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Implants – Regulation of Medical Devices

This category contains 9 posts

Scotland’s Sunday Mail: Scottish women may be able to sue NHS

In the latest article by Marion Scott of the Sunday Mail, lawyer Cameron Fyfe, who is representing 300 women suffering complications, argues that every woman in Scotland given a mesh implant can now sue the NHS even if they have not suffered complications. A law which was devised to  compensate workers exposed to asbestos, but … Continue reading

Meshing with People’s Lives: MHRA and the Mesh Implant Problem

Despite growing and convincing evidence that complications from synthetic mesh implants are not rare and are ruining the lives of many women, the Medicines and Healthcare products Regulatory Agency (MHRA) remain reluctant to fully acknowledge the problem and to act with any real vigour to address the mesh problem adequately.  This is a scandal in … Continue reading

BBC Radio 4 report: PiP implants, the cosmetic industry and criticism of the European regulatory system

In this BBC Radio 4 report aired on 6th September 2012, Melanie Abbott reports on the aftermath of the PiP breast implant scandal, and reveals how two leading cosmetic surgery companies have blamed the European regulatory system for the scandal. PiP implants sold by a French company were found to contain industrial grade silicone filler … Continue reading

More experts give evidence on device regulation to UK Select Committee

More expert witnesses gave evidence to the UK Health Select Committee on 13th June as part of an inquiry into device regulation in the UK and Europe. The Science and Technology Committee held the second evidence session of its inquiry into ‘Regulation of medical implants’.  At this meeting, the Committee was seeking to understand the perspective of: the implant manufacturers … Continue reading

UK Parliament: expert panel give evidence on device regulation

A panel of experts recently gave evidence to a Health Select Committee at the first meeting of an inquiry into device regulation in the UK and Europe. The Committee had invited written submissions on the terms of reference which were as follows: 1.  Are current legislation and regulations on safety and efficacy of medical implants fit for purpose? … Continue reading

Royal College of Surgeons calls for mandatory database for all surgical implants

In response to news that an independent group of experts led by Sir Bruce Keogh has published their final report following the PiP implant investigations, the President of the Royal College of Surgeons has called for a mandatory database for all surgical implants “as a minimum”. The Final Report of the Expert Group concludes that the breast implants, despite containing non-medical … Continue reading

UK Parliament: Statistics on Mesh Implant Surgery and Mesh Removals

In February 2012, Teresa Hughes of Meshies United Support Group asked her MP to table questions in Parliament regarding the number of surgeries undertaken to implant a TVT or TOT mesh to treat stress urinary incontinence and the number of surgeries undertaken to remove the TVT or TOT mesh. Mr Shaun Woodward, MP for St Helen’s, asked the Secretary … Continue reading

The Problem with TVT Surgery

TVT – What is it? TVT (or Tension-Free Vaginal Tape) is a woven polypropylene mesh designed to support the mid-urethra to prevent stress incontinence.  The mesh strip is a permanent implant which is inserted transvaginally under the urethra to provide extra support during times of increased abdominal pressure such as when coughing or sneezing.   Many UK NHS hospitals use the Gynecare TVT retropubic tape which is manufactured by Ethicon, a subsidiary … Continue reading

BBC Newsnight on Implants and MHRA

Synthetic polypropylene slings (such as TVT, TVT-O and TOT) are implants but, as the BBC Newsnight feature on artificial hips explained, implants in the UK are very poorly regulated. Jeremy Paxman questioned Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) about their regulation process and Woods admitted that the de Puy implant … Continue reading