Update in Selected Gynaecology Medico-Legal Aspects

By Mr Ellis Downes FRCOG, Consultant Obstetrician and Gynaecologist

Ellis Downes FRCOG is a Consultant Obstetrician and Gynaecologist based in London. He has an active clinical practice, specialising in endoscopic surgery and urogynaecology. He receives over thirty instructions annually and is a member of The Faculty of Expert Witnesses (FEW).

Endometrial Ablation & Bowel Injury

Endometrial ablation has now firmly established itself as an excellent surgical option to treat heavy periods. There are a number of different automated devices available of which Novasure, using bi-polar radio-frequency energy, is the market leader. All these ablation techniques use different energy modalities to essentially destroy the endometrium, the lining of the uterus. This reduces menstrual blood loss and has been shown in clinical studies to be a safe, effective day case/outpatient treatment. Like all surgical procedures complications, potentially serious can occur. However in studies, endometrial ablation has a much lower complication rate than hysterectomy. The most serious complication occurs if the uterus is perforated, during initial dilation of the cervix or during the placement of the device, bowel injury can occur and the patient may present with lifethreatening peritonitis. Without prompt treatment usually involving a laparotomy and sometimes a stoma the patients life may be threatened. Patients typically have a stormy post-operative course on ITU but thankfully generally recover. A claim generally follows alleging breach of duty. Having participated in ablation studies, and in the past consulted with manufacturers, during the regulatory process to allow these devices to be used in routine clinical practice, the manufacturers devise a very clear and concise protocol – Instructions For Use (IFU) which is robustly tested in clinical trials. The IFU lists which patients are suitable, and not suitable for each specific ablation procedure and gives a clear step-wise guide as to how the procedure should be performed. If a complication occurs during endometrial ablation, and it can be shown the surgeon has deviated from the IFU and introduced their own procedures 'that’s how I do it', then the case is impossible to defend and prompt settlement is recommended.

Montgomery Principle and Gynaecology

All readers will be intimately familiar with the Montgomery Principle, initially developed following a sad obstetric complication. This firmly established that doctors have a duty to discuss all treatment options with patient, including their risks and benefits, to allow the patient to decide which treatment modality they prefer. When instructed by a legal colleague following a surgical mishap, one of the first parts of the records I turn to are the outpatient notes where the patient is initially assessed following a GP referral, examined, and a treatment plan formulated. All too often I see poor documentation by the doctor of management options, this makes defending a subsequent problem much more challenging. A recent instruction was of a case of haemorrhage after a vaginal hysterectomy performed for heavy periods. The patient needed repeat surgery to stop the bleeding, had a six unit blood transfusion and a prolonged stay in hospital. The claimant, assisted by her legal team and expert, argued that alternative treatment options were not discussed with her, and had they been so, she would not have chosen a hysterectomy. The poor documentation made this point difficult to defend and a settlement was negotiated.

Laparoscopic Surgery Complications

Over the last few years there has been a significant rise in laparoscopic surgery in gynaecological practice. Open procedures (laparotomies) are now performed much less commonly. At laparoscopy, instruments are used with the assistance of a video camera to allow surgical procedures to be performed. To enter the abdomen involves placing a special needle through the umbilicus, inflating with carbon dioxide to distend the abdomen and then inserting surgical trochars into the abdomen, this method (known as the 'Veress needle technique') is the commonest in UK gynaecological practice. It will be understood therefore that the initial insertion of the veress needle, to distend the abdomen, and umbilical trochar to allow the laparoscope to be put into the abdominal cavity are essentially blind techniques. While inserting the instruments into the abdominal cavity initially, bowel, bladder or even major blood vessels may be damaged. This may cause lifethreatening injuries which need rapid corrective treatment. For a straightforward diagnostic laparoscopy the risk of bowel injury is in the order of 1-2 per thousand patients, for more advanced operative laparoscopies 5-8 per thousand. Evidence based guidelines have been developed by the Royal College of Obstetricians & Gynaecologists (RCOG) and the British Society of Gynaecological Endosccopy (BSGE) detailing the techniques for entering the abdomen which have been shown to be the safest with the lowest risk of complications. Generally speaking if the surgeon has used a recognised technique and has a complication on initial entry, this is defendable. Once a pneumo-peritoneum has been established and the initial umbilical port has been safely inserted, if there were any complications during insertion of additional (accessory) ports, this is indefensible.

Mesh in Gynaecology

The story of mesh in gynaecology is a tragic one which has affected many women. In trying to develop new ideas to help treat vaginal prolapse, a growing clinical problem which can be challenging to treat, medical device manufacturers five to ten years ago introduced a range of meshes to be used surgically to help reinforce weak vaginal tissues during the prolapse repair. These meshes were often introduced with minimal research studies and 'similarity' regulatory approval. Sadly they had a high complication rate of erosion, vaginal discharge, painful sexual intercourse or damage to bladder and or bowel. Most of these meshes have now been withdrawn from the market. I have been instructed on a number of cases of mesh related complications, the vast majority of which were settled in favour of the claimant.

In UK practice currently, I believe there is virtually no role in their use for first time (primary) prolapse surgery. For patients who develop a subsequent prolapse after surgery, needing repeat surgery, some meshes may have a limited role to improve long-term outcomes.

The prolapse mesh controversy should not be confused with the mesh used to treat bladder incontinence via the sub-urethral approach. The tension free vaginal tape (TVT) is one of the commonest procedures performed to treat urinary stress incontinence. This mesh is much smaller and narrower than prolapse meshes and has a much lower complication rate, although erosion may still occur.