Deadly Complications after Off-label Liquid Silicone Injections

The most often silicone injected sites are thighs and buttocks can cause serious complications; even death should be wholly contraindicated for body contouring purposes!

• Liquid silicone injection is not FDA-approved for body contouring purposes, usually administered by unauthorized, unlicensed, and non-medical persons.

• The use of industrial liquid silicone should be completely contraindicated as a filling material and modification of body contouring because silicone injection can cause deadly risks.

• Most reports come from countries in Asia and South America, and the victims are mostly women and transgender people.

• Various complications have been reported with liquid silicone, ranging from localized inflammation, scar tissue formation, and silicone migration throughout the body. Its medical use has become restricted.

44 year old Hispanic female who had silicone injected into her buttocks about 12 years prior to presentation. She had buttock silicone injections done for elective cosmetic reasons. Unfortunately, over the years, she developed painful lumps throughout her buttocks and hips, pain radiating down her legs (sciatica), and severe skin discoloration throughout her buttocks and hips. She desired removal. Because of the position of the silicone injections and scar tissue, a lower than normal incision was placed in the middle of the buttock. This was to allow for maximum removal of the silicone product. This incision is called a posterior buttock lift. About four months after her posterior buttock lift to remove silicone, she presented for buttock reconstruction which included insertion of bilateral FDA approved, semi-solid silicone buttock implants and fat transfer (Brazilian butt lift or a BBL).

A retrospective analysis of patients' medical records admitted the deadly consequences of liquid silicone injection in body contouring by unauthorized persons.

Dr. J. Timothy Katzen, M.D., has evaluated the data based on gender, age, volume injected, location, application time, clinical manifestations, complications, treatments, and outcomes. Various complications have been seen and reported using liquid silicone injections. Thus, the FDA (The U.S. Food & Drug Administration) has released a safety alert to warn about the severe complications of injectable silicone and issued recommendations for healthcare practitioners.

Unfortunately, the injections of off-label liquid silicone are used by non-medical professionals, and injections are made in the face-frontal, upper lip, breasts, buttocks, and thighs.

Patients who were the victim of illegal liquid silicone injections reported the signs of severe complications after the injection shot, either right away or years later.

Dr. J. Timothy Katzen, M.D., evaluated the silicone injections victims/patients with the following early complications:

1. Infectious and inflammatory manifestations: Inflammation caused by liquid silicone injection may occur immediately. Silicone can migrate throughout the body, and circulating silicone can be identified in blood vessels and many distant organs. Thus, chronic silicone deposits and inflammatory reactions are observed in various distant organs suggesting chronic silicone migration.

2. Intermittent subjective fevers and pain: A patient may report intermittent subjective fevers and pain in the injected areas immediately or within a month. The side effects even may take years to occur; however, neglecting the consequences of silicone injections is not mindful.

Note: Patients who underwent silicone injections for soft tissue augmentation to enhance breasts, buttocks, back, or thigh by an unauthorized practitioner admitted to our facility with complications of inflammation, intermittent subjective fever, bilateral breasts pain, scarring, and stony consistency masses with erythema involving the breasts, buttocks, thigh, and back.

1. Silicone embolism syndrome: Liquid off-label silicone is subcutaneously injected. This illegal and massive silicone injection can cause silicone embolism syndrome and acute pneumonitis within the first few hours. The systematic embolization could result from local tissue damage allowing silicone migration into the vascular circulation.

2. Ischemic skin changes and fasciitis: Significant skin discoloration can occur at injection sites. The categories of skin color changes include redness, inflammation, itchiness, hyperpigmentation, black marks, and ischemic skin changes around the injection sites. Retinal ischemia is a rare but severe complication when the liquid silicone inadvertently enters the ocular circulation through retrograde arterial flow into the ophthalmic artery. Immediate blurring and potential visual blindness can result from the injected material moving distally to the retina and blocking the blood supply.

Late complications linked to off-label liquid silicone injections, as described by Dr. J. Timothy Katzen after examining his patients, are:

1. Infection in deep tissue: Some patients may remain asymptomatic after having a silicone injection, but complications can occur any time or years later. Infection in deep tissue may even occur after ten years of silicone injections requiring surgical treatment. Usually, the region injected is the breasts, with manifestations of chronic mastitis, abscesses, and fistulas.

2. Skin necrosis or skin death: Immediately after silicone injection, your body responds against foreign materials. However, an inflammatory response is initiated, resulting in redness, inflammation, and itchiness around the injection sites—your body walls off the injected silicone with scar tissue. Still, unfortunately, not all the silicone can get out of the body on its own. Thus, skin pores become plugged with silicone, and skin begins to die. The changes in skin color from red to purple and eventually turning black are called skin death or necrosis.

Note: Surgical treatment should be indicated in the acute phase in the presence of more extensive or deep areas of ischemia/necrosis and cases of abscesses, fistulas, and fasciitis.

1. Silicone migration: Silicone deposits after liquid silicone injection are experienced, identified with a skin biopsy. Latent silicone pneumonitis may be observed in patients who develop local inflammatory reactions at injection sites. Since silicone and other injectables move throughout the body, silicone spreads on its own and often follows gravity. Silicone migration from the buttocks to the thighs and ankles and from the hips and into the groin region can also migrate into the perineal or the labium and cause a whole host of problems.

2. Death due to refractory septic shock: In several cases, death was also reported after liquid silicone injection due to refractory septic shock. The development of skin necrosis due to the silicone injections does not improve with additional debridement and intensive support. Thus, death as a deadly complication can occur after liquid silicone injection.

Conclusion:

This blog aims to warn about the life-threatening risks of injectable silicone. Injectable silicone can migrate throughout the body and cause many health hazards, including swelling, discomfort, pain, scarring, permanent disfigurement, stroke, blockage of a blood vessel (embolism), hypercalcemia, renal failure, brain fog, chronic fatigue, and sciatica. Unfortunately, some patients die during the illegal silicone injections or years later.

We conclude that using liquid silicone is an off-label practice that must be completely contraindicated for body contouring purposes because the complications can be severe and difficult to treat.

These are the eight deadly potential complications of silicone injections. If you consider injections, always check what is being injected and by whom before you inject. If you were thinking specifically about silicone injections, DO NOT GET SILICONE INJECTIONS. If you have silicone injections, please call me at (310) 859-7770.