Breast Implants Information

  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

Interference with mammography

Changes in nipple and breast sensation

Interference with breast feeding