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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

ABC News, Australia: J&J facing massive class action

A news report in Australia’s ABC News on 16th October 2012 tells how Johnson & Johnson is facing a massive class action which could make legal history in Australia.  The case was filed in the Federal Court on 15th October 2012 and relates to a transvaginal mesh implant for pelvic organ prolapse. The news article … Continue reading

New Zealand Herald: surgical mesh costs millions

A news article published in the New Zealand Herald on 30th September 2012 explains how surgical mesh is being implanted into hundreds of New Zealanders despite the mesh being the subject of international lawsuits and warnings. The report refers to synthetic mesh used for hernia repairs and in gynaecological surgery to repair pelvic organ prolapse … 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

Daily Mail: Scandal of women who STILL aren’t told risk of bladder operations

In this article printed in the Daily Mail on 4th September 2012, Teresa Hughes says having surgery to implant a TVT tape was one of the worst decisions she ever made.  The news story tells how Teresa Hughes, a 61-year-old mother of two, suffered terrible complications after undergoing TVT surgery to treat stress urinary incontinence, … Continue reading

Bard loses first vaginal mesh lawsuit and must pay $5.5 million in damages

Vaginal mesh manufacturer CR Bard Inc. has been ordered to pay damages of $5.5 million to a woman who was harmed by transvaginal mesh used to treat stress urinary incontinence. A jury found Bard negligent in its handling of the device, and concluded that the woman deserved the award because of the complications she has … 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

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

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