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In focus: medico-legal aspects of bariatric and metabolic surgery

Posted: 03/08/2016

The prevalence of obesity among adults increased sharply during the 1990s and early 2000s. According to the Health Survey for England, the proportion of the population categorised as obese (BMI 30kg/m² or over) increased from 13.2% of men in 1993 to 24.3% in 2014 and from 16.4% of women in 1993 to 26.8% in 2014.

Obesity is associated with a range of health problems including type 2 diabetes, cardiovascular disease, high blood pressure, obstructive sleep apnoea and cancer. The resulting NHS costs attributable to patients being overweight and obese are projected to reach £9.7 billion by 2050, with wider costs to society estimated to reach £49.9 billion per year.

When combined with a comprehensive treatment plan, bariatric surgery can be an effective tool to achieve sustained weight loss and significant improvement in an obese patient’s quality of life. Surgery has been shown to help improve or resolve many of the obesity-related conditions described above and to be cost-effective in the medium and long term.

Despite the obvious benefits of surgery, there seems to be an increase in litigation after bariatric surgery, which is reflected in the high medical insurance premiums. In fact, in the UK, bariatric surgery and cosmetic surgery appear to have the highest insurance premiums amongst surgical specialities. There may be many factors underlying this. Patients undergoing surgery tend to have high expectations and, if surgery does not go to plan, the consequences can be potentially devastating for the patient and those around them.

There may be many reasons for this. The population of patients undergoing bariatric surgery for morbid obesity tends to be young and often relatively active. They are undergoing surgery to prevent future medical complications rather than to deal with immediate life-threatening conditions. They therefore feel particularly aggrieved when complications arise.

In addition, the use of bariatric surgery is dramatically expanding. For example, in the US, laparoscopic gastric bypass surgery is now one of the most commonly performed operations and, as a result of this increase in the number of surgeries being performed, there has been an increase in the number of potential complaints.

In highly cash-strapped health care systems such as the NHS, there is strict regulation of publicly funded bariatric surgery. Patients therefore often fund surgery themselves in the private sector and are more likely to complain. The nature of bariatric surgery is such that patients who have undergone surgery may develop complications many years down the line. Patients who have had gastric bands fitted may develop band slippages, band erosions or obstruction. Patients who have had a gastric bypass may suffer internal hernias, adhesions and possible bowel obstruction. Often, due to ‘package’ deals on their surgery in the private sector, these complications may develop after the package has expired. A delay in diagnosing these problems by non-specialists and the morbidity or even mortality associated with this failure can lead to litigation claims.

Bariatric surgery is a relatively new sub-speciality and formal higher-level training opportunities are few and far between. Upper gastro-intestinal tract surgeons who may have not undergone formal specialist training often perform private sector bariatric surgery. Although they may be good general gastro-intestinal surgeons, they may not appreciate the particular nuances of bariatric surgery.

Bariatric surgery - particularly the gastric bypass - is a technically challenging operation and a lack of a period of supervised training can lead to difficulties post-operatively and open a surgeon to litigation based on the grounds of lack of specialism.

The Medical Defence Union (MDU) indicates that the most common problems encountered following this type of surgery include:

  • post-operative infection
  • gastric bands slipping or leaking
  • delay in diagnosing these problems
  • difficulties and complications in adjusting bands
  • failure to obtain consent from patients, for example not consulting them about the risks involved.

It is important to note that not all the problems highlighted by the MDU represent negligent care and some are simply recognised complications of the procedure. It is, however, imperative that the patients are appropriately counselled about the risks involved with this type of surgery (as with any type of surgery) before they make their decision to proceed.

The importance of patients being appropriately counselled is particularly important following the Supreme Court decision in the case of Montgomery v Lanarkshire Health Board. This decision changed the historic consent position where a doctor only needed to discuss risks which other doctors felt should be discussed. 

The Supreme Court decided that a doctor must make sure that the patient knows about the material risks of treatment and that reasonable alternatives have been discussed. In deciding whether a risk is material, the court will now consider the question from the patient’s rather than the doctor’s perspective.

Another aspect that must be taken into consideration when counselling patients pre-operatively is whether or not they are suitable candidates for bariatric surgery. The current debate is whether people electing to undergo elective cosmetic surgery (including bariatric surgery) or bariatric surgery for medical reasons should be psychologically assessed to determine both whether they are suitable and will benefit from the surgery.

The clinical negligence team at Penningtons Manches receives many enquiries from people who have not been appropriately counselled as to their suitability for surgery and who have not tolerated the effects of surgery as a result.

From a medicolegal perspective, the following issues are examples which may be regarded as substandard or negligent care that results in claims:

  • the band is put on the wrong part of the stomach or at the wrong angle during the operation leading to a complete blockage requiring emergency surgery. A failure to spot the situation developing post-operatively can often, in itself, be negligent;
  • failure to perform the anastomoses properly in gastric bypass surgery or to fire the mechanical stapler correctly in a sleeve gastrectomy can cause a leak. Again, a failure to recognise the development of a leak post-operatively can often be open to criticism;
  • sometimes the wrong type of bariatric procedure has been performed;
  • surgeons performing the procedure without sufficient expertise and making unacceptable technical errors;
  • there can be issues with the quality of the gastric band itself which may result in a product liability claim against the manufacturer rather than the surgeon.

It is important from both a clinical and medicolegal perspective that anyone undergoing weight loss surgery is given sufficient information about what the surgery entails and any problems that may arise and that the surgery is only undertaken by those who are experienced in this field. A high standard of post-operative care and quick recognition of developing complications appear to be key.

The clinical negligence team at Penningtons Manches is currently dealing with claims for patients with a variety of unexpected problems arising from gastric band surgery. These range from faulty band and incorrect insertion to bleeding as a result of arterial damage during the procedure. All of these clients have suffered very significant problems and are evidence of the importance of patients being properly advised before their surgery is undertaken by a suitably experienced practitioner. 

A further consideration from a medicolegal perspective is that this type of surgery is often carried out at a private clinic. This is perfectly acceptable if the patient fully understands the procedure, it goes smoothly and there are no complications. However, the Penningtons Manches clinical negligence team has experience of patients who have had surgery privately and suffered complications where the clinic has not been equipped to deal with emergency care, resulting in emergency hospital transfers and, potentially, further surgery.

As an example, the clinical negligence team has recently settled a claim against a private surgeon who, it was alleged, had failed to warn a patient of the recognised complications of gastric banding surgery. In this case, the client suffered a significant bleed during surgery and required transfer as an emergency to a hospital with full facilities to manage the bleeding. Post-operatively, it became apparent that the surgeon had damaged the aorta and had failed to identify the source of bleeding. This led to the client requiring further emergency surgery, a prolonged recovery and an adverse psychological reaction.

It was the client’s case that, had she been appropriately advised of the risks of surgery, she would not have undergone the procedure at all.

Now more than ever, it appears evident that bariatric surgery must be offered and performed safely. Surgeons must have undertaken specialist training and remain up-to-date on national and international guidelines. Surgery should only be offered to patients who are suitable candidates and have shown adequate comprehension of the procedure and its related risks.

Patients who demonstrate poor understanding of the information supplied or show poor compliance with medical advice should be discouraged from undergoing surgery. Hospitals offering bariatric surgery should be equipped to deal with emergency complications and adequate follow-up should be planned and offered by a team of professionals with experience in the field.

In the private sector with its increasingly competitive market, advertising is often used to promote surgery. It is important that promotional material is thoroughly reviewed and tailored to avoid suggesting unrealistic outcomes. Material should refrain from suggesting a frequency or percentage of success, because this is often secondary to patient selection and can be misleading, rather than the proficiency of the staff or facility. The potential benefits of the operation could be detailed but should not be presented in a categorical manner and should not be exaggerated.

This article was produced by Amy Milner, Khaleel Fareed DM, FRCS, and Bruno Lorenzi MD, PhD.

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Penningtons Manches Cooper LLP

Penningtons Manches Cooper LLP is a limited liability partnership registered in England and Wales with registered number OC311575 and is authorised and regulated by the Solicitors Regulation Authority under number 419867.

Penningtons Manches Cooper LLP