Mesh Medical Device News Desk, May 23, 2017 ~ An official mesh inquiry has blown up in Scotland, falling short of protecting the public, claim campaigners.
A story in the Sunday Post from reporter Marion Scott (here) says an independent inquiry will be conducted into conflicts of interest among authors of an official report that stopped short of banning most types of mesh implants.
Health Secretary Shona Robison has ordered a review of the official mesh implant inquiry.
In Scotland, estimates are that between the years 2000 and 2014, up to 1,500 women suffering from stress urinary incontinence, and 350 suffering from pelvic organ prolapse had synthetic mesh implant surgery using a polypropylene (PP) mesh medical device.
By comparison, there are more than 130,000 product liability lawsuits against seven mesh makers filed in U.S. courts. Visible appearances by anti-mesh campaigners and extensive media coverage have made the issue front-page news in Scotland and forced the inquiry.
The Scottish Government investigated pelvic mesh implants after hundreds of women came forward and spoke directly to a Parliamentary Committee.
The Independent Review of Transvaginal Mesh Implants, published March 27, 2017 is here.
The Health Board banned the use of most mesh in that country in June 2014 until the release of the independent review.
But the official report followed the publication of an earlier interim report published in October 2015 so campaigners were especially disappointed when this final report fell short.
The campaigners, Scottish Mesh Survivors, wanted six points of a petition to be met including banning polypropylene transvaginal mesh procedures, requiring mandatory reporting of all adverse events and the establishment of a Scottish transvaginal mesh implant register.
While the Independent Review of Transvaginal Mesh Implants, said transvaginal mesh implants procedures must not be offered routinely, it stopped short of an outright ban that campaigners sought.
Also omitted was establishment of a central registry of all data about mesh implant clinical procedures that would be gathered in one place.
Four clinical experts on the 20-person panel have links to industry that makes mesh implants, say campaigners. Panelists were only required to declare any conflicts 12-months prior. Boston Scientific told the paper that any funding of educational sessions follows strict internal guidelines.
Three members of the panel resigned in protest of the removal of recommendations before the report was issued. Elaine Holmes who was a campaigner who resigned from the review said “Vital evidence was ignored by the review which hasn’t taken account of so many significant issues and safety warnings, we fear it will leave more women at risk.”
Like the U.S. Food and Drug Administration’s 510(k) clearance for medical devices, a hands-off fast-track get-to-market clearance, the United Kingdom has a CE Mark. That means the manufacturer met the minimum regulatory requirements and a CE Mark clears the device to sell. ###