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Medicines and Healthcare products Regulatory Agency (MHRA)

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Sunday Mail (Scotland): Mesh operation victim reveals agony in emotional plea to Health Secretary

A woman who has suffered appalling complications following mesh surgery has made an emotional plea in a letter to the Health Secretary which was published in the Sunday Mail on 7th April 2013. In this third article on pelvic mesh by journalist Marion Scott, we hear the story of Lynn Thyne who suffered unwanted complications … 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

MHRA seeks views on the regulation of medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a press release on 12th November urging healthcare professionals and the public to give their views on new draft European laws for the regulation of medical devices. The EU proposals are intended to ‘increase transparency, simplification and cooperation between Member States’. It is also hoped that … 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

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

MHRA update: vaginal tapes for stress urinary incontinence

The MHRA have recently updated their page on vaginal tapes for stress urinary incontinence: “Vaginal tapes for stress urinary incontinence Patients should be aware that the role of the MHRA is primarily for ensuring that medical devices and medicines work as intended and are acceptably safe. We are unable to answer clinical questions, which should … Continue reading

MHRA update: vaginal mesh for pelvic organ prolapse

The MHRA have recently updated their webpage (see earlier posts) on meshes used for pelvic organ prolapse (POP):  “Vaginal mesh for pelvic organ prolapse  Patients should be aware that the role of the MHRA is primarily for ensuring that medical devices and medicines work as intended and are acceptably safe. We are unable to answer … 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

Lord Howe’s Review into PiP Implants: MHRA to make improvements

Health Minister Lord Howe’s review into PiP breast implants published on 14th May 2012 has found that there is room for improvement and serious lessons must be learned, although it considers the MHRA to have acted appropriately and to have followed scientific and clinical advice when it became aware of problems with PiP implants. “There is … Continue reading

MHRA commission independent review of vaginal tapes and mesh

In light of an increasing number of adverse events and patient concerns being reported in recent years, the Medicines and Healthcare Products Regulatory Agency (MHRA) has launched an investigation to better understand the use of the mesh used to treat pelvic organ prolapse and the complications associated with their use. In February 2012, the MHRA commissioned an independent … Continue reading

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