arthroplasty components, such as the Harris-Galante, porous coated anatomic (PCA), and anatomic medullary locking (AML®) designs, which required metal alloys that provided a good bearing surface and were optimized for bone ingrowth.

Initially, the components in these models were either entirely cobalt-chrome or a mix of titanium alloy and cobalt-chrome. After early studies reported initial outcomes of hip pain and expressed concern about the high stiffness of cobalt-chrome femoral stems, the standard shifted to a cobalt-chrome head and a titanium alloy femoral stem.

What motivated the need for multiple material composition of the THA femoral component? Cobalt-chrome is an excellent material for the design of a femoral head. Its hardness is ideal for decreasing wear as a bearing surface. It is not as ideal for a femoral stem, given its significantly higher modulus of elasticity compared to bone.

Titanium alloys, on the other hand, are better as femoral stem components because they allow more bone ingrowth and have a closer modulus of elasticity to bone, resulting in less stress shielding of the implant. Titanium is also more biocompatible, fatigue-resistant, and easier (from a manufacturing perspective) to shape with the necessary geometry and substrate to encourage bone ingrowth.

The crucial connection for these two components occurs at the modular taper interface between the femoral head and neck. The taper essentially locks the head onto the neck. Friction prevents movement, but the junction is not impervious to fluid. These modular junctions can become the weak point in arthroplasty design, susceptible to wear and breakdown.

Multiple studies have demonstrated that crevice and fretting corrosion (ie, mechanically assisted crevice corrosion)—not galvanic corrosion—are the dominant modes of corrosion of the passivation layer at the head-neck taper interface. Even without galvanic corrosion, however, the corrosion can still be significant.

Mechanically assisted crevice corrosion can lead to numerous problems, including implant failure from loss of mechanical integrity, third-body wear due to trapped particles between the articulating surfaces, osteolysis, and localized granulomatous reactions. Recent reports of pseudotumor formation in well-fixed metal-on-polyethylene hip implants are likely the result of mechanically assisted crevice corrosion.

Fretting corrosion can be increased in a large metal-on-metal head due to the greater surface area of the bearing and the increased forces across the taper junction. When modularity is introduced at the neck, adding another taper junction, the debris from fretting corrosion can increase significantly (Fig. 1).

Fig. 1 Modularity can be the weak point in the implant design and the source of more debris from corrosion.
Courtesy of Kenneth L. Urish

Corrosion continues to be a problem in orthopaedic implant despite more than four decades of experience. The passivation layer prevented initial fears of galvanic corrosion between certain pairs of mixed metals from occurring, but fretting corrosion is a major contributor to debris in many newer designs. When the correct criteria are met, crevice corrosion and fretting can lead to early implant failure. All surgeons should be cautious when adding levels of modularity that can add more debris to an implant system.

Drs. Urish, Anderson, and Mihalko are members of the AAOS Biomedical Engineering Committee.

Disclosure information: Dr. Urish—no conflicts. Dr. Anderson—Pioneer Surgical; Stryker; Aesculap; Expanding Orthopedics; SI Bone; Spartec; Titan Surgical; Clinical Orthopaedics and Related Research; Journal of Bone and Joint Surgery–American; Journal of Orthopaedics and Traumatology; Journal of Spinal Disorders; Neurosurgery; Spine; Spine Arthroplasty Journal; AAOS; ASTM; North American Spine Society; Spine Arthroplasty Society; Spine section of AANS/CNS. Dr. Mihalko—Aesculap/B.Braun; Saunders/Mosby-Elsevier; Journal of Arthroplasty;ASTM International.

References

Gilbert JL, Buckley CA, Jacobs JJ. In vivo corrosion of modular hip prosthesis components in mixed and similar metal combinations. The effect of crevice, stress, motion, and alloy coupling. J Biomed Mater Res 27, (1993) 1533–1544.
Jacobs JJ, Gilbert JL, Urban RM. Corrosion of metal orthopaedic implants. J Bone Joint Surg Am 80, (1998) 268–282.
Mao X, Tay GH, Godbolt DB, Crawford RW. Pseudotumor in a well-fixed metal-on-polyethylene uncemented hip arthroplasty. J Arthroplasty 27, (2012) 493 e13–17.
McKee GK, Charnley J, Hicks JH, Zarek JM. Symposium: the use of metal in bone surgery. Proc R Soc Med 50, (1957) 837–846.

AAOS Now
April 2013 Issue
http://www.aaos.org/news/aaosnow/apr13/research4.asp

Conflict of Interest of “industry experts” – Open letter from Dr Steve to Dr Frick… (earlsview.com)
Recalls-R-Us – DePuy/J&J Strike Again – More Hip Trouble (earlsview.com)
Open Letter – Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications. (earlsview.com)
Metal-on-metal hip replacement toxicity | NPS MedicineWise (earlsview.com)
#Shopping# : Electrochemical Techniques in Corrosion Science and Engineering (Corrosion Technology) (determined67tsd.wordpress.com)
Install copper wire for your home: costs and estimates (qualitysmith.com)
Iowa Resident Brings Suit Against Stryker For Damages Caused By Recalled Hip Implant – News Press Release | PharmiWeb.com (earlsview.com)
Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants (earlsview.com)
DePuy Defective Hip Implant Claims | eLocal (elocallawyers.com)
What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Total Hip Replacement Tagged: Cobalt chrome, corrosion, Crevice corrosion, DePuy, dissimilar metals, Galvanic corrosion, hip arthroplasty, Hip Replacement, JOHN CHARNLEY, molybdenum alloys, orthopaedic implants, Orthopedic surgery

J&J pressured to settle Australian hip lawsuits – FierceMedicalDevices

earlstevens58 — Tue, 26 Mar 2013 23:40:32 +0000

J&J pressured to settle Australian hip lawsuits – FierceMedicalDevices.

J&J pressured to settle Australian hip lawsuits

March 26, 2013 | By Mark Hollmer

Johnson & Johnson’s ($JNJ) $8.3 million defeat in a U.S. jury trial over its ASR metal-on-metal hip implant could force it to settle a massive class action lawsuit in Australia over the same product.

Lawyers representing 4,500 ASR implant patients in Australia may ask the country’s Federal Court to order Johnson & Johnson (and executives from DePuy division that made the implants) to focus on negotiating a settlement in the wake of the company’s defeat at the hands of a Los Angeles jury earlier this month, the Sydney Morning Herald reports this week. The negotiations would take place through a week of mediation in May.

Beyond the outcome itself, some of the testimony during the Los Angeles trial has also given their case a shot in the arm: J&J executives appear to have been told they didn’t act to address faulty ASR implants even though they knew about the product’s mounting safety and mechanical problems.

Presumably, J&J is prepared. The company pursued a global recall of the ASR implant system in 2010, and has boosted the amount of money set aside to handle rising legal costs stemming from lawsuits and settlement cases around the world. To date, J&J has already spent nearly $1 billion on ASR-related settlements.

More than 10,000 ASR-related lawsuits against J&J remain, and, since the Los Angeles case, a New Jersey jury ordered it to pay $11.2 million to an ASR plaintiff whose device failed and then faced a number of repeat surgeries. The lawsuits allege J&J designed a defective product and didn’t pursue proper safety and regulatory practices, but J&J denies any wrongdoing and has countered that patients complaining of ASR-related health problems endured unrelated issues. Many plaintiffs claim the implant damaged tissue around it and released metal fragments into their bodies.

Meanwhile, as the Sydney Morning Herald reports, the ASR hip implant had a 44% failure rate in Australia within seven years, according to Australian registry data cited by the story.

- here’s the story

DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
Pressure rises for settlement of hip implants case (theage.com.au)
Compensation hopes for faulty hip implant victims (smh.com.au)
VICTORY FOR MoM Sufferer – Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com (earlsview.com)
Common Problems Associated With Titanium Hip Replacements (orthopedics.answers.com)
Learning the Truth About Sulzer Orthopedics (arthritis.answers.com)
HELLO – Earth to Major Tom – What Planet is this guy on? At trial of Johnson & Johnson recalled hip implants, doctor testifies device wasn’t defective | NJ.com (earlsview.com)
Signs Your Hip Implants Are Hurting You (earlsview.com)
Smith & Nephew Failure Warning for Birmingham Hip Implant (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: Australia, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy Hip Recall Litigation, DePuy Lawsuit, Food & Drug Administration, Hip Replacement, Johnson, Johnson & Johnson, lawsuit, Los Angeles, Medicine, Metal on metal hip, metal-on-metal hips, metallosis, Sydney Morning Herald

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

Earl's View » Cobalt chrome

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.

Related articles

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

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

Related articles

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

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

Related articles

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

Related articles

Hillary’s Story – Resurfacing Nightmare

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

Related articles

Paige’s Hunger Strike – cancelled on legal advice

The Challenge of Corrosion in Orthopaedic Implants

The Challenge of Corrosion in Orthopaedic Implants

Galvanic corrosion

Passivation layers

Hip arthroplasty implants

Related articles

J&J pressured to settle Australian hip lawsuits – FierceMedicalDevices

J&J pressured to settle Australian hip lawsuits

Related articles

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

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

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

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

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

Letter from Dr Frick

Related articles

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

Related articles