British Medical Journal
Thousands of people face painful and expensive surgery to remove failing medical devices such as metal hip replacements and cardiovascular implants, according to investigations by the BMJ and Channel 4 Dispatches. Please view here for more information: dispatches-the-truth-about-going-under-the-knife.html
From our Medical Expert Advisor:
The problems with vaginal meshes is just as serious as the hip and cardiac devices but it has not received the same publicity. The MHRA has been severely criticised for doing very little and the commercial activities of the companies involved have been a disgrace.
The BMJ (British Medical Journal) is an international peer reviewed medical journal and a fully “online first” publication. Please find following some of the concerns raised on the BMJ website as below:-
In 1993 a BMJ editorial warned of the “fashion trade” in joint replacements (BMJ 1993;306:732). It said this was costing health services many millions of pounds each year and causing patients pain and distress through early failure of unproved implants. This week an investigation by the BMJ and Channel 4 Dispatches shows how right this view was and how little has changed.
Full PDF: The-trouble-with-medical-devices.pdf >>>
The UK regulator, the Medicines and Healthcare Products
Regulatory Agency (MHRA), has concerns about the current
system, saying that “the evidence on safety and efficacy of new
devices and new procedures at the time they are introduced into
UK practice is very variable.” It has also suggested that the
evidence base for most devices was poor.
Full PDF: Europeans-are-left-to-their-own-devices.pdf >>>
Competing interests have an unhealthy influence on drug
prescription. Drug companies publish selective data aided by
clinical researchers, who accept payment to be gift authors of
ghost written articles.4 Universities that receive research funding
from industry can turn a blind eye to misreporting of research.
Full PDF: The-regulation-of-medical-devices.pdf >>>
Also read this article I found in the Guardian Newspaper:
How drug companies' PR tactics skew the presentation of medical research
Elliot Ross reveals the secret 'army of hidden scribes' paid by the drug companies to influence doctors
Source: www.guardian.co.uk/science/2011/may/20/drug-companies-ghost-writing-journalism >>>
Ideally, collection of clinical data should be an integral part of
healthcare systems. Without systematic collection of individual
patient data and outcome it is impossible for individual doctors,
healthcare providers, or regulatory agencies to understand how,
when, and to whom healthcare is provided and the actual
outcome of specific procedures or devices. Furthermore,
complications of new devices or strategies, particularly those
that are unexpected or infrequent, may be impossible to identify
without systematic data collection in a registry.
Full PDF: Use-of-registries-to-investigate-the-past.pdf >>>
There are many kinds of medical devices for myriad purposes
in healthcare. All require an adequate regulatory framework to
ensure that patients gain clear benefits and are not placed at
unreasonable and avoidable risk.
Full PDF: Evaluating-and-regulating-device-therapy.pdf >>>
It is one of the biggest disasters in orthopaedic history, according
to one senior surgeon. On 24 August 2010, DePuy, a subsidiary
of American giant Johnson and Johnson, recalled its ASR
(articular surface replacement) hip prostheses from the market.
The recall followed years of denial by the company that the
ASR implants had caused pain and disability in patients. In a
statement to the BMJ, DePuy claim that “given the available
information, we believe we made the appropriate decision to
recall at the appropriate time.”
Full PDF: Out-of-joint-The-story-of-the-ASR.pdf >>>
No implantable medical device is perfectly safe. It is the duty
of manufacturers and regulators to minimise risks—and the
purpose of evaluating and regulating devices is to ensure safety
Full PDF: International-collaboration.pdf >>>
Medical device regulation is currently being questioned in both
Europe and the United States.1 Although both systems are under
review, that’s where the similarity ends. Both the approval
process and policies on access to data are very different. And
our research, published this week in BMJ Open and part of a
wider series of investigations in which the BMJ has been
involved, shows how difficult it makes it to find out about
recalled devices in the UK.2
Ful PDF: Medical-device-recalls-and-transparency-in-the-UK.pdf >>>
Problems with hip resurfacing that were initially reported
included raised blood cobalt and chromium ions,4 loosening of
components,5 hip fracture,6 and soft tissue reactions around the
Full PDF: Metal-on-metal-hips.pdf >>>
Regulatory bodies are expected to protect the public from the
danger of inappropriately tested treatments—a shield against
the vested interest of drug and device companies to sell products
irrespective of their safety and effectiveness. The idea of the
greedy industrialist focused on short term advantage and
endangering lives with low quality components used to save
manufacturing costs is familiar to the public and seems to justify
stringent regulatory processes. But one person is forgotten in
this equation—the doctor.
Full PDF: The-risk-of-over-regulation.pdf >>>
Your feature edition (Published 18 May 2011) has certainly highlighted the problems of the regulation of medical devices, particularly in Europe. Attempts to draw parallels between drug regulation and that of medical devices however can only be taken so far.
FUll PDF: In-response-to-the-Editor.pdf >>>
You will see and hear from people who decided not to go ahead with surgery after reading our website. They have been saved from harm!
For more information on our petition please visit here www.tvt-messed-up-mesh.org.uk/petitions.html >>>