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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

German newspaper article warns of risky mesh for pelvic floor

An article published recently (2/1/12) in the “Badische Zeitung” in Germany describes problems with “risky mesh for pelvic floor”.  This article has been translated into English as follows: “Risky Mesh for Pelvic Floor Doctors are warning against this operation. Several births, being severely overweight, or weak pelvic floor structures can result in a woman having a  pelvic organ prolapse.  In many cases, … 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

Bloomberg News: J&J tells judge it will stop sales of vaginal implants

An article published in Bloomberg News on 5th June 2012 reports that Johnson & Johnson’s Ethicon division has told a federal judge in West Virginia that it intends to stop selling four vaginal mesh implants after being sued by over 600 women who claim the products caused them injury.   In a letter filed yesterday with US District Judge … 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