Silicone injections: selected medical papers

(clik aquí para la traducción española)

Transgender-specific deaths and injuries

Hage JJ, Kanhai RC, Oen AL, van Diest PJ, Karim RB. : The devastating outcome of massive subcutaneous injection of highly viscous fluids in male-to-female transsexuals. Plast Reconstr Surg 2001 Mar;107(3):734-41

Duong T, Schonfeld AJ, Yungbluth M, Slotten R. : Acute pneumopathy in a nonsurgical transsexual. Chest 1998 Apr;113(4):1127-9

Farina LA, Palacio V, Salles M, Fernandez-Villanueva D, Vidal B, Menendez P. : [Scrotal granuloma caused by oil migrating from the hip in 2 transsexual males (scrotal sclerosing lipogranuloma)] Arch Esp Urol 1997 Jan-Feb;50(1):51-3 in Spanish)

Chastre J, Brun P, Soler P, Basset F, Trouillet JL, Fagon JY, Gibert C, Hance AJ. Acute and latent pneumonitis after subcutaneous injections of silicone in transsexual men. Am Rev Respir Dis 1987 Jan;135(1):236-40

Chastre J, Brun P, Gibert C. [Acute respiratory insufficiency following illicit silicone injections: the value of broncho-alveolar lavage] Bull Acad Natl Med 1986 Apr;170(4):531-5 [Article in French]

Chastre J, Basset F, Viau F, Dournovo P, Bouchama A, Akesbi A, Gibert C. Acute pneumonitis after subcutaneous injections of silicone in transsexual men. N Engl J Med 1983 Mar 31;308(13):764-7.

Vilde F, Arkwright S, Galliot M, Galle P, Labrousse J, Lissac J. : [Fatal pneumopathy linked to subcutaneous injections of liquid silicone into soft tissue] Ann Pathol 1983 Dec;3(4):307-12

Coulaud JM, Labrousse J, Carli P, Galliot M, Vilde F, Lissac J. : Adult respiratory distress syndrome and silicone injection. Toxicol Eur Res 1983 Jul;5(4):171-4

General reviews, animal studies and adverse reaction reports

Chaplin, C.H. (1969). Loss of both breasts from injections of silicone (with additive). Plastic and Reconstructive Surgery, 44(5), 447-450.

Ellenbogen, R., & Rubin L. (1975). Injectable fluid silicone therapy: Human morbidity and mortality. Journal of the American Medical Association, 234, 309-309.

Villa A, Sparacio F. Severe pulmonary complications after silicone fluid injection. Am J Emerg Med 2000 May;18(3):336-7

Kubota J, Fujino T, Sugymoto C, Abe T : Long term complications caused by injected silicone gel and paraffin oil. Keio J Med 1984; 33 : 127-136.

Bigata X, Ribera M, Bielsa I, Ferrandiz C. Adverse granulomatous reaction after cosmetic dermal silicone injection. : Dermatol Surg 2001 Feb;27(2):198-200

Schoeller T, Gschnitzer C, Wechselberger G, Otto A, Hussl H, Piza-Katzer H. [Chronic recurrent, locally destructive siliconomas after breast augmentation by liquid silicone oil]. Chirurg 2000 Nov;71(11):1370-3

Frey HP, Lemperle G, Exner K. [Siliconoma and rheumatic symptoms--a familiar and a questionable complication of silicone implantation] Handchir Mikrochir Plast Chir 1992 Jul;24(4):171-7; discussion 178

Holm C, Muhlbauer W. Toxic shock syndrome in plastic surgery patients: case report and review of the literature. Aesthetic Plast Surg. 1998 May-Jun;22(3):180-4.

Sergott TJ, Limoli JP, Baldwin CM, Laub DR : Human adjuvant disease, possible autoimmune disease after silicone implantation : A review of the literature, case studies, and speculation for the future. Plast Reconstr Surg 1986; 78 : 104-114.

Meigel W, Winzer M, Berg A, Wolff HH. [Siliconoma] Z Hautkr 1989 Sep 15;64(9):815-6

Jansen T, Kossmann E, Plewig G. [Siliconoma. An interdisciplinary problem]. Hautarzt 1993 Oct;44(10):636-43

Lai YL, Weng CJ, Noordhoff MS. Breast reconstruction with TRAM flap after subcutaneous mastectomy for injected material (siliconoma). Br J Plast Surg 2001 Jun;54(4):331-4

Zager W. Silicone flash after laser use Archives of Otolaryngology--Head and Neck Surgery 2001;127:418-421.

Kopf, E.H., Vinnik, C.A., Bongiovi, J.J., & Dombrowski, D.J. (1976). Complications of silicone injections. Rocky Mountain Medical Journal, 75, 77-80.

Kopf EH. Injectable silicones. Rocky Mt Med J. 1966 Mar;63(3):34-6.

Solomons ET, Jones JK. The determination of polydimethylsiloxane (silicone oil) in biological materials: a case report. J Forensic Sci 1975 Jan;20(1):191-9

Parsons, R.W., & Titering, H.R. (1977). Management of the silicone injected breast. Plastic and Reconstructive Surgery, 60, 534.

Spira M, Rosen T : Injectable soft tissue substitutes. Clin Plast Surg 1993; 20 : 181-188.

Megumi Y. Immediate breast reconstruction with subpectoral implantation after transaxillary subcutaneous mastectomy for siliconoma. Aesthetic Plast Surg. 1989 Winter;13(1):27-32.

Baruch J, Wechsler J, Bodin B, Raulo Y. [Slowly evolving breast siliconoma] Ann Chir Plast. 1982;27(2):183-4. French.

Ashley FL, Braley S, Rees TD : The present status of silicone fluid in soft tissue augmentation. Plast Reconstr Surg 1967; 39 : 411-418.

Ashley FL, Braley S, McNall EG. The current status of silicone injection therapy. Surg Clin North Am. 1971 Apr;51(2):501-9.

Habal MB : The biologic basis for the clinical application of the silicones. Arch Surg 1984; 119 : 843- 848.

Habal MB, Powell ML, Schimpff RD. Immunological evaluation of the tumorigenic response to implanted polymers. J Biomed Mater Res. 1980 Jul;14(4):455-66.

Duffy MJ, Woods JE. Health risks of failed silicone gel breast implants: a 30-year clinical experience. Plast Reconstr Surg 1994 Aug;94(2):295-9

Selmanowitz VJ, Orentreich N. Medical-grade fluid silicone. A monographic review. J Dermatol Surg Oncol. 1977 Nov-Dec;3(6):597-611.

Orentreich DS. Liquid injectable silicone: techniques for soft tissue augmentation. Clin Plast Surg. 2000 Oct;27(4):595-612.

Ben-Hur N, Neuman Z. Siliconoma--another cutaneous response to dimethylpolysiloxane. Experimental study in mice. Plast Reconstr Surg. 1965 Dec;36(6):629-31.

Sclafani AP, Romo T 3rd.Injectable fillers for facial soft tissue enhancement. Facial Plast Surg. 2000;16(1):29-34.

Millard D.R., Maisels D.D. : Silicone granuloma of the skin and subcutaneous tissue. Am J Surg 1966;112 : 119.

Travis WD, Balogh K, Abraham JL : Silicone granulomas : Report of three cases and review of the literature. Human Pathol 1985; 16 : 19-27.

Lorenz R, Stark GB, Hedde JP. [The value of sonography for the discovery of complications after the implantation of silicone gel prostheses for breast augmentation or reconstruction]
Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr. 1997 Mar;166(3):233-7. German.

Mitnick JS : Fine needle aspiration biopsy in patients with augmentation prostheses and a palpable mass. Ann Plast Surg 1993; 31 : 241-244.

Requena C : Adverse reactions to injectable aesthetic microimplants. Am J Dermatopathol 2001 Jun;23(3):197-202

Duffy MJ, Woods JE. Health risks of failed silicone gel breast implants: a 30-year clinical experience. Plast Reconstr Surg. 1994 Aug;94(2):295-9.


Naoum C, Dasiou-Plakida D, Pantelidaki K, Dara C, Chrisanthakis D, Perissios A. A histological and immunohistochemical study of medical-grade fluid silicone. Dermatol Surg. 1998 Aug;24(8):867-70. PMID: 9723051

BACKGROUND: Medical-grade injectable silicone for use in soft tissue augmentation is administered subcutaneously by injections of the pure material. OBJECTIVE: To examine histologically and immunohistochemically the characteristics of medical-grade silicone and to identify the advantages and disadvantages of the serial puncture technique. RESULTS: In early biopsies, perivascular lymphocytic infiltration with the characteristic reaction of delayed hypersensitivity (doses, 0.05-0.07 mL) was observed. Immunohistochemically, small local deposits of IgG and IgA were observed around the walls of small vessels. In later biopsies, the inflammation had progressed to a fibroblastic reaction. Additionally, the implantation of large doses provoked giant cell granulomas. CONCLUSIONS: Small doses (0.05-0.07 mL) of injected silicone produce an immunologic and fibroblastic reaction in the skin. The use of this substance with the serial puncture technique is not hazardous when proper technique is used.

Rapaport MJ, Vinnik C, Zarem H. Injectable silicone: cause of facial nodules, cellulitis, ulceration, and migration. Aesthetic Plast Surg. 1996 May-Jun;20(3):267-76. PMID: 8670396

Fifty-four patients with problems following "medical grade" silicone injections into the face and legs were seen from 1974 until 1995. Complications consisted of chronic cellulitis, nodules, foreign body reactions, and movement of material to near and distant parts of the body. These difficulties usually demonstrated themselves many years after injection. It is suggested that problems occur despite good technique, good material, and small amounts injected. Because the side effects are unpredictable and often uncorrectable, further studies must be performed to insure silicone's safety.

Beekman WH, Hage JJ, Jorna LB, Mulder JW. Augmentation mammaplasty: the story before the silicone bag prosthesis. Ann Plast Surg. 1999 Oct;43(4):446-51. PMID: 10517477

Czerny from Heidelberg is generally accepted to have performed the first augmentation mammaplasty in 1895. Since then, a variety of nonsilicone materials have been injected or implanted to augment or to reconstruct the hypoplastic female breast, including autologous tissues, intramammary- or submammary-injected alloplastic materials, and preformed alloplastic materials other than silicone. For various reasons outlined in this review, none was fully acceptable. The introduction of the medical-grade silicone bag prosthesis in the early 1960s improved the results of mammary augmentation dramatically and reduced the incidence of fibrous contracture and implant extrusion. Other methods of breast augmentation became obsolete.

Leibman AJ, Sybers R. Mammographic and sonographic findings after silicone injection. Ann Plast Surg. 1994 Oct;33(4):412-4. PMID: 7810958

The illicit use of silicone injection for cosmetic augmentation was performed in the 1960s. However, this method of augmentation was subsequently abandoned. Recently, a resurgence of this practice has occurred. We present reports of 2 patients who had non-medical-grade silicone injected into their breasts clandestinely. The clinical findings and imaging features are presented.

Duffy DM. Silicone: a critical review. Adv Dermatol. 1990;5:93-107; discussion 108-9. PMID: 2204381

The response of biologic systems to implanted foreign materials is subject to a lesion of variables. Each type of implant must be individually evaluated in a specific application and host. Pure DMPS polymer injected into subcutaneous tissues behaves in a specific and characteristic way. An analysis of the behavior of other types of implants in other applications will not necessarily reveal insights applicable to the behavior of liquid silicone. Most adverse case reports relate to injected fluids of unknown purity or identity used in inappropriate volumes in poorly chosen anatomical sites. It is ironic that pure DMPS in small volumes, a theoretically ideal combination, is so mistrusted. However, liquid silicone's sinful potential was easy to predict. It was cheap, available, easy to use, and, when injected in large volumes, produced instant and financially profitable results. Moreover, a welter of confusing titles, "authorized investigators" and "medical grade silicone" coupled with sensationally adverse reports detailing a criminal misuse of this modality led to draconian measures banning its use and made a meaningful analysis of true incidence and type of side effects following its use nearly impossible to assess. The advocates' position that liquid silicone is safe when used properly cannot be refuted. Only a handful of serious adverse reactions can be documented following its use; however, the concept that pure DMPS polymer can, even in expert hands, occasionally produce immunologically mediated adverse effects is equally irrefutable. This concept is supported by the following evidence: 1. Minor idiosyncratic and granulomatous reactions occurring in 1 in 10,000 are reported in association with a nidus of infection or as a consequence of allergic events. 2. At least one serious inflammatory reaction occurred in a patient afflicted with both autoimmune disease and concurrent infection. These reactions are best understood in the broader context of tissue responses to all classes of implanted foreign material, and they are most easily understood in the narrow context of autoimmune disease after injection of implantable paraffin, silicone, and possibly "silicone polymers." "Certain authors speculate that silicone acting as a primary antigen is not likely," however, silicone acting as an adjuvant associated with a subclinical infection as an antigen source may be the cause of adjuvant disease. A careful review of published anecdotal and personal experience involving the use of 350 centistoke pure dimethypolysiloxane fluid (liquid silicone) for soft-tissue augmentation in small volumes (and in large volumes for facial hemiatrophy) suggests that the bias against its proper use is unfounded.

Wilkie TF. Late development of granuloma after liquid silicone injections. Plast Reconstr Surg. 1977 Aug;60(2):179-88. PMID: 887659

In a 10-year experience with silicone injections involving 92 patients, there was subsequent development of a granuloma in 13 injection sites. Most of these occurred within 12 months, but some took a few years and one appeared 7 years later. It is believed that the injected material was medical grade liquid silicone, without additives or contaminants.

Webster RC, Gaunt JM, Hamdan US, Fuleihan NS, Smith RC. Injectable silicone for facial soft-tissue augmentation. Arch Otolaryngol Head Neck Surg. 1986 Mar;112(3):290-6. PMID: 3942634

Medical-grade injectable silicone has been safely and efficiently used for facial soft-tissue augmentation in 235 patients. Our 20-year experience with the microdroplet technique included 2,811 treatments performed for camouflaging furrows and grooves, augmentation of facial eminences, and elevation of certain depressed scars. The indications and techniques of injection are discussed. The augmenting effect is greater than that produced by the small volumes of silicone injected. Our study supports other work indicating induction of collagen deposition in the patients around the microdroplets of silicone, thus providing augmentation from volumes of collagen and silicone as well.

Hexsel DM, Hexsel CL, Iyengar V. Liquid injectable silicone: history, mechanism of action, indications, technique, and complications. Semin Cutan Med Surg. 2003 Jun;22(2):107-14. PMID: 12877229

Medical grade liquid injectable silicone can be used for soft tissue augmentation to correct and replace lost volumes of the subcutaneous tissue. It is potentially a permanent tissue augmentation agent and is the most effective filler for certain indications. This article presents the history, mechanism of action, indications and contraindications, technique, and the possible complications of silicone and their treatment.

Bigata X, Ribera M, Bielsa I, Ferrandiz C. Adverse granulomatous reaction after cosmetic dermal silicone injection. Dermatol Surg. 2001 Feb;27(2):198-200. PMID: 11207699

BACKGROUND: Various alloplastic injectable implants have been developed for soft tissue augmentation without surgery, but different local or systemic adverse reactions have limited their use for cosmetic purposes. OBJECTIVE: To examine the problems associated with silicone injection. METHODS: Case report and literature review. RESULTS: We describe an adverse granulomatous reaction after the injection of liquid silicone for lip augmentation, causing facial disfigurement. Although the initial response to steroids was poor, after 3 years of follow-up the nodules have almost disappeared spontaneously. CONCLUSION: We advise that silicone injection be performed solely by trained physicians using medical-grade silicone or consider other injectable materials.

Other silicone sites

FDA warnings

U.S. Food and Drug Administration documents show links to autoimmune disorders, connective tissue disorders, genetic mutations, and cancer.

From http://www.fda.gov/cdrh/ost/rpt97/OST1997AR86.HTML

Autoimmune diseases have been reported in women with silicone breast implants. The presence of autoantibodies in some of the women, as well as studies in experimental animals, suggest that silicone may play a role in these adverse effects on the immune system.

Our earlier studies have shown that silicone gel/oil can promote autoantibody production against the connective tissue proteins, collagen, and can migrate from the implant site to other parts of the body.

Serum samples of 180 women have been analyzed for autoantibodies to collagen, a connective tissue protein. Patients included women with or without breast implants, with or without autoimmune symptoms, and from normal controls. Autoantibodies to collagen were detected in patients with connective tissue disease + silicone breast implants, with connective tissue disease without silicone breast implants, and with silicone breast implants without connective tissue disease. Autoantibodies to collagen were not detected in control sera from normal volunteers.

Published studies also have shown that animals with autoimmune disease produce antibodies against their own DNA. We have found anti-DNA antibodies in the serum of experimental animals injected with silicone gel/oil. Based on these results we will determine if women with breast implants also produce autoantibodies against DNA.

From http://www.fda.gov/opacom/backgrounders/collagen.html

Has liquid silicone been approved by FDA for injection?

No. FDA has not approved the marketing of liquid silicone for injection for any cosmetic purpose, including the treatment of facial defects or wrinkles, or enlarging the breasts. The adverse effects of liquid silicone injections have included movement of the silicone to other parts of the body, inflammation and discoloration of surrounding tissues, and the formation of granulomas (nodules of granulated, inflamed tissue).

Can FDA prohibit doctors from promoting the injection of liquid silicone, since its marketing has not been approved?

Yes. FDA prohibits manufacturers or doctors from marketing or promoting unapproved products such as liquid silicone. This means that a doctor cannot legally advertise or sell this material.

From http://vm.cfsan.fda.gov/~frf/forum97/97G14.htm

FDA on mutations and cancer (foreign body carcinogenesis):

After 12 months, fibrosarcoma in situ developed in 100% of rats implanted with either silicone or cellulose.

AEGIS warnings

The American Educational Gender Information Service (AEGIS) was an important early TG advocate in the field of health issues. They put out a series of articles, ads and pamphlets called Dangerous Curves Ahead, which remains an important overview of injectable silicone's dangers.

Advisories against the procedure:

http://www.gender.org/resources/curves.html

http://www.gender.org/resources/bad_news.html <-- highly recommended
http://www.gender.org/resources/malas_noticias.html (traduccion en español)

Other warnings and reports

American Society for Aesthetic Plastic Surgery advisory against the procedure:
http://surgery.org/news_releases/oct3001silicone.html

Side effects described by victim:
http://neuro-www.mgh.harvard.edu:16080/forum_2/SiliconeRelatedF/11.6.998.29AMREMOVALOFFAC.html

Granulomas:
http://ej.rsna.org/ej3/0112-99.fin/body/introduction-4.htm

Report on the silicone craze in Florida:
http://abcnews.go.com/sections/GMA/GoodMorningAmerica/GMA020128Silicone_lip_investigation.html
http://www.click10.com/mia/news/stories/news-56479220010329-130339.html
http://www.sptimes.com/News/041801/State/_It_s_food__drink_and.shtml

Silicone + laser skin resurfacing = flash fire:
http://archotol.ama-assn.org/issues/v127n4/abs/ooa00018.html

Risk overviews:
http://www.med.gazi.edu.tr/journal/1997_2_93_95.html
http://www.avitro.com/silsafe.htm

Naoum C, Dasiou-Plakida D, Pantelidaki K, Dara C, Chrisanthakis D, Perissios A. A histological and immunohistochemical study of medical-grade fluid silicone. Dermatol Surg. 1998 Aug;24(8):867-70. PMID: 9723051

BACKGROUND: Medical-grade injectable silicone for use in soft tissue augmentation is administered subcutaneously by injections of the pure material. OBJECTIVE: To examine histologically and immunohistochemically the characteristics of medical-grade silicone and to identify the advantages and disadvantages of the serial puncture technique. RESULTS: In early biopsies, perivascular lymphocytic infiltration with the characteristic reaction of delayed hypersensitivity (doses, 0.05-0.07 mL) was observed. Immunohistochemically, small local deposits of IgG and IgA were observed around the walls of small vessels. In later biopsies, the inflammation had progressed to a fibroblastic reaction. Additionally, the implantation of large doses provoked giant cell granulomas. CONCLUSIONS: Small doses (0.05-0.07 mL) of injected silicone produce an immunologic and fibroblastic reaction in the skin. The use of this substance with the serial puncture technique is not hazardous when proper technique is used.

Rapaport MJ, Vinnik C, Zarem H. Injectable silicone: cause of facial nodules, cellulitis, ulceration, and migration. Aesthetic Plast Surg. 1996 May-Jun;20(3):267-76. PMID: 8670396

Fifty-four patients with problems following "medical grade" silicone injections into the face and legs were seen from 1974 until 1995. Complications consisted of chronic cellulitis, nodules, foreign body reactions, and movement of material to near and distant parts of the body. These difficulties usually demonstrated themselves many years after injection. It is suggested that problems occur despite good technique, good material, and small amounts injected. Because the side effects are unpredictable and often uncorrectable, further studies must be performed to insure silicone's safety.

Beekman WH, Hage JJ, Jorna LB, Mulder JW. Augmentation mammaplasty: the story before the silicone bag prosthesis. Ann Plast Surg. 1999 Oct;43(4):446-51. PMID: 10517477

Czerny from Heidelberg is generally accepted to have performed the first augmentation mammaplasty in 1895. Since then, a variety of nonsilicone materials have been injected or implanted to augment or to reconstruct the hypoplastic female breast, including autologous tissues, intramammary- or submammary-injected alloplastic materials, and preformed alloplastic materials other than silicone. For various reasons outlined in this review, none was fully acceptable. The introduction of the medical-grade silicone bag prosthesis in the early 1960s improved the results of mammary augmentation dramatically and reduced the incidence of fibrous contracture and implant extrusion. Other methods of breast augmentation became obsolete.

Leibman AJ, Sybers R. Mammographic and sonographic findings after silicone injection. Ann Plast Surg. 1994 Oct;33(4):412-4. PMID: 7810958

The illicit use of silicone injection for cosmetic augmentation was performed in the 1960s. However, this method of augmentation was subsequently abandoned. Recently, a resurgence of this practice has occurred. We present reports of 2 patients who had non-medical-grade silicone injected into their breasts clandestinely. The clinical findings and imaging features are presented.

Duffy DM. Silicone: a critical review. Adv Dermatol. 1990;5:93-107; discussion 108-9. PMID: 2204381

The response of biologic systems to implanted foreign materials is subject to a lesion of variables. Each type of implant must be individually evaluated in a specific application and host. Pure DMPS polymer injected into subcutaneous tissues behaves in a specific and characteristic way. An analysis of the behavior of other types of implants in other applications will not necessarily reveal insights applicable to the behavior of liquid silicone. Most adverse case reports relate to injected fluids of unknown purity or identity used in inappropriate volumes in poorly chosen anatomical sites. It is ironic that pure DMPS in small volumes, a theoretically ideal combination, is so mistrusted. However, liquid silicone's sinful potential was easy to predict. It was cheap, available, easy to use, and, when injected in large volumes, produced instant and financially profitable results. Moreover, a welter of confusing titles, "authorized investigators" and "medical grade silicone" coupled with sensationally adverse reports detailing a criminal misuse of this modality led to draconian measures banning its use and made a meaningful analysis of true incidence and type of side effects following its use nearly impossible to assess. The advocates' position that liquid silicone is safe when used properly cannot be refuted. Only a handful of serious adverse reactions can be documented following its use; however, the concept that pure DMPS polymer can, even in expert hands, occasionally produce immunologically mediated adverse effects is equally irrefutable. This concept is supported by the following evidence: 1. Minor idiosyncratic and granulomatous reactions occurring in 1 in 10,000 are reported in association with a nidus of infection or as a consequence of allergic events. 2. At least one serious inflammatory reaction occurred in a patient afflicted with both autoimmune disease and concurrent infection. These reactions are best understood in the broader context of tissue responses to all classes of implanted foreign material, and they are most easily understood in the narrow context of autoimmune disease after injection of implantable paraffin, silicone, and possibly "silicone polymers." "Certain authors speculate that silicone acting as a primary antigen is not likely," however, silicone acting as an adjuvant associated with a subclinical infection as an antigen source may be the cause of adjuvant disease. A careful review of published anecdotal and personal experience involving the use of 350 centistoke pure dimethypolysiloxane fluid (liquid silicone) for soft-tissue augmentation in small volumes (and in large volumes for facial hemiatrophy) suggests that the bias against its proper use is unfounded.

Wilkie TF. Late development of granuloma after liquid silicone injections. Plast Reconstr Surg. 1977 Aug;60(2):179-88. PMID: 887659

In a 10-year experience with silicone injections involving 92 patients, there was subsequent development of a granuloma in 13 injection sites. Most of these occurred within 12 months, but some took a few years and one appeared 7 years later. It is believed that the injected material was medical grade liquid silicone, without additives or contaminants.

Webster RC, Gaunt JM, Hamdan US, Fuleihan NS, Smith RC. Injectable silicone for facial soft-tissue augmentation. Arch Otolaryngol Head Neck Surg. 1986 Mar;112(3):290-6. PMID: 3942634

Medical-grade injectable silicone has been safely and efficiently used for facial soft-tissue augmentation in 235 patients. Our 20-year experience with the microdroplet technique included 2,811 treatments performed for camouflaging furrows and grooves, augmentation of facial eminences, and elevation of certain depressed scars. The indications and techniques of injection are discussed. The augmenting effect is greater than that produced by the small volumes of silicone injected. Our study supports other work indicating induction of collagen deposition in the patients around the microdroplets of silicone, thus providing augmentation from volumes of collagen and silicone as well.

Hexsel DM, Hexsel CL, Iyengar V. Liquid injectable silicone: history, mechanism of action, indications, technique, and complications. Semin Cutan Med Surg. 2003 Jun;22(2):107-14. PMID: 12877229

Medical grade liquid injectable silicone can be used for soft tissue augmentation to correct and replace lost volumes of the subcutaneous tissue. It is potentially a permanent tissue augmentation agent and is the most effective filler for certain indications. This article presents the history, mechanism of action, indications and contraindications, technique, and the possible complications of silicone and their treatment.

Bigata X, Ribera M, Bielsa I, Ferrandiz C. Adverse granulomatous reaction after cosmetic dermal silicone injection. Dermatol Surg. 2001 Feb;27(2):198-200. PMID: 11207699

BACKGROUND: Various alloplastic injectable implants have been developed for soft tissue augmentation without surgery, but different local or systemic adverse reactions have limited their use for cosmetic purposes. OBJECTIVE: To examine the problems associated with silicone injection. METHODS: Case report and literature review. RESULTS: We describe an adverse granulomatous reaction after the injection of liquid silicone for lip augmentation, causing facial disfigurement. Although the initial response to steroids was poor, after 3 years of follow-up the nodules have almost disappeared spontaneously. CONCLUSION: We advise that silicone injection be performed solely by trained physicians using medical-grade silicone or consider other injectable materials.