Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Wednesday, April 12, 2017

Johnson & Johnson toxic metal-on-metal hips: trial 'discovery' exposes secrets of scandal

11 APRIL 2017 • 10:00PM  The Telegraph
British patients were fitted with controversial hip implants despite the company behind them being warned by experts that the type of device was unsafe, secret documents reveal.
A senior engineer working for DePuy reported in 1995 that metal-on-metal constructions were “unpredictable” and parts prone to “catastrophic breakdown” five years before DePuy’s hips began to be implanted in Britons.
More than 20,000 patients were later fitted with the implants, which experts say can deposit toxic ions into the bloodstream as they wear. Thousands  were left in agony and had to have costly operations to have them replaced with safer alternatives.

Andrew Selous, a Conservative MP on the Commons health committee,  described the disclosure as “appalling”, saying: “If the company was aware of problems, they should have acted on the precautionary principle.”
A Daily Telegraph investigation today exposes a series of previously unseen memos, reports and emails, obtained from DePuy, that raised questions about the safety of metal-on-metal devices.
Dr Graham Isaac, a senior engineer based in DePuy’s Yorkshire factory, warned in a 1995 report that testing showed metal implants were “working well for a period of time” before wearing down, prompting the “release of a large volume” of debris.
In the same year, a surgeon advising DePuy told the firm that “we need to be cautious of the legal/litigation issues, lawyers etc ... perception of metal debris and metal ion release.” 

More than two decades later, the firm faces thousands of legal claims by patients who say they have suffered as a result of the metal-on-metal joint subsequently produced by DePuy wearing away in their bodies.

The Telegraph’s investigation also reveals how: 
  • Senior company figures were told in 2003 that one surgeon had already collected “a lot of bad data about metal-on-metal debris” in patients who had received DePuy implants; 
  •  A 2005 report warned that risks to patients of metal-on-metal were “as yet undetermined” but “the risk to DePuy may be major in terms of product liability or business impact”; 
  • An internal email in September 2008 acknowledged there were “growing concerns over metal-on-metal hips”. Surgeons needed “a high stability non-metal option”; 
  • Tony Nargol, a surgeon based in North Tees, repeatedly told DePuy from around 2008 about problems with its implants but was labelled an “outlier” and told his patients may simply have high volumes of metal in their blood because of a local “water supply problem”; 
  • A report commissioned by the company in 2008 about the use of one of DePuy’s first metal-on-metal implants found that tiny particles released from the devices “have killed the bone” and soft tissues around the hip and “resulted in the tendons ripping away”. 
The papers, filed in a US court, include an email from John Irving, a US orthopaedic surgeon, in 2010, forwarded internally to the company’s president, insisting that “it borders on unethical to continue to market” the Pinnacle type of metal-on-metal hips “until the issues are elucidated”. 
The metal ions released have killed the bone and soft tissues around the hip replacement resulting in:
a. Fluid retention often under high pressure causing pain
b. Tendon rupture causing hip dislocation
c. Bone death resulting in fractures around the implant

Excerpt from Investigation into the Performance of the Ultima Metal-on Metal Hip Replacement, East Norfolk and Waveney Research Consortium, 2008
He accused the firm of a “head-in-the-sand response to this problem” and warned that “the products are harming patients” – three years before the implant was eventually discontinued.

DePuy’s Pinnacle implant was first used in the UK in 2002, with the ASR, another metal-on-metal device, released two years later. They were promoted as offering better mobility than devices that used a metal ball and plastic socket.
In his 1995 memo, Dr Isaac, now “distinguished engineering fellow” at the firm, examined data on metal-on-metal hips produced by rival companies. He wrote: “It is clear from the literature the survivorship of cobalt chromium [the materials used in metal implants], metal-on-metal prostheses in the past have been far from satisfactory.
Paul Peters MD: We need to be cautious of the legal/litigation issues and lawyers etc… perception of metal debris and metal-ion release.

Minutes from the first Alternate Bearing Project designing surgeon meeting, May 1995
“Manufacturing methods have improved. However, simulator testing of such components suggests their performance is as unpredictable as ever, working well for a period of time before suffering a sudden catastrophic breakdown of the bearing surface accompanied by a release of a large volume of wear debris.”
He quoted an expert warning that the combination of metal with metal was “likely to give rise to toxic levels of metal under clinical conditions”.
I do not feel DePuy is doing enough to understand the extent of Pinnacle MOM hip disease. I believe it borders on unethical to continue to market the product until the issues are elucidated. These products are harming patients. DePuy needs to contact physicians that have used the product and encourage them to contact their patients for an urgent follow-up. Many of our hips have asymptomatic osteolysis!

Excerpt of letter to DePuy head of US marketing, Paul Berman, from John F Irving MD
The document was part of papers read out in a Texas court, where patients are suing DePuy over the Pinnacle implant. They were passed to the Telegraph by their lawyers. 
Mark Lanier, a lawyer,  said: “These documents show that DePuy knew this hip would fail.”
DePuy’s lawyers have said in court that the company had “always warned about the potential for a tissue reaction in a metal-on-metal device”.
A spokesman said patient safety was its “first priority” and it “acted appropriately and responsibly in the design and testing” of the Pinnacle.

The implant was cleared for sale by national regulators and “is backed by a strong track record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain”.
The spokesman added that the plastic and ceramic alternatives also “wear and produce debris”, and “the body reacts to any foreign material”.
Boz Michalowska Howells, representing more than 300 UK claims, said  it “appeared to be commonly known in the 90s that metal-on-metal hips cause could adverse reactions and it should have rung alarm bells”. 
Metal implants put under scrutiny

  • 2002

    Pinnacle hip implants, including metal-on-metal type, sold in UK by DePuy

  • March 2004

    DePuy sells its ASR metal-on-metal implants in Britain

  • 2008

    DePuy aware some metal-on-metal parts for Pinnacle Ultamet “were slightly outside our manufacturing specifications”. Internal investigation finds it would not cause “safety issues”

  • August 2010

    DePuy recalls its ASR Hip System “after receiving new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data”

  • June 2011

    US Food and Drug Administration report states that “production capabilities for the Pinnacle metal-on-metal liners and femoral heads at the Leeds facility should be reviewed”

  • June 2012

    Medicines and Healthcare Products Regulatory Agency guidelines say larger metal-on-metal hip implants should be checked for “life”, not just five years, with tests for metal particles in patients’ blood

  • March 2013

    DePuy announces “discontinuation” of Pinnacle Ultamet device “because of low clinician use”

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