Case ReportAesthetic Facial Surgery

Int. J. Oral Maxillofac. Surg. 2008; 37: 955–960doi:10.1016/j.ijom.2008.04.020, available online at http://www.sciencedirect.com

Complications after facialcontour augmentation withinjectable silicone. Diagnosisand treatment. Report of asevere caseG. E. Anastassov, S. Schulhof, H. Lumerman: Complications after facial contouraugmentation with injectable silicone. Diagnosis and treatment. Report of a severecase. Int. J. Oral Maxillofac. Surg. 2008; 37: 955–960. # 2008 InternationalAssociation of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rightsreserved.

G. E. Anastassov1, S. Schulhof1,H. Lumerman2

1Maxillofacial Surgery, Mount Sinai School ofMedicine, New York, USA; 2Department ofPathology, Mount Sinai School of Medicine,New York, USA

0901-5027/100955 +

rpose of this article is to increase the pract

Abstract. The pu itioner’s awareness of theadverse effects associated with the clinical utilization of foreign bodies(heterofillers), especially silicones for contour augmentation of the face. Diagnosticmodes for such difficult cases as well as means for their treatment are discussed inthe light of a severe case of facial siliconomas. The case of a 46-year-old femalepatient with severe facial irregularities and pain secondary to siliconomas 5 yearsafter facial augmentation with silicone is presented. The patient was treatedsurgically after histological and radiographical confirmation of the diagnosis offacial siliconomas. Extensive dissection of the siliconomas and infiltratedsurrounding fascial planes was performed. The patient underwent a protractedcourse of oral minocycline followed by facial lipofilling with autogenous fat forcorrection of residual contour irregularities. Silicone may produce unpredictableand devastating complications, which are difficult if not impossible to treatadequately. It is cautious not to use foreign bodies that are not approved by the FDAas contour enhancers, especially not in large quantities.

06 $30.00/0 # 2008 Interna

tional Association of Oral and Maxillofacial Surgeo

Keywords: facial fillers; silicone; heterofillers;siliconoma; granuloma; facial disfigurement; fatgrafting.

Accepted for publication 24 April 2008Available online 12 June 2008

The desire for facial and body volumeenhancement is not new. In the 18th cen-tury and at the beginning of the 19thcentury, paraffin injections were usedfor contour augmentation. The use ofinjectable paraffin became popular in the

1900s. In 1899, Gersuny used paraffin tocreate a testicular prosthesis in a youngindividual via scrotal injections. Thepatient had lost his testicles due to tuber-culosis. In 1902, Eckstein observed par-affin migration and soft tissue induration

and consequent mutilation11. Paraffino-mas, leading in some cases to malignanttransformation of the surrounding tissueswere also reported18. According to thesereports the paraffin usually was displaceddue to the gravitational as well as dynamic

ns. Published by Elsevier Ltd. All rights reserved.

956 Anastassov et al.

Fig. 1. Preoperative clinical photographs.

Fig. 2. Maxillofacial CT scans. Note diffuse , extensive irregular asymmetric multiple nodularradiodensities secondary to infiltration of the midfacial region, nasolabial folds and periorbitalsoft tissues.

Fig. 3. Clinical photograph during biopsy, depicting pale, indurated foreign body in the rightmaxillary vestibule (arrow).

forces producing unpredictable andunsightly outcomes. The era of modernsoft tissue augmentation dates back toNeuber, who first described the use ofautogenous adipose tissue for contour aug-mentation11. He used fat blocks obtainedfrom the arms via open lipectomy to aug-ment depressed facial defects.

Multiple synthetic formulations are onthe market today. These are based onderivatives of polyvinylsiloxane, ePTFE(GoreTex), homologous preserved dermis(AlloDerm), homologous lyophilized fas-cia lata (Fascian), derivatives of hialuronicacid (Restiline), homologous and hetero-logous as well as autologous collagen (e.g.Zyderm), and others. For a material to bean ‘ideal’ tissue filler it must meet certaincriteria. It should be biologically inert,retain its physical properties, be easy tomanipulate, be easily obtainable, inexpen-sive, and produce consistently predictable,good results in the short and long term1.Such material currently does not exist.Silicones are synthetic long-chain organo-silicones. The most popular of these com-pounds is polydimethylsiloxane. Siliconecan exist in many different forms, fromliquid, gel to solid. Silicone became pop-ular in the 1950s, especially in the Far Eastwhere it was used extensively for contourenhancements. It was used mainly on theface, breast and hips. Silicone was used asan injectable material and as a shell andshell filler in breast prostheses. The pro-ponents of silicone use believe that poly-vinylsiloxane is inert and stable onceinjected subcutaneously causing no or

Complications after facial contour augmentation 957

Fig. 4. Histopathology of the biopsy sample (magnification x200). Note the clear spaces fromthe pre-existing silicone in the soft tissues as well as in the multinucleated foreign body typehistiocytes. In addition, there is a chronic inflammatory reaction (lymphocytes, plasma cells,histiocytes).

only a mild immunological response5.Devastating consequences to siliconeinjections have also been reported2–25.The pathophysiology of the granuloma-tous reaction caused by silicone isunknown but thought to be a cross reactionto a viral agent, the material acting as afocus for infection, impure additives andcross-contamination during injection3.Repeated exposure to silicone gel mayinduce an antigen-specific lymphocyte-mediated response6. The tissue reactionto silicone varies and depends on the formin which it is being used. The siliconeshells (implants) produce ‘walling-off’via a foreign-body giant-cell reaction withpossible leakage to the regional or distantlymph nodes. When used as a gel or liquidsilicone usually produces empty, micro-cystic spaces, which are generally small ormedium sized and depend on the amountof silicone injected to the tissues6. Theseside effects can present immediately afterinjection or many years later. The granu-lomas associated with silicone injectionsin the soft tissues are known as ‘silicono-mas’, a term used by Winer in 196427. Thediagnosis is usually established reliablythrough CT or MRI imaging and histo-pathological investigation. The treatmentof these lesions is controversial and rangesfrom intralesional injections of steroids,systemic steroids, immunomodulators,antibiotics, suction assisted lipectomy toopen surgical removal of the lesions. Thetreatment depends on the location, theextent of the lesion, the wishes of thepatient and the surgeon’s preference andexperience.

Fig. 5. Preoperative outline of the areas involved with palpable siliconomas to be dissected ouduring the surgical intervention.

Case presentation

A 46-year-old Latin American female pre-sented in June 2005 with complaints offacial contour irregularities, skin tightnessand pain. The history included injectionsof ‘vitamins’ to her face 5 years pre-viously. The symptoms started appearingshortly thereafter and gradually pro-gressed to constant nuisance. On clinicalexamination (Fig. 1) the patient had multi-ple facial irregularities and indurations inthe frontal, glabellar, periorbital, malar,temporal, upper and lower labial, buccaland pre-masseteric areas. The overlyingskin was slightly erythematous and theareas were tender to palpation. Therewas evidence of prior facial rhytidectomy(pre- and post-auricular scars), which wasdone prior to the injections according tothe patient. The facial motor and neuro-sensory functions were otherwise notaltered. The preliminary diagnosis wasforeign body reaction. Facial CT imaging

and incissional biopsy were performed(Figs. 2 and 3). The CT scan showedmultiple irregular asymmetric nodulardensities surrounding the facial muscles.The biopsy specimen was taken from theright buccal region via a transoral-vestib-ular approach. The lesion biopsied had apale, pearly appearance and felt induratedand rubbery in consistency. On sectioning

through the specimen, rubber-like resis-tance was felt. The histopathology reportconfirmed silicone granuloma (Fig. 4).The patient was brought to the operatingroom in July 2005 for removal of silico-nomas. The lesions were outlined on theskin preoperatively (Fig. 5). The access tothese granulomas was through a facialrhytidectomy approach and pre-trichial

t

958 Anastassov et al.

Fig. 6. Intraoperative photograph showing extensive involvement of the subcutaneous tissueswith siliconomas and lack of clear plane between the lesions and the surrounding tissues.

forehead incision combined with intraoralvestibular incisions (Fig. 6). On reflectionof the skin flaps, it was noted that thelesions were infiltrating the surroundingsubcutaneous plane and fasciae of theunderlying muscles. These lesions formedalmost a uniform intrafascial plane. Carewas taken to identify and protect thebranches of the facial nerve. The lesionswere painstakingly dissected. Approxi-mately 200 mg of granulomatous tissuewas removed and submitted. The post-operative course was uneventful. Thepatient had some persistent skin irregula-rities due to siliconomas, which could notbe safely removed without compromisingthe functional integrity of the muscles offacial expression, such as the orbicularisoculi (Fig. 7). Some of the lesions wereintimately associated with the overlyingskin and caused skin depressions aftertheir removal. To reduce the residualinflammation the patient was started onoral regimen of minocycline 100 mg twicea day. The residual facial irregularitieswere augmented with autogenous fat vialipofilling after sufficient time for resolu-tion of the oedema had passed. The min-ocycline improved the residual skinirregularities. The patient was brought tothe operating room 6 months after the

initial procedure where abdominal suc-tion-assisted lipectomy was performed,lipoaspirate collected sterile, centrifugedand injected in the face in the deficientareas. This improved the contour of theface significantly. It also improved thequality of the overlying skin (Fig. 8). Cur-rently the patient is free of symptoms andsatisfied with the outcome of the multiplesurgical procedures. The patient has com-pleted a 12-month course of minocyclinewithout adverse reactions.

Discussion

The complications associated with theinjection of foreign substances to the faceand body are well recognized8,10,15,26. Ifthe injected substance comprises smallsize particles, amenable for phagocytosisby macrophages then the matter will beeliminated or replaced by fibroblasts orcollagen fibers within 1–3 months post-injection. If it is larger, foreign-body reac-tion and walling-off of the lesion willoccur2,17. The size of the silicone particlesis 170 micrometers. The phagocytic abil-ity of the microphages is limited to 15micrometers and hence, they are unable toprocess silicone particles15. In vitro stu-dies have shown significant changes of the

cellular configuration and alteration offibroblast proliferation16. The complica-tions reported in the literature related toinjection of silicone for cosmetic purposesare numerous. They are pain, local inflam-mation, dyschromia, migration, abscessformation22, indurated granulomas2–7,severe migratory granulomatous reac-tions24, connective-tissue disease8,10,12,calcinosis cutis with hypercalcemia13,lupus milliaris disseminatus and siccacomplex23 and even death3.

For these reasons, the Food and DrugAdministration (FDA) has not approvedsilicone for volume augmentation.Recently, the FDA approved Adatosil5000 and Silicon 1000 for the treatmentof retinal detachment in ophthalmology.There are proponents for the use of sili-cone as fillers who have presented large,retrospective series of patients with rela-tively low complication rates and excel-lent results. These authors base theirsupport on the premise that successdepends on training and the use of sterile,medical grade silicone by microdroplet,using a multistage technique and properpatient selection5.

The rationale for the application ofminocycline is based on its anti-inflam-matory, immunomodulating, and anti-granulomatous properties2,21. Thereported cases show that protracted useof minocycline is safe and efficient inalleviating the chronic inflammatorysymptoms of siliconomas2. Side effectssuch as skin depigmentation have beenreported2. Other chemotherapeutic agentshave been described for treatment of sili-cone-related granulomas, such as corticos-teroids and immunomodulators(Imiquimod 5% cream)3. The case pre-sented by these authors, however wasmilder and of short duration; only sixmonths after the administration of siliconeinjections. This may be one of the reasonsfor the positive effect of this therapeuticmodality. The authors stated, ‘of course,placebo effect cannot be excluded as wellas spontaneous improvement of the con-dition’. The present case was severe withthe involvement of multiple regions, a‘mask-like’ area of the face and associatedwith pain. It was felt that owing to theextent of the siliconomas the most appro-priate treatment was surgical removal ofthe lesions although, there are reports onuse of ultrasonic suction-assisted lipect-omy (SAL) for elimination of facial andcorporal siliconomas7. In the present casethe siliconomas were diffusely infiltratingmultiple fascial planes, muscles in closeproximity to vital structures (nerves, ves-sels) and an open, controlled procedure

Complications after facial contour augmentation 959

Fig. 8. Photographs taken after lipofilling. Note improved facial con-tour and skin quality.

ig. 7. Clinical photographs taken 2 months postoperatively showingultiple skin .

Fm

960 Anastassov et al.

provided advantages over a closed, blindprocedure. Neither SAL nor open debride-ment provides ideal results and additionalprocedures are often required for an opti-mal result to be achieved12. Autogenous fatobtained via SAL and centrifuged, injectedatraumatically still remains the material ofchoice for contour augmentation.

References

1. Anastassov GA, Haiavy J. Aesthetic lipaugmentation with autologous superficialmusculoapponeurotic system free grafts.J Aesthet Dermatol and Cosm Surg 2000:1: 247–250.

2. Arin MJ, Bate J, Kreig TH, Hunzel-

man N. Silicone granulomas of the facetreated with minocycline. J Amer AcadDermatol 2005: 52: 53–56.

3. Baumann LS, Halem ML. Lip siliconegranulomatous foreign body reactiontreated with Aldara (Imiquimod 5%).Dermatol Surg 2003: 29: 429–432.

4. Bigata X, Ribera M, Bielsa I, Fernan-

dez C. Adverse granulomatous reactionAfter Cosmetic dermal silicone injection.Dermatol Surg 2001: 27: 198–200.

5. Duffy DM. Liquid Silicone for Soft Tis-sue Augmentation. Dermatol Surg 2005:31: 1530–1541.

6. Ficarra G, Mosqueda-Taylor A, Car-

los R. Silicone granulomas of the facialtissues: A report of seven cases. Oral SurgOral Med Oral Pathol 2002: 94: 65–73.

7. Grippaudo FR, Spalvieri C, Rossi A,Onesti MG, Scuderi N. Ultrasound-assisted liposuction for the removal ofsiliconomas. Scand J Plast Reconstr SurgHand Surg 2004: 38: 21–26.

8. Habal MB. The biologic basis for theclinical application of the silicones. Acorrelate to their biocompatibility. ArchSurg 1984: 119: 843–848.

9. Janovsky EC, Kupper LL, Hulka BS.Meta-analyses of the relation betweensilicone breast implants and the risk of

connective-tissue diseases. New Engl JMed 2000: 342: 781–790.

10. JANSEN T, KOSSMAN E, PLEWIG G. Silico-nome. Ein interdisziplinares problem.Der Hautarzt; Zeitschrift fur dermatol-ogy, venerologie, und verwandte gebeite1993; 44: 636–643.

11. Klein AW, Elson ML. The history ofsubstances for soft tissue augmentation.Dermatol Surg 2000: 26: 1096–1105.

12. Lai YL, Weng CJ, Noordhoff MS.Breast reconstruction with TRAM flapafter subcutaneous mastectomy forinjected material (siliconoma). Br J PlastSurg 2001: 54: 331–334.

13. Loke SC, Leow MKS. Calcinosis cutiswith siliconomas complicated by hyper-calcemia. Endocr Pract 2005: 11: 341–345.

14. Lombardi T, Samson J, Plantier F,Husson C, Kuffer R. Orofacial granu-lomas after injection of cosmetic fillers.Histopathologic and clinical study of 11cases. J Oral Pathol Med 2004: 33: 115–120.

15. Maas CS, Papel ID, Greene D, Stoker

DA, Duffy DM. Complications of inject-able synthetic polymers in facial augmen-tation. Dermatol Surg 1997: 23: 871–877.

16. McCauley RL, Riley WB, Juliano

RA, Brown P, Evans MJ, Robson

MC. In vitro alterations in human fibro-blasts behavior secondary to siliconepolymers. J Surg Research 1990: 49:103–109.

17. Morhenn VB, Lemperle G, Gallo RL.Phagocytosis of different particulate der-mal filler substances by human macro-phages and skin cells. Dermatol Surg2002: 28: 484–490.

18. Padgett EA. Surgical Diseases of theMouth and Jaws. Philadelphia: W.B.Saunders and Co. 1942: pp.502-503.

19. Poveda R, Bagan JV, Murillo J, Jime-

nez J. Granulomatous facial reaction toinjected cosmetic fillers- a presentation offive cases. Med Oral Pathol Oral CirBuccal 2006: 11: 1–5.

20. Salmi R, Boari B, Manfredini R. Sili-conoma: an unusual entity for the inter-nist. Amer J Med 2004: 116: 67.

21. Senet P, Bacelez L, Ollivaud L, Vig-

non-Pennamen D, Dubernet L. Min-ocycline for the treatment of cutaneoussilicone granulomas. Br J Dermatol 1999:140: 985–987.

22. Shmidt-Westhausen AM, Frege J,Reichert PA. Abscess formation afterlip augmentation with silicone: Casereport. Int J Oral Maxillofac Surg 2004:33: 198–200.

23. Suzuki K, Aoki M, Kawana S, Hya-

kusoku H, Myazava S. Metastatic sili-cone granulomas: Lupus milliarisdisseminatus faciei-like facial nodulesand sicca complex in a silicone breastimplant recipient. Arch Dermatol 2002:138: 537–538.

24. Teuber SS, Reilly DA, Howell L,Oide C, Gershwin ME. Severe migra-tory granulomatous reactions to siliconegel in 3 patients. J Rheumatol 1999: 26:699–704.

25. Travis WD, Balogh K, Abraham JL.Silicone granulomas: Report of threecases and review of the literature. HumPathol 1985: 16: 19–27.

26. Wilkie TF. Late development ofgranulomas after liquid silicone injec-tions. Plast Reconstr Surg 1977: 60:179–188.

27. Winer LH, Stenberg TH, Lehman R,Ashley FL. Tissue reactions to injectablesilicone liquids. Arch Dermatol 1964: 90:588–592.

Address:George E. AnastassovMaxillofacial Surgery Services18 East 50’th Street5 FloorNew YorkNY 10022Tel.: +1 212 751 0001Fax: +1 212 753 0540E-mail: ganastassov@mfss.net