Tissue reactions to silicone gel-filled implants have been well publicized, with injectable silicone and gel-filled implants being associated with induration, lymphadenopathy, fever, joint pain, systemic lupus erythematosus, mixed connective tissue disease, scleroderma, rheumatoid arthritis, Sjogren syndrome, Hashimoto's thyroiditis, arthralgias, and iritis. In addition, granuloma formation to medical grade silicone products has been widely noted, although the incidence of immunological disease is reported in the literature to be small. The purpose of this review is to examine the literature on reactions to silicone facial implants and to promote the collection of additional information on the safety of these devices. We conclude that it is necessary for the FDA, manufacturers, and physicians using silicone implants to collect more information in a systematic fashion on the number of patients who show reactions to silicone implants. This information is needed to properly inform patients of the risks associated with silicone implants and to set performance standards for medical devices.
|Original language||English (US)|
|Number of pages||8|
|Journal||Journal of long-term effects of medical implants|
|State||Published - 1993|
All Science Journal Classification (ASJC) codes
- Biomedical Engineering