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  • Laparoscopic surgery and the law

    Gregory Kalu MRCOG

    edical negligence litigation is an important issue ticcause of the rising cost of settlements and its M implication for the provision of healthcare

    services. In its Fifth Report. the Commons Select Commit- tee on Public A )unts stated that, in 1997-1998, the National Health Service (NHS) paid out 579 million in

    t ol‘ clinical negligence but still faced potential of 61.8 billion. Furthermore, liabilities to incid-

    ents incurred but not reported could amount to a further 51 billion.’ As a result, the NHS Litigation Authority (NHSLA) has made data collection a key objective in a bid t o improve its records. At present, less than 5% of claims handled by the NIlSLA go to trial.

    In 1997, obstetrics and gynaecology accounted for 70% of the Clinical Negligence Scheme for Trusts’ contingent liability by value, although the number of claims was more evenly distributed among the specialties.2 Medical Defence Union (MDU) data show that obstetrics and gynaecology is second only to orthopaedics and trauma in cost and frequency of claim settlement (H Goodwin, MDU, personal communication). The most expensive gynaecology claims are those for perforation of internal viscera (including vascular injury), which in the main arise from laparoscopic surgery. Small bowel perforation at 1aparoscopyiadhesic)lysis accounts for the highest award paid out so far (&210,000; legal costs not included) by the defence organisation.3 Injuries are often due to ‘blind’ insertion of sharp instruments into the abdomen at initial entry.4

    The MDIJ’s laparoscopic surgery files for the UK for 1993-97 show that damage due to instrumentation occurred mostly with the trocar (39%) (see Figure 1) and that 77% of all intraoperative complications were only recognised postoperatively.

    Jeremy Wright FRCOG

    Figure 1. UK laparoscopic files notified to the MDU 1993-97: damage due to instrumentation (copyright The Medical Defence Union, 2000)

    For informed consent prior to gynaecological laparo- scopic surgery, the risks of bowel and major vessel injury (see Figure 2) quoted should be 0.4/1000 and 0.2i1000, respective1y.j Higher rates have been reported in single- centre studies, with bowel injury occurring in excess of 3/1000 cases6 This still compares favourably with rates of 8.4/1000 at Iaparotomy and 7.3/1000 at vaginal surgery.’

    In spite of these figures, it still appears that almost all laparoscopic accidents, unlike those occurring after classic surgery, will proceed to litigation.8 This may be partly explained by women who choose minimal-access surgery having higher expectations and being more particular about surgical outcome, especially the resulting aesthetic appearance.

    Furthermore, if at a laparotomy (often undertaken because of significant pathology giving rise to clinical symptoms) injury such as an inadvertent enterostomy occurs, this is often immediately recognised and sutured. Such a mishap would usually he regarded as an accept- able risk of the procedure in a way that a similar injury at

    7;be Obstetrician & Gynaecologist July 2001 Vol. 3 No. 3

    RISK MANAGEMENT

    141139138

  • Common iliac arteryhein

    External iliac artery/vein

    Inferior epigastric artery

    Uterine artery

    Inferior vena cava

    Right iliac artery

    Abdominal aorta

    Portal vein

    Hepatic artery

    Cystic artery

    0 1 2 3 4

    Frequency

    7 8

    Figure 2. UK laparoscopic files notified to the MDU 1993-97: type of damage (perforation of vessels) (copyright The Medical Defence Union, 2000)

    laparoscopy (necessitating a second operation) would be regarded as negligent.

    It is important to recognise that important differences exist between basic and advanced laparoscopic surgery. A significant proportion of adverse outcomes occur in the course o f basic laparoscopic surgery. Contributory- factors are:

    0 The high numbers of basic laparoscopic procedures per- formed, mainly for pelvic pain and female sterilisation.

    o Variable operator skills: trainees undertake a significant proportion of basic laparoscopy, whereas advanced laparoscopic surgery is performed by a small number of very skilled individuals.

    a Patients’ acceptance of the increased risk of injury (and laparotomy) associated with advanced laparoscopy; this is probably the result of more in-depth counselling.

    During pre-operative laparoscopy counselling. the following points should be raised:

    Laparoscopy is a ‘blind’ procedure and therefore inadvert- ent injury may occur to internal structures, including bowel and vessels.

    @ Operative laparoscopy carries an increased risk of dam- age to these structures because tissue dissection is a necessary and often integral part of it, in addition to the use of various instruments and energy sources.

    @ Discuss alternatives to laparoscopic surgery, including medical treatment and conventional ‘open‘ surgery, that may be effective in treating the patient’s condition. This is necessary for a freely obtained and informed consent.

    *As far as possible, the likely extent of surgery must be discussed and agreed with the patient prior t o the operation. The consent form should reflect this.

    o Patients should be advised that, depending on the pro- cedure performed, shoulder pain, bowel dysfunction and colicky abdominal discomfort may occur, but it

    should he emphasised that, postoperatively, relief from these symptoms is progressive Such symptoms should not worsen.

    The irreversibility and risk of failure associated a-ith laparoscopic sterilisation should be discussed and recorded in the notes.

    Practitioners of laparoscopic surgery may find the following a useful information checklist [note that specimen information leaflets are being posted on the British Society- of Gynaecological Endoscopy website (www.bsge.org.uk) and may be adapted to individual surgeons’ needs]:

    Ensure that the most suitable operation for the individual patient is the one selected.

    The principal surgeon must have the requisite laparo- scopic expertise.

    The patient should have a full understanding of the limitations, benefits and risks of the proposed surgical procedure.

    Keep clear, concise and accurate clinical notes.

    Ensure adequate pre-operative work-up, which may include 11owel preparation.

    Use safe technique at surgery.

    Failure of the patient to make a steady postoperative recovery may be the earliest sign of visceral damage and should be investigated.

    In the event of adverse outcome, prompt treatment is imperative and a mdtidisciplinary approach should be considered.

    The circumstances of the adverse event should be explained to the patient hy the principal surgeon as soon as is practicable, with an apology where

    Key points in reducing litigation risk include:

    Adequate training and supen7ision.

    Careful riskibenefit analysis of laparoscopic surgery as the treatment of choice fo r the individual patient. Adequate patient counselling.

    TJse of safe, recognised and previously described laparo- scopic technique (i.e. ‘hanging drop’ and saline return). It is worth mentioning that, even with meticulous atten- tion to the different techniques described to reduce visceral puncture at entry, there is no conclusive evidence that these reduce the risk.

    Prompt diagnosis and treatment of complications related to surgery. Openness and honesty in the event of adverse outcome.

    Continuous audit and evidence-based practice.

    Awareness of changes in the law and Court practice.

    $92 Tbe Obstetrician C Gynaecologist Jzdy 2001 Vol. 3 IVO. 3

    RISK MANAGEMENT Fregory Kaly, Jeremy Wright

  • Laparoscopic surge~y and the law

    MEDICAL NEGLIGENCE LJTIGATION: some cases in brief

    Eyre v Measday [1986] 1 All ER 488

    The gynaecologist Failed to advise a patient that her laparoscopic sterilisation carried a risk of failure. She became pregnant and, arguing that she expected to be 100% sterile, sued on the grounds of breach of contract. Having failed at the lower Court, she appealed. The appeal was dismissed, the Court ruling that, in the absence of an17 express warranty, it would be slow to imply against a medical man an unqualified warranty as to the results of any operation. See comment on Gold v Haringey Area Health Authority.

    Gold v Haringey Area Health Authority [1987] 3 WLR 649

    The health authority appealed against a judgement that was made against it for Failing to warn the patient that her sterilisation procedure carried a risk of failure. The Court of Appeal held that evidence at the relevant time was that a substantial body of doctors would not have warned of the risk of failure. The appeal was allowed. It should be noted that it has since become normal practice to warn uomen of the small risk cf failure associated with laparoscopic sterilisation and failure to do so may no longer he as easily defensible.

    DeFreitas v O’Brien & Anor [1995] 6 Med LR 108

    “he plaintiff appealed against the dismissal of her action for medical negligence on the grounds that the trial judge relied on too small a number of medical practitioners supporting the defendants’ orthopaedic and neurosurgical practice. The Court of appeal ruled that a small number cnuld well con- stitute a responsible body of medical opinion. The appeal