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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Thursday, June 5, 2014

FAIL: Vaginal Surgical Mesh - Women in Scotland report catastrophic adverse events



by TOM PETERKIN  The Scotsman  June 4. 2014

Alex Neil has been pressed into action to help women whose lives have been ruined by the painful side-effects of plastic vaginal mesh implants.
The health secretary yesterday said he would seek an urgent meeting with the United Kingdom regulatory body for medical devices after a group of women told Holyrood of their suffering due to the controversial treatment.
Members of pressure group Scottish Mesh Survivors – Hear Our Voice have presented a petition to the Scottish Parliament urging treatment be suspended.
Polypropylene mesh medical devices are implanted in women who experience bladder and prolapse problems, typically after pregnancy.
Appearing in front of Holyrood’s petitions committee, sufferers told MSPs (Ministers of Scottish Parliament) their lives had been blighted after having the implant. Some were in tears as they spoke of severe mobility restrictions, immune system problems and damage to internal organs caused by the mesh or tape implanted in the pelvis.
There were reports of the mesh becoming infected and contracting – cutting through organs “like cheesewire” – and the extreme difficulty in removing the material safely.
Despite a campaign to have the procedures suspended until a full investigation is carried out, sufferers say government ministers are passing the buck.
Elaine Holmes, 49, from Newton Mearns, East Renfrewshire, had an implant to treat a leaky bladder in February 2011. Since then she has had four operations to remove the mesh.
“Too many women in Scotland are being hurt on a daily basis while we wait on the slow-moving wheels of Westminster to turn,” she said. “We already have the legal powers needed to make a difference in Scotland, today. The rest of the UK can follow suit, but let us lead the way.
“We have been told that regulation and safety is an issue for the European Commission. But we would contend that the current EU system is not working and if our First Minister shows political willingness to intercede over fishing quotas, he can surely show political willingness to intercede over something which is having such a detrimental effect on human life.”
MSPs requested that the health secretary and deputy Michael Matheson, the public health minister, appear before the petitions committee to give evidence on the Scottish Government’s position.
Yesterday, Mr Neil wrote to the Medicines and Healthcare Products Regulatory Agency (MHRA). He called on the MHRA to reach a swift conclusion to 
ensure that no further women suffered complications as a result of having the implant.
He said: “I met with some of the women affected and I am clear that no-one else should have to go through the suffering they have experienced.”
The Scottish Government has written to all GPs to ensure they make patients who may be considering this treatment aware of the potential side-effects.
Labour’s health spokesman, Neil Findlay, said: “The ball is firmly in the court of the government and I hope they finally take note of the evidence presented by the women.”
An MHRA spokesperson said the body would be happy to meet Mr Neil: “We listened to and understand the concerns many women have about vaginal tapes and meshes.

“The evidence currently available indicates that the benefits continue to outweigh the risks and can help in dealing with upsetting conditions such as urinary stress incontinence and pelvic organ prolapse.”

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