Silicone is considered a chemically stable substance that can even be used for cooking and other household purposes. The safety of silicone, however, may vary with the particle size of silicone. Thus, silicone compounds with a small particle size can pass through the skin and biological barriers (membranes) causing toxicity to humans. The United States Food and Drug Administration (US FDA) has issued a warning against the use of injectable silicone for augmenting body parts, such as a hip (gluteal) or breast enlargement. According to the US FDA, injectable silicone can cause ongoing pain, infections, serious injuries (such as scarring and permanent disfigurement), blockage of a blood vessel (embolism), stroke, and death. Injectable silicone stays in the body because it is not broken down or eliminated by the body. It can also migrate easily to various parts of the body that can make the surgical removal of silicone fillers difficult. It can migrate and block the blood vessels of vital organs, such as the brain, heart, and kidneys, causing serious damage to them. The US FDA does not approve the use of liquid silicone injections anywhere in the body except inside the eye for medical purposes.
What is silicone?
Silicone or siloxane is a man-made substance. It is made from several chemicals, such as silicon elements, oxygen, carbon, and hydrogen. It is generally manufactured as a flexible material resembling plastic. The word silicone is often considered a synonym of the naturally occurring element silicon (Si). However, they both are not the same substances. Silicon is one of the most abundant elements on earth. For making silicone, silicon is extracted from a naturally occurring compound called silica (sand). Silicon is then passed through chemicals called hydrocarbons to create a new polymer called silicone. Silicone is used for various purposes, including the manufacture of cookware, electronics, medical equipment, and storage containers.
What are the risks of silicone breast implants?
The US FDA has approved two types of breast implants that have an outer shell made up of silicone: implants filled with a saltwater solution (saline-filled implants) and silicone gel-filled implants. It must be noted that liquid silicone injections or fillers are not approved by the US FDA. The liquid silicone is different from silicone used in breast implants.
The implants have undergone extensive research to ascertain their safety and effectiveness before getting approval from the US FDA. However, there may be some risks associated with the implants. The risks may include:
- Failed surgery giving rise to a need for additional surgeries
- Cancer of the immune system called BIA-ALCL (breast implant-associated anaplastic large cell lymphoma)
- Breast pain and tenderness
- Scarring that may squeeze the implant (called capsular contracture)
- Rupture or tears in the implant shell (it can cause a change in the shape, size, or texture of the breast along with pain and swelling of the breast tissue)
- Breast implant illness or BII (symptoms are rashes, fatigue, joint and muscle pain, headache, and breathing problems after getting a breast implant)
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U. S. Food and Drug Administration. FDA Warns Against Use of Injectable Silicone for Body Contouring and Enhancement: FDA Safety Communication. November 14, 2017. https://www.fda.gov/medical-devices/safety-communications/fda-warns-against-use-injectable-silicone-body-contouring-and-enhancement-fda-safety-communication