The BPC response to the ban on synthetic (TVT) based slings and vaginal meshes in Scotland

For some time, there have been very serious concerns about whether vaginal slings and meshes constructed from synthetic material are safe. This week there was a significant and unexpected new development when the Scottish Health Minister issued a ban on all synthetic sling and vaginal mesh procedures while further investigations were carried out. Although the ban does not apply to England, the implications to this important debate are considerable.

An estimated 40,000 women in the UK have had synthetic (TVT) sling implants. Constructed from polypropylene mesh tape to create a ‘hammock’ around the bladder neck and urethra, for some, the material has broken down. Unfortunately, I regularly see women who need treatment to address the severe pain this causes, as the material perforates the bladder and vagina area. Bleeding, infection and difficulty passing urine are common problems and there is often a need for repeated operations.

Our view at the Birmingham Prostate Clinic has consistently been that the traditional autologous pubovaginal sling offers a much better long term option in terms of durability and safety in particular, for the younger patient group. This approach, which pre-dates the introduction of TVT, is based on the same principle of creating a hammock, but we do so using your own tissue (usually a length of tissue from the stomach area). For older patients and those who may not suit the operation, we would consider newer urethral bulking agents as the best treatment option. In other words, there is a good ‘arsenal’ of treatments for stress incontinence. Our emphasis is always upon an individualised approach and we would be very mindful of the concerns around TVT mesh slings.

Why did TVT tape become so popular? It was widely promoted for being less invasive than the autologous sling or colposuspension with a shorter recovery time. In fact, in my practice at least, this is outdated – I now apply minimally invasive techniques to a pubovaginal sling also. This means that very often, patients with a pubovaginal (autologous) sling leave hospital on the day of their procedure; their hospital stay is no longer than the expected stay after a TVT insertion.

With the autologous approach, there is a slightly longer abdominal incision and there can be a little discomfort in the abdomen area from which tissue has been taken. There is a very slightly greater risk of short term voiding problems after a pubovaginal sling (15 to 20 per cent risk) compared with TVT (10 to 15 per cent). So in other words, in terms of post-operative factors, there is not a great deal of difference between TVT and autologous sling insertions.

However, it is important to add that short term, post-operative issues are not the only factors which should be considered. Long term outcomes are very important; in fact more important in terms of patients’ overall satisfaction with a procedure. There is emerging evidence that in the case of slings, the emphasis was placed too heavily upon short term benefits rather than long term outcome. Patients have reported feeling angry that although they quickly recovered from the surgery itself, months later, they faced severe pain and complications after the material became dislodged.

It should also be noted that the autologous pubovaginal sling is also a more complex operation from the surgeon’s point of view. Many surgeons offer a synthetic sling procedures, but a much smaller number regularly carry out both. As a patient, it is very important that you are appraised of all possible complications, short and long term, and that you are able to consider all appropriate treatment options, not only the procedure that your surgeon is able to do.

More needs to be done to fully investigate the complications rate from synthetic slings and vaginal meshes and there is a lack of evidence to compare the two different types of approaches to creating a sling. However, at BPC our starting point is that an autologous sling has a better, longer term safety and durability record and we would consider this the best option if a sling is being considered for patients concerned about synthetic tape. However we pride ourselves on an individualised approach to every patient dependent on their own needs and preference.