An Independent Review of transvaginal mesh implants was set up by the former Cabinet Secretary for Health and Wellbeing, Alex Neil, to assess the evidence relating to surgery using synthetic mesh implants for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in Scotland.
In June last year, Mr Neil asked the acting chief medical officer to request all NHS boards in Scotland to consider suspending routine mesh implant procedures for pelvic organ prolapse and stress urinary incontinence.
NHS Borders stated: “Following the Scottish Government directive in July 2014, only patients already on the waiting list for a mid-urethral sling using synthetic material and those enrolled in a multicentre randomised controlled trial (SIMS study) have had these procedures for stress urinary incontinence.
“The patients who were already on the waiting list were all offered a further appointment and given the information and consent leaflet prepared by NHS Scotland. In addition, the patients also received a locally-prepared information leaflet on TVT-O [tension-free vaginal tape-obturator]. The majority of patients who were already on the waiting list decided to go ahead with the operation.”
Last month, Health Secretary Shona Robison welcomed the publication of an interim report into the use of transvaginal mesh implant procedures.
It includes evaluation of both the efficacy and the extent and causes of adverse incidents and complication rates associated with these types of surgery.
We asked NHS Borders, through a Freedom of Information request, how many of these operations had been carried out.
Over four years, the numbers were as follows:
l 2011 – 151 TVTO implants and 1 Apogee and 3 Gynecare mesh PS
l 2012 – 115 TVTO mesh implants
l 2013 – 113 TVTO mesh implants
l 2014 – 16 TVTO mesh implants to March 2014.
Since July 2014 to date, 40 procedures involving synthetic vaginal mesh had been performed, mostly for patients involved in the SIMS study and have been randomised to either the TVT-O or Altis tape procedures.
An audit of all the patients having the procedure at the BGH in 2013 was performed, which brought up the following problems:
l Failure – 3% still suffered from urinary incontinence at the six-week follow-up appointment.
l Voiding Difficulty – 8% had voiding difficulties after their operation. (5% needing a catheter overnight, 1% needing a catheter for 48 hours, 2% needing a catheter for 1 week) and 2% of patients had the tape divided.
l Tape Exposure – 10% had evidence of mesh exposure at the six-week follow-up appointment. (9% required mesh trimming).
l Leg or Groin pain – 5% reported groin pain at the six-week follow-up appointment.
l Urinary tract infection – 2% had evidence of a urinary tract infection after their operation.
Around 11,000 women in Scotland have had the procedure, and MSPs have been told that as many as one in five can go wrong, with the interim report noting mesh implants “carry a risk of complications which, in some cases, are life-changing and cannot be corrected”.
An NHS Borders spokesperson said: “If a patient declines the standard mid-urethral sling procedures for urinary stress incontinence, and instead opts for one of the alternative procedures, then she will be referred to the regional referral centre in Lothian for an appointment with the relevant consultant.”