I thank you for the opportunity to respond to the letter “U.S. Food and Drug Administration Authors Publish Articles on Dermal Filler Materials, Injections, Methods, and Skin Preparation” by K. Scott Phillips and Yi Wang. I am delighted to receive a commendation from these researchers and, more particularly, am heartened by the attention that this is receiving from the U.S. Food and Drug Administration. It is ultimately the role of the regulator to protect the U.S. public from the inappropriate and potentially dangerous use of medical treatments, devices, and interventions; thus, the more clarity we gain on the issue through good research, the better.
I have had the opportunity to read both of their publications and would like to reiterate the importance of better defining clinical steps that either increase or decrease the risk of biofilm contamination of dermal fillers.1,2 Their findings of inadequate removal of biofilm on skin despite “adequate” skin preparation echoes our findings with respect to the difficulty of standard antiseptics removing established biofilm on surfaces.3 These findings complement our work with respect to multiple passes through contaminated skin as a significant potentiator for infection.4 It would be good to look critically at various aspects of injector practice and technique and quantify the potential for bacterial contamination. I hope that, in time, a series of biofilm-mitigation strategies can be outlined and then translated into practice through evidence and then education of clinical practitioners. This will possibly result in (1) less infection following filler injection and (2) benefits to patients. We have achieved this for breast implant surgery through the development and translation of the 14-point plan to reduce biofilm contamination on breast implants.5 I would therefore like to seek like-minded researchers to develop a similar biofilm-mitigation strategy plan for dermal fillers.
To start with, we have:
- Adequate skin preparation and repeated skin preparation to reduce the bacterial load after 30 minutes of treatment.
- Better planning of injector sites to preclude the need for:
- a. Multiple needle passes.
- b. Fanning injections.
We are currently looking at the relationship between bolus volume of injectable material, hematoma, and the risk of infection. I also think that filler injections should be more correctly relabeled as “dermal implants,” as the risk of placing anything inanimate into the human body carries with it a definable risk of chronic biofilm infection with potentially serious consequences.
There is, however, a complementary approach that needs to be initiated by the profession in concert with industry and the regulators. There is an imperative to define both the numerator (patients experiencing adverse events) and the denominator (total number of patients undergoing these treatments) to gain better clarity on the nature and extent of adverse outcomes following dermal implant delivery. At present, many of these treatments sit outside the usual regulatory and funding pathways, and there is little accurate information on the number of dermal filler procedures being undertaken, who is performing them, and where they are being performed. The wider issues of quality of training, skill, and credentialing of injectors and facilities for these treatments also need to be better understood. The development of an accurate patient record—the filler passport—is being developed and proposed in Australia with the help of industry, and will enable close and accurate recording of these parameters. We have a smaller population and a smaller number of injectors in Australia, and thus the practicality of developing such a tool is easier compared with the United States. Better documentation of the timing, type, and location of treatments will also be invaluable for approaching treatment of complications and potentially avoiding overtreatment.
These changes to practice and documentation need to be patient and practitioner driven and perhaps, in time, overseen by the regulator. The combination of basic science research and better clinical monitoring/data capture will ensure that dermal implants are used appropriately and safely and backed by the best evidence-based research, resulting in improved outcomes for all patients.
Professor Deva is a consultant and conducts research for Mentor (J&J), Allergan, and Acelity.
Anand K. Deva, B.Sc.(Med.), M.B.B.S.(Hons.), M.S.Department of Plastic and Reconstructive SurgeryMacquarie UniversityThe Integrated Specialist HealthcareEducation and Research FoundationSydney, Australia
1. Wang Y, Guan A, Isayeva I, et al. Interactions of Staphylococcus aureus
with ultrasoft hydrogel biomaterials. Biomaterials 2016;95:7485.
2. Wang Y, Leng V, Patel V, Phillips KS. Injections through skin colonized with Staphylococcus aureus
biofilm introduce contamination despite standard antimicrobial preparation procedures. Sci Rep. 2017;7:45070.
3. Almatroudi A, Gosbell IB, Hu H, et al. Staphylococcus aureus
dry-surface biofilms are not killed by sodium hypochlorite: Implications for infection control. J Hosp Infect. 2016;93:263270.
4. Saththianathan M, Johani K, Taylor A, et al. The role of bacterial biofilm in adverse soft-tissue filler reactions: A combined laboratory and clinical study. Plast Reconstr Surg. 2017;139:613621.
5. Deva AK, Adams WP Jr, Vickery K. The role of bacterial biofilms in device-associated infection. Plast Reconstr Surg. 2013;132:13191328.