Scotland Limits Use of Pelvic Mesh Implants
Mesh News Desk, October 5, 2015 ~ According to a story in Scotland’s The Daily Record, here, on Friday, the Health Secretary of Scotland published an interim report on the use of transvaginal mesh.
It says three of the four procedures doctors routinely recommend to treat incontinence and pelvic organ prolapse will no longer be used.
The reforms are outlined in a safety review by the government largely encouraged by a series of reports by Marion Scott and the Sunday Mail as well as Scottish Mesh Survivors patient group. Their Hear Our Voice campaign carried to testimony before a Parliamentary Committee on the dangers of mesh implants.
What will change is using pelvic mesh to treat prolapse will not be approved, even though the U.S. version of the FDA, the MHRA, insists the procedure is safe and the benefits outweigh the risks.
Mesh procedures to treat stress urinary incontinence (SUI) also will not be routinely offered as a first line of care unless they are authorized by a multi-disciplinary medical team.
Hundreds of women in Scotland had complained to Parliament that their complications or adverse events were not being reported to the government. As a result, now that those incidents must be reported or the doctor will face possible sanctions.
Marion Scott tells Mesh News, “The mesh victims played a huge role in writing the patient information leaflets and they have ensured all possible side effects ate explained clearly. The SUI leaflet has already been done and they are working on the POP leaflet as we speak. This is a great example of what can be achieved. I’m so proud of all these incredible women who put their own pain to one side and pushed for these changes so no other women need suffer. They really are incredible.”
There is still voluntary reporting in the U.S. and the complications recorded by the U.S Food and Drug Administration are thought to represent one to ten percent of real-life complications.
Reporter Marion Scott began her series of investigations beginning in March 2013 for the Sunday Mail where the injuries from pelvic mesh became front page news. Women told the paper they had dire complications including an inability to walk and function and still faced dozens of surgeries. As in the States, many patients were told the problems were in their head and they should get mental health treatment.
That too was taken into consideration by the independent reviewers who urged surgeons to increase their “listening and empathy” skills.
The campaigners had asked for a total ban on mesh products but Elaine Holmes told the Daily Record “We’re happy to support the review recommendations as long as they and our petition points are put in place and actioned before any suspension is lifted.”
She added that the safety of patients is finally being put first.
Marion Scott tells Mesh News Desk,
“This is a momentous step forward and will ensure the devices which have caused the most damage will no longer be used and the one procedure that is left will only be used as a last resort rather than the first. Doctors will have to go in front of a panel to justify each and every use of the one SUI procedure left available, using retropubic tapes, and it will only be carried out as a last resort and when patients are fully informed of all the risks. Doctors will also face possible sanctions if they fail to report adverse incidents as there is a strong feeling over their failure to report previously. We reckon the new restrictions will have wide reaching effect.
“It has been a hard fought battle by women who have all suffered horrific injury. They are the true heroines of the piece. None of this will help them as their injuries are permanent. But they could not stand back and allow any other women to be injured.
“Thanks for all your support Jane. We just hope other countries will follow suit. I fully believe mesh will eventually be recognised as one of the biggest medical scandals of all time. Keep up the good fight. “
Here is the report