Soft Tissue Filler Therapy and Informed Consent: A Canadian Review

Abstract

Soft Tissue Filler (STF) Therapy for cosmetic facial rejuvenation is associated with known complications. The manifestation of these known complications can lead to patients commencing civil litigation actions or making complaints to provincial regulatory authorities and alleging that the practitioner failed to obtain the patient’s informed consent to the therapy. Data provided by the Canadian Medical Protective Association (CMPA) on medical-legal cases arising from the provision of STF therapy between 2005 and 2019 are presented. Select reported case law decisions from Canadian courts and regulatory bodies addressing the concept of informed consent are reviewed. Insights about the risk factors pertaining to the process of obtaining informed consent for STF therapy are presented to increase an understanding of the elements of communication and documentation needed to ensure patients are aware of the consequences of this treatment.

Perspectives on the Safety of Botulinum Toxin and Facial Filler Injections

“…11 Further, the review identified that the top factors that led to increased medical-legal risk were the lack of discussion of expected treatment outcomes, the absence of discussion of complications associated with filler treatment, and a lack of comprehensive documentation of the consent discussion. 11 The unfamiliarity with the risks of facial filler injection among the general public and those considering filler injections represents a barrier to the informed and collaborative delivery of care. This barrier can be overcome by the comprehensive and well-documented obtainment of informed consent for the benefit of both patient and provider.…”

“…13 The increased utilization of soft tissue fillers for cosmetic services is associated with an increased frequency of the known consequences of treatment. 11 Although these procedures are very safe, as the popularity of injectables increases, it becomes ever more important to ensure that the risks of these procedures are understood and included in public discourse surrounding injectables. Today, many people consume health information online.…”

“…Informed consent is not only essential for patient autonomy and a core ethical principle in the practice of medicine, but it is also important for shielding the provider against legal risk. A Canadian review of medical-legal cases related to soft tissue filler found that inadequate consent discussion was the most common allegation 11 . Further, the review identified that the top factors that led to increased medical-legal risk were the lack of discussion of expected treatment outcomes, the absence of discussion of complications associated with filler treatment, and a lack of comprehensive documentation of the consent discussion 11 .…”

“…A Canadian review of medical-legal cases related to soft tissue filler found that inadequate consent discussion was the most common allegation 11 . Further, the review identified that the top factors that led to increased medical-legal risk were the lack of discussion of expected treatment outcomes, the absence of discussion of complications associated with filler treatment, and a lack of comprehensive documentation of the consent discussion 11 . The unfamiliarity with the risks of facial filler injection among the general public and those considering filler injections represents a barrier to the informed and collaborative delivery of care.…”

“…In just a year, the American Society for Dermatologic Surgery reported a 20% increase in neuromodulators and a 100% increase in injectable filler procedures among patients younger 30 years old 13 . The increased utilization of soft tissue fillers for cosmetic services is associated with an increased frequency of the known consequences of treatment 11 . Although these procedures are very safe, as the popularity of injectables increases, it becomes ever more important to ensure that the risks of these procedures are understood and included in public discourse surrounding injectables.…”