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Tracy Hampton, PhD

JAMA. 2006;296:2916.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

The US Food and Drug Administration has lifted a 14-year virtual ban on the use of silicone breast implants for breast reconstruction and augmentation. (Photo credit: www.sciencesource.com)

The Food and Drug Administration will continue to monitor silicone breast implants by requiring the 2 companies manufacturing them to conduct a large postapproval study of approximately 40 000 implant recipients with follow-up for 10 years. Each company also must continue laboratory . . . [Full Text of this Article]