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Systematic Review/Meta-analysis

Otolaryngology–
Head and Neck Surgery

Complications Secondary to Nonsurgical 2021, Vol. 165(5) 611–616


Ó American Academy of
Otolaryngology–Head and Neck
Rhinoplasty: A Systematic Review Surgery Foundation 2021
Reprints and permission:
and Meta-analysis sagepub.com/journalsPermissions.nav
DOI: 10.1177/0194599820987827
http://otojournal.org

Sam DeVictor, MD1, Adrian A. Ong, MD1,


and David A. Sherris, MD1

Abstract ease of technique, minimal downtime and swelling, and


Objective. The popularity of nonsurgical rhinoplasty with inject- quick results, injectable fillers have been adopted by physi-
able fillers continues to rise, and it is important to understand cians and patients for many cosmetic indications, with its
the scope of potential adverse outcomes. The purpose of our use soaring in the United States at over 2.7 million inject-
study is to determine the prevalence and types of adverse out- able filler procedures in 2019.2 For these reasons, providers
comes secondary to nonsurgical rhinoplasty. have pushed the limits of injectable fillers in an attempt to
achieve surgical results, such as in cosmetic rhinoplasty.
Data Sources. PubMed, Cochrane, Embase. Surgical rhinoplasty remains the standard for correction of
Review Methods. The data sources were explored using the nasal deformities, both cosmetic and functional. However,
following combination of terms: ((‘‘inject*’’ OR ‘‘nonsurgical’’ nonsurgical rhinoplasty (NSR) is able to improve some
OR ‘‘augmentation’’ OR ‘‘filler’’) AND ‘‘rhinoplast*’’) AND cosmetic deformities such as nasal side wall deformities,
(‘‘complication’’ OR ‘‘adverse’’ OR ‘‘embol*’’). Studies on augmentation of the dorsum, or even tip projection and rota-
human nonsurgical rhinoplasty using injectable fillers were tion.3-5 There are a variety of injectable substances used for
included. A quantitative meta-analysis was performed on nonsurgical rhinoplasty, including hyaluronic acid (HA) and
articles with low risk of bias. calcium hydroxyapatite (CaHA), as well as autologous fat
and cartilage.6,7 All have varying degrees of reabsorption
Results. The search yielded 37 publications for review, with depending on the substance and patients’ individual physiol-
23 included cohort studies and 14 case reports with 8604 ogy. Patients and surgeons are being increasingly drawn to
patients undergoing nonsurgical rhinoplasty with reported NSR due to the lower cost, shorter downtime, cosmetic
complications. The overall rate of adverse outcome across improvement, and easy of technique vs surgical rhinoplasty.8
all cohort studies was 2.52%. The most commonly reported With the rise of NSR, it is important to understand the
complications were bruising (1.58%) and hematoma (0.13%). scope of potential complications and adverse outcomes. The
While uncommon, there are several reports of major com- growing literature provides evidence for the safety of inject-
plications including 30 episodes of vessel occlusion (0.35%), able fillers for NSR with favorable success rates and low
7 reports of skin necrosis (0.08%), 8 reports of vision loss rates of complications. However, serious complications,
(0.09%), and 6 reports of infection (0.07%). such as skin necrosis and blindness, are potential risks of
Conclusion. Overall, nonsurgical rhinoplasty with injectable the procedure. The purpose of this study was to systemati-
fillers is safe with low rates of complications. However, seri- cally review the prevalence and types of adverse outcomes
ous complications, such as vision loss, skin necrosis, and secondary to NSR reported in the literature.
vessel occlusion, can occur. Further studies are needed to
Materials and Methods
optimize delivery of injectable fillers in the nose to decrease
the rate of adverse outcomes. This systematic review was conducted in accordance
with the Preferred Reporting Items for Systematic Reviews
Keywords
1
nonsurgical rhinoplasty, complications Department of Otolaryngology, Jacobs School of Medicine and Biomedical
Sciences, University at Buffalo, The State University of New York, Buffalo,
New York, USA
Received October 26, 2020; accepted December 23, 2020.
The article was presented as an oral presentation at the American
Academy of Otolaryngology–Head & Neck Surgery (AAO-HNSF) 2020
Virtual Annual Meeting & OTO Experience, September 13-16, 2020.

A
cross the world, wellness has become a mainstay of
society, with personal care, antiaging, and beauty Corresponding Author:
Sam DeVictor, MD, Department of Otolaryngology, Jacobs School of
making up $1.08 billion of a trillion-dollar indus- Medicine and Biomedical Sciences, University at Buffalo, The State
try.1 Within this growth, the popularity of minimally inva- University of New York, 1237 Delaware Avenue, Buffalo, NY 14209, USA.
sive, nonsurgical interventions has also grown. With the Email: srdevict@buffalo.edu
612 Otolaryngology–Head and Neck Surgery 165(5)

and Meta-Analyses guidelines. Three databases (PubMed,


Cochrane, Embase) were explored using the following
combination of terms: ((‘‘inject*’’ OR ‘‘nonsurgical’’ OR
‘‘augmentation’’ OR ‘‘filler’’) AND ‘‘rhinoplast*’’) AND
(‘‘complication’’ OR ‘‘adverse’’ OR ‘‘embol*’’). Two inde-
pendent reviewers (S.D. and A.A.O.) screened each study
for relevance based on title and abstract based on predefined
inclusion criteria. After removal of excluded studies, the full
text of remaining studies was then reviewed to determine
inclusion in the study. Any conflicts were resolved by dis-
cussion until a conclusion was agreed upon. Institutional
review board approval was not required for this study, as it
was a retrospective review of published literature.
For each article, the journal source, year of publication,
number of authors, subspecialty of journal, type of study,
filler substance used, and complications were documented.
Articles were selected for inclusion if they presented pri-
mary data for human nonsurgical rhinoplasty using inject-
able fillers and were limited to the English-language
literature. Studies using cartilage grafts and autologous fat
grafts as the filler substance were excluded as they often
require harvesting under general anesthesia or sedation in a
surgery center or operating room. In addition, studies using
silicone as an injectable material were excluded as this
material is not currently approved by the US Food and
Drug Administration for facial injections. Finally, studies Figure 1. Preferred Reporting Items for Systematic Reviews and
looking at use of fillers for ‘‘fine tuning’’ a recently per- Meta-Analyses flow diagram.
formed surgical rhinoplasty were also excluded; however,
patients with a remote history of rhinoplasty were included.
Primary outcomes were specific complications and com- included extensive bruising and hematoma. While uncommon,
plication rates. Secondary outcomes included injection there are several reports of major complications, including
material, journal type, year of publication, and number of skin necrosis, vessel occlusion, vision loss, and infection. A
authors on publication. Complications were tabulated using summary of specific complications is in Table 2.
number of complications divided by number of procedures. By far, the most common substance used for injection
One study included patients undergoing botulinum toxin was HA. Twenty-eight of the 37 studies used HA as the pri-
and injectable fillers, and those patients who received botu- mary filler (75.67%). The second most common filler was
linum toxin were excluded from subsequent analysis. CaHA, which was studied in 7 of 37 studies (18.92%). A
summary of the fillers used and their associated complica-
Results tion rates is in Table 3.
The initial search yielded 435 articles, and after screening
by title and abstract, 84 articles were deemed relevant for Discussion
initial inclusion. After full-text review, 37 articles (8604 The growing popularity of NSR is evident by the growing
patients) were included in the study, including 12 prospec- number of publications. Forty percent of the included publi-
tive cohort studies, 11 retrospective cohort studies, and 14 cations were from the past 3 years. As the popularity is
case reports (Figure 1, Table 1). Among NSR publica- growing among patients and physicians, there is a continued
tions, the average number of authors per publication was need to address not only best practices and best fillers but
3.65. The most common countries of origin for the articles also potential pitfalls and adverse events. In addition, NSR is
were Italy (9), South Korea (8), United Kingdom (4), and the offered by a variety of medical specialties, including facial
United States (3). Dermatology journals represented the most plastic and reconstructive surgery, plastic surgery, oral and
common platform for publishing articles on NSR, followed by maxillofacial surgery, and dermatology. As a result, our
plastic surgery journals. Forty percent of the included articles study reviews the currently published literature from all spe-
were published in the past 3 years (Figure 2). cialties to identify complications associated with NSR.
A total number of 217 complications were reviewed, Understanding of the soft tissue anatomy of the nose and
which yielded a complication rate of 2.52%. Excluding its vascular system is the foundation for avoiding adverse
complications reported in the case reports, the overall rate outcomes. There are 5 layers of the nose: the skin, superfi-
of adverse events among the cohort studies is 2.34%. The cial fatty layer, fibromuscular layer, deep fatty layer, and
most common reported complications were minor and the periosteum/perichondrium. The major vasculature of the
DeVictor et al 613

Table 1. Summary of the Articles Included in the Study.


Total No. of Total No. of
Article Year Country Specialty Article type patients complications Filler

Bertossi et al9 2019 Italy OMFS Prospective 150 3 HA


Bertossi et al16 2020 Italy OMFS Retrospective 61 18 HA
Cassuto17 2010 Italy Dermatology Prospective 14 0 Porcine collagen
Chen et al18 2014 China PRS Prospective 252 2 HAa
Chen et al19 2016 United Kingdom PRS Case report 1 1 HA
Cohen et al20 2016 Israel Ophthalmology Case report 1 1 CaHA
Colombo et al21 2010 Italy PRS Case report 1 1 HA
Dayan et al22 2007 United States PRS Retrospective 8 0 HA
Fan et al23 2016 China OMFS Case report 2 2 HA
Han et al24 2006 Korea PRS Prospective 11 0 HA
Harb and Brewster11 2020 United Kingdom PRS Retrospective 5000 129 HA
Helmy25 2018 Egypt PRS Retrospective 332 1 HA
0 CaHA
0 PDTb
Jolly et al26 2019 United Kingdom Ophthalmology Case report 1 1 HA
Jung27 2019 United Kingdom PRS Prospective 96 2 HA
Kang et al28 2020 Korea Dermatology Retrospective 31 2 PDT
Kim et al29 2014 Korea PRS Case report 1 1 HA
Kim et al30 2014 Korea Neurology Case report 1 1 HA
Kim et al31 2011 Korea Ophthalmology Case report 1 1 HA
Lee et al32 2017 Korea PRS Case report 1 2 HA
Leupe et al33 2016 Belgium PRS Case report 1 1 HA
Liapakis et al34 2013 Greece PRS Retrospective 11 0 HA
Liew et al35 2016 Australia PRS Prospective 29 18 HA
Marumo et al36 2018 Japan Ophthalmology Case report 1 1 HA
Moulonguet et al37 2013 France Dermatology Case report 2 2 CaHA
Rauso et al38 2017 Italy OMFS Prospective 52 0 HA
Rauso et al39 2020 Italy OMFS Prospective 148 1 HA
Redaelli40 2008 Italy Dermatology Retrospective 95 2 HA
Rivkin41 2014 United States Dermatology Prospective 19 0 PMMA
Santorelli et al42 2020 Italy PRS Prospective 62 2 HA
Schuster43 2015 Germany PRS Retrospective 46 0 HA
6 CaHA
Segreto et al44 2019 Italy PRS Prospective 70 0 HA
Stupak et al45 2007 United States PRS Prospective 13 0 CaHA
Sung et al46 2010 Korea Ophthalmology Case report 1 1 CaHA
Sung et al47 2018 Taiwan Ophthalmology Case report 1 2 CaHA
Yagi et al48 2009 Japan PRS Retrospective 1816 2 PAH
Yordanov et al49 2019 Bulgaria PRS Retrospective 11 0 HA
Youn et al50 2016 Japan Dermatology Retrospective 242 3 HA

Abbreviations: CaHA, calcium hydroxyapatite; HA, hyaluronic acid; OMFS, oral and maxillofacial surgery; PAH, polyacrylamide hydrogel; PDT, polydioxane
thread; PMMA, polymethylmethacrylate; PRS, plastic and reconstructive surgery.
a
Silicone injections reported were not included.
b
Botox injections reported were not included.

nose is within the superficial muscular aponeurotic system lower nose is supplied by the angular and superior labial
(SMAS) or the combination of the superficial fatty layer arteries, branches of the facial artery. Avoiding these ves-
and fibromuscular layer. Most surgeons then seek to place sels is key to minimizing some of the major complications
the filler in the deep fatty layer between the fibromuscular associated with NSR. Certain techniques in administrating
layer and the periosteum or perichondrium. The main blood the filler may be helpful to reduce complications. For
supply to the upper part of the nose from the anterior eth- example, digital pressure at the site distal to the injection to
moid artery is a branch of the ophthalmic artery, while the occlude the vasculature, postprocedure application of ice to
614 Otolaryngology–Head and Neck Surgery 165(5)

Harb and Brewster11 published a retrospective review of


their NSR cases, which included a majority of patients with
no prior nasal procedures and about 20% of the study popu-
lation having a history of rhinoplasty. While their study
accounts for both an increase in the total number of proce-
dures performed and complications within our study, the
reported rate of complications remains low, with an
infection and skin necrosis rate of 0.04% and 0.06%,
respectively.11
Several studies included a detailed look at several severe
complications. Ouyang et al12 compiled a patient population
of 35 who had undergone NSR and had subsequent vascular
Figure 2. The year the studies were published.
compromise, including skin necrosis and vision loss, while
Robati et al13 reviewed 7 cases of skin necrosis following
use of injectable fillers for NSR. However, the total patient
population was not included in either study and, as a result,
Table 2. Total Complications and Complication Rates Among the not included in our quantitative analysis. Nonetheless, the
Study Population (N = 217). importance of reporting these complications cannot be over-
Complication Total No. (%) stated for educating both the physician and patient.
Specifically looking at filler, overall HA has a safe pro-
Skin necrosis 7 (0.08) file among synthetic fillers.14 However, this does not mean
Vision changes 8 (0.09) HA is without risk. HA was the substance used in many of
Infection 6 (0.07) the serious complications seen within our study. Part of the
Transient vessel occlusion 30 (0.35) safety profile with use of HA is the ability to use hyaluroni-
Hematoma 11 (0.13) dase in the event of vascular compromise. Animal studies
Bruising 136 (1.58) have demonstrated that hyaluronidase is able to reverse
Telangiectasia 1 (\0.01) potential skin necrosis, one of the more serious complica-
Nodule 6 (0.07) tions of NSR, as long as it is subcutaneously injected
Granuloma 2 (\0.01) within 4 hours of the vascular compromise.15
Blepharoptosis 1 (\0.01) Within our study, CaHA had a much higher complica-
Anaphylaxis 1 (\0.01) tion rate compared to the other fillers at 19%. The elevated
Asymmetry or displacement 5 (0.06) complication rate may simply be inflated as 7 of the 12
reported complications were from case reports. However,
those case reports were of serious complications such as
skin necrosis and permanent vision loss, raising the concern
promote vessel constriction, and decreased speed of injec- for the elevated complication rate associated with CaHA in
tion are used by the authors while blunt cannulas compared our study. While this may simply be an outlier resulting
to sharp cannulas may decrease the possibility of intravas- from the limitations of systematic reviews, future studies
cular injection.9 Understanding the nasal vascular anatomy should investigate this further.
and proper procedure technique are key to avoiding serious Our study has several limitations. As a systematic
complications such as visual disturbances and skin necrosis. review, the summary of the data is only as reliable as the
Williams et al10 recently published a review of NSR, primary studies included in the analysis. The authors did
specifically looking at technique and satisfactory outcomes include case reports within the study, which themselves
in addition to complications. The authors found HA to be have inherent biases in favor of complications. The study
the most commonly used filler at 73.38% while reporting a also depends on the reliability of the primary study report-
lower complication rate at 1.63% in contrast to our study. ing its complications accurately and uniformly. For exam-
However, they excluded case reports with their search cri- ple, the severity of bruising is highly subjective and may
teria from their primary data set. Our study design opted to not universally be reported the same. In addition, over half
include case reports as the authors believed inclusion of of this study’s patient population came from a single study
serious complications such as vision loss and skin necrosis and is therefore influenced by that report.11
is a necessity when reviewing complication rates of NSR.
Finally, the total number of patients included in the Conclusion
Williams et al10 study (n = 1600) is lower than our study (n Even with the rise in popularity of NSR, complications
= 8604) due to the inclusion of a recent publication by remain low and, for the most part, minor. However, serious
Harb and Brewster11 and their experience with 5000 non- complications of blindness and skin necrosis are not
surgical rhinoplasties performed. negligible and need to be accurately understood by both
DeVictor et al 615

Table 3. Summary of Substances Used for Filler Among the Study Population.a
Filler Total No. of publications Total No. of patients Total No. of complications Complication rate, % Case reports, No.

HA 28 6385 199 3.12 7


CaHA 8 63 12 19.05 7
Porcine collagen 1 14 0 0 0
PMMA 2 145 2 1.38 0
PDT 2 70 2 2.86 0
PAH 1 1816 2 0.11 0
Abbreviations: CaHA, calcium hydroxyapatite; HA, hyaluronic acid; PAH, polyacrylamide hydrogel; PDT, polydioxane thread; PMMA, polymethylmethacrylate.
a
Note the number of case reports among the CaHA population.

physicians and patients across all specialty groups. Further 5. Kontis TC. Nonsurgical rhinoplasty. JAMA Facial Plast Surg.
studies are needed to optimize delivery of injectable fillers 2017;19:430-431.
in the nose to decrease the rate of adverse outcomes. 6. Manafi A, Hamedi ZS, Manafi A, et al. Injectable cartilage
shaving: an autologous and long lasting filler material for cor-
Author Contributions rection of minor contour deformities in rhinoplasty. World J
Sam DeVictor, substantial contribution to conception, acquisition Plast Surg. 2015;4(2):93-100.
of data, analysis, and design; substantial contribution to drafting 7. Monreal J. Fat grafting to the nose: personal experience with
and revising manuscript for critically important intellectual data; 36 patients. Aesthetic Plast Surg. 2011;35(5):916-922.
approves final version of manuscript and agrees to be accountable 8. Jasin ME. Nonsurgical rhinoplasty using dermal fillers. Facial
for all aspects of the work in ensuring that questions related to the Plast Surg Clin North Am. 2013;21(2):241-252.
accuracy or integrity of any part of the work are appropriately 9. Bertossi D, Giampaoli G, Verner I, et al. Complications and
investigated and resolved; Adrian A. Ong, dubstantial contribution management after nonsurgical rhinoplasty: a literature review.
to conception, acquisition of data, analysis, and design; substantial
Derm Ther. 2019;32:e12978.
contribution to drafting and revising manuscript for critically
10. Williams LC, Kidwai SM, Mehta K, et al. Nonsurgical rhino-
important intellectual data; approves final version of manuscript
and agrees to be accountable for all aspects of the work in ensuring plasty: a systematic review of technique, outcomes, and com-
that questions related to the accuracy or integrity of any part of the plications. Plast Reconstr Surg. 2020;146(1):41-51.
work are appropriately investigated and resolved; David A. 11. Harb A, Brewster CT. The nonsurgical rhinoplasty: a retro-
Sherris, substantial contribution to conception, acquisition of data, spective review of 5000 treatments. Plast Reconstr Surg.
analysis, and design; substantial contribution to drafting and revis- 2020;145(3):661-667.
ing manuscript for critically important intellectual data; approves 12. Ouyang HW, Li GF, Zhu Y, et al. Treatment of skin soft
final version of manuscript and agrees to be accountable for all tissue embolism after hyaluronic acid injection for injection
aspects of the work in ensuring that questions related to the accu- rhinoplasty in Asian patients. J Cosmet Dermatol. 2019;18(3):
racy or integrity of any part of the work are appropriately investi- 747-754.
gated and resolved.
13. Robati RM, Moeineddin F, Almasi-Nasrabadi M. The risk of
Disclosures skin necrosis following hyaluronic acid filler injection in
Competing interests: None. patients with a history of cosmetic rhinoplasty. Aesthet Surg J.
2018;38(8):883-888.
Sponsorships: None.
14. Greene JJ, Sidle DM. The hyaluronic acid fillers. Facial Plast
Funding source: None.
Surg Clin North Am. 2015;23(4):423-432.
15. Kim DW, Yoon ES, Ji YH, et al. Vascular complications of
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