A settlement has been reached following a clinical negligence claim against Hampshire Hospitals NHS Foundation Trust relating to the unnecessary insertion of a transvaginal tape (TVT) in March 2009.
Our client started to experience problems with stress urinary incontinence in 2008. This was not severe but she noticed she was leaking when exercising. She had been referred to the urology department at Basingstoke and North Hampshire Hospital as a result of other urinary symptoms but, during her investigations and treatment with the urology department, she was subsequently referred to the urogynaecology department.
She was advised to undergo a transvaginal tape and she was seen once again in the urogynaecology department at Basingstoke and North Hampshire Hospital. She was told that the TVT was a sling which would hold her bladder up. This was all that our client understood about the procedure. She was not informed of any of the risks associated with the procedure such as dyspareunia, erosion or any long-term voiding dysfunction. She was not told what material would be used for the tape, whether there might be a need for further surgery in the future or that any such surgery would be extremely difficult given that the tape was designed to imbed itself into the surrounding tissues.
Our client was not advised of any other forms of treatment for her mild stress urinary incontinence including any conservative treatment such as pelvic floor physiotherapy prior to the insertion of a TVT.
On the reassurance of the doctors, our client proceeded to undergo a transvaginal tape operation on 18 March 2009.
Some years later, after suffering from various symptoms including vaginal pain, our client sought the opinion of another urogynaecologist and was examined on 8 February 2016. At this appointment, our client explained that she had vaginal discomfort and pain and, following an internal examination, it was found that there were exposed TVT fibres between the folds of the vaginal skin which may have been causing some of her vaginal pain.
Given that there was evidence that our client’s TVT had eroded, our client took the decision to undergo surgery to remove the TVT which was largely successful in addressing the vaginal pain.
Following an independent clinical negligence investigation into the case, supportive expert evidence was obtained to indicate that our client had not been fully informed on the risks associated with the insertion of the transvaginal tape nor had she been advised of any alternative options including conservative treatment by way of pelvic floor physiotherapy.
A case was put to the defendant that had our client been aware of the risks associated with the transvaginal tape and the nature of this procedure, she would not have proceeded. Furthermore, had she been advised to undergo conservative treatment by way of pelvic floor physiotherapy, this would have been successful in treating her limited stress urinary incontinence symptoms so that it would have been unnecessary for her to proceed to have a TVT.
Initially, the defendant refused to address the substantive allegations of negligence in this claim, seeking to argue that our client’s case was out of time. Accordingly, court proceedings were issued and the claim was litigated.
The defendant tried to argue that, despite it being clear that there was no information within the records to confirm that there had been a proper discussion regarding the risks of the TVT, nor had there been any discussion with our client regarding any conservative treatment, it was still likely that there would have been such a discussion. The defendant argued that the urogynaecologyy department at Basingstoke and North Hampshire Hospital received accreditation with the BSUG (British Society of Urogynaecologists) and this demonstrated that there is likely to have been a discussion about conservative treatment options. The argument was rebutted on the basis that our client's surgery took place in 2009 and Basingstoke and North Hampshire Hospital did not receive accreditation until 2015, some six years later.
It was clear that NICE guidance issued in 2006 set out evidence that it was well-known at the time of our client's surgery (ie in 2009) that the transvaginal tape was a piece of synthetic mesh which permanently embedded itself and was not designed to be removed. Removal of a transvaginal tape was considered to be difficult and very much a specialist procedure. Risks included the need for self-catheterisation, voiding difficulty, dyspareunia, erosion and chronic pain. Our client should have been made aware of all of this information in order for her to give her informed consent to the procedure and any reasonably competent gynaecologist would have provided this information to their patient.
Following further discussions with the defendant and negotiations, we are pleased that we were able to reach a settlement for our client and achieve a resolution which compensates our client for the unnecessary procedure she underwent.