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The Risks of Silicone Oil Injections in the Penis: What You Need to Know

The Kama Sutra described penile injection with foreign material over 1,500 years ago. Penile augmentation through injections of foreign substances like silicone oil, paraffin, Vaseline,1 cod liver oil,2 mineral oil,3 and baby oil has gained popularity as a cosmetic procedure. While it may seem like a simple and quick way to enhance penile appearance, girth, and/or sexual satisfaction,4 it carries serious risks that can lead to severe long-term complications. Patients should be counseled that silicone injections ‘work’ by causing collagen deposition leading to inflammatory reaction, formation of a granuloma, and scar tissue. Scar tissue increases the appearance of girth.5 However, the formation of granuloma and scar tissue is extremely dangerous and can cause functional issues including pain and sexual dysfunction as well as contour irregularities and poor aesthetic outcome. If you’ve undergone penile augmentation with silicone or any other non-FDA approved substance, it’s essential to understand the potential dangers and, most importantly, seek medical attention without delay.

Man covering crotch, Marquis Plastic Surgery, Miami, FL.

Isn’t Injectable Silicone Oil FDA-Approved?

Yes, but no. Silikon® 1000 is FDA-approved. However, its approval is limited to injections into the eye.6 This area of the eye is analogous to a “Tupperware®” container; i.e., it keeps the silicone sealed inside. The eye is also considered an “immune-privileged” site, meaning it has a unique ability to tolerate foreign substances without triggering a typical immune response.
Unlike the eye, liquid silicone in other parts of the body can cause devastating consequences. The FDA7 and the American Society of Plastic Surgeons8 have each issued serious warnings against using liquid silicone in other areas of the body. These warnings emphasize significant risks such as scarring, tissue necrosis, and permanent disfigurement. One case report even describes a tragic incident where a patient died after injecting a large volume of silicone into the penis and scrotum, leading to silicone entering the bloodstream and lodging in the lungs and liver.9 Because of this, reputable board certified plastic surgeons and urologists do not inject Silikon® 1000 as a body filler.

Moreover, if someone claims they are injecting FDA-approved silicone, it is likely not true. We consulted with a national medical supplier in September 2024 and learned that the regular wholesale price for Silikon® 1000 exceeds $1,000 per 8.5 mL vial. For reference, 8.5mL is less than 2 teaspoons of product. Injecting 2 teaspoons of product is unlikely to produce a visually significant increase in penile size. If you’re being charged significantly less than $5–10,000 for a treatment, it raises concerns about the quality and authenticity of the product. Regardless, physicians take the Hippocratic Oath to do no harm. For this reason, any reputable physician will not recommend injecting silicone oil into your penis or try to convince you it’s safe simply because they claim to use an FDA-approved product.

Help. I Had Silicone Injected Into My Penis!

If you’ve already undergone penile augmentation with silicone or a non-FDA approved substance, seek medical help immediately. It’s important to see a board-certified plastic surgeon or urologist who has experience with silicone removal and penile reconstruction. They can provide you with the care and support you need to assess your situation and provide guidance. Remember, early intervention is often key to minimizing further issues and improving your chances of a less complicated recovery. Early surgical removal can sometimes prevent the formation of scar tissue and/or granulomas.10

Penis Enlargement with Silicone: What Can Go Wrong?

A study from a UK group titled “Complications and outcomes following injection of foreign material into the male external genitalia for augmentation: a single-centre experience and systematic review” provides a detailed look into what can happen after penile augmentation injections with non-approved substances.11

Potential Complications Include:

Cosmetic Dissatisfaction (57.1%): Many patients report being unhappy with the final appearance of their penis after the procedure, noting irregularities such as hard lumps, unnatural shapes, and deformities.

Pain and Swelling (45.7%): Persistent pain and swelling are common and can interfere with sexual activity, daily life, and overall well-being.

Tight Foreskin/Phimosis (22.9%): Some men experience tightness in the foreskin, which can lead to painful retraction or phimosis.

Necrosis (8.6%): In the worst cases, the injected substances can cause tissue death (necrosis), a severe and potentially life-threatening complication that requires urgent medical attention. This can result in full or partial loss of the genitals.

Rare: There are case reports of silicone embolism syndrome as well as temporary blindness.12
When Do Complications from Silicone Injections in the Penis Occur?
Symptoms from penile augmentation injections can develop at any time. Acute complications such as silicone embolism occur early, often within days; acute-on-chronic complications such as pain, swelling, and sexual dysfunction can occur months to years down the road;13 and long-term complications such as an abscess that requires surgery can occur 10-15 years later.14 Among the study population in the UK study cohort, the mean time from injection to presentation for a complication was 7.8 years, with a range from as little as 0 to 20 years.15 Another study from Europe looked at complications from a large cohort of 680 patients from Thailand. In the Thai study, mean time from injection to presentation of a complication was 36.7 months and the median time for reporting symptoms was 12 months. The most frequently reported complications were the following: penile pain (84%), swelling (82.5%), induration (42.9%), purulent secretion (21.8%), and ulceration (12.8%). Of the 680 patients, 507 (74.6%) underwent surgical treatment (503 excision and 4 circumcision), while 173 (25.4%) were treated conservatively.16

Should I Have Silicone Oil Removed?

For many patients, the answer is yes—removal can help reduce current and future complications.

Silicone oil and other non-FDA approved substances are not biocompatible, meaning they can trigger inflammatory reactions that damage tissues. Over time, these substances tend to migrate, causing localized inflammation and potentially affecting distant areas of the body.

You can see what silicone granulomas can look like here.

The literature suggests that reducing the amount of these substances in the body can lower the risk of complications by removing harmful material. However, because it’s rarely possible to remove 100% of these materials, it’s important to understand that removal does not guarantee the prevention of future issues. Any remaining material in the body can still cause problems, and ongoing monitoring and care may be necessary.

How is Silicone Oil Removed from the Penis?

If silicone removal is performed early after injection, it can sometimes be accomplished using small incisions and a liposuction cannula. However, depending on how long the silicone has been in the body and the severity of complications, your healthcare provider may recommend one or more surgical procedures to address the issues caused by the injected substances. In the Thai study approximately 75% of the men required surgical correction, most often with surgical excision and skin grafting. Based on the UK study cohort, the following procedures were most performed:

1. Excision and Primary Closure

The most common surgery, performed in 59.4% of cases, involves removing the abnormal tissue and closing the wound. This category includes two patients who required partial scrotal removal due to severe tissue damage.

If the foreskin becomes too tight or problematic, circumcision may be recommended. This was performed in 15.6% of the initial surgeries, particularly for those experiencing phimosis (tight foreskin).

For more severe cases where there has been significant tissue damage, a skin graft may be necessary to repair the affected area. This procedure was required by 12.5% of patients in the study.

In rare, but extreme cases, scrotal flap surgery may be required to reconstruct the penis or scrotum. This procedure was performed in 3.1% of patients.

In cases where necrosis occurs, dead tissue must be promptly removed to prevent further damage and infection. This was part of 9.4% of the initial surgeries.

In the most severe cases where tissue death is extensive, surgical removal of the compromised tissue and reconstructive surgery may be required.

How Many Surgeries Might Be Needed?

The number of surgeries required varies depending on the extent of the complications. Some patients may only need one procedure, while others might require multiple. Based on the UK study, here’s the breakdown of how many procedures were needed:

  • One procedure: 40% of patients underwent just a single corrective surgery.
  • Two procedures: 28.6% required two surgeries to address ongoing complications.
  • Three procedures: 17.1% of patients needed three surgeries.
  • Four to five procedures: The remaining patients underwent four or five procedures to address persistent issues.

In total, 61 procedures were performed across the 35 patients, showing that some men required multiple surgeries to achieve a satisfactory outcome.

Are there any injections into the Penis that are Safe?
Hyaluronic acid (HA) fillers that are FDA-approved for the face are seemingly safe in the penis.17 HA is a natural sugar molecule typically found in the extracellular matrix of connective tissue. HA is biocompatible, bioactive, non-immunogenic and non-thrombogenic. Small cohort studies have shown that injectable hyaluronic acid-based gels can significantly increase penile girth (2.27cm) without significant complications (except for decreased tactile sensation).18 Further, it is reversible with Hylenex (hyaluronidase). Patients in these studies have reported increased satisfaction following their procedure. The limitation for patients is the gels are slowly reabsorbed; because the augmentation is not permanent, it is with associated high costs to patients and requires periodic reinjections. In South Florida, the average cost for 1 mL of HA filler is about $800. Some providers offer discounts for larger volumes. However, if the price seems too good to be true, it should raise concerns about the product’s quality or authenticity.

Another option studied is autologous fat transfer (liposuction and then fat grafting to the penis). This is safer than silicone. However, it does have its own (potential) complications. Studies have described significant reabsorption of the fat and/or fat necrosis resulting in diminished cosmetic results and/or deformities secondary to calcified fat. Complications may require surgical correction and/or be permanent.

Conclusion: The Risks Far Outweigh the Rewards

Penile augmentation through injections of silicone or other non-FDA approved substances carries significant risks that can lead to long-term, potentially life-altering complications. While these procedures may seem like an easy solution for enhancement, the reality is that they often cause serious issues such as lumps, deformities, necrosis, and even loss of tissue. If you’ve already undergone this type of procedure, it’s critical to seek help from a medical professional right away. Early intervention can prevent further damage and increase the likelihood of recovery. Always remember that a licensed, reputable healthcare provider will not recommend or perform these kinds of injections, as they are not only unsafe but can cause lasting harm to your body. If you are experiencing complications or concerns, don’t wait—consult with a board-certified plastic surgeon or urologist who has experience in handling these types of cases. They will be able to guide you through the necessary steps to manage or correct the complications, helping you take control of your health and well-being.

[1] Nyirády P, Kelemen Z, Kiss A, Bánfi G, Borka K, Romics I. Treatment and outcome of vaseline-induced sclerosing lipogranuloma of the penis. Urology. 2008 Jun;71(6):1132-7. doi: 10.1016/j.urology.2007.12.081. PMID: 18538694.

[2] Al-Ansari AA, Shamsodini A, Talib RA, Gul T, Shokeir AA. Subcutaneous cod liver oil injection for penile augmentation: review of literature and report of eight cases. Urology. 2010 May;75(5):1181-4. doi: 10.1016/j.urology.2009.11.023. Epub 2010 Feb 6. PMID: 20138344.

[3] Svensøy JN, Travers V, Osther PJS. Complications of penile self-injections: investigation of 680 patients with complications following penile self-injections with mineral oil. World J Urol. 2018 Jan;36(1):135-143. doi: 10.1007/s00345-017-2110-9. Epub 2017 Oct 28. PMID: 29080947; PMCID: PMC5758654.

[4] Oates J, Sharp G. Nonsurgical Medical Penile Girth Augmentation: Experience-Based Recommendations. Aesthet Surg J. 2017 Oct 1;37(9):1032-1038. doi: 10.1093/asj/sjx068. PMID: 28498879.

[5] Sedigh O, Pizzuto G, Barale M, Dashti M, Mazzoli S, Righi D, Dalmasso E, Frea B, Gontero P. Penile injection of aedile silicone: A dangerous shortcut. Urologia. 2022 Aug;89(3):456-459. doi: 10.1177/03915603211040277. Epub 2021 Aug 17. PMID: 34399651.

[6] FDA PMA Database, SILIKON 1000, accessed at: https://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfpma/pma.cfm?id=P950008.

[7] FDA Newsroom, Press Announcements, FDA warns about illegal use of injectable silicone for body contouring and associated health risks, published November 2017, accessed at https://www.fda.gov/news-events/press-announcements/fda-warns-about-illegal-use-injectable-silicone-body-contouring-and-associated-health-risks.

[8] American Society of Plastic Surgery, Blog, Published January 24, 2024, accessed at: https://www.plasticsurgery.org/news/blog/be-aware-of-the-risks-and-complications-of-silicone-fillers.

[9] Annika Nebel, Florian Veit, Anne Weber, Walter Martz, Gabriele Lasczkowski, Reinhard Dettmeyer, Liquid silicone embolism syndrome (SES) in lungs and liver – A case report, Forensic Science International, Volume 325, 2021, 110872, ISSN 0379-0738, accessed at:
https://www.sciencedirect.com/science/article/abs/pii/S0379073821001924.

[10] Nyirády, supra 1.

[11] Pang KH, Randhawa K, Tang S, Fallara G, Katelaris A, Castiglione F, Ahmed K, Blecher G, Christopher N, Ralph DJ, Muneer A, Alnajjar HM. Complications and outcomes following injection of foreign material into the male external genitalia for augmentation: a single-centre experience and systematic review. Int J Impot Res. 2024 Aug;36(5):498-508. doi: 10.1038/s41443-023-00675-8. Epub 2023 Mar 1. PMID: 36859681; PMCID: PMC11251987, access at: https://pmc.ncbi.nlm.nih.gov/articles/PMC11251987/.

[12] Echegaray JJ, Echegaray PM, Townsend-Pico W. Penile Filler Injection Leading to Silicone Embolism Syndrome and Paracentral Acute Middle Maculopathy. Ophthalmic Surg Lasers Imaging Retina. 2022 Nov;53(11):635-638. doi: 10.3928/23258160-20221018-03. Epub 2022 Nov 1. PMID: 36378616.

[13] Shamsodini A, Al-Ansari AA, Talib RA, Alkhafaji HM, Shokeir AA, Toth C. Complications of penile augmentation by use of nonmedical industrial silicone. J Sex Med. 2012 Dec;9(12):3279-83. doi: 10.1111/j.1743-6109.2011.02563.x. Epub 2011 Dec 6. PMID: 22145947.

[14] Bubishate S, Al Sharrah S, Almedej H, Elshebiny H, Almahmid M, Alenezi H. Rare presentation of penile abscess after 15 years of penile silicone injection. Urol Case Rep. 2021 Sep 28;39:101867. doi: 10.1016/j.eucr.2021.101867. PMID: 34631430; PMCID: PMC8487980.

[15] Pang, supra 11.

[16] Svensøy, supra 3.

[17] Salloum A, Bazzi N, Haber R. Nonsurgical Methods for Penile Augmentation: A Systematic Review. Dermatol Surg. 2021 Mar 1;47(3):e81-e85. doi: 10.1097/DSS.0000000000002816. PMID: 33587382.

[18] Ahn ST, Shim JS, Bae WJ, et al. Efficacy and safety of penile girth enhancement using hyaluronic acid filler and the clinical impact on ejaculation: a multi-center, patient/evaluator-blinded, randomized active-controlled trial. World J Mens Health 2022;40(2):299-307.

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