What Is Silicone?
Silicone is a chemical polymer derived through a heating and refining process from the element silicon--which is more commonplace than you might realize. In fact, the sand on the beach is made from a combination of silicon and oxygen called silica. Read more about silicone.
Are Silicone Breast Implants Safe?
In 1992, the FDA imposed a moratorium on the use of silicone breast implants for cosmetic breast augmentation. The ban was enacted because the FDA determined that not enough data was available to prove that the implants were safe. Following the ruling, silicone gel implants were available in the U.S. only for use in clinical trials, and for breast reconstruction procedures performed on women who already had these implants and needed a replacement for medical reasons.
As most people have heard by now, the results of the subsequent clinical trials and numerous studies showed no increased risk of breast cancer, connective tissue diseases, neurological diseases or other illnesses in women with silicone breast implants. As a result, the 14-year moratorium on silicone implants ended in November 2006 when the FDA approved silicone gel breast implants made by two companies -- Mentor and Allergan (formerly Inamed) -- for cosmetic breast augmentation surgery. Read more about silicone breast implants.
What About Silicone Injections?
For more than fifty years, liquid injectable silicone has been used for soft-tissue augmentation, drawing polarized reactions both from the public and from physicians. While many doctors consider silicone too risky for facial cosmetic injections (and it is not FDA-approved for this use), there are doctors who use it legally (and successfully, they say) as an off-label use. Read more about cosmetic liquid silicone injections.
More Uses for Silicone in Plastic Surgery
Solid silicone implants have been used successfully for decades to augment the structure of the face. These implants can be made in varying levels of strength and flexibility for a wide variety of cosmetic purposes, including chin augmentation, cheek augmentation, and male pectoral implants.
Silicone is also the material that comprises the outer shell of tissue expanders used in reconstructive surgery after trauma, in post-Mohs (skin cancer) reconstructive surgery, or post-mastectomy breast reconstruction.
Facial Implants, American Society for Aesthetic and Plastic Surgery
FDA Approves Silicone Gel-Filled Breast Implants After In-Depth Evaluation, FDA News Release, November, 2006
Interview with Robert Kotler, MD, FACS, facial cosmetic surgeon in private practice, author of Secrets of a Beverly Hills Cosmetic Surgeon; Beverly Hills, CA, conducted on August 31, 2009
Liquid Injectable Silicone: A Review of Its History, Immunology, Technical Considerations, Complications, and Potential; Narins RS, Beer K.; Plast Reconstr Surg. 2006 Sep;118(3 Suppl):77S-84S
Liquid Injectable Silicone for Soft Tissue Augmentation; Prather CL, Jones DH; Dermatol Ther. 2006 May-Jun;19(3):159-68
Tissue Expansion, Consumer Information Sheet, American Society of Plastic Surgeons
Workshop on Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical, and Regulatory Challenges; United States of America Food and Drug Administration; July 8, 2003