Mesh Medical Device News Desk, November 13, 2017 ~ While Australia says it will consider all vaginally- placed mesh and surgical mesh as “high risk,” news from the UK says pelvic organ prolapse (POP) mesh may be made obsolete.
In the United Kingdom (UK, Northern Ireland, Britain and Scotland), the National Institute for Health and Care Excellence (NICE) guidelines, due out in December, say POP mesh must only be used in a research context.
What may result, if this interim decision becomes a final guideline, is that unless there is upcoming research, POP mesh will not be able to be sold or used as a standard treatment for prolapsing pelvic organs.
The result – it’s highly unlikely that any doctor will any longer implant the controversial polypropylene product in a patient suffering from POP.
According to the founder of the Sling the Mesh Campaign in the UK, Kath Sansom, “This is a subtly brought-in ban on vaginally placed prolapse mesh and is excellent news, not just for UK women but campaigners globally as it sends a clear message to surgeons that it will not be tolerated unless it is in a research setting. I am glad that NICE has some sense.”
This news is a departure from the National Health Service working groups in England and Scotland that reported it was safe to use pelvic mesh as a last resort in a multi-disciplinary setting. A Mesh Oversight Group Report issued in July, encourages doctors to learn more about mesh implantation and for specialist centers to treat complications. It does not recommend any curtailing of the current use of mesh for POP and SUI.
Sansom says that many surgeons in the United Kingdom (as in the U.S.) believe transabdominally placed prolapse mesh is safe and will start pushing that procedure as an alternative.
“Yet it ends up in the same site in the body and has same problems of shrinkage, twisting at edges, degradation, erosion. Also, it all ends up in the vaginal vault and we know from seeing women in campaign groups globally that it all causes the same problems of excruciating pain and ruined quality of life.”
In the UK, final guidelines on the use of both stress urinary incontinence (SUI) and POP mesh will be published in 2019.
Meanwhile the National Health Service (NHS) continues to insist the risk of mesh complications is low, at 1-3%.
In January 2016, the U.S. Food and Drug Administration reclassified POP mesh, generally a larger piece of polypropylene, to class III or high risk. Manufacturers were given 30 months years to take POP mesh off the market or prove with clinical trials that the mesh is safe and effective.
See MND story here.
As Australia moves to reclassify all pelvic mesh devices from moderate to “high risk” over the next 24 months, see MND story here), women in that country suffering pelvic mesh complications want to hold accountable regulators assigned with protecting the public health.
See Herald story here.
Women from Western Australia (WA) implanted with the Intra Vaginal Sling (IVS) and Tissue Fixation System (TFS) have plans to sue, not just pelvic mesh manufacturers, but the state health systems and regulators that put the medical devices on the market.
Solicitor Adrian Barakat, of AJB Stevens Lawyers in Sydney, is bringing the action with a focus on Western Australian (WA) Health Department alleging a cover-up of mesh device surgical trials in public and private hospitals.
For example, two doctors from WA, who conducted clinical trials in WA hospitals claimed they had ethics committee approvals, which cannot be confirmed.
Mr Barakat told the Herald they are looking to sue health departments in each state in Australia. Also being considered, is action against the TGA, the Therapeutic Goods Administration for clearing devices with little or no evidence of safety and efficacy.
There are more than 1,350 Australian women involved in class action lawsuits naming mesh makers Johnson & Johnson (J&J), American Medical Systems.
There is currently a six-month trial involving 700 mesh injured plaintiffs being conducted in Sydney against defendant, J&J. ###