The scene
A consultant gynaecologist performed surgery on a patient during which vaginal mesh tape was inserted to treat stress urinary incontinence. This took place the year before the national pause in such procedures in July 2018. The MDU member also performed vaginal hysterectomy and surgery to treat vaginal prolapse.
The patient had been referred to our member by a GP to investigate a suspected prolapse and post-menopausal bleeding. The patient also reported some urinary incontinence and that she could no longer exercise as a result.
The member carried out an examination and discussed a treatment plan with the patient. She arranged for tests to investigate post-menopausal bleeding, including a pelvic ultrasound scan, hysteroscopy and biopsy.
She also provided the patient with the contact details of a nurse who could carry out supervised pelvic floor physiotherapy for stress urinary incontinence - recommending the patient make an appointment. Our member suggested to the patient that a review could be arranged in a few months, to discuss the option of surgery. Examination under anaesthesia showed the patient had vaginal prolapse. The test results subsequently confirmed the absence of cancer.
At a follow up consultation, the patient reported discomfort from her symptoms of prolapse and that stress incontinence was interfering with her ability to exercise. Our member discussed potential treatments with the patient and the risks and benefits of them. She arranged a vaginal hysterectomy and repair of prolapse, together with tension free transvaginal tape (TVT) to treat the patient's stress incontinence.
Our member's evidence was that she would have included a further offer of pelvic floor exercise physiotherapy at this stage.
The notes of the consultation included a diagram the member had drawn, to illustrate and describe what the procedure entailed to the patient. The patient was also provided with information leaflets on the surgical procedures discussed, which mentioned the benefits of pelvic floor exercises.
The gynaecologist undertook the surgery, which proceeded uneventfully. Some months later, the patient was referred by the GP to another surgeon, with symptoms of abdominal and pelvic pain and recurrence of stress incontinence. The second surgeon carried out two further surgical procedures - removal of the tape (mesh excision) and colposuspension.
The claim
The patient later made a claim against the gynaecologist member. The compensation sought was for just over £1.7M for injuries from the tape being implanted by our member and for the later surgery by the second surgeon.
The claim against the MDU gynaecology member alleged the following points.
- There was a failure to offer conservative treatment, such as pelvic floor exercises before proceeding with surgery. Had this been offered, the claimant would have accepted this and avoided the mesh implant surgery taking place or have deferred it until after the time there was a national pause in the procedure.
- There was a failure to follow NICE guidelines in not arranging for urodynamic studies (UDS) before surgery took place and that this was a breach of duty.
- There was a failure to obtain the patient's informed consent in compliance with the Montgomery test. The problematic consequences of surgery would therefore have been avoided. Our member's surgery itself was not criticised.
This and the 2015 Montgomery judgment underline the need for doctors to take reasonable care to make sure patients are aware of 'material risks' when obtaining consent.
The outcome
With the MDU's support, the claim was successfully defended at trial. The judge dismissed the case, finding that our member had offered the patient conservative treatment, including pelvic floor exercises but that the patient preferred a surgical option.
The judge also found that there was no breach of duty in the gynaecologist departing from NICE guidelines. The judge stated that, "it is common ground that NICE guidelines do not have the force of law, and that a clinician is not necessarily in breach of duty if they depart from them."
The judge went on to say she was satisfied that the member, "did not overlook UDS but rather took a positive decision not to perform UDS. That was because in her assessment…UDS would not have influenced the treatment plan."
On the issue of informed consent, the judge found that the patient was "sufficiently informed about the extent and nature of the procedures involved." She also stated that, "there was a full and sufficient discussion about the material risks and benefits of surgery," and of alternative conservative treatment options.
Learning points
Consent
A key element of this case - and of many claims the MDU sees - centres on consent issues. It's common for a patient to allege that if they been appropriately warned about the risks of a particular treatment, they would not have gone ahead with it, either at all or at that particular time.
In this case, the member was found to have appropriately warned the patient about the risks and benefits of any treatment and of the alternatives. However, it's worth reviewing your knowledge of legal and ethical guidelines around consent, such as the GMC's guidance, 'Decision making and consent'.
This and the 2015 Montgomery judgment underline the need for doctors to take reasonable care to make sure patients are aware of 'material risks' when obtaining consent. These include any risk where a reasonable person in the patient's position would attach significance. Our guide to the Montgomery judgment has more details.
Guidelines
The case also underlines the well-established principle that clinicians can depart from guidelines in certain circumstances, such as when the doctor considers doing so best serves the patient's needs after discussing it with them.
While it can help build a successful defence of a claim if you can demonstrate you followed widely accepted guidance, supported by expert opinion, it's equally possible to mount a successful defence of a doctor who has not followed guidelines because it is not clinically appropriate for an individual patient.
Our website has more advice on the significance of clinical guidance.
Records
The records made by our member formed a key part of the defence of this claim. Some time had passed since the consultations and surgery had taken place, and our member was able to rely on the records and her usual practice.
Make sure you fully document your discussions with patients and the reasons for choosing a particular treatment pathway. This helps with continuity of care and can be useful in defending claims.
Supporting information like leaflets and information sheets can help a patient's understanding. Document your use of these in the records too.