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Free silicone and other filler use

Primary authors: Barry Zevin, MD and Madeline B. Deutsch, MD, MPH

Introduction

Medical grade silicone has origins in aircraft lubricants developed after World War II; U.S. Army staff noticed that drums of Dow 200 silicone lubricant were disappearing from supply rooms, and traced these drums to providers who were injecting the material. By the 1960s, Dow Chemical had introduced a purified medical silicone (Dow 360), intended for use as a syringe lubricant and as a pharmaceutical vehicle. Subsequent off-label use of Dow 360 was associated with a number of poor outcomes, and by the 1970s some laws had been passed banning the use of such injections.[1] By the 1990s, a more viscous silicone material (Silikon-1000) had been approved by the FDA for vitreal injections, with soft tissue injections considered "acceptable off-label use".[1] Medically appropriate use of free silicone injections involves recurrent injections of <0.1cc by a trained practitioner, with the intention of causing a local fibroblasic reaction and collagen growth, ultimately resulting in changes in the subcutaneous contour.[2] Such an approach has been described in the management of HIV-related lipodystrophy.[2]

"Silicone injections" in the context of transgender health actually refer to any one of a number of soft tissue fillers, typically injected by an unlicensed or unscrupulous medical provider. The actual composition of the injected substances is often unknown and may not be of medical grade; contents may include aircraft lubricant, tire sealant, window caulk, mineral oil, methylacrylates, petroleum jelly, or other substances.[3] In cases of these unsupervised injections, the injected volume (1-3 liters or more) far exceeds what may be performed by a licensed medical provider. Additionally, attention sterility and techniques to avoid embolization may be lacking. Large events ("pumping parties") may take place at which many transgender women receive large volume injections.[4] Estimates of the frequency of injections range from 20% to more than 50% of some populations of transgender women.[5,6] Data from outside the U.S. includes an estimate of 40% of transgender women in Lima, Peru,[3] and 68% of transgender women in several large Thai cities.[7] While most data and anecdotes on soft tissue injections are in transgender women, use among transgender men is also theoretically possible.

Motivations for seeking soft tissue injections

Motivation for receiving the injections may include a strong desire for immediate body changes to relieve gender dysphoria, especially when other modalities of treatment are, unavailable, inaccessible, or perceived as ineffective or slow. The immediate results may encourage community members to recommend the procedures to their peers before any signs of adverse effects appear. A qualitative study of silicone use in transgender women found four contributing factors to this epidemic: poor self-image, misperceptions about silicone, discomfort in public settings (rapid and extensive feminization from silicone helps transgender women blend or "pass"), and low access to health insurance.[8] Other contributing factors include lack of a general awareness of risks in the community, peer pressure, enhanced feminine features to support survival sex work, and the ability to achieve feminization without hormones in order to retain erectile function.[9]

Complications and adverse reactions

Complications may be categorized by time of onset (immediate, early, delayed/late) and by location of effect (local, remote, systemic).[10-12]

Immediate adverse effects of silicone and other substances include silicone embolization, bleeding, pain, and focal erosions and necrosis. Localized skin papules and hypersensitivity reactions are possible. Silicone embolization involving the lungs may result in adult respiratory distress syndrome (ARDS) and death. Some patients have survived multisystem failure due to this condition with severe disability as sequelae including loss of limbs.[11,13-18]

Early adverse effects in the days or weeks following injection include inflammatory nodules with infection due to traditional skin and soft tissue pathogens as well as atypical mycobacteria, and which may be fluctuant. Non-inflammatory nodules may also develop causing pain, itching, and abnormal pigmentation.[18,19] Angioedema is also possible.

Long term adverse effects occurring weeks to years after the injection include migration of silicone with associated pain or deformity. Local or remote inflammatory and non-inflammatory nodules may develop; some may evolve into sterile abscesses or fistulas. Silicone granulomas may develop, with findings of pain, swelling, ulcerations, lymphadenopathy, and possible systemic constitutional symptoms. Biopsy of such lesions shows foreign body granulomas with white vacuoles and surrounding inflammatory cells. Pathogenesis of these lesions may include T cell activation and the presence of biofilms. Other potential complications include secondary lymphedema, telangiectasias and persistent erythema.[18]

Major systemic complications include systemic inflammatory response syndrome (SIRS)/ARDS, sepsis, embolization, hypersensitivity pneumonitis, immune reconstitution inflammatory syndrome (IRIS), or hypercalcemia,[14,18,20] Organ failure is also possible due to direct mass-effects.

Diagnosis

A detailed history can help identify any prior soft tissue injections, or risk factors for use. Patients may be hesitant to disclose prior procedures. Ultrasound, CT or MRI may be helpful adjuncts. Mammography may be ineffective in breasts that have been previously injected. In those patients with a history of extensive injections, soft tissue ultrasound may be a useful tool to guide therapeutic injections for the management of syphilis, gonorrhea, HIV (enfuvirtide), or for vaccines.[21]

Prevention: No research has been conducted on the best practices in preventing the use of medically unsupervised soft tissue fillers. Strategies likely to reduce the prevalence of unlicensed silicone injection include: educating transgender women about risks and alternatives, as well as making available more conventional gender affirming treatment such as hormones and surgery. Community level interventions, utilizing peer health advocates or promotoras may be more effective than provider-originated interventions.

Treatment Approaches: Successful treatment of acute emergencies related to soft tissue injections requires rapid recognition and quick application of intensive care. Delays occur both because of patient hesitation to seek care or report that they received soft tissue injections, and a failure of health care providers to recognize the emergency and to have the knowledge of the necessary treatment.

Management of most complications is supportive and symptom-driven. Minocycline shows promise as a first line antibiotic in the setting of infections due to additional anti-inflammatory properties.[12] Use of surgical excision and reconstruction flaps/grafts may be necessary.[22] Complete mastectomy with breast reconstruction may be necessary for patients with free silicone spread throughout the breasts.[23,24] Other potential approaches include intralesional corticosteroid injections, topical imiquimod, or etanercept 25mg subcutaneously twice/weekly.[19] Liposuction has been described in the past but is not likely to be of benefit.[25]

References

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  2. Narins RS, Beer K. Liquid injectable silicone: a review of its history, immunology, technical considerations, complications, and potential. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):77S - 84S.
  3. Silva-Santisteban A, Raymond HF, Salazar X, Villayzan J, Leon S, McFarland W, et al. Understanding the HIV/AIDS epidemic in transgender women of Lima, Peru: results from a sero-epidemiologic study using respondent driven sampling. AIDS Behav. 2012;1-10.
  4. Wallace PM, Rasmussen S. Analysis of adulterated silicone: implications for health promotion. Int J Transgenderism. 2010 Oct 12;12(3):167-75.
  5. Xavier JM, Bobbin M, Singer B, Budd E. A needs assessment of transgendered people of color living in Washington, DC. Int J Transgenderism. 2005;8(2-3):31-47.
  6. Nemoto T, Operario D, Keatley J. Health and social services for male-to-female transgender persons of color in San Francisco. Int J Transgenderism. 2005;8(2-3):5-19.
  7. Guadamuz TE, Wimonsate W, Varangrat A, Phanuphak P, Jommaroeng R, McNicholl JM, et al. HIV prevalence, risk behavior, hormone use and surgical history among transgender persons in Thailand. AIDS Behav. 2011;15(3):650-8.
  8. Wallace PM. Finding self: A qualitative study of transgender, transitioning, and adulterated silicone. Health Educ J. 2010 Sep 21;0017896910384317.
  9. Wilson E, Rapues J, Jin H, Raymond HF. The use and correlates of illicit silicone or "fillers" in a population-based sample of transwomen, San Francisco, 2013. J Sex Med. 2014 Jul;11(7):1717-24.
  10. Shvartsbeyn M, Rapkiewicz A. Silicon-associated subcutaneous lesion presenting as a mass: a confounding histopathologic correlation. Hum Pathol. 2011 Sep;42(9):1364-7.
  11. Clark RF, Cantrell FL, Pacal A, chen W, Betten DP. Subcutaneous silicone injection leading to multi-system organ failure. Clin Toxicol. 2008 Jan;46(9):834-7.
  12. Silva MM, Modolin M, Faintuch J, Yamaguchi CM, Zandona CB, Cintra W, et al. Systemic inflammatory reaction after silicone breast implant. Aesthetic Plast Surg. 2011 Mar 18;35(5):789-94.
  13. Bartsich S, Wu JK. Silicon emboli syndrome: A sequela of clandestine liquid silicone injections. A case report and review of the literature. J Plast Reconstr Aesthet Surg. 2010 Jan;63(1):e1-3.
  14. Hariri LP, Gaissert HA, Brown R, Ciaranello A, Greene RE, Selig MK, et al. Progressive granulomatous pneumonitis in response to cosmetic subcutaneous silicone injections in a patient with HIV-1 infection: case report and review of the literature. Arch Pathol Lab Med. 2012;136(2):204-7.
  15. Price EA, Schueler H, Perper JA. Massive systemic silicone embolism: a case report and review of literature. Am J Forensic Med Pathol. 2006 Jun;27(2):97-102.
  16. Smith SW, Graber NM, Johnson RC, Barr JR, Hoffman RS, Nelson LS. Multisystem organ failure after large volume injection of castor oil. Ann Plast Surg. 2009 Jan;62(1):12-4.
  17. 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.
  18. Styperek A, Bayers S, Beer M, Beer K. Nonmedical-grade injections of permanent fillers: medical and medicolegal considerations. J Clin Aesthetic Dermatol. 2013 Apr;6(4):22-9.
  19. Paul S, Goyal A, Duncan LM, Smith GP. Granulomatous reaction to liquid injectable silicone for gluteal enhancement: review of management options and success of doxycycline. Dermatol Ther. 2015 Apr;28(2):98-101.
  20. Visnyei K, Samuel M, Heacock L, Cortes JA. Hypercalcemia in a male-to-female transgender patient after body contouring injections: a case report. J Med Case Reports. 2014;8:71.
  21. Gabrielli E, Ferraioli G, Ferraris L, Riva A, Galli M, Filice C, et al. Enfuvirtide administration in HIV-positive transgender patient with soft tissue augmentation: U.S. evaluation. New Microbiol. 2010 Jul;33(3):263-5.
  22. Loustau HD, Mayer HF, Catterino L. Dermolipectomy of the thighs and buttocks to solve a massive silicone oil injection. Aesthetic Plast Surg. 2008 Aug 14;33(4):657-60.
  23. Cárdenas-Camarena L. Managing the mammary gland infiltrated with foreign substances: different surgical alternatives. Ann Plast Surg. 2009 Jun;62(6):621-6.
  24. Echo A, Otake LR, Mehrara BJ, Kraneburg UM, Agrawal N, Da Lio AL, et al. Surgical management of silicone mastitis: case series and review of the literature. Aesthetic Plast Surg. 2013 Aug;37(4):738-45.
  25. Zandi I. Failure to remove soft tissue injected with liquid silicone with use of suction and honesty in scientific medical reports. Plast Reconstr Surg. 2000;105(4):1555.