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The cost of invalid consent

01 May 2013

Ms M, a 38-year-woman, consulted Dr F, an ophthalmologist, for surgical correction of high hypermetropia. Dr F recommended clear lens extraction and intraocular lens implantation with subsequent excimer laser treatment to correct any residual refractive error.

There was no record of any consent process describing the complications of intraocular lens implantation. Ms M underwent uncomplicated clear lens extraction and a silicone intraocular lens was implanted. She was not given any postoperative anti-inflammatory treatment.

On the fourth day post-surgery, Ms M was reviewed and was noted to have moderate postoperative uveitis. She was started on Maxitrol (dexamethasone, polymixin B and neomycin) and cyclopentolate eye drops and was managed as an outpatient. Over the next two days, Ms M was reviewed daily and some improvement was noted, but a ‘tiny hypopyon’ persisted.

On the seventh day post-surgery, Ms M presented to the Emergency Department of another hospital with pain and reduced vision. A diagnosis of endophthalmitis was made. The endophthalmitis was treated according to local protocol and Ms M improved.

She eventually regained excellent vision and had good binocular vision at final follow-up. Mild posterior capsular opacification was noted, but she remained asymptomatic.

Ms M made a claim alleging that she was not given informed consent prior to the surgical procedure, that the postoperative treatment of the infection was poor and that she suffered a period of reduced visual acuity.

Expert opinion found that the postoperative care of Ms M was suboptimal and resulted in a prolonged course to recovery. The absence of detailed informed consent in the patient’s notes made the case indefensible.

Learning points

  • Even though the final visual outcome was excellent, failure to take informed consent made this case indefensible. Ample guidance on taking consent is available from professional bodies and employers.
  • In this case, inappropriate postoperative prophylaxis for uveitis and infection compounded the problem. Following lens extraction surgery, the majority of ophthalmologists would prescribe topical antibiotics as prophylaxis against infection and topical corticosteroid therapy as prophylaxis against uveitis.
    Furthermore, older generation silicone intraocular lenses have been associated with a higher incidence of postoperative uveitis. In the absence of strong evidence to support alternative practice, it would have been prudent to use prophylactic anti-inflammatory treatment in this patient.
  • Postoperative adverse incidents should be treated promptly and mitigated immediately. Endophthalmitis is a sight-threatening emergency that should be evaluated and treated promptly and usually requires in-patient care and monitoring. The presence of a hypopyon and the failure of rapid resolution should alert the ophthalmologist to the possibility of endophthalmitis.
  • This case was identified as being indefensible at an early stage – so MPS did all it could to ensure a swift settlement to keep legal costs controlled.