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Science Forum Index » Immunology Forum » Lancet articles: Very important info on medical devices
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| Ilena Rose |
 Posted: Wed Apr 25, 2007 12:41 pm |
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Very important studies Ruby. Thanks for posting these.
This is especially troubling since I just read an advertisement from
the PS's in Australia that they were going to experiment on Australian
women with titanium covered implants.
http://www.carefair.com/html/Australian_Women_to_Test_Metal_Breast_Implants_2078.html
Quote from Metallic debris from orthopaedic implants article:
"Metals are known to produce complex biological actions with
immunological, mutagenic, and toxic effects. Both the law and health-
and-safety committees provide a clear and exacting framework for the
control of exposure and monitoring of human beings, should they be in
contact with chromium and cobalt from the environment or as a result
of working in industry. However, no corresponding guideline or legal
requirement exists for the control of exposure of orthopaedic patients
to these same metals if a surgeon has implanted a joint replacement.
Different countries provide guidelines or acceptable limits of
environmental and industrial exposures, with thresholds which, if
exceeded, require a change in industrial practice to limit the
exposure. But no corresponding exposure limits exist for metals
released from orthopaedic implants, although concentrations have
frequently been recorded that exceed the thresholds established in
industry. Currently, no practical notion of biomonitoring can be
applied to orthopaedic implantation surgery, as it is in industry for
a worker exposed to the same metals."
We need to inform our representatives of the need to pass laws that
would require ALL manufacturers, of implanted medical devices, to
established biomonitoring guidelines and exposure limits to toxic
chemicals, metals and debris particles from aging and degrading
implanted medical devices.
My Questions:
How many people who have Alzheimer's or any form of dementia also have
an implanted medical device/s?
How many people who have heart disease or high blood pressure also
have an implanted medical device/s?
How many people who have asthma and increased allergies also have an
implanted medical device/s?
How many people who have type 2 diabetes also have an implanted
medical device/s?
1. Review: The Lancet Early Online Publication, 29 March 2007
The operation of the century: total hip replacement
Learmonth ID, Young C, Rorabeck C
The Lancet DOI:10.1016/S0140-6736(07)60457-7
2. Metallic debris from orthopaedic implants
Learmonth ID, Case CP
The Lancet - Vol. 369, Issue 9561, 17 February 2007, Pages 542-544
(My comments in parentheses)
The Lancet 2007; 369:542-544
DOI:10.1016/S0140-6736(07)60251-7
Comment: M e t a l l i c d e b r i s f r o m o r t h o p a e d i
c i m p l a n t s
Ian D Learmonth a and C Patrick Case a
Total hip replacement has revolutionised the management of patients
with endstage arthritis of the hip. It is the second most common
elective surgical procedure in the UK. In the 1960s and 1970s, total
hip replacement was reserved for elderly and substantially disabled
people. Now, ever younger patients seek replacement surgery to deliver
quality-of-life aspirations.1
An implant of metal coupled on ultrahigh-molecular-weight polyethylene
(a resilient plastic) was the globally preferred articulation
throughout the 1970s and 1980s. Aseptic loosening caused mainly by
osteolysis emerged as the major cause of failure of total hip
replacement.2 The osteolysis was attributed to the cytochemical
response to the generation of micron and submicron particles of
polyethylene.3
(Or in other words, the main reason for replacement surgery is from a
compounded, foreign body reaction to tiny splinter-like debris
particles that have been liberated from the aging and degrading
implant)
Recognition of the problems associated with polyethylene resulted in a
striking increase in the use of metal-on-metal implants, especially
for younger patients [<50 years of age]. More than 300000 metal-on-
metal [cobalt chrome on cobalt chrome] couples have been inserted in
the past 10 years. Two types of metal-on-metal implants are in use:
total joint replacement and the bone-conserving surface replacement
endorsed by the UK National Institute of Clinical Excellence.4
Although the volumetric wear of metal-on-metal bearings is
substantially less than that with metal-on-polyethylene, a far greater
number of much smaller particles are produced.
(The more debris particles = more cytochemical response = more
symptoms)
Increased concentrations of metal ions have been widely reported in
the peripheral blood and urine of patients with metal-on-metal
couples.
5,6 The changes in patients' demographics and the materials used for
the articulation will increasingly result in younger patients being
exposed to higher amounts of metal ions and particles for extended
periods. Both particle-mediated and metal-mediated diseases could have
long latency periods.
(It could be a long time before the adverse effects of this foreign
body reaction - cytochemical response - and their symptoms appear -
and when they do manifest as a disease or a disease-like symptom - no
medical professional will attribute them to the medical device but to
the natural aging process)
Therefore, health and safety assessments are essential to monitor
changes in the very long term. (Ya think)
The long-term risk of cancer has been examined in several
epidemiological studies,7–11 especially from Scandinavia, where there
are good records and hip registries. Thus far, no consistent risks
have been identified. However, many of these studies were underpowered
and the follow-up period was short and less than the accepted latent
period for metal-induced cancers. The International Agency of Research
on Cancer reviewed the evidence of 14 epidemiological cohort studies
in six countries in 2000.12 Because of insufficient evidence, the
Agency assigned orthopaedic implants of complex composition to a group
3 classification [not classifiable for carcinogenicity in human
beings].
Metal ions in solution or in particulate form have been shown to cause
delayed type IV T-cell hypersensitivity,13,14 dose-dependent cell
necrosis,15 and mutagenic changes.16 The Committee on Mutagenicity of
Chemicals in Food, Consumer Products and the Environment released a
statement in July, 2006,17 which concluded that “there was good
evidence for an association between cobalt chrome on cobalt chrome and
cobalt chrome or titanium-aluminium-vanadium on polyethylene hip
replacements and increased genotoxicity in patients”. The implications
of these mutagenic changes are unclear.
(They do not have a clue what kind of disease/s this longtime exposure
to metalic debris particles will cause OR how to diagnose and treat
them once they manifest)
Metals are known to produce complex biological actions with
immunological, mutagenic, and toxic effects. Both the law and health-
and-safety committees provide a clear and exacting framework for the
control of exposure and monitoring of human beings, should they be in
contact with chromium and cobalt from the environment or as a result
of working in industry. However, no corresponding guideline or legal
requirement exists for the control of exposure of orthopaedic patients
to these same metals if a surgeon has implanted a joint replacement.
Different countries provide guidelines or acceptable limits of
environmental and industrial exposures, with thresholds which, if
exceeded, require a change in industrial practice to limit the
exposure. But no corresponding exposure limits exist for metals
released from orthopaedic implants, although concentrations have
frequently been recorded that exceed the thresholds established in
industry. Currently, no practical notion of biomonitoring can be
applied to orthopaedic implantation surgery, as it is in industry for
a worker exposed to the same metals.
However, joint replacement surgery has revolutionised the management
of patients with endstage arthritis, and will remain to be the
treatment of choice for the foreseeable future. Therefore risks should
be carefully weighed against benefits. Risks associated with
strategies introduced to reduce the occurrence of revision surgery
need to be assessed against a 2·6% risk of death within 90 days after
total hip revision.18 Notwithstanding the huge benefits of joint
replacement, a system should be introduced to monitor any putative [so
far untested] clinical side-effects of the procedure.
The establishment of a National Joint Registry in England and Wales is
to be applauded. However, all requisite information regarding
composition of the component and materials used for the bearing
surfaces must be available either from the registry or from the
clinical records. Data generated from this registry should be readily
cross-correlated with other medical data to assess various short-term
and long-term effects.
Little is known about the transport, distribution, and excretion of
metal ions in the body. The long-term biological implications of the
systemic dissemination of metallic debris and toxic-effect thresholds
have not been characterised, nor has the risk of exposure to metallic
debris for 20–60 years. However, ignorance is no cause for
complacency. Although these concerns are currently theoretical, our
lack of knowledge dictates that we urgently need to implement a
programme of research that will address these issues.
(A call for action, long overdue)
We declare no conflict of interest.
References
1. Canadian Joint Replacement Registry. 2004 report: total hip and
total knee replacements in Canada. 2004: 30–34
http://dsp-psd.pwgsc.gc.ca/Collection/H115-7-2004E.pdf
(accessed Jan 11, 2007)..
2. Harris WH. Osteolysis and particle disease in hip replacement: a
review. Acta Orthop Scand 1994; 65: 113-123. MEDLINE
3. Archibeck MJ, Jacobs JJ, Roebuck KA, Glant TT. The basic science of
periprosthetic osteolysis. Instr Course Lect 2001; 50: 185-195.
MEDLINE
4. National Institute for Clinical Excellence. Guidance on the use of
metal on metal hip resurfacing arthroplasty. Technology Appraisal
Guidance no, 44: NO102. 2002:
http://www.nice.org.uk/pdf/HipResurfacing-FinalGuidance...
(accessed Jan 11, 2007)..
5. Witzleb WC, Ziegler J, Krummenauer F, Neumeister V, Guenther KP.
Exposure to chromium, cobalt and molybdenum from metal-on-metal total
hip replacement and hip resurfacing arthroplasty. Acta Orthop 2006;
77: 697-705.
6. Grubl A, Weissinger M, Brodner W, et al. Serum aluminium and cobalt
levels after ceramic-on-ceramic and metal-on-metal total hip
replacement. J Bone Joint Surg Br 2006; 88: 1003-1005. MEDLINE |
CrossRef
7. Gillespie WJ, Frampton CM, Henderson RJ, Ryan PM. The incidence of
cancer following total hip replacement. J Bone Joint Surg Br 1988; 70:
539-542. MEDLINE
8. Visuri T, Koskenvuo M. Cancer risk after Mckee-Farrar total hip
replacement. Orthopedics 1991; 14: 137-142. MEDLINE
9. Gillespie WJ, Henry DA, O'Connell DL, et al. Development of
hematopoietic cancers after implantation of total joint replacement.
Clin Orthop Relat Res 1996; 329 (suppl): S290-S296. CrossRef
10. Goldacre MJ, Wotton CJ, Seagroatt V, Yeates D. Cancer following
hip and knee arthroplasty: record linkage study. Br J Cancer 2005; 92:
1298-1301. MEDLINE | CrossRef
11. Visuri TI, Pukkala E, Pulkkinen P, Paavolainen P. Cancer incidence
and causes of death among total hip replacement patients: a review
based on Nordic cohorts with a special emphasis on metal-on-metal
bearings. Proc Inst Mech Eng [H] 2006; 220: 399-407. MEDLINE
12. McGregor DB, Baan RA, Partensky C, Rice JM, Wilbourn JD.
Evaluation of the carcinogenic risks to humans associated with
surgical implants and other foreign bodies—a report of an IARC
Monographs Programme Meeting. International Agency for Research on
Cancer. Eur J Cancer 2000; 36: 307-313. Abstract | Full Text | Full-
Text PDF (103 KB) | MEDLINE | CrossRef
13. Korovessis P, Petsinis G, Repanti M, Repantis T. Metallosis after
contemporary metal-on-metal total hip arthroplasty: five to nine-year
follow-up. J Bone Joint Surg Am 2006; 88: 1183-1191. MEDLINE |
CrossRef
14. Davies AP, Willert HG, Campbell PA, Learmonth ID, Case CP. An
unusual lymphocytic perivascular infiltration in tissues around
contemporary metal-on-metal joint replacements. J Bone Joint Surg Am
2005; 87: 18-27. MEDLINE
15. Huk OL, Catelas I, Mwale F, Antoniou J, Zukor DJ, Petit A.
Induction of apoptosis and necrosis by metal ions in vitro. J
Arthroplasty 2004; 19 (suppl 3): 84-87. Abstract | Full Text | Full-
Text PDF (311 KB) | MEDLINE | CrossRef
16. Ladon D, Doherty A, Newson R, Turner J, Bhamra M, Case CP. Changes
in metal levels and chromosome aberrations in the peripheral blood of
patients after metal-on-metal hip arthroplasty. J Arthroplasty 2004;
19 (suppl 3): 78-83. Abstract | Full Text | Full-Text PDF (100 KB) |
MEDLINE | CrossRef
17. UK Department of Health. Statement on biological effects of wear
debris generated from metal on metal bearing surfaces: evidence for
genotoxicity. Committee on Mutagenicity of Chemicals in Food, Consumer
Products and the Environment (COM), COM/06/S1: July, 2006
http://www.advisorybodies.doh.gov.uk/com/hip.htm
(accessed Jan 11, 2007)..
18. Mahomed NN, Barrett JA, Katz JN, et al. Rates and outcomes of
primary and revision total hip replacement in the United States
medicare population. J Bone Joint Surg Am 2003; 85: 27-32.
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Affiliations
a. Department of Orthopaedic Surgery, University of Bristol, Bristol
BS2 8HW, UK |
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