The US Food and Drug Administration has approved the sale of silicone breast implants, after a 14-year virtual ban on the devices (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01512.html). After reviewing information, including data from clinical trials of women studied for up to 4 years, the agency found silicone breast implants to be safe. However, studies reported various implant-related complications, included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture, and the need for additional surgery.
Hampton T. Breast Implants. JAMA. 2006;296(24):2916. doi:10.1001/jama.296.24.2916-b