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A review of dermal fillers in facial plastic surgery

August 2010
Current Opinion in Otolaryngology & Head and Neck Surgery 18(4):295-302

DOI:10.1097/MOO.0b013e32833b5162

Source
PubMed

Authors:

Dominic Bray

Claire Hopkins

Guy's and St Thomas' NHS Foundation Trust

Purpose of review: Over the last decade, injectable soft tissue fillers have become an integral part of facial plastic surgery practice. The vast choice of new products being brought to the market, improved safety profile, lower costs in the current economic climate and high street availability mean that demand for nonsurgical rejuvenation treatments are increasing at an exponential rate and are no longer the preserve of the affluent. Recent findings: Recent published work has focused on the addition of local anaesthetic into fillers, widening their indications, reporting longer term results, avoidance of complications, regulation and future directions. Summary implications: The refinement of techniques to restore facial volume with dermal fillers, and widely available botulinum (BTX) injections to treat dynamic facial rhytids, fuelled by widespread mainstream advertising, has led to a surge in demand for nonsurgical rejuvenation procedures. An increasingly well informed and discerning patient population now seek better value procedures that require minimal downtime and have instant results. A thorough knowledge of the dermal fillers available for soft tissue facial augmentation is therefore essential to any clinician involved in facial plastic surgery.

njection techniques

…

Summary of FDA-approved dermal fillers on the market

…

Nonsurgical 'injection' rhinoplasty

…

Restylane-lidocaine for lower facial rejuvenation

…

Figures - uploaded by Claire Hopkins

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Content uploaded by Claire Hopkins

Content may be subject to copyright.

A review of dermal ﬁllers in facial plastic surgery

Dominic Bray, Claire Hopkins and David N. Roberts

Introduction

Nonsurgical rejuvenation procedures such as botulinum

toxin (BTX) and dermal ﬁller injections are now the most

common aesthetic treatments performed worldwide. In

2008, the American Society of Aesthetic Plastic Surgeons

(ASAPS) published projected nationwide statistics of US

dermal ﬁller practice [1]. Hyaluronic acid-based ﬁllers

(Restylane, Juvederm, Hylaform) were the most com-

monly performed with over 1.26 million treatments.

Calcium hydroxylapatite (Radiesse) accounted for just

under 123 000 ﬁller injections, collagen 58 000, and poly-

L-lactic acid (Sculptra) nearly 32 000 [standard error (SE)

3.21% at 95% conﬁdence level (CI)]. These ﬁgures are

likely to be a conservative estimate as they are based on a

members’ survey that was projected to include only

board-certiﬁed plastic surgeons, otolaryngologists and

dermatologists. This article reviews the dermal ﬁllers

available today in the USA and Europe, the injection

techniques, indications, avoidance of complications and

regulation of dermal ﬁllers in facial plastic surgery.

Techniques

Most injectable dermal ﬁllers are supplied with a dis-

posable plastic syringe and Luer-Lok ﬁtting, co-packaged

with a sterilized needle gauge appropriate for the ﬁller

viscosity. Depth of the defect determines the depth of

injection, and generally speaking the deeper the defect,

the more viscous the ﬁller. Superﬁcial lines require

shallow correction in the upper dermis and cause blanch-

ing on delivery; deeper furrows and folds require place-

ment in the mid, deep or subdermis. Four techniques for

injection are reported: serial puncture, linear threading,

fanning and cross-hatching [2] (Fig. 1).

Serial puncture

The skin is pulled taught to stabilize the defect and

multiple boluses of ﬁller are delivered along the defect

line. The injection sites should be close enough to form a

continuous smooth bead; however, small gaps can be

moulded with massage. This technique is useful for acne

scarring, shallow forehead rhytids, the glabella, philtrum

enhancement and nonsurgical rhinoplasty.

Linear threading

The full length of the needle is advanced along the

wrinkle or fold to create a tunnel for ﬁller placement.

Injection can be anterograde ‘the push-ahead technique’

as the needle is advanced or retrograde as it is withdrawn.

Anterograde delivery may displace small blood vessels,

but retrograde delivery allows more uniform placement,

Department of Otolaryngology, Guy’s Hospital, London,

Correspondence to Mr Dominic Bray,

FRCS(ORL-HNS), Department of Otolaryngology,

Guy’s Hospital, Great Maze Pond, London SE1 9RT,

Tel: +44 207 188 2215; e-mail: dbray@doctors.org.uk

Current Opinion in Otolaryngology & Head and

Neck Surgery 2010, 18:295– 302

Purpose of review

Over the last decade, injectable soft tissue ﬁllers have become an integral part of facial

plastic surgery practice. The vast choice of new products being brought to the market,

improved safety proﬁle, lower costs in the current economic climate and high street

availability mean that demand for nonsurgical rejuvenation treatments are increasing at

an exponential rate and are no longer the preserve of the afﬂuent.

Recent ﬁndings

Recent published work has focused on the addition of local anaesthetic into ﬁllers,

widening their indications, reporting longer term results, avoidance of complications,

regulation and future directions.

Summary implications

The reﬁnement of techniques to restore facial volume with dermal ﬁllers, and widely

available botulinum (BTX) injections to treat dynamic facial rhytids, fuelled by

widespread mainstream advertising, has led to a surge in demand for nonsurgical

rejuvenation procedures. An increasingly well informed and discerning patient

population now seek better value procedures that require minimal downtime and have

instant results. A thorough knowledge of the dermal ﬁllers available for soft tissue facial

augmentation is therefore essential to any clinician involved in facial plastic surgery.

Keywords

dermal ﬁllers, dermal implants, facial ﬁllers, facial rejuvenation, soft tissue augmentation

Curr Opin Otolaryngol Head Neck Surg 18:295 –302

ß2010 Wolters Kluwer Health | Lippincott Williams & Wilkins

1068-9508

1068-9508 ß2010 Wolters Kluwer Health | Lippincott Williams & Wilkins DOI:10.1097/MOO.0b013e32833b5162

the preference being largely operator-dependent. Linear

threading is best for the nasolabial folds and vermillion

contour. Serial threading uses elements of both tech-

niques and is useful in wider folds.

Cross-hatching/fanning

The fanning and cross-hatching techniques are variations

of linear threading that allow ﬁlling of larger defects or

facial contouring. In the fanning technique a single

needle puncture allows ‘fan-like’ placement of successive

linear threads by radially changing the needle direction.

Cross-hatching delivers linear threads in a predetermined

grid by multiple punctures. Both techniques are useful in

the malar region and oral commissures.

Indications

Dermal ﬁllers are licensed for injection into the mid to

deep dermis for the correction of moderate to severe

wrinkles and folds (such as the nasolabial lines). Some

have limited indication for correction of facial lipoatrophy

in HIV and acne scarring [3]. Dermal ﬁllers are also used

‘off-label’ to treat facial rhytids, folds and depressions;

restore age-related facial soft tissue volume loss; augment

existing facial structures and improve nasal function. The

off-label use of medical devices was legalized by the US

Food and drug Administration (FDA) Modernization Act

of 1997. For ease of review indications are separated into

horizontal facial thirds [4



Upper face

The most commonly treated areas in the upper face are

the ﬁne forehead lines created by the action of frontalis,

the vertical glabella furrows created by the depressor

corrugator complex and the crow’s feet formed by action

of orbicularis oculi. Whilst these dynamic lines are best

treated initially with BTX, in recalcitrant cases con-

comitant intradermal injection of hyaluronic acid ﬁller

by serial puncture (e.g. Restylane Touch, Juvederm 18)

works well. Deeper furrows are best ﬁlled using Perlane

or Juvederm 24/30 by subdermal linear threading. Acne

scars can be elevated by needle subcision followed by

ﬁller injection. Age-related temporal volume loss can be

replaced by subcutaneous injection of Restylane Sub-Q

(FDA approval pending) or Sculptra by cross-hatching.

Mid-face

Sinking or effacement of the malar eminence and hollow-

ing of the cheeks can be corrected with dermal ﬁllers.

Restylane Sub-Q (the largest particle size in the hyaluro-

nic acid facial ﬁller range at 1000 particles/ml) is an

effective alternative to fat transfer for mid-facial augmen-

tation and contouring [5]. Sculptra, whilst not a true

‘dermal ﬁller’, stimulates collagen neogenesis. ‘Tear

296 Facial plastic surgery

Figure 1 Injection techniques

(a) Serial puncture; (b) linear threading; (c) fanning; (d) cross-hatching (from Rohrich et al. [2]).

troughs’ formed by the naso-jugal fold can be corrected

with ﬁller but achieving good results in this area is

challenging [6]. Accurate facial analysis, product choice,

injection technique and preparation are key to a good

outcome. The area should be anaesthetized with topical

cream to avoid distortion of the soft tissues and ice should

be used for vasoconstriction to reduce ecchymosis. The

patient should be seated upright to prevent gravitational

movement of the orbital fat pads and to best delineate the

area of correction. Preseptal injection of ﬁller by linear

threading along the orbital rim avoids exacerbation of the

pseudoherniation of orbital fat that creates the original

deformity. Product choice depends upon degree of cor-

rection required but, in our experience, Restylane or

Juvederm give an excellent result. The area should be

gently massaged after injection to ensure even distri-

bution. If bruising becomes evident prompt pressure

and ice should be applied and injection postponed until

review at least 4 weeks later to allow time for dissociation

of water from the hyaluronic acid and oedema to settle.

Too superﬁcial placement leads to bluish discoloration by

the Tyndall effect, which may improve with observation

but can be treated with hyaluronidase injection [7] or

Nd:YaG laser [8]. A good correction can last up to 2 years

owing to the relative immobility of the area.

A recent use of dermal ﬁller is in nonsurgical ‘injection’

rhinoplasty [9]. Discreet volumetric changes in the

fronto-nasal angle, nasal dorsum and nasolabial angle

lead to signiﬁcant differences in our perception of the

nasal aesthetic. These areas can be injected with dermal

ﬁller to rejuvenate the nasal proﬁle and correct asymme-

tries. In our experience the correction can last up to

2 years with Restylane [10], and 3 years with Radiesse,

probably because of the relative immobility of the mid-

face.

Injection augmentation of a deep radix will soften the

fronto-nasal angle (Fig. 2c,d) and may disguise a promi-

nent rhinon and dorsal cartilaginous hump. Medial linear

subcutaneous threading of the bony and cartilaginous

dorsum will narrow a broad nose, and lengthen a shor-

tened nose. Saddle nose deformity and/or upper lateral

collapse may be disguised with injection superﬁcial to

perichondrium. An underprojected tip may be built up by

supratip injection followed by moulding to the desired

aesthetic result. Nasal tip ptosis is addressed with single

puncture injection into the collumellar base to open the

nasolabial angle. This angle may be opened further with

injection of 2 units of Botox (Allergan Inc.) into the

depressor septi muscle.

Functional internal valve collapse may be addressed with

an endonasal ‘spreader’ injection of calcium hydroxyl-

apatite (Radiesse) into the apex of the internal nasal valve

[11] (Fig. 2a,b).

Lower face

The most commonly treated area is the lower face. Aging,

volume loss and gravity cause descent of facial soft tissue,

leading to down-turned oral commissures and develop-

ment of marionette lines exacerbated by the action of

depressor anguli oris. Descent of the malar fat pad leads

to deepened nasolabial folds and a prejowl sulcus and loss

of jawline deﬁnition is exacerbated by mandibular resorp-

tion. Selective correction with site appropriate ﬁller can

restore volume and ‘lift’ the lower face nonsurgically

(Fig. 3a,b).

Deeper nasolabial folds can be softened with retrograde

subdermal linear threading of hyaluronic acid, Radiesse

or collagen derivatives, but ﬁner nasolabial lines are best

effaced by intradermal injection of hyaluronic acid.

Superﬁcial injection during needle withdrawal risks

nodularity and should be avoided.

The lip is a common ‘off-label’ area for injection.

Orbicularis oris action causes development of perioral

rhytids, and age-related atrophy leads to volume loss,

A review of dermal fillers in facial plastic surgery Bray et al. 297

Figure 2 Nonsurgical ‘injection’ rhinoplasty

Right upper lateral cartilage collapse causing right internal nasal valve

dysfunction (a); at 18 months corrected with endonasal Restylane

injection (b). Saddle nose deformity (c); at 18 months following sub-

dermal radix Restylane injection (d).

ﬂattening of the cupid’s bow, loss of vermillion contour

and convexity of the pout on proﬁle view. These features

can be restored and our preference is to use Restylane –

lidocaine as the gel is ﬁrm enough to provide support, can

be moulded into position, and rapidly softens. Treatment

in this area is painful and a local infraorbital and mental

block with 2% lidocaine and 1 : 100 000 epinephrine is

advised. Starting at the commissure, the needle is

advanced along the vermillion line. Retrograde linear

threading in the subdermis enables ﬁller hydrodissection

and augmentation of the vermillio-cutaneous border. The

cupid’s bow can be sculpted and the commissures

upturned by selective ﬁlling of the upper and lower

lateral commissure vermillion. Perioral rhytids are ﬁlled

with mid-dermis serial puncture [2]. Lip volume is

enhanced by injection of ﬁller at the junction of the

wet/dry mucosa in the middle third (Fig. 3c,d).

Fillers

There are over 150 injectable ﬁllers on the global market,

but at the time of writing only a dozen or so have FDA

approval. These include modiﬁcations (larger particle

size, addition of lidocaine) of existing ﬁllers and ﬁllers

no longer available [12]. Fillers can be permanent or

temporary and classiﬁed into three categories: collagens,

hyaluronic acids and biosynthetic polymers. Commonly

used FDA-approved/Conformite

´Europe

´enne (CE)-

marked ﬁllers available at the time of writing are sum-

marized in Table 1 [13].

Collagens

Collagen is the major structural component of skin. Inject-

able forms consist of varying concentrations of bovine

(Zyderm 1&2, Zyplast), human bio-engineered or more

recently porcine (Evolence) collagen. Human collagens

are derived from cadaveric skin (Alloderm, Cymetra) or

laboratory culture of human ﬁbroblasts (Cosmoderm 1&2,

Cosmoplast). They have a signiﬁcantly reduced allergic

risk compared with their bovine counterparts. Autologous

collagen from punch skin sampling (Isolagen) was recently

in vogue but, owing to its cost, complexity and processing

time, did not realize the initial interest and is no longer

available. Despite FDAapproval in 2008, Evolence, which

is derived from porcine collagen, stopped distribution in

November 2009. Allergan, following their 2006 acquisition

of INAMED (manufacturers of Zyderm, Zyplast, Cosmo-

derm and Cosmoplast), have not actively marketed their

collagen dermal ﬁllers – a reﬂection of the global move

towards hyaluronic acid injectables.

Hyaluronic acids

Since its 1934 discovery in the vitreous of cow’s eyes [14],

hyaluronic acid has become the most commonly used

298 Facial plastic surgery

Figure 3 Restylane– lidocaine for lower facial rejuvenation

Lower facial third volume loss characteristic of ageing (a); 3-month review following Restylane injection to the nasolabial folds, marionette lines, perioral

rhytids, commissures and vermillion contour (b). Ageing lips with decreased volume, loss of cupid’s bow and down-turned commissures (c); 3-month

review following injection augmentation (d).

A review of dermal fillers in facial plastic surgery Bray et al. 299

Table 1 Summary of FDA-approved dermal ﬁllers on the market

Filler type Subtype Name (manufacturer) Distributor Indication (off-label use) Durability Market status

Collagens Bovine Zyderm 1 Allergan Correction of dermal contour deﬁciencies

(superﬁcial defects and rhytids, acne scars)

2– 4 months FDA-approved

(1981)/CE-marked

Zyderm 2 Allergan Correction of dermal contour

deﬁciencies (moderate defects,

deep acne scars, lip volume)

2– 6 months FDA-approved

(1981)/CE-marked

Zyplast Allergan Correction of dermal contour

deﬁciencies (deep defects,

lip volume)

2– 6 months FDA-approved

(1981)/CE-marked

Cell-cultured Cosmoderm Allergan Superﬁcial dermis for soft tissue contour

deﬁciencies, rhytids and acne scars

3– 4 months FDA-approved

(2003)/CE-marked

Cosmoplast Allergan Mild to deep dermis for soft tissue

contour deﬁciencies, rhytids and

acne scars

3– 4 months FDA-approved

(2003)/CE-marked

Cadaveric Alloderm Lifecell Corp.

Woodlands, TX

Deep rhytids, scars, lip volume 6– 12 months CE-marked

Cymetra micronized

injectable Alloderm

Lifecell Corp.

Woodlands, TX

Deep rhytids, scars, lip volume 3– 6 months CE-marked

Hyaluronic acids Avian derived Hylaform (Genzyme) Allergan, CA Mild to deep dermis for mod-

severe folds (superﬁcial

rhytids, glabella, nose and lips)

3– 4 months FDA-approved

(2004)/CE-marked

Prevelle Silk (Genzyme) Mentor, Irving, TX Moderate to deep dermis for

mod-severe folds, for example

nasolabial folds (superﬁcial

rhytids, glabella, nose and lips)

3– 4 months FDA-approved

(2008)/CE-marked

Bacterial-cultured Perlane (Qmed) Qmed Deep dermis to superﬁcial subcutis

for mod-severe folds, for example

nasolabial folds

6– 12 months FDA-approved

(2003)/CE-marked

Perlane lidocaine (Qmed) Qmed 6– 12 months FDA-approved

(2010)/CE-marked

Restylane/Restylane

touch (Qmed)

Qmed Mild to deep dermis for mod-severe

folds, for example nasolabial

(superﬁcial rhytids, glabella,

nose and lips)

6– 12 months FDA-approved

(2003)/CE-marked

Restylane lidocaine (Qmed) Qmed 6– 12 months FDA-approved

(2010)/CE-marked

Elevess (Annika Therapeutics) Annika Therapeutics

Woburn, MA

Mild to deep dermis for mod-severe

folds, for example nasolabial

(superﬁcial rhytids, glabella,

nose and lips)

6– 12 months FDA-approved

(2006)/CE-marked

Captique (Genzyme) Allergan, CA Mild to deep dermis for mod-severe

folds (superﬁcial rhytids, glabella,

nose and lips)

3– 6 months FDA-approved

(2004)/CE-marked

Juvederm (Corneal, Paris) Allergan, CA Mild to deep dermis for mod-severe

folds, for example nasolabial

(superﬁcial rhytids, glabella,

nose and lips)

6– 12 months FDA-approved

(2006)/CE-marked

Juvederm lidocaine

(Corneal, Paris)

Allergan, CA 6– 12 months FDA-approved

(2010)/CE-marked

Synthetic polymers Poly-L-lactic acid Sculptra Sanoﬁ Aventis Facial lipoartophy in HIV (facial

contouring and volumetric

augmentation)

1– 2 years FDA-approved

(2004)/CE-marked

Calcium hydroxylapatite Radiesse Bioform medical Moderate to severe folds, for example

nasolabial, facial lipoatrophy in

HIV (nose)

1– 2 years FDA-approved

(2006)/CE-marked

4% Polyalkylimide Bio-alcamid Ascente Medical Deep defects Permanent CE-marked

Polyacrylamide hydrogel Aquamid Contura International Deep defects Permanent CE-marked

Adapted and updated from Buck et al. [13].

dermal ﬁller worldwide. It has been identiﬁed as the main

polysaccharide in the extracellular matrix of human con-

nective tissue. Hyaluronic acid stabilizes intercellular

structures, and produces a viscoelastic framework for

collagen and elastin to bind; it potently binds water

and when injected, volumizes, softens and hydrates

the skin. As the skin ages, hyaluronic acid content

decreases leading to decreased cell hydration, elasticity

and movement. The half-life of hyaluronic acid in the

dermis is 1 day as it degraded by hyaluronidase. The

hyaluronic acid molecule can be stabilized by bio-

chemical reticulation (cross-linking) with butanediol

diglycidyl ether (BDDE – Restylane, Juvederm), or

divinyl sulfone (DVS – Prevelle Silk, Captique, Hyla-

form) conferring resistance to degradation by heat or

enzymatic action [15



]. Hyaluronic acid implants can

be divided depending upon their reticulation character-

istics into biphasic (reticulated chains in ﬂuid suspension

that is resorbed after implantation) and monophasic (con-

tinuous polysaccharide reticulated chain) implants. The

former enables even distribution of hyaluronic acid HA

macromolecules, the latter is more homogeneous with

theoretically easier delivery [16]. The cross-linking pro-

cess can be further engineered to produce particulate or

nonparticulate forms. The jury is currently out as to

which form delivers a better outcome – the particulates

depend on particle size to increase volumetric lift and

longevity, the nonparticulates (of which Juvederm is the

only FDA-approved product) depend on greater cross-

linking to produce volume. The ideal degree of cross-

linking is unknown, as signiﬁcant cross-linking may

reduce the hydrophilic properties of hyaluronic acid

and therefore reduce lift or could affect biocompatibility

and cause rejection or encapsulation [17].

Restylane was the ﬁrst hyaluronic acid to gain FDA

approval in December 2003 and remains the market

leader today. A recent advance is the addition of 0.3%

lidocaine to the ﬁller (Restylane-L, Juvederm XC). In a

multicentre, double-blind, randomized clinical trial, 72

patients received Juvederm XC and Juvederm in separate

nasolabial folds. Ninety-three per cent of patients

reported less procedural pain when treated with the

lidocaine-containing dermal ﬁller compared with the

original version. The safety proﬁle and outcomes were

similar [18]. Another multicentre study of 3566 patients

in 16 European countries reported greater than 95%

patient and injector satisfaction with the lidocaine-con-

taining ﬁller [19]. Within a week of writing, Restylane-L

and Juvederm XC have gained FDA approval and await

US market release.

Biosynthetic polymers

Synthetic facial ﬁllers are composed of a biosynthetic

polymer (poly-L-lactic acid, calcium hydroxylapatite,

polymethylmethacrylate) combined with differing inject-

able carriers including hydrogels, beads and liquids [13].

Concerns remain about the long-term effects of the

permanent synthetic compounds – Bio-Alcamid and

Aquamid [20–24] and, in our opinion, cannot be justiﬁed

when other ﬁllers with more predictable outcomes and

safety proﬁles exist.

Radiesse

Calcium hydroxylapatite (Radiesse) consists of a 30%

concentration of 25 –45 mm spherical particles suspended

in sodium carboxymethylcellulose gel. It is FDA-approved

for facial soft tissue augmentation,speciﬁcally correction of

moderate to severe facial lines and folds and correction of

soft tissue loss from HIV lipoatrophy, vocal cord augmen-

tation and as a radiological tissue marker. In addition, the

off-label use of Radiesse has been reported for the infra-

orbital rim [25], nose [26], internal nasal valve [11] and

malar/submalar augmentation [27]. Following injection,

the gel is phagocytized and the calcium hydroxylapatite

microspheres displace surrounding soft tissue. Collagen

proliferation and slow degradation of the microspheres

lead to a prolonged duration of effect up to 2 years.

Sculptra

Poly-L-lactic acid (PLA) is not designed as a ﬁlling

agent per se. It is indicated for HIV-associated lipoa-

trophy but is widely used off-label for cosmetic facial

volumization. It is given by subdermal injection and

activates collagen neogenesis by granulomatous inﬂam-

mation [28]. This process takes at least 6 weeks but

the ‘ﬁlling’ effect is noticeable for up to 2 years. Serial

treatments are often necessary. Sculptra, like Radiesse,

contains sodium carboxymethylcellulose gel to aid

particle displacement.

Complications

Adverse events from dermal ﬁllers are classiﬁed into

immediate (pain, hypersensitivity, anaphylaxis), early

(swelling, erythema, infection, overcorrection, necrosis),

late (activation of HSV, nodules, granuloma formation)

and permanent (scarring) [29



Patients’ expectations should be addressed prior to treat-

ment and they should be informed of the risks, altern-

atives, and aftercare instructions. Fillers have FDA

approval for soft tissue augmentation in the nasolabial

fold; all other sites are off-label and the patient should be

informed of this. Injectors should be aware of facial

danger zones, speciﬁcally embolization of the supra-

trochlear (glabella), facial (alar – facial angle) and dorsal

nasal (nasal dorsum) arteries [30,31].

International regulations vary with regard to who can

inject ﬁllers. In the USA, ﬁllers must be FDA-approved

and prescribed as medicine. However, in the UK and

300 Facial plastic surgery

Europe they require only CE marking (pertaining to

production standards not efﬁcacy) and are classed as non-

prescription medical devices [32]. Over 140 injectable

ﬁllers are therefore available to the UK/European market

compared with only six in the USA. The massive growthof

the industry, fuelled by exponential demand, demedica-

lization through advertising, and lack of regulation, has led

to dentists, nurses and beauticians offering ﬁller injections

on the high street. There is currently no requirement for

certiﬁed training or background in facial plastic surgery.

An international report in 2008 by the FDA of adverse

events highlighted the potential for serious complications

resulting from ﬁller injection, especially from inexperi-

enced practitioners [2]. Of the 823 adverse events

reported, 638 (78%) responded to medication (from

topical steroid cream to systemic steroids, antibiotics,

anti-inﬂammatories and antihistamines), 94 (11%)

required surgical intervention (abscess drainage and/or

nodule excision) and 19 (2%) required emergency admis-

sion for hypersensitivity reaction.

Despite widespread variation in injector experience, per-

manent complications are fortunately rare. In the UK,

these most commonly arise with permanent ﬁllers (e.g.

Bio-Alcamid/Aquamid) and no permanent ﬁller is cur-

rently FDA-approved after Artes Medical, manufacturers

of Arteﬁll, went into administration in late 2008 [29



A quarter of British Association of Aesthetic Plastic

Surgeons (BAAPS) members have reported surgery for

complications following their use and 96% of BAAPS

members want regulation and UK adoption of FDA

approval for dermal ﬁllers [33].

Conclusion

Dermal ﬁllers are now an essential part of any facial

plastic and aesthetic surgical practice. The ﬁeld is moving

so quickly, with new ﬁllers being manufactured at an

ever-increasing rate, that published reviews less than a

year old at the time of writing include products no longer

available [4



,13]. The FDA is responding to this by

streamlining the approval process and improving safety

testing, event reporting and product labelling.

We echo the call by the BAAPS for tighter regulation in

the UK [33]. The increased choice of products available

in the UK and Europe has not conferred better outcomes

as the literature is full of adverse events from ﬁllers now

withdrawn from the market [34]. The FDA approval

process has in some way protected American patients

from these products.

Lastly, despite perceived demedicalization of ﬁllers,

it is essential that the injector remains their patients’

advocate. They should understand the differences,

indications and safety proﬁles of available products to

achieve a mutually desired outcome.

References and recommended reading

Papers of particular interest, published within the annual period of review, have

been highlighted as:

of special interest

 of outstanding interest

Additional references related to this topic can also be found in the Current

World Literature section in this issue (p. 346).

1American Society of Aesthetic Plastic Surgery Practice Survey 2008 http://

www.surgery.org/sites/default/ﬁles/2008stats.pdf (accessed 19th February

2010).

2Rohrich R, Ghavami A, Crosby M. The role of hyaluronic acid ﬁllers (Restylane)

in cosmetic surgery: review and technical considerations. Plast Reconstr Surg

2007; 120:41s– 54s.

3US Food and Drug Administration. General and Plastic Surgery devices panel

report 2008 [http://www.fda.gov/ohrms/DOCKETS/ac/08/brieﬁng/2008-

4391b1-01%20-%20FDA%20Executive%20Summary%20Dermal%20Fil

lers.pdf] accessed 19th February 2010.



Alam M, Hayes G, Kramer E, et al. ASDS guidelines of care for injectable

ﬁllers. Dermatol Surg 2008; 34:S115– 148.

A well referenced supplement of dermal ﬁllers focusing on regulatory status,

patient selection, indications, techniques and mechanisms of action of commonly

used ﬁllers.

5Lowe NJ, Grover R. Injectable hyaluronic acid implant for malar and mental

enhancement. Dermatol Surg 2006; 32:881 –885.

6Hirmand H. Anatomy and nonsurgical correction of the tear trough deformity.

Plast Recontstruct Surg 2010; 125:699–708.

7Hirsch RJ, Cohen JL, Carruthers JD. Successful management of an unusual

presentation of impending necrosis following a hyaluronic acid injection

embolus and proposed algorithm for management with hyaluronidase. Der-

matol Surg 2007; 33:357– 360.

8Cho SB, Lee SJ, Kang JM, et al. Effective treatment of a injected hyaluronic

acid-induced Tyndall effect with a 1064-nm Q-switched Nd:YAG laser. Clin

Exp Dermatol 2009; 34:637–638.

9De Lacerda DA, Zancanaro MD. Filler rhinoplasty. Dermatol Surg 2007;

33:S207– S211.

10 Bray D, Hopkins C, Roberts DN. Injection rhinoplasty: nonsurgical nasal

augmentation and correction of postrhinoplasty contour asymmetries with

hyaluronic acid. Clin Otolaryngol (in press).

11 Nyte CP. Spreader graft injection with calcium hydroxylapatite: a non surgical

technique for internal nasal valve collapse. Laryngoscope 2006; 116:1291 –

1292.

12 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Cos

meticDevices/WrinkleFillers/default.htm (accessed 19/2/2010).

13 Buck DW 2nd, Alam M, Kim JY. Injectable ﬁllers for facial rejuvenation: a

review. J Plast Reconstr Aesthet Surg 2009; 62:11 – 18.

14 Meyer K, Palmer JW. The polysaccharide of the vitreous humor. J Biol Chem

1934; 107:629– 634.

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Beasley KL, Weiss MA, Weiss RA. Hyaluronic acid ﬁllers a comprehensive

review. Facial Plast Surg 2009; 25:86–94.

A good biotechnological review of hyaluronic acid ﬁllers.

16 Bergeret-Galley C. Choosing Injectable treatments according to treatment

area: the European experience. Facial Plast Surg 2009; 25:135–142.

17 Tezel A, Fredrickson GH. The science of hyaluronic acid dermal ﬁllers.

J Cosmet Laser Ther 2008; 10:35–42.

18 Weinkle SH, Bank DE, Boyd CM, et al. A multicenter, double-blind, rando-

mized controlled study of the safety and effectiveness of JUVE

´DERM1

injectable gel with and without lidocaine. J Cosmet Dermatol 2009;

8:205– 210.

19 Wahl G. European evaluation of a new hyaluronic acid ﬁller incorporating

lidocaine. J Cosmet Dermatol 2008; 7:298 –303.

20 Alijotas-Reig J, Garcia-Gimenez V, Miro

´-Mur F, Vilardell-Tarre

´s M. Delayed

immune-mediated adverse effects related to polyacrylamide dermal ﬁllers:

clinical ﬁndings, management, and follow-up. Dermatol Surg 2009; 35

(Suppl 1):360– 366.

21 Ross AH, Malhotra R. Long-term orbitofacial complications of polyalkylimide

4% (bio-alcamid). Ophthal Plast Reconstr Surg 2009; 25:394 –397.

A review of dermal fillers in facial plastic surgery Bray et al. 301

22 Chrastil-LaTowsky B, Wesley NO, MacGregor JL, et al. Delayed inﬂammatory

reaction to bio-alcamid polyacrylamide gel used for soft-tissue augmentation.

Arch Dermatol 2009; 145:1309– 1312.

23 Schelke LW, van den Elzen HJ, Canninga M, Neumann MH. Complications

after treatment with polyalkylimide. Dermatol Surg 2009; 35 (Suppl 2):1625 –

1628.

24 Akrish S, Dayan D, Taicher S, et al. Foreign body granulomas after injection of

Bio-alcamid for lip augmentation. Am J Otolaryngol 2009; 30:356 –359.

25 Hevia O. A retrospective review of calcium hydroxylapatite for correction of

volume loss in the infraorbital region. Dermatol Surg 2009; 35:1487 –1494.

26 Stupak HD, Moulthrope TH, Wheatley P, et al. Calcium hydroxylapatite gel

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asymmetries. Arch Facial Plast Surg 2007; 9:130 –136.

27 Ridenour B, Kontis TC. Injectable calcium hydroxylapatite microspheres

(Radiesse). Facial Plast Surg 2009; 25:100–105.

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A summary of ﬁller complications, illustrated with examples and treatment strate-

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338:b2321.

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302 Facial plastic surgery

NEW IS NOT STRANGE ALWAYS-'NOTOX' IN DENTISTRY -A REVIEW

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May 2025

Advancements in Non-Invasive Plastic Surgery Techniques: Evaluating Efficacy, Safety, Patient Outcomes and Potential Complications

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Full-text available

Mar 2025

Traditional plastic surgeries have been a major concern for many patients as for their possible complications and estimated costs. Meanwhile, non-invasive procedures have shown a magnificent progress as they offer significant aesthetic outcomes compared to traditional methods with reduced recovery time and fewer complications. However, non-invasive techniques can cause minor complications such as erythema, mild pain, and swelling, which usually resolve without intervention. Major complications are rare to occur. Non-invasive procedures include neuromodulator injections known as Botox, dermal fillers, fat reduction which aims to improve the body's appearance, fat freezing (cryo-lipolysis), Radio frequency (RF), and High-intensity focused ultrasound (HIFU). Other non-invasive techniques can include Laser and Intense Pulse Light (IPL) treatment for discoloration and tighten sagging skin, Chemical peels to remove damaged outer skin layers, and Sclerotherapy injections for collapsing surface veins. This study has found that the overall patient satisfaction rate is 74.5%, with a reported 40% rise in minimally invasive techniques since 2021. The review highlights several popular non-invasive procedures. These methods offer reduced hospitalization, anesthesia risks, and shorter recovery periods. This review aims to explore the latest advancements in non-invasive plastic surgery, focusing on key areas such as facial enhancements, skin rejuvenation, and fat reduction. Studies show high satisfaction rates with non-invasive procedures. By evaluating the efficacy, safety, and patient satisfaction associated with these procedures, we aim to provide a comprehensive overview of their advantages and potential limitations, offering valuable insights for both practitioners and patients.

Development and Characterization of PEGylated Poly D,L-Lactic Acid Nanoparticles for Skin Rejuvenation

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Full-text available

Mar 2025

Recently, various biocompatible and biodegradable materials have garnered significant attention as cosmetic fillers for skin rejuvenation. Among these, poly ε-caprolactone (PCL), poly L-lactic acid (PLLA), poly D,L-lactic acid (PDLLA), and polydioxanone (PDO) microspheres have been developed and commercialized as a dermal filler. However, its irregularly hydrophobic microspheres pose hydration challenges, often causing syringe needle blockages and side effects such as delayed onset nodules and papules after the procedure. In this study, we synthesized a polyethylene glycol-poly D,L-lactic acid (mPEG-PDLLA) copolymer to address the limitations of conventional polymer fillers. Comprehensive characterization of the copolymer was performed using nuclear magnetic resonance spectroscopy, Fourier transform infrared spectroscopy, and differential scanning calorimetry. The mPEG-PDLLA copolymers demonstrated a unimodal size distribution of approximately 121 ± 20 nm in an aqueous solution. The in vitro cytotoxicity and collagen genesis of mPEG-PDLLA copolymers were evaluated using human dermal fibroblast cells. In this study, angiogenesis was observed over time in hairless mice injected with mPEG-PDLLA copolymers, confirming its potential role in enhancing collagen synthesis. To assess the inflammatory response, the expression levels of the genes MMP1 and IL-1β were analyzed. Additionally, gene expression levels such as transforming growth factor-β and collagen types I and III were compared with Rejuran® in animal studies. The newly developed collagen-stimulating PEGylated PDLLA may be a safe and effective option for skin rejuvenation.

Anatomical-Based Filler Injection Techniques: Anteromedial, Buccal, and Lateral Cheek Hollow

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Jan 2025
AESTHET PLAST SURG

Hollowness in the anteromedial, buccal, and lateral cheek regions is a common concern in aesthetic medicine, often resulting from age-related volume loss and structural changes. Advanced filler injection techniques that incorporate a thorough understanding of facial anatomy are critical for achieving optimal and safe outcomes. To review and detail anatomically guided filler injection techniques for addressing hollowness in specific cheek regions, considering facial anatomy, ethnic variations, and patient-specific aesthetic goals. A comprehensive analysis of the layered cheek structure—including skin, fat compartments, muscles, and neurovascular elements—was conducted to define effective injection techniques. Step-by-step procedures using cannula-based filler injections were described, focusing on targeting appropriate tissue planes while avoiding critical structures. Ethnic differences between Western and Asian populations were also considered to provide tailored approaches. Targeted filler injections in the anteromedial, buccal, and lateral cheek regions were shown to effectively restore volume and contour by addressing hollow areas. Precision in selecting tissue planes and using cannulas minimized complications and optimized outcomes. Ethnic-specific anatomical variations and aesthetic preferences played a significant role in technique modification and treatment planning. Anatomical-based filler injection techniques offer a precise and safe approach to nonsurgical facial rejuvenation of the cheek. A deep understanding of facial anatomy, combined with consideration of ethnic differences, enhances treatment efficacy. Future advancements, such as integrating imaging technologies and combination therapies, are expected to further refine facial rejuvenation practices. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

A Pilot One and Two‐Year Prospective, Blinded Clinical Evaluation of Efficacy, and Safety of Combined Treatment With Crosslinked Hyaluronic Acid Dermal Filler and Barbed Polydioxanone Suspension Threads for Mid‐Face Contour Enhancement

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Dec 2024
J Cosmet Dermatol

Introduction The combination of hyaluronic acid (HA) fillers and polydioxanone (PDO) thread lifting is gaining popularity for mid‐face rejuvenation, especially among the Asian population. Despite the common use of these techniques, there is a paucity of long‐term studies assessing their combined efficacy and safety. This study aims to evaluate the efficacy and safety of combined HA filler and PDO thread treatment for mid‐face rejuvenation over a 24‐month period in a Korean population. Materials and Methods This prospective, blinded, single‐center, open‐label trial included 11 Korean subjects, aged 29–70 years, with mid‐face volume loss graded 1–4 on the antero‐medial cheek fullness scale. Participants were treated with crosslinked HA dermal fillers and PDO threads. Assessments were conducted using the Global Aesthetic Improvement Scale (GAIS), investigator‐led clinical evaluations, and volumetric measurements using the Morpheus 3D system at baseline, 6, 12, and 24 months post‐treatment. Results Quantitative analysis revealed a significant reduction in mid‐face width from an average baseline of 149.27–145.00 mm at 24 months (p < 0.00001). Similarly, lower‐face width decreased from 130.36 to 117.27 mm at 24 months (p < 0.00001). The GAIS scores demonstrated high levels of subject satisfaction, with 9 out of 11 patients reporting consistent satisfaction or improvement over 24 months. Minimal adverse events were reported, and no serious complications occurred. Discussion The combination of HA fillers and PDO threads was effective in achieving and maintaining long‐term improvements in facial volume and contour. The Morpheus 3D system provided objective volumetric data, which supported the subjective improvements observed by patients and investigators. The study results highlight the benefits of ongoing neocollagenesis and tissue remodeling beyond the dissolution period of the materials. Conclusion The combination of HA filler injections and PDO thread lifting offers a promising and minimally invasive option for long‐term mid‐face rejuvenation with high patient satisfaction and a favorable safety profile. Further studies are warranted to confirm these findings across diverse populations and compare this approach with other aesthetic treatments.

Cold Plasma Application for Skin Cleansing on Wistar Rats: Power Levels, Particle Removal, and Skin Moisture Preservation

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Jan 2024

Dermatological conditions can significantly impact an individual's self-confidence and psychological health, with the quest for perfect skin frequently leading to heightened levels of stress. Current research is investigating the extensive capabilities of cold plasma technology for skin cleansing, given its remarkable potential. In this project, Wistar rats were treated with a floating electrode dielectric barrier discharge (FEDBD) plasma device. The animals were divided into two groups, each receiving treatment with different power levels, specifically 3.3 W and 7.4 W. Plasma processing was applied to the dorsal neck area of the rats, covering a surface area of 18 square centimeters. The parameters analyzed encompassed the number of particles removed from the skin surface, the levels of carbon monoxide (CO) and ozone generated by the plasma, transferred energy, and the contact angle to evaluate changes in the skin surface following plasma exposure. Furthermore, the moisture content of the skin surface was also assessed. The 7.4 W treatment resulted in a notable increase in moisture retention compared with the 3.3 W treatment, and significantly more particles were removed from the skin surface. These findings highlight the superior efficacy of higher power levels in preserving skin hydration and enhancing cleansing efficiency, which could inform the development of effective plasma-based therapies for skin rejuvenation with potential applications in clinical settings.

Review of the Adverse Effects Associated with Dermal Filler Treatments: Part I Nodules, Granuloma, and Migration

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Jul 2024

The increase in the use of filler treatments within minimally invasive cosmetic surgery has correspondingly escalated the variety and frequency of associated side effects. Initially, unregulated procedures led to primary side effects such as infections, foreign body reactions, and granuloma formation. However, severe vascular complications like skin and tissue necrosis and blindness have emerged as recognized risks. Side effects from filler treatments can range from mild to life-threatening, including edema, pain, tenderness, numbness, bleeding, bruising, hematoma, redness, erythema, pigmentation, allergic reactions, itching, pruritus, the Tyndall effect, asymmetry, irregularity, migration, skin and soft tissue infections, nodules, granulomas, and vascular compromise. These side effects are categorized into early and delayed types. Many complications, particularly those related to vascular abnormalities, are frequently linked to procedural issues, emphasizing the importance of understanding filler properties, injection techniques, and facial anatomy. Preventing side effects is ideal, but early detection and treatment are crucial. Recognizing potential side effects based on their timing and understanding appropriate preemptive treatment methods is essential. This discussion addresses non-vascular side effects, highlighting their onset, symptoms, and management strategies. The comprehensive understanding and careful management of these side effects are vital for minimizing complications and ensuring patient safety in filler treatments.

Injectable hyaluronic acid hydrogels via Michael addition as dermal fillers for skin regeneration applications

Article

Jun 2025

The Cosmetic Use of Injectables in Oculoplasty

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Jan 2024

Facial rejuvenation has become an important subject of psychosocial wellbeing in this era of fashion and beauty. Injectables offer an excellent non-surgical method of facial rejuvenation. Among which, botulinum toxin and soft tissue fillers are one of the most common and favorite tools for non-surgical rejuvenation.

Intracorporeal evaluation of hyaluronic acid fillers with varied rheological properties and correlations with aesthetic outcomes

Article

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Jul 2024
SKIN RES TECHNOL

Background Understanding the differences in soft tissue filler rheology and how these properties can impact clinical results is a fundamental concepts for any injector. This study aimed to assess the tissue integration characteristics of hyaluronic acid (HA) fillers manufactured with different technologies (Non‐Animal Stabilized HA [HA‐N] or Optimal Balance Technology [HA‐O]) using ultra‐high‐frequency ultrasound. Methods Twelve female participants with mild‐to‐moderate midface volume loss and temporal hollowing were enrolled and treated with HA‐N and/or HA‐O. Participants were seen at five visits (screening/baseline [treatment], and Weeks 1 [optional touch‐up], 4, 6, and 8 [follow‐up visits]). Ultrasound was used to evaluate the degree of product integration. Results On ultrasound, HA‐N presented with distinct borders, minimal tissue integration, and a capacity to displace tissues. Conversely, HA‐O tended to spread horizontally within the same tissue plane and integrated within tissues. The volumizing capacity of the HA‐O fillers was dependent on particle size. Conclusion HA‐N is suited for deep injections in areas such as the upper lateral cheek and under the muscle of the temporal region when a lifting effect is desired; HA‐O is best suited for subcutaneous injections, in areas of dynamic movement or for patients with thin skin; and can be injected subcutaneously or supraperiosteally when a volumizing effect is desired.

Watching over the medical device industry

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Jul 2009

Jeanne Lenzer

Arterial embolization caused by injection of hyaluronic acid (RestylaneR)

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The Polysaccharide of the Vitreous Humor

Article

Dec 1934

A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvederm (R) injectable gel with and without lidocaine

Article

Sep 2009
J Cosmet Dermatol

Introduction Pain is a common patient complaint during dermal filler injections. The primary objective of this study was to compare a new formulation of Juvéderm® injectable gel with lidocaine (denoted as JUV + L) to commercially-available Juvéderm® injectable gel without lidocaine (denoted as JUV) with respect to procedural pain scores in subjects desiring nasolabial fold (NLF) correction. Methods Subjects received randomized treatment with the lidocaine filler in one NLF and the filler without lidocaine in the other NLF. Investigators determined the appropriate formulation (Ultra or Ultra Plus) and volume of material to inject but were blinded as to which syringe contained lidocaine. Subjects rated procedural pain (pain during injection) using an 11-point scale within 30 min after receiving treatment in both NLFs and compared procedural pain between right and left NLFs using a 5-point scale. NLF severity was rated by both subjects and investigators before and 2 weeks after treatment. Results The mean difference on the procedural pain scale was 3.4 (P < 0.0001), and 93% of subjects found JUV + L to be less or slightly less painful than JUV. Improvement in NLF severity was comparable for both products. Common treatment site reactions (CTRs) of pain and tenderness were considerably less frequent for JUV + L than JUV while all other CTRs showed no statistically significant differences. Conclusion The dermal filler formulated with lidocaine is effective in reducing procedural pain during correction of facial wrinkles and folds while maintaining a similar safety and effectiveness profile to the filler without lidocaine.

Complications after Treatment with Polyalkylimide

Article

Oct 2009
DERMATOL SURG

Polyalkylimide is a nonresorbable, biocompatible polymeric filler that has been used for several years to treat soft tissue deficits. The literature has shown a minor complication rate. We noticed that complications typically appear several years after injection. To evaluate the complications reported after treatment with polyalkylimide. We describe a retrospective evaluation, reported by members and candidate members of the Dutch Society of Cosmetic Medicine, of complications after use of polyalkylimide. In total, 3,196 patients were treated, and 4,738 treatments were performed, from which 154 complications (patient complication rate 4.8%, treatment complication rate 3.3%) were reported. The most common complication was inflammation; other complications were hardening, migration, and accumulation of the product. In some patients, skin biopsy followed by histologic examination was performed. Treatments with polyalkylimide have been reported to give rise to complications years after treatment. Even though the study described is a retrospective evaluation, we consider an overall complication rate of 4.8%, the severity of the complications, and the difficulty in treating them too high a risk for a cosmetic treatment. The Dutch Society of Cosmetic Medicine advises against the use of polyalkylimide.

Injection rhinoplasty: Non-surgical nasal augmentation and correction of post-rhinoplasty contour asymmetries with hyaluronic acid: How we do it

Article

Jun 2010
Clin Otolaryngol

Anatomy and Nonsurgical Correction of the Tear Trough Deformity

Article

Feb 2010

Haideh Hirmand

SUMMARY: The development of dark circles under the eyes is one of the early signs of periorbital aging, lending a fatigued and aged appearance to the face. Loeb, in 1961, used the term "nasojugal groove" to describe the concavity at the border of the eyelid and the cheek medially. Flowers, in 1969, first named this groove the "tear trough." In the present article, the author presents a detailed description of the anatomy and nonsurgical correction of this deformity. Nonsurgical correction of the tear trough deformity with hyaluronic acid is effective and safe and is associated with high patient satisfaction. The procedure offers both an adjunct to surgery and an alternative to it in some patients. It also provides an opportunity for global midfacial volume correction. Careful patient selection and attention to technique will minimize side effects.

Long-Term Orbitofacial Complications of Polyalkylimide 4% (Bio-Alcamid)

Article

Sep 2009

To review our experience with the long-term orbitofacial complications of polyalkylimide 4% (Bio-Alcamid), including migration, infection, and recurrent swelling. A retrospective case series of 4 patients who received preperiosteal polyalkylimide 4% filler treatment: 3 patients received treatment to cheeks and/or nasolabial folds and 1 received treatment to the tear-trough region. All 4 patients were referred with delayed complications. Four patients presented with the unusual delayed complications of infection including abscess formation, migration of filler, recurrent swelling, and inflammatory nodules. Because of the hydrophilic and endoprosthetic nature of polyalkylimide 4%, migration of the product is unexpected. We hypothesise that in our patients, filler migration occurred after bimanual expression and/or manipulation of the product with disruption of the surrounding collagen capsule. Because removal of polyalkylimide 4% is only achieved via aspiration and bimanual expression, which itself may precipitate long-term migration of the product, it is vital that clinicians are mindful of these complications and the pitfalls of overfill and misplacement of the product, for informed patient consent.

Delayed Inflammatory Reaction to Bio-Alcamid Polyacrylamide Gel Used for Soft-Tissue Augmentation

Article

Nov 2009

Given the recent boom of the cosmetic industry, there is a wealth of new products available to patients and physicians, including soft-tissue fillers. Bio-Alcamid polyacrylamide gel (Polymekon, Milan, Italy) is a filler that has potential to cause adverse reactions. Two patients who had previously been treated with Bio-Alcamid outside of the United States presented with different manifestations of inflammatory responses to the product. These reactions were challenging to treat. Despite claims of safety, Bio-Alcamid and possibly other soft-tissue fillers available worldwide have the potential to cause adverse reactions. Physicians should be aware of the various presentations and treatment options for these reactions.

Foreign body granulomas after injection of Bio-alcamid for lip augmentation

Article

Sep 2009

Bio-alcamid is one of the newest agents on the market for soft tissue augmentation. Seven studies were documented in the medical literature that examined the safety of Bio-alcamid (Polymekon, Brindisy, Italy); all reported no cases of tissue migration, foreign body granulomas, allergenicity, or interference with the control of cell proliferation. On 2 separate occasions, a woman who had recently undergone lip augmentation presented at our hospital with submucosal nodules of the lip. Histologic examination revealed multiple foreign body-type granulomas composed of giant cells, epithelioid cells, and chronic inflammation of the lip. Efforts to produce a cosmetic material that fulfills all the criteria as an "ideal" agent has not yet been found because all injectable foreign agents have the potential to induce adverse reactions. Caution must be exercised in all cases and the risks explained to the patient before its use.