Effect of Prophylactic Antibiotics on Polyacrylamide Gel Safety in Facial Augmentation

May 2014 | Volume 13 | Issue 5 | Original Article | 571 | Copyright © 2014

Jesper F. Nygart MD,a Victoria A. Nygart MSoc,a Marie Borggren PhD,b Michael Tvede MDc

aNygart Privathospital A/S, Copenhagen, Denmark
bContura International A/S, Copenhagen, Denmark
cDepartment of Clinical Microbiology, Rigshospitalet, Copenhagen, Denmark

Abstract

BACKGROUND: Polyacrylamide hydrogel has in the last decade gained popularity as an injectable filler for facial augmentation due to its features of non-toxicity, biocompatibility, safety profile, and immediate effect. However, as all types of injections carry the risk of infection and since the polyacrylamide hydrogel is a non-degradable implant, the possibility of bacterial biofilm formation exists. Theoretically, the risk of infection and subsequent biofilm formation can be avoided by using prophylactic antibiotic treatment prior to the time of injection.
METHOD: This retrospective study of outcomes following polyacrylamide hydrogel injections includes 657 subjects from one centre, which had facial injections from 2001 and 2011. Until 2007 prophylactic antibiotics were not given prior to treatment, but in September 2007 a single oral dose of azithromycin (Zitromax) and moxifloxacin (Avelox) was introduced as prophylactic antibiotics. A total of 496 subjects were injected before 2007 without antibiotic prophylactic treatment, and 161 subjects received these two antibiotics prior to treatment from September 2007.
RESULTS: The prophylactic antibiotics (azithromycin and moxifloxacin) significantly reduced the incidence of clinical signs of inflammation/infections from 7 to 2% (P=0.03).
CONCLUSION: Even though the incidence of inflammation/infections following injection of polyacrylamide hydrogel is relatively low, it may be reduced further by using prophylactic antibiotic treatment. Based on our experience, we recommend prophylactic antibiotics to patients who have facial augmentation with polyacrylamide hydrogel in order to avoid infection and risk of biofilm formation due to contamination during injection with naturally occurring micro flora from skin and lips.

J Drugs Dermatol. 2014;13(5):571-573.

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INTRODUCTION

Polyacrylamide hydrogel is a non-degradable, well-characterized filler agent, which becomes intimately integrated with its surrounding host tissue through vessel-ingrowth.1 Aquamid® (Contura International A/S, Denmark) is a 2.5% polyacrylamide hydrogel that has been used in the cosmetic industry for the past 10 years, where it has been injected into facial dermal and subcutaneous tissues to augment lips and eradicate wrinkles, scars, or other cavities.2-6 During this time it has been observed that the gel, just like other foreign body implants7 carries the risk of being invaded by contaminating normal skin bacteria like Propionibacterium acnes and Staphylococcus epidermidis. It has long been known that these bacteria can grow within implants, such as prostheses, and give rise to a low-grade chronic infection and biofilm formation,7,8 but it is only in recent years that the aesthetic society handling gel fillers has become aware of this problem.8-10 These bacteria are normally considered non-pathogenic, because they live unattended within skin keratin layers, hair follicles or sebaceous glands for long periods of time, but when they are accidentally injected into sites like dermal or subcutaneous tissues, these bacteria can survive within the gel and cause infection. Clinical symptoms of these infections (swelling and pain) depend on the onset after injection, type and number of bacteria injected, site (lips vs other sites), and size of gel bolus. They may set in immediately or up to one year after the injection, but usually they occur after 1-2 weeks.8,11

A thorough rinse of the injected site is not sufficient to avoid this contamination, which occurs during the injection process. The bacteria are typically deeply seated within hair structures and glands, ready to be led into the gel injection site by the needle. With the purpose of reducing these soft-tissue infections, prophylactic antibiotics were introduced into our clinic in 2007.

The overall purpose of this retrospective study has been to evaluate whether prophylactic administration of relevant antibiotics had any effect on complication rate. We present a consecutive series of 657 subjects that have been divided into two groups: group 1 receiving prophylactic antibiotics prior to gel injection (n=161) and group 2, receiving no prophylaxis before gel injection (n=496).

PATIENTS AND METHODS

A total of 657 subjects (605 women and 52 men) were injected by the same physician using the same injection technique, from August 28th 2001 to September 15th 2011. Injection sites included lips (n=422), glabella (n=95), and nasolabial folds, mentolabial folds, wrinkles around the mouth, philtrum and forehead, cheeks, chin, nose, defects and scars (n=140). Prophylactic antibiotic treatment (a combination of azithromycin, 500 mg, and moxifloxacin, 400 mg) was introduced as standard procedure from September 2007. The subjects were instructed to administer antibiotics as a single

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