Procedure performed without informed consent

Executive summary

This report concerns the Fenton’s procedure performed by a gynaecologist. The Commissioner found the gynaecologist in breach of Right 7(1) of the Code of Health and Disability Services Consumers’ Rights (the Code) for having performed the procedure without the woman’s informed consent, and found Wairarapa District Health Board (DHB) vicariously liable for the gynaecologist’s breach.

Following a presentation with problematic symptoms, the gynaecologist proposed to examine the woman’s urethra and bladder under general anaesthetic, and — if indicated — perform surgery on her anterior vagina. The woman signed a Wairarapa DHB consent form for an “EUA [examination under anaesthetic] Cystoscopy Inject LA [local anaesthetic]/Steroid to Perineum/?Refashion Anterior Vagina”. The consent form contained a standard clause stating: “I understand that procedures additional to that specified above may be carried out if it is in my/the patient’s best interests and can be justified for medical reasons.”

During the procedure, the gynaecologist noticed some abnormal transverse tethering of the posterior vagina. He performed a Fenton’s procedure (a removal of scar tissue) on her posterior vagina, as he considered that this might help to alleviate her symptoms.

The woman told HDC that she did not consent to the Fenton’s procedure. Conversely, the gynaecologist said that he genuinely believed he had consent to perform the procedure.

Findings

The Commissioner found that “[the gynaecologist] did not have [the woman’s] consent to undertake the Fenton’s procedure”, and reiterated that “surgical services may be provided to a competent adult in non-emergency situations only if that patient makes an informed choice and gives informed consent, irrespective of what the doctor considers to be in the patient’s best interests”.

The Commissioner considered that “the standard clause in Wairarapa DHB’s consent form had the potential to confuse or mislead its employees about the situations in which they could deviate from a consumer’s express written consent”. Accordingly, he found that “Wairarapa DHB did not take such steps as were reasonably practicable to prevent the gynaecologist from breaching the Code”.

Recommendations

The Commissioner recommended that the gynaecologist apologise to the woman, review the effectiveness of his changes to practice, and undertake education on informed consent.

The Commissioner recommended that Wairarapa DHB apologise to the woman and review the training on informed consent that it provides to its staff.

During this investigation, Wairarapa DHB revised its standard consent form and prepared a “provisional revised consent form”.

Read the full decision here