NHS England has announced it has taken the advice of a new review into the harm reported by women treated surgically with mesh implants for stress urinary incontinence and accepted their recommendation to halt the use of the procedure for the time being.
The review's chair, Baroness Julia Cumberlege, is reported to have commented that her team were in no doubt that this pause was necessary, but that use of the procedure to treat urinary incontinence could begin again if certain checks and measures are met by March 2019.
The latest review did not propose a total ban nor did an earlier review by health watchdog NICE, which resulted in revised guidance that vaginal mesh operations for treating organ prolapse should largely be stopped in England, but made no comment on the procedure in treating urinary incontinence.
A treatment of first or last resort?
In comparison, a number of Scottish health boards have already stopped using mesh implants completely, while in Wales, medical professionals are encouraged to regard the procedure as a 'last resort' and therein lies what Kashmir Uppal, a partner in Shoosmiths medical negligence team, believes may be a significant issue:
‘We have several current cases involving women who have had this operation where the issue has been a failure to fully explain the risk of what seems to have been a procedure of first resort, often presented to our clients as the only option for treating their condition. There are alternative procedures available, but our clients all say they were never given information about them and therefore did not give their genuine informed consent.’
Following the Supreme Court’s judgment in the case of Montgomery v Lanarkshire Health Board in March 2015, doctors and surgeons are legally obliged to demonstrate that they have obtained a patient’s ‘informed consent’ to a proposed treatment or surgery, even if the likelihood of harm is very small. Failure to do so constitutes negligence. A recent example of this was the case of Collette Culbertson, successfully concluded by Amy Greaves, an associate in the firm’s medical negligence team.
Failure to obtain informed consent
Collette had been referred to Gateshead NHS Foundation Trust by her GP for a gynaecological review because she had been complaining of incontinence after minimal exertion for about a year. Her symptoms were diagnosed as stress incontinence and she confirmed she wished to consider surgery.
However, the risks of such surgery and other possible approaches were not fully explained to her and the only treatment option discussed was Tension-Free Vaginal Tape (TVT) surgery. Options such as colposuspension and fascial sling surgery as well as the least invasive treatment (although also the least successful) urethral injection were never mentioned to Collette.
During surgery her bladder was perforated and, as a consequence, she required a catheter, however that became blocked and she suffered extreme pain which continued even after the catheter had been re-sited. Her incontinence became worse after the operation.
‘This was a difficult case as we had to establish what Collette would have done at the time if she had been offered alternative treatments. Had the benefits and risks of all available options (including the option of doing nothing) been fully explained, she may not have simply gone along with what seemed to be doctor’s preferred option.’
Pause may be needed – but will it be observed?
Kashmir also express the hope that whilst this ‘pause’ in the use of mesh implants for urinary incontinence is in place the opportunity will be taken to examine further the proven risks of complications of the procedure against the benefits.
Shoosmiths settled a case for a woman who suffered painful complications and endured several surgeries following mesh surgery performed by uro-gynaecologist, Mr Arunkalaivanan (better known as Mr Arun) who ignored another moratorium during his employment with Sandwell & West Birmingham Hospitals NHS Trust.
Despite The Trust making a decision in January 2009 to stop implanting synthetic mesh as a first-option surgical treatment to repair pelvic floor prolapses (following the guidance from NICE), Mr Arun failed to comply with that directive and continued to use the mesh. It took the Trust a further three years before they contacted other patients Mr Arun similarly treated.
‘Every surgical procedure carries some risk and mesh will likely remain a treatment of last resort for some carefully selected patients in discussion with their consultants, but it is important that it is just that – one among many other appropriate treatment options, each with their own risks and benefits.
The cases we have settled and those currently in litigation reinforce the fact that medical professionals must make sure patients in their care are fully aware of any material risk involved in a proposed treatment and what the reasonable alternative treatments might be so that those patients have the opportunity to make a truly informed judgement themselves.’