U.K. health secretary mandates vaginal mesh safety audit

Jeremy Hunt, the U.K.’s health & social care secretary, this week ordered a National Health System safety audit of the use of plastic mesh implants to treat vaginal prolapse and female urinary incontinence. Hunt said the review of vaginal mesh and two other products – the Primodos hormone-based pregnancy test and the anti-epilepsy drugsodium valproate – were prompted by “serious concerns … raised by patients and their families.” Some of those complaints about vaginal mesh included calls for the products to be banned in the U.K. The health secretary said he asked NHS chief medical officer Dr. Sally Davies for advice on a ban. “She has been clear that clinical experts here and abroad agree that, when used appropriately, many women gain benefit from this intervention, hence a full ban is not the right answer in the light of the current evidence available,” Hunt said during a Feb. 21 address to the House of Commons. “However, this is not to minimize the suffering many women have experienced, which is why today I can announce that we will be publishing a retrospective audit to investigate the links between patient-level data to explore outcomes, and investing £1.1 million [$1.5 million] to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues.” The Primodos test led to miscarriages and birth defects during the 1960s and ’70s before it was withdrawn in 1978, he added, an...
Source: Mass Device - Category: Medical Devices Authors: Tags: Regulatory/Compliance Women's Health Patient Safety Source Type: news