The increasing popularity of hyaluronic acid (HA) injections in aesthetic medicine is associated with rising numbers of cases of rare but serious vascular complications such as ischemia, necrosis, scarring, and blindness. These events, primarily caused by arterial occlusion from embolism, spasm, or compression, require swift and effective management. Recognizing the critical need for standardized intervention protocols, the ISAC World Board, consisting of 55 physicians from 23 countries, conducted an international survey addressing 20 key questions regarding acute complication management. The results revealed an extraordinary consensus, with several points achieving 100% agreement, enabling the development of an evidence-based, step-by-step algorithm for first-line treatment.

This protocol has been integrated into training programs worldwide, serving as the foundation for national and international guidelines. For instance, Germany has introduced a comprehensive ‘I-Secure Emergency Course’ to equip practitioners with the skills to manage such complications effectively. Adhering to these standardized protocols not only improves patient safety but also provides legal protection for practitioners. Furthermore, thorough patient education, including the use of emergency interventions such as hyaluronidase (Hylase), remains vital.

The ISAC consensus and its algorithm represent a global safety standard in aesthetic medicine. They provide a foundational framework for the creation of national guidelines, ensuring consistency and reliability in managing complications across diverse healthcare settings.

 

Introduction

The global aesthetic medicine industry has experienced significant growth in recent years, with hyaluronic acid (HA) injections becoming one of the most popular non-surgical procedures. However, with this rise comes the increased recognition of rare but severe complications, including ischemia, necrosis, scarring, and blindness. These complications, often resulting from arterial occlusion due to embolism, spasm, or compression, are particularly challenging to manage in the facial region. Despite advancements in understanding these mechanisms, the exact pathophysiology remains to be elucidated.

 

Recognizing this critical need, the ISAC World Board, comprising 55 physicians from 23 countries, initiated a global consensus process to develop a standardized approach for managing acute complications from HA injections. An international survey addressing 20 key questions revealed a remarkable alignment of expert opinions, with some points achieving 100% agreement. This high level of consensus facilitated the creation of an algorithm outlining the most effective steps for managing arterial occlusion and its sequelae.

 

Consensus Algorithm and National Guidelines

The consensus protocol established by the ISAC World Board serves as the foundation for training and national guidelines worldwide. For example, Germany has developed dedicated guidelines for the recognition and management of HA-related complications, incorporating the ISAC algorithm. Training programs such as the ‘Secure Emergency Course’ in Germany have been designed to teach practitioners how to apply these protocols effectively.

The algorithm (Fig. 1) was developed from the items with the highest consent (< 94%) and provides a step-by-step approach for the acute management of complications:

1. Stop the injection immediately.
   2. Analyze the skin for signs of ischemia: paleness, pain, or specific patterns of discoloration.
   3. Involve the medical team and initiate therapy with hyaluronidase (Hylase) to dissolve the filler causing the blockage.
   4. Monitor the time and consider repeated injections of hyaluronidase as needed until circulation normalizes.
   5. Apply heat (warm compresses) and perform a gentle massage to improve blood flow in the affected area.
   6. Discharge the patient only when the symptoms have improved and the patient is stable. Schedule a follow-up the next day.

If necessary, implement additional therapies such as antiseptic creams, corticosteroids, pain relief, aspirin (ASA), or vasodilatory substances, hyperbaric chamber.

For other issues, e.g. ‘Time to inform about off-label use of hyaluronidase’ or ‘Use of ultrasound during hyaluronidase injection’ the answers were less unequivocal and not included in the guideline.

 

Legal and Educational Implications

Standardized protocols also play a crucial role in legal protection for practitioners. Adherence to evidence-based algorithms provides a defensible position in medico-legal cases, emphasizing the importance of documented protocols in protecting both patients and physicians. Furthermore, patient education is critical, including thorough discussions of potential adverse events and the role of emergency interventions such as hyaluronidase (Hylase) in dissolving filler material.

 

Conclusion

The ISAC World Board’s consensus represents a landmark achievement in the global effort to ensure safety in aesthetic medicine. By creating a step-by-step algorithm for managing complications and serving as the basis for national guidelines, this initiative addresses a critical gap in practitioner preparedness and patient safety. As the aesthetic medicine market continues to grow, these protocols provide a much-needed framework for effective and consistent management of complications, fostering confidence and safety in the field. Future studies using large datasets of cases or controlled clinical studies are required to substantiate these best practice recommendations by clinical evidence.

 

References

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Partners of this article:

1. Tanja Fischer, M.D., Haut- und Lasercentrum Potsdam | Berlin, Germany
2. Chytra Anand, M.D. | Kosmoderma Healthcare | Bengaluru, India
3. Pierre Andre, M.D. | Paris Université Laser Skin Clinic | Paris, France
4. Ofir Artzi, M.D. | Tel Aviv Medical Center – Ichilov, | Tel Aviv, Israel
5. Beatriz Beltran, M.D. | Clínica Dra. Beatriz Beltrán | Barcelona, Spain
6. Hagai Betzer, D.M.D. | MediSinus | Yavne, Israel
7. Hugues Cartier, M.D. | Arras Hospital | Arras, France
8. Olivier Claude, M.D. | Claude Plastic Surgery and Aesthetic Medicine | Paris, France
9. Iñigo De Felipe, M.D., Ph.D. | Clínica Dermatológica De Felipe | Barcelona, Spain
10. Tom Decates, M.D., Ph.D. | Medical Laser Center | Amsterdam, The Netherlands
11. Ziah Taufig, M.D., | Klinik Dr. Taufig | Köln, Germany
12. Ronald Ian David Feiner, M.D., MBBS | Cosmetica Medical Aesthetic Clinic | Sydney, Australia
13. Greg Goodman, M.D., Ph.D., MBBS | Dermatology Institute of Victoria | Melbourne, Australia
14. Lisa Grunebaum, M.D., PhD. | Mayo Clinic | Phoenix, USA
15. Jonathan Kadouch, M.D., Ph.D. | Private Practice for Dermatology | Amstelveen, The Netherlands
16. Saami Khalifian, M.D. | SOMA Skin & Laser Center | Encinitas, USA
17. Marina Landau, M.D. | Marina Landau Clinic | Herzliya, Israel
18. Wendy Lee, M.D. | Bascom Palmer Eye Institute, University of Miami | Miami, USA
19. Steven Liew, M.D. | Shape Clinic | Sydney, Australia
20. Leonardo Martini, MD Ph.D | Brigham and Women’s Hospital | Cambridge, USA
21. John Martin, M.D. | Private Practice for Oculoplastic Surgery | Coral Gables, USA
22. Beatriz Molina, M.D., | Medikas Clinics Ltd | Meare, UK
23. Rachna Murthy, MBBS, | FaceRestoration Clinic | Newmarket, UK
24. James Neffendorf, M.D., MBBS | Imperial College | London, UK
25. Ha Nguyen Hong, M.D., Ph.D. | Vietnam National Institute of Ophthalmology | Hanoi, Vietnam
26. Alexandra Ogilvie, M.D. | SkinConcept | Munich, Germany
27. Tapan Patel, M.D. | PHI Clinic, London, UK
28. Eric Petzold, M.D. | Haut- und Lasercentrum Potsdam) | Berlin, Germany
29. Thomas Rappl, M.D. | Private Practice for Plastic Surgery| Graz, Austria
30. Hervé Raspaldo, M.D. | Face Clinic Geneve | Geneva Switzerland
31. Wolfgang Redka-Swoboda, M.D., | Surgical Practice | Ruderatshofen, Germany
32. Alexander Rivkin, M.D. | Westside Aesthetics Los Angeles | Los Angeles, USA
33. Kelsey Roelofs, M.D. | University of Alberta Edmonton Canada
34. Jonathan Roos, MBChB; PhD| FaceRestoration Clinic | London, UK
35. Christopher Rowland Payne, MBBS | Devonshire Dermatology | London, UK
36. Leonie Schelke, M.D. | Leonie Schelke Cosmetische Kliniek | Amsterdam,The Netherlands
37. Todd Schlesinger, M.D. | Dermatology and Laser Center of Charleston | Charleston, USA
38. Robyn Siperstein, M.D. | Siperstein Dermatology Group | Delray Beach, USA
39. Philippe Snozzi, M.D. | Private Practice | Zurich, Switzerland
40. Nenad Stankovic, DDS; DMD | Private Practice for Dentistry| Belgrade, Serbia
41. Su Youn Becker-Weimann, M.D. | Private Practice | Karlsruhe, Germany
42. Jesper Thulesen, PhD; M.D.; DMD | Capitol Cosmetic Eyelids Clinic Aesthetica | Copenhagen, Denmark
43. Patrick Treacy, MBChB | Ailesbury Clinics Ltd | Dublin, Ireland
44. Jani van Loghem, M.D.; PhD | UMA Institute | Amsterdam, The Netherlands
45. Joan Vandeputte, M.D. | Private Practice for Plastic Surgery | Oudenaarde, Belgiium
46. Peter Velthuis, PhD; M.D. | Velthuis Kliniek | Rotterdam, The Netherlands
47. Ines Verner, M.D.; MBA | Private Practice for Dermatology | Savyon, Israel
48. Andre Vieira Braz, M.D. | Private Practice for Dermatology | Rio de Janeiro, Brazil
49. Simone Vogel, M.D. | Haut- und Lasercentrum Potsdam | Berlin, Deutschland
50. Heidi A Waldorf, M.D. | Waldorf Dermatology & Laser Associates | New York City, USA
51. Steven Weiner, M.D. | The Aesthetic Clinique | Rosemary Beach, USA
52. Sandy Zhang-Nunes, M.D. | USC Roski Eye Institute | Los Angeles, USA
53. Thomas Zimmermann, M.D.| Private Practice for Dermatology and Aesthetics | Heusenstamm, Germany