Illegal use of injectable silicone for body contouring is associated with significant health risks. The FDA has issued several consumer warning notices to bring awareness to the unauthorized marketing and use of these products.[1] Studies have reported a range of dermatologic complications, including: lymphatic and subcutaneous migration of silicone (59%), inflammation (50%), varicose veins (39%), post-inflammatory pigmentation (20%), infection (14%) and abscesses (4%).[2] Other studies have associated liquid silicone with devastating and irreversible kidney injury.[3]
Patients generally benefit from the removal of silicone injections. However, a frequent concern of silicone removal is the risk of infection. Our goal is to reduce this risk by: 1) educating patients on the potential sources of infection and 2) discuss some of the proactive measures that can be taken to support safer and more successful outcomes.
Infection is a common concern for two reasons: 1) the silicone is unlikely sterile and 2) post-surgical contamination.
Illegal silicone injections are almost always performed by unlicensed practitioners under non-sterile conditions. Silicone body filler is not FDA-approved and can harbor bacteria on its surface and in its biofilms.[4] When the silicone is removed, there’s potential for the bacteria to spread to surrounding tissues and potentially lead to an infection. Several precautionary steps are taken to minimize the risk of infection; however, it’s important to note that the chance of infection is significantly higher compared to, for example, the removal of ruptured FDA-approved silicone breast implants.
Some patients might be unconcerned about the risk of infection – especially if they haven’t experienced symptoms of a silicone-related infection previously. However, understanding this risk remains important. Silicone can harbor bacteria without the body showing immediate symptoms of infection.[5] One possibility is the body walls off the silicone with scar tissue that forms around the silicone ball as it forms a granuloma. Another possibility is that bacteria is present but is not causing an active infection, this is termed “colonization.” However, the difference between developing an active infection and mere colonization is often “only a matter of circumstance.”[6] Major stressors such as surgery or illness may trigger the shift from colonization to active infection.
The key takeaway is that even if there were no previous signs of infection, it doesn’t mean the silicone is free of bacteria.
Even if you’ve had a prior silicone infection treated, it does not always mean the silicone is bacteria free. Often, foreign material – whether liquid silicone or a knee implant – can remain colonized with bacteria even after successful treatment with antibiotics. This is, in-part, because bacteria form biofilms. Biofilms are a microscopic “slime” secreted by colonies of bacteria to protect them from the immune system and antibiotics.[7] Biofilms have sometimes been called “molecular containers” because bacteria can live behind the biofilm wall protected from the immune system.
Another reason why infection is common is location. Many, if not most, illegal silicone injections are in the buttocks. To remove silicone from this area, incisions are typically made on the buttock, which is near the perineum—a region that naturally harbors bacteria that cannot be completely sterilized.
During surgery, we can quarantine off the perineum to protect our surgical site. However, patients cannot go home this way because they must void / defecate (go to the bathroom). Going to the bathroom is necessary but it presents a special concern for post-operative contamination leading to infection.
If you’ve had a prior silicone infection, your surgeon will likely discuss prescribing intra-operative and/or post-operative antibiotics that worked to clear this infection. Also, if you saw an infectious disease doctor or had wound cultures performed, your surgeon will likely want to see the culture results and speak with your infection disease doctor. This information will help inform antibiotic selection.
Note, if you’ve experienced symptoms of a silicone infection and were treated with antibiotics but your cultures came back negative, it’s also important to discuss this with your surgeon. This helps the surgeon understand how your body might be reacting, and it might impact pre-surgical planning.
If all cultures were negative, one possibility is that your symptoms weren’t due to an infection but due to something called silicone granulomas.[8] These are small lumps of white blood cells and other tissue that form when your immune system reacts to silicone. They can develop shortly after the silicone is injected or even years later. Silicone granulomas often go through cycles where the symptoms get worse (exacerbation) and then improve (remission). During these flare-ups, you might experience symptoms similar to an infection – e.g., fever, redness, and/or pain.
It’s common for patients to visit their primary care doctor during these flare-ups, receive antibiotics, and feel better afterward. You might wonder why antibiotics were effective if there wasn’t an infection. The explanation lies in the immune-modulating properties of certain antibiotics, which can help reduce inflammation in the body. Therefore, the improvement may result from the anti-inflammatory effects of the antibiotics rather than their action against bacteria.
Given the incision placement relative to the perineum, it’s helpful to understand the natural microbiome and what bacteria may be more likely to create a post-operative infection. For this reason, cultures of the perineum are sometimes taken before the surgery. This information can help inform your surgeon’s choice of intra-operative and post-operative antibiotics.
As noted, the perinum cannot be sterilized. However, it’s conceivable that the bacterial burden can be reduced. For this reason, several days before surgery, your surgeon may have you begin cleansing the perineum with chlorhexidine bathroom wipes once per day and after you defecate. To reduce the number of bacteria on the skin, your surgeon may also have you take 1-2 chlorhexidine showers before the procedure.
Commonly, patients are given broad-spectrum IV antibiotics during the surgery: one to cover gram-negative bacteria and another to cover gram-positive bacteria.
Your surgeon may culture a sample of the removed silicone material, though the results may vary in usefulness. This is because 1) the type of contamination tested for is generally not visible to the naked eye and 2) not all the silicone may be contaminated with bacteria. Broadly, it’s like closing your eyes and plucking one hair from a head of salt-and-pepper-colored hair and hoping you grab a grey one. If the sample is obtained from a contaminated section, valuable insight is gained. However, if the sample is not contaminated, the culture might not provide the desired information.
During surgery, we minimize the risk of infection by thoroughly irrigating the surgical sites with antiseptic solutions like Dakins, Betadine, and/or antibiotic-infused saline. After irrigation, the surgical team typically allows fresh antiseptic solution to remain in the surgical sites for about 30 minutes. This extended contact time helps enhance the effectiveness of the antiseptic and helps reduce the bacterial load. This lowers the risk of postoperative infection.
After the surgery, it’s important to strictly follow your doctor’s instructions regarding wound care and antibiotics. It is especially easy to inadvertently contaminate the wounds when going to the bathroom. For this reason, your doctor may direct you to:
Illegal silicone injections can cause serious complications, including inflammation, infections, and kidney injury.
Non-sterile Product: Injected silicone is likely not sterile.
Non-sterile Conditions: Often injected by unlicensed practitioners, increasing the risk of bacterial contamination.
Post-Surgical Risk: Surgery near the perineum raises infection risk due to inherent bacteria.
Medical History: Discuss previous infections and antibiotic responses.
Bacterial Reduction: Chlorhexidine wipes and showers before surgery might reduce risk.
Antibiotics: Broad-spectrum IV antibiotics are commonly administered.
Irrigation: Surgical sites are commonly irrigated with antiseptics to reduce infection risk.
Wound Care: Follow strict hygiene protocols, as directed by your doctor.
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[1] FDA News Release, FDA warns about illegal use of injectable silicone for body contouring and associated health risks.
[2] Bertin C, Abbas R, Andrieu V, Michard F, Rioux C, Descamps V, Yazdanpanah Y, Bouscarat F. Illicit massive silicone injections always induce chronic and definitive silicone blood diffusion with dermatologic complications. Medicine (Baltimore). 2019 Jan.
[3] Fareen N, Zafar MU, Ahmed Z, Hossain MA, Diraviam SP, Taj S, Masud A. Modifying Beauty Is Not Priceless: A Rare Case of Silicone-Induced Hypercalcemia With Renal Failure. Cureus. 2022 Jun 13.
[4] Some patients have inquired whether Silikon® 1000 may have been used. While Silikon® 1000 is FDA-approved, its approval is limited to injections into the eye (you can view the FDA-approved indication here). There are two reasons why Silikon® 1000 was unlikely used. First, we consulted with a national medical supplier in September 2024, and were informed the regular wholesale price of Silikon® 1000 exceeds $1000 per 8.5 mL vial Given that most body filler procedures involve well over 100 mL of material, the price paid is typically far lower than the cost of Silikon® 1000, suggesting that a different, non-FDA-approved silicone was likely used. Second, injecting silicone under the skin is widely known and documented to be hazardous when injected under or in the skin. The FDA and the American Society of Plastic Surgeons (ASPS) have each issued warnings about the significant dangers of such procedures. Because of this, reputable licensed providers that can purchase Silikon® 1000 do not inject it as a body filler.
[5] Singh M, Solomon IH, Calderwood MS, Talbot SG. Silicone-induced Granuloma After Buttock Augmentation. Plast Reconstr Surg Glob Open. 2016 Feb 19; Jessop ZM, Welck M, Zinser E, Garlick N, Hopkins S. Late Presentation of Infected Silicone Granulomas in the Lower Limb. Clin Med Insights Arthritis Musculoskelet Disord. 2018 Feb 22 (infection after 4 years); Mello DF, Gonçalves KC, Fraga MF, Perin LF, Helene A Jr. Local complications after industrial liquid silicone injection: case series. Rev Col Bras Cir. 2013 Jan-Feb;40(1):37-42 (infection after 10 years).
[6] Dani A. Colonization and infection. Cent European J Urol. 2014;67(1):86-7 (“The difference between an infection and colonization is often only a matter of circumstance. Non-pathogenic organisms can become pathogenic given specific conditions, and even the most virulent organism requires certain circumstances to cause a compromising infection”).
[7] Zhao A, Sun J, Liu Y. Understanding bacterial biofilms: From definition to treatment strategies. Front Cell Infect Microbiol. 2023 Apr 6;13.
[8] Park ME, Curreri AT, Taylor GA, Burris K. Silicone Granulomas, a Growing Problem? J Clin Aesthet Dermatol. 2016 May;9(5):48-51; Pasternack FR, Fox LP, Engler DE. Silicone Granulomas Treated With Etanercept. Arch Dermatol. 2005;141(1):13–15.
