Mesh Medical Device News Desk, July 26, 2017 ~ A report from the UK government stops short of calling for an outright mesh ban such as is underway in Scotland.
Anger is erupting at a newly released government report on transvaginal mesh.
The report released this week is here.
At least 7,800 women in the UK have been implanted with polypropylene transvaginal mesh used to treat incontinence and pelvic organ prolapse.
U.S. manufacturers export their meshes globally so mesh injuries are showing up in Australia and New Zealand, Israel, Scotland, Ireland, Britain, So. Africa, among other countries.
The Daily Mail reports the three-year investigation by NHS England calls for a helpline to support victims and concludes there are many more women then are known who have been injured by surgical mesh, but it rejects calls for a ban.
The report says surgeons should be adequately trained to implant pelvic mesh. At the present time, any gynecologists can implant mesh. And it says women should receive informed consent. What is rarely discussed is what constitutes “Informed Consent” since no one agrees on an estimated number of injuries expected to occur from various mesh implant procedures.
Talks about informed consent, improving reporting and offering all appropriate treatments, non surgical mesh and non-mesh to patients. But what is informed consent? And how can doctors deliver it when they don’t agree on the percentage of complications?
The summary talks about ideals, goals and best practices, the use of a national database and appraisal system- things not practically in force now. If anything it encourages surgeons to be performing at least 20 sub-urethral slings procedures every year to stay current.
The group still support the use of mesh for incontinence although encourages further research.
As far as mesh for pelvic organ prolapse or POP?
“The use of vaginal mesh in primary procedures to treat POP is not supported by the current evidence and this should not be offered routinely for the first surgical intervention.”
This is also the standing of the FDA because of the awareness of complications that arise later after the procedure, even up to ten years after a POP mesh implant.
MESH COMPLICATION REPORTING
The “Yellow Card” is a reporting system that is supposed to record adverse event, not unlike the MAUDE system that is part of the U.S. Food and Drug Administration. Sling The Mesh campaigner, Kath Sansom tells Mesh News Desk no one is aware of it so it is not used. This report urges women to make their complication reports to the Yellow Card.
The Daily Mail quotes Teresa Hughes who has been an active mesh campaigner after her implant in 2006. “All the doctors I’ve seen think this material should be banned. We wanted a proper register of how many meshes were implanted, how many were removed and mandatory reporting of problems to get a scale of the problem. ‘This inquiry and the way we have been dealt with has been utterly disgraceful, and whitewash is the only word for this report.’
Hughes was one of seven representatives from victims group who reported to the Mesh Oversight Group, headed by the National Health Service.
The Daily Mail reports one year after the group was formed three years ago, the group stopped intake from involved doctors.
Dr. Suzy Elneil tells the newspaper she thinks the government hopes this problem will just go away.
“They insist the complications are only 1 to 3 percent, but that’s ignoring data showing complications averaging up to 40 percent in some studies.”
Anti-mesh campaigns criticize the Mesh Oversight Group for having conflicts of interest with industry that makes mesh implants.
An interim report was issued by the Mesh Working Group in December 2015 here.
While it encourages more reporting of adverse events and collection of that data, informed consent is important and should be reviewed every two years. Informed consent might take longer. It does not call for any ban into the procedure or on the use of transvaginal mesh.
The question was would it be another whitewash as campaigners called the Scottish report on mesh, which is here. (March 2017). ###