Breast implants have been marketed in the United States since the early 1960s. At that time, there was no medical device law to regulate these devices. In fact, the medical device law was not enacted until 1976, when the FDA was charged with regulation of medical devices, including breast implants. In the 1980's, the FDA asked the manufacturers of silicone gel-filled breast implants to submit the required clinical trials and safety evidence. Without overwhelming evidence of their safety and an increase in the reports of side effects and damages caused by the breast implants, the FDA agreed that more research was needed into the question of what kinds of effects, if any, silicone implants have on human health.
As such, the silicone gel-filled breast implants were removed from the market for general use in 1992. In their place arrived the saline breast implants. These saline-filled implants do use a silicone envelope, whose long-term safety has not been demonstrated, thus making the implants not entirely without risk. Increased risk for fibromyalgia has been linked to leakage of the silicone from the breast implants. In addition, the following are potential silicone-gel breast implants side effects.
Capsular contracture - scar tissue that forms around the breast
implant which causes the breasts to harden
Calcium deposits - in tissue around the breast implant
Granulomas - small lumps in tissues caused by inflammation
Rupture - of the breast implants
Leak of silicone gel - may escape from the breast implant and
reach distant parts of the body, causing autoimmune-like disorders
