References

Medicines and Healthcare products Regulatory Agency. Yellow card scheme. 2019. https://yellowcard.mhra.gov.uk (accessed 13 August 2019)

Practice standard for the management of dermal filler complications

02 September 2019
Volume 8 · Issue 7

Abstract

In recent years, a great deal of attention has been paid to the diagnosis and management of complications arising from the use of dermal fillers. However, alongside the clinical factors, professional considerations must not be neglected, because to do so can lead to often avoidable claims

This article is provided as a guide, and it focuses on those practice standards that, when overlooked, can potentially lead to clinical negligence claims. It uses a framework that has been produced by Save Face in partnership with the Aesthetic Complications Expert (ACE) Group. Understanding and following these standards is essential to ensure that known risks are mitigated and that patients who do experience complications are managed and cared for professionally.

Competencies

To be competent to administer dermal fillers, professionals must ensure that they are able to:

  • Administer treatments using a safe and appropriate technique
  • Administer appropriate, evidence-based products, medicines and devices sourced from a reputable supplier as per manufacturer guidelines
  • Identify ‘red flags,’ which include medical, social and psychological risks
  • Select patients suitable for treatment
  • Manage patient expectations
  • Manage the consent process to ensure informed consent is gained
  • Identify learning and professional development needs and make use of available credible resources to address them
  • Undertake appropriate CPD activities to update and maintain knowledge and skills.
  • Professionals must also ensure that they are familiar with or understand:

  • The anatomy of the face, neck and other treatment areas
  • The pharmacology, biochemistry and physiology of the medicines and devices used in practice
  • Common side-effects, such as bruising and swelling, and how to mitigate these risks
  • Known risks and possible complications, as well as how to mitigate and manage them
  • Known contraindications and interactions.
  • Evidence-based practice

    It is acknowledged that the evidence base in aesthetic medicine is lacking, continually shifting and subject to bias. Practitioners should endeavour to explore and review the evidence base critically and, wherever possible, refer to it to defend how their choice of treatments and products is in the patients' best interests, including technique and aftercare advice.

    Patient treatment and care

    Treatments should be provided in a safe environment with appropriate facilities. Risks, cautions and contraindications should be identified with good, medical, social and psychological history-taking, which should be well documented. The patient must fully understand possible risks and complications, which means the practitioner should be able to clearly explain and answer any questions with reference to the evidence base.

    Pre- and post-treatment photographs must be taken by the practitioner or clinic staff, and be kept as part of the medical record according to the requirements of the procedure undertaken. As a part of the consent process, practitioners must make clear their terms for reporting any adverse events and ensure a prompt face-to-face review should a concern or a complaint arise. Practitioners must:

  • Avoid assessment and advice based on the patient self-reporting remotely via telephone/text and selfie photographs
  • Have access to an emergency kit as per Save Face/ACE guidelines
  • Have access to a telephone during procedures
  • Have a written protocol to follow should an adverse event occur
  • Share information and seek support and referral.
  • Prior to seeking advice and support, the practitioner must:

  • Assess the patient face-to-face
  • Record presenting physical symptoms and take photographs
  • Undertake a review of the medical and social history to include any recent events, illness or behaviours that may have precipitated symptoms
  • Gain patient consent, in writing, to share information, including photographs/videos, with peers for help with the management of a potential complication/adverse event
  • Refer to ACE guidelines (www.acegroup.online) to consider diagnosis and management options.
  • Referral

    Referral pathways should be considered and a protocol prepared in advance to deal with any complications promptly. A range of local experts who could be contacted directly should be identified, and a mutually agreed fast-track referral process should be put in place.

    Complication risks need to be managed

    Routine information sharing

    It is best practice to gain the patient's consent to share information with their GP, particularly when management may affect decisions on concomitant treatment prescribed by the GP. Serious adverse events, which may be product related, should always be shared with manufacturers and reported using the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme (MHRA, 2019). In case of adverse events, the practitioner's insurers should always be notified.

    Presenting a case for advice, opinion and shared learning

    If presenting a case for advice or opinion, it is important that full information is given, as practitioners cannot rely on advice that has been provided based on an incomplete history. Complete information is also important for the quality of shared learning. When presenting a case, the following points should be included:

  • Written and specific consent from the patient
  • A clear timeline of events
  • Relevant medical and social history and lifestyle factors
  • Details of the treatment, product(s) used, indication/outcome, volume/dose/sites, technique
  • Assessment of symptoms and history of presentation
  • Provisional diagnosis and management plan
  • Patient-specific concerns
  • Practitioner's questions and concerns. Patient-identifiable details must not be included, and any photographs should not show a full face unless absolutely necessary. Reporting the outcome of the intervention to others is helpful for learning and prevention of similar cases.
  • Complications from treatment provided elsewhere

    If a patient presents with complications caused by treatment provided by another practitioner, a number of factors should be taken into consideration. Practitioners must respect the right of the patient to seek treatment from whomever they choose and act in a respectful and collaborative manner, in keeping with professional standards, to support the best outcome for the patient. Additionally, as a professional courtesy, the patient should always be encouraged to return to the treating practitioner for management. It is also important to be mindful that patients may not be reliable historians, so practitioners should not depend on patient-reported history alone to diagnose and determine a management plan. Any comments on another practitioner's treatment should be professional and cautious, as anyone making comments may not be aware of all the facts and may be held legally accountable for any remarks made.

    The patient is entitled to a copy of their treatment records. Records can be requested by the patient, or, should they have lost trust and confidence in their previous practitioner, the new practitioner can make the request in writing, including a signed patient consent. In the interests of learning and audit, and with the patient's consent, the current management and outcome details could be sent to the previous practitioner.

    Non-prescribing practitioners

    Given the known risks, all practitioners who administer treatments have a duty of care should a complication arise. Complications often require prescription-only medicine for management, particularly following treatment with dermal fillers. It is the view of Save Face that it is not appropriate to refer patients with complications related to treatment to their GP.

    Prescribing partnerships are often based on the assessment and prescription for botulinum toxins. In the interests of patient safety, non-prescribing practitioners should have an arranged referral protocol with a prescriber in order to ensure timely and safe treatment and care should a complication arise. Both the prescriber and the treating practitioner must consider the risks and identify their responsibilities and accountabilities, in case of a complication. Ideally the details of such an arrangement should be formally agreed in advance of any problems arising. Prescribing practitioners willing to provide such support must be competent to do so. It is not the function of Save Face or ACE Group to facilitate such arrangements.

    Professional behaviour

    Practitioners must always communicate professionally, treating each other and patients and their relatives with respect. Complications and unwanted outcomes can and do cause anxiety and distress for both patients and practitioners. However, a complication need not turn into a complaint. From the outset, professionals should lean on a sympathetic, disciplined, professional and organised process that can be documented and evidenced.

    At all costs, professionals must avoid protracted communication by text and selfie. It is important to resist commenting or advising beyond an acknowledgement of the patient's concerns and providing an invitation to see them at their earliest convenience, which explains the necessity of seeing, assessing and documenting them properly to determine a management plan. Adverse events should always be documented for audit purposes; they can also be invaluable learning for reflection and revalidation.

    Conclusion

    Practitioners need to be thoroughly familiar with the guidance available on diagnosis and management of dermal filler complications (www.acegroup.online). This will help reduce the risk of complications and ensure that they are dealt with appropriately, should they arise.