Federal health officials say the latest data on silicone breast implants show they are relatively safe, despite frequent complications that lead about one in five women to have the implants removed within 10 years. An FDA report issued today is the agency's first safety assessment of the devices since they returned to the market in 2006, following a 14-year ban when only saline-filled implants were widely available. The most common side effect remains scar tissue that hardens around the implant, warping its shape.
"Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use," the agency concludes. The findings are primarily based on follow-up studies conducted by the two US manufacturers of the devices, Allergan and Johnson & Johnson's Mentor unit. Industry critics point out most of the studies are incomplete, and many women have already dropped out. (Read more breast implants stories.)