Mr B, an experienced and highly respected otolaryngologist, arranged to perform a right middle meatal antrostomy and bilateral sinus washouts on a young woman (Miss Z) with severe sinusitis. The operation was scheduled to take place in a theatre he did not ordinarily use so he did not have the support of nurses familiar with ENT surgery.
After carrying out the sinus washouts, Dr B performed an infundibulectomy of the right lateral wall of the nose to expose the maxillary antrum. He then inserted Tily-Henkel forceps to remove samples of mucosa for biopsy; the nurses did not immerse the tissue in saline until he had procured five or six; two of them floated, indicating that they were orbital fat. Mr B immediately abandoned the operation.
When Miss Z awoke from the anaesthetic she had lost all vision in her right eye and was immediately transferred to a nearby hospital to see an eye surgeon. A CT scan showed that the optic nerve was intact and subsequent exploration confirmed that the medial rectus muscle had not been divided. Nevertheless, Miss Z was left with a divergent squint and what seemed to be permanent loss of vision in her right eye.
Miss Z brought a claim against Mr B, who acknowledged that he had not warned her about the risk of this particular complication of the surgery: ‘Since I had never experienced the complication of blindness or damage to the cranial cavity, I would not have been in a position to adequately warn about these risks. I could not have given an accurate estimation of how likely it was. It has not been in the past my practice to frighten my patients by warning them of very rare risks, although obviously this has changed since this incident.
Neither Mr B’s decision to operate nor his technique were in dispute; the essential questions as far as the claim was concerned were whether he should have told Miss Z about this known but rare complication and whether he should have arranged for a CT scan in preparation for the surgery. Had he done so, it is likely that the complication could have been avoided because a later CT scan showed that Miss Z had an unusually small maxillary sinus with a very abnormal anatomy on the right side of her nose and sinuses.
We consulted an expert in otolaryngology: in his opinion, ‘the majority of otolaryngologists [in this country] would now warn patients of damage to vision and eye muscle movement as a consequence of endoscopic surgery, even though this risk is negligible in experienced hands’.
Regarding the issue of preoperative scanning, he thought that ‘with the introduction of endoscopic surgical techniques, the majority of otolaryngologists now recommend ... a CT scan… prior to embarking on nasal surgery, especially if one is entering the osteomeatal complex, because of the close proximity to the very thin orbital wall.’ He concluded, ‘even though this rare complication occurred in the hands of a very experienced otolaryngologist, the case cannot be defended because the patient was not warned of the risks and the preoperative scan was not performed.’
The claim was settled.
Informed consent is a tricky issue. The courts used to apply the ‘prudent doctor’ principle – i.e. the doctor weighs the risk of a certain complication occurring against the risk of putting a patient off necessary treatment. Complications with an extremely low incidence were generally considered not worth mentioning unless the particular complication would have serious consequences for the patient.
In recent years, however, there has been a general shift towards the ‘prudent patient’ model prevalent in the USA. The emphasis here is on what the average ‘prudent patient’ would want to know about potential risks and treatment options. Whether or not one applies the ‘prudent doctor’ or the ‘prudent patient’ principle, the problem of knowing exactly what the risks are and assessing their likelihood is far from easy.
As Dr B said (above), none of his previous patients had suffered this complication and he would not be able to quantify the risk. Where is the incontrovertible and quantifiable evidence, easily accessible and pplicable in all circumstances? Assuming that this standard of evidence is available, how does one then translate and transmit it to (different) patients so that they can appreciate the risks and view them in perspective?
We would welcome readers' views on this, and are especially interested in advice, useful sources of statistical data, experiences and opinions that will help to open up this issue for debate. Please email firstname.lastname@example.org.