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.
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Friday, April 6, 2012

UK victim: registry will reduce implant harm

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St Helens mum left in agony by medical mesh launches campaign to save others   by Liza Williams, Liverpool Echo  Apr 5 2012
A MUM has launched a campaign against a medical mesh incontinence product which she said left her in unbearable pain.
Teresa Hughes, 60, from St Helens, claimed her health has rapidly deteriorated since an operation to cure her incontinence.
Doctors operated using medical mesh, a product about which women across the country have raised their concerns.
Mrs Hughes, who has presented a petition to the Government, said it was now causing excruciating pain and discomfort.
She said: “We are calling on the Government to set up a register of people who used these products.
“It makes no sense that drugs have to pass many years of tests, but devices like these mesh products have very minimal testing.
“Many women are suffering in silence and when complications arise there are few doctors who know how to deal with it.”
Christian Beadell, of Goodmans solicitors, in Liverpool, said he had been contacted by women affected by the mesh. But he said it was difficult to take legal action because there was no conclusive proof it was dangerous.
Mr Beadell told the ECHO: “It is a complicated issue and we are not entirely sure where it will go.
“It is a similar case to the PIP breast implants, in that we have no proof the product causes problems.
“Doctors have conflicting views – some refuse to use it because they think it is dangerous.
“The general complaints patient report are that the product erodes, can travel around the body and cause infection.
“It is also very difficult to remove afterwards because it sticks to tissue.
“But others think they are fantastic devices.
“The issue here, like with PIPs, is that medical devices are not regulated properly and there needs to be an overhaul.
“Effectively, if a study in Europe says a product is safe, the Medicines and Healthcare products Regulatory Authority (MHRA) just rubber stamp it.
“There is no extra investigation. There is not even a register of everyone who has had it used.”
The mesh is manufactured by more than 20 different firms, including Ethicon.
Its spokesman said: “The use of surgical mesh to treat conditions such as stress urinary incontinence is an important treatment option.
“Numerous clinical studies suggest that, when combined with proper surgical technique, surgical mesh can improve patient outcomes.”
An MHRA spokesperson added: “We aim to prevent adverse incidents happening and, where they have already happened, to prevent them happening again.
“No device should ever be considered 100% safe, and constant effort is needed to reduce both the rate at which adverse incidents occur and the severity of the outcome.”


1 comment:

  1. At long last the figures for Mesh Removals in England alone have been put on The Medicine Health Regulator website which I received from Parliament UK.

    Also a meeting has been arranged with The Medicine Health Regulator to have talks about the serious complications of transvaginal mesh.

    ReplyDelete