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Lack of informed consent led to inappropriate and ineffective surgery

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Risks of surgery and options were not fully explained

Collette Culbertson (44) was referred to Gateshead NHS Foundation Trust by her GP for a gynaecological review because she had been complaining of incontinence after minimal exertion such as coughing, sneezing or raising her voice - for about a year.

She was referred for a urodynamics assessment which uses a catheter to show how the bladder and urethra are performing their job of storing and releasing urine. That took place on 7 March 2013 at Queen Elizabeth Hospital, Gateshead when Collette’s symptoms were diagnosed as stress incontinence.

Following the assessment, Collette confirmed she wished to consider surgery. The only limiting factor for her was a preference for local anaesthesia if possible since she had a history of post-operative seizures associated with general anaesthetic.

Risks of surgery and options available not fully explained

She attended a clinic on 25 March 2013 where the only treatment option discussed was Tension-Free Vaginal Tape (TVT) surgery. In this procedure a piece of plastic tape is inserted through a cut inside the vagina and threaded behind the tube (the urethra) that carries urine out of the body. The middle part of the tape supports the urethra in the correct position, helping to reduce the leaking of urine.

However, this is not the only treatment option available for this condition. There are several others such as colposuspension and fascial sling surgery, but the least invasive treatment option (although also the least successful) is urethral injection. This involves the injection of a bulking agent that increases the size of the urethral walls and allows the urethra to stay closed with more force.

As none of the alternatives had been discussed with her, she underwent the TVT surgery at Queen Elizabeth Hospital, Gateshead on 4 July 2014. Before surgery she was once again taken through the consent form for the procedure and once again, no other treatment options were discussed.

Negligent surgery perforation of the bladder

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 and she was leaking all the time even when the catheter was in place.

Collette turned to Access Legal Solicitors for help and advice. Her case was handled by Amy Greaves, a specialist solicitor in the firm’s clinical negligence department, who listened to Collette’s story. Amy concluded that mistakes had definitely been made and had Collette been made aware of all the options available to her, things might have turned out very differently.

A failure to obtain informed consent

The basis of the claim was the doctors’ failure to obtain ‘informed consent’ from Collette in line with the procedure that should have been followed as in the landmark case of Montgommery v Lanarkshire Health Board. Simply reciting a list of medical terms and explaining things in a jargon-laden way is not enough for the doctor to show that they obtained informed consent from a patient. The various treatment options, risks and benefits should be explained in non-technical language, but all the treatment options must at least be discussed.

The fact that a procedure is not carried out at the particular hospital itself (as was the case here - the QE Hospital Gateshead did not perform the urethral injection procedure at the time and Collette would have to be referred to Newcastle for this to take place) is no excuse for failure to discuss that treatment option.

By failing to discuss alternatives of colposuspension, fascial sling and urethral injection (along with the risks and benefits of each procedure) and failing to warn Collette of the inherent risk of detrusor over-activity associated with TVT surgery, there was a breach of the duty of care owed to any patient.

The basis of the claim

The case has now concluded with a settlement for Collette, although no formal admission of liability was made. Collette’s case was that, had other treatment options been discussed, she would have opted for the urethral injection. She would have opted for this because, although there was a low success rate associated with this choice, it was the least risky. Given that low success rate, she may well have had to go back for further treatment, but, in all likelihood, had the TVT procedure been performed on a different day, it is likely her symptoms would not have got worse and she would not have suffered from a perforated bladder.

Amy commented:

‘This was a difficult case as we were having to establish what Collette would have done at the time if she had been offered alternative treatments. It is important for patient care moving forward that, when undergoing any procedure, patients are given the benefits and risks of all available options (including the option of doing nothing) and not just be advised of the doctor’s preferred option.’

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