The complainant made a complaint to the Commissioner concerning the treatment her grand-niece, the consumer, received from the paediatric surgeon. The complaints are:
- When the consumer was taken to the paediatric surgeon, by her mother and grandmother, for a consultation in regard to labial adhesions, the paediatric surgeon used an unsterilised paper clip to separate the consumer's labia causing the consumer to bleed profusely and to become distressed.
- The accompanying family members were not informed of the procedure prior to it being carried out and did not consent to the procedure.
- The procedure was performed without an anaesthetic.
The complaint was received by the Commissioner on 13 October 1997. An investigation was undertaken and information obtained from:
- The Great-Aunt of the Consumer / the Complainant
- The Mother of the Consumer
- The Grandmother of the Consumer
- The Paediatric Surgeon, Provider
Medical records relating to the treatment of the consumer were obtained and reviewed. The Commissioner sought advice from an independent paediatric surgeon.
Information Gathered During Investigation
In late September 1997, the consumer, her mother, and her grandmother, attended a consultation with the paediatric surgeon regarding the consumer's labial adhesions. The consumer's mother stated that her understanding was that the appointment was to have a consultation about the options available to separate the consumer's adhesions. The consumer's GP had referred her to the paediatric surgeon, as medical therapy to resolve the problem had been unsuccessful.
During the consultation, the consumer's grandmother stated, the paediatric surgeon asked the consumer if he could have a look at her vagina. The consumer's grandmother stated the consumer was uncomfortable with this but agreed. She further stated the consumer's mother was asked by the paediatric surgeon to hold the consumer's legs so he could view the adhesions easily. The consumer's grandmother stated the paediatric surgeon explained that the consumer had a very small vaginal opening through which to urinate, possibly causing a build up of bacteria resulting in discomfort and odour. During this discussion, the consumer's grandmother stated, the paediatric surgeon took a paperclip from his drawer and "with absolutely no hesitation or consultation with [the consumer's mother] proceeded to split Labia [sic]." During the procedure, the consumer's grandmother stated, the consumer was "screaming and extremely traumatised", and "[the consumer's mother] was in total shock and couldn't say anything." Following the procedure, the consumer's grandmother stated, the paediatric surgeon advised "I possibly should not have tried this as it is very tough and was bleeding more than I expected." Further, the paediatric surgeon suggested to the consumer's mother that she should apply vaseline to the area as often as possible in order that the adhesions did not re-join.
The paediatric surgeon stated in his response to the Commissioner:
"Labial adhesions are normally a very thin web of tissue which usually can be separated without causing discomfort, particularly in infants and younger children. It is normal practice of paediatric surgeons in Australasia to do this without an anaesthetic (because it is normally unnecessary, and because an anaesthetic itself has some risks), and with a paper clip. A paper clip is used because it is ideally shaped for this particular manoeuvre. To my knowledge no-one sterilises the clip, as it is not a sterile manoeuvre and infection never occurs subsequently."
Further to this the paediatric surgeon stated:
"The claim by [the complainant] that there was profuse bleeding is untrue. If the attachment has been broad one sometimes sees a slight spot of blood on the raw surface. In terms of volume this would be less than 0.01ml, and has no significance."
The paediatric surgeon further stated, in his response to the Commissioner, that usually with older children, over six years of age, separation of labial adhesions is performed under a short general anaesthetic. The reason for this being that:
"the adhesions are often firmer if they have been present for many years, and the older child may find it distressful." The paediatric surgeon stated "I was expecting the adhesions in [the consumer] to be easily separated without causing any discomfit, but as events have turned out, they were stronger than usual for her age and it did cause her some discomfit."
The paediatric surgeon commented that perhaps he did not spend a long time explaining and discussing the procedure with the consumer's mother in order for her to "assimilate" the procedure. The paediatric surgeon stated that he has apologised for this directly to the consumer's mother. The paediatric surgeon further stated
"I did not obtain written permission to separate the adhesion, and it has not been my practice to do so, as the manoeuvre is normally so straightforward, non-invasive, and atraumatic, that I have not considered it necessary."
In mid-November 1997 the consumer's mother, the consumer's grandparents and a Health and Disability Advocate met with the medical advisor from the Crown health Enterprise ("CHE") to discuss the family's concerns. The consumer's mother outlined her concerns regarding the use of the paper clip, the discomfit caused to the consumer, the rapidness of the procedure and the lack of informed consent for the procedure to occur. Further to this, a meeting was arranged for late November 1997, for the family to discuss their concerns with the paediatric surgeon. The outcome of this meeting was that:
"1. A better explanation should be given prior to examination and surgery for this condition.
2. An information sheet for parents about labial adhesions and their treatment would be helpful.
3. It may be useful to have different packaging for the paperclips used for surgical procedures."
The paediatric surgeon finally stated:
"I am deeply disturbed at the distress I have caused [the consumer's mother], and I hope that my meeting with her today will go some way to resolving that distress. Moreover, the constructive measures we came up with together should prevent this type of occurrence happening in the future."
Independent Advice to Commissioner
The Commissioner sought advice from an independent paediatric surgeon who reported:
"In Melbourne the paper clip or a spatula used in the consulting room has been the accepted form of treatment for many years. The perineum is not sterile and infection has not been a problem using these devices."
Further to this,
"Some adhesions can be quite dense and [the paediatric surgeon] admits this was the case with [the consumer] and may have contributed to the distress caused.
I agree that bleeding is not a problem with this procedure and find the comment about profuse bleeding hard to accept. One must however, examine the method of separating labial fusion in the light of the public's expectations in the 90's. I personally became aware, over twenty years ago, that parents found the "attack" on a little girl's vagina unacceptable and have only performed the procedure under anesthesia, when creams have failed."
The Code of Health and Disability Services Consumers' Rights
Right to Services of an Appropriate Standard
2) Every consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant standards.
Right to be Fully Informed
1) Every consumer has the right to the information that a reasonable consumer, in that consumer's circumstances, would expect to receive, including -
a) An explanation of his or her condition; and
b) An explanation of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option; and
Right to Make an Informed Choice and Give Informed Consent
1) Services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent, except where any enactment, or the common law, or any other provision of this Code provides otherwise.
Opinion: No Breach - the Paediatric Surgeon
In my opinion the paediatric surgeon did not breach Right 4(2) of the Code of Health and Disability Services Consumers' Rights as he provided the consumer with services that were appropriate in the circumstances.
Whilst, in my opinion, the separating of labial adhesions with a paper clip without anaesthetic seems a harsh procedure, I have received advice from an independent paediatric surgeon that clearly stated it is a procedure that is widely used by practitioners in the field. For this reason, in my opinion, the paediatric surgeon did not breach Right 4(2) of the Code.
Opinion: Breach - the Paediatric Surgeon
Right 6(1), Right 6(2) and Right 7(1)
In my opinion the paediatric surgeon breached Right 6(1), Right 6(2) and Right 7(1) of the Code of Health and Disability Services Consumers' Rights.
The paediatric surgeon had an obligation to ensure that the consumer's mother gave informed consent to the procedure to separate the consumer's labial adhesions. The paediatric surgeon stated that he did not discuss, at length, the procedure with the consumer's mother and has apologised directly to the consumer's mother for this. Further, the consumer's mother and the consumer's grandmother believed the consultation in late September 1997 was an appointment to discuss the options available to separate the consumer's adhesions rather than a consultation to have a procedure performed.
The paediatric surgeon should have ensured he discussed with the consumer's mother the procedure in detail, ensuring she fully understood what he was proposing, including discussions on other options available. The consumer's mother was not in a position to give her consent to the procedure, as the paediatric surgeon had not fully informed her about the procedure or alternative options.
I recommend the paediatric surgeon take the following actions:
- Provides a written apology to the consumer's mother. This apology is to be sent to the Commissioner who will forward it on to the consumer's mother.
- Ensures he provides parents with an information sheet explaining the nature of labia adhesions and all treatment options available and obtains informed consent to any future procedures. A copy of this information sheet is to be provided to the Commissioner for inclusion on this investigation file.
- Reviews his practice based on the comments made by my advisor.
A copy of this opinion will be sent to the Medical Council of New Zealand.
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