FDA Warns About Injectable Silicone for Beauty
The warning involves silicone oil, a liquid polymer of siloxane. You can find it in your hardware store where it purchased to be used in caulking materials and lubricants.
Silicone oil has not been approved for use in body contouring, butt and breast enhancement, warns the Food and Drug Administration (FDA).
The only FDA-approved injectable silicone oil is used for specific ophthalmic use inside the eye.
In an FDA Safety Communication, the agency is alerting the public and medical professionals that injectable silicone oil is not approved for body enhancement, despite what some injectors are telling consumers.
Silicone can cause chronic pain, infections and serious injuries such as scarring and permanent disfigurement, the blockage of blood vessels, stroke and death. Silicone can migrate within the body making removal impossible. The effects are permanent.
There are FDA-approved Dermal Fillers that have undergone the premarket approval process, similar to the scrutiny drugs undergo before being marketed.
Injectables for body use may include absorbable collagen, a protein scaffold of the skin that is obtained from bovine or human cells. Collagen is injected as a filler with results generally lasting three or four months.
Injectable silicone approved from 1981 to 2003 include Zyderm, Zyplast, Fibrel and Cosmoderm.
Hyaluronic acid – a type of polysaccharide sugar that is present in skin and cartilage is sourced from rooster combs (avian) or bacteria. When it swells with water, it forms a smooth filler and may last up to one year.
Juvederm 24 HV, 30 and 30 HV were all approved in 2006, while the latest version from Allergan is Juvederm Vollure XC, approved in March 2017.
Restylane Injectable was approved in 2005 with the latest from Galderma Laboratories Restylane Lyft with Lidocaine, approved in July 2015.
Lasting longer is a filler of Calcium Hydrolapatite, a mineral found in human bones and teeth. The gel-based formula is injected into the wrinkle and may last up to 18 months. See Radiesse made by Bioform Medical and approved in June 2015.
The last filler that is absorbable is Poly-L-lactic acid or PLLA, which is a biodegradable manmade polymer, a longer lasting filler given in a series of injections. The effects may last up to 24 months.
Another popular brand is Sculptra Aesthetic by Sanofi Aventis, approved in July 2009.
Non-absorbable fillers are made up of manmade polymer beads which are said to be non-biodegradable and yet biocompatible.
Polymethylmethacrylate beads (PMMA) are suspended in a gel made of cow collagen injected into the face. Artefill is made of up PMMA and collagen, made by Suneva Medical and approved in October 2006.
Unapproved dermal fillers include Juvederm Ultra 2, 3, and 4 which is distributed in the US online.
Liquid silicone or silicone gel has not be approved for any injections to fill wrinkles or augment the body for sculpting or enhancing. You can check on the FDA’s website to determine if your treatment is an approved dermal filler.