Breast implants have had a long and chequered history of periodic regulatory activity and class actions and are associated with significant medium and long term health risks, including the development breast implant associated anaplastic large cell lymphoma (BIA-ALCL).1–3 NSW Health through the Agency of Clinical Innovation has just released a toolkit for the management of breast implants.4 These are the result of collaborative clinical consensus across leaders in plastic and reconstructive surgery, breast surgery and radiology with support from the Surgical Services Taskforce and evidence directorate of the agency. Input was also sought from health consumers to ensure that the language and structure of the information was both comprehensive and accessible to women who were either considering either cosmetic augmentation or reconstruction and/or have breast implants in place.
Every patient undergoing a medical intervention has to give his/her informed consent. The ethically valid process of informed consent includes five elements: voluntarism, capacity, disclosure, understanding and decision.5 While documentation of the process may be completed, the patient’s knowledge of risk and benefit of a proposed medical treatment and the ability for the patient to withdraw consent for the intervention at any time was not well understood, but can be improved by the use of multiple modalities of communication.6 Ingelfinger wrote in 1972 that “the trouble with informed consent is that it is not educated consent”.7
In cosmetic surgery and medicine, the stakes are raised higher, as the proposed treatments are both elective and discretionary. Empowerment of patients and encouragement of shared and protected decision making with, where possible, multiple time points for discussion are recommended.
The toolkit includes a template for informed educated consent that represents the balance between comprehensive and accessible information that should be provided to a patient who is considering breast implant insertion or removal. Furthermore, the recommendation is that patients have two, face-to-face consultations with an intervening cooling off period directly with the practitioner performing the surgery, to ensure this information is well understood and accepted.
The toolkit also provides suggested preoperative and operative steps including transparency with respect to credentialing and experience of the practitioner and the need for this procedure to be performed in a licensed hospital or day surgery. Mandatory reporting of the device and any adverse events associated with the device should be made to the Australian Breast Device Registry. Finally, patients should be given clear advice on the need for ongoing surveillance either by the treating practitioner or through their local general practitioner. Resources for evaluation of implants by general practitioners have been recently published.8
This toolkit hopefully represents the first of many that seek to outline the necessary standards of safe clinical practice, credentialing, informed and educated consent and ongoing duty of care/ surveillance in the cosmetic surgical and medical space.