The U.S. Food and Drug Administration (FDA) approved on Friday the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older.

The products are manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa Barbara, Calif.

"FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA.

Now that the products have been determined to be safe and effective. The FDA will continue to monitor them by requiring each company to conduct a large postapproval study following about 40, 000 women for 10 years after receiving breast implants.

But the FDA warned that some of the complications reported in the clinical studies included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery. However, the majority of women in these studies reported being satisfied with their implants.

The FDA approved the silicone gel-filled breast implants with a number of conditions, including requiring each company to conduct a large postapproval study, continue its core study through 10 years and conduct a focus group study of the patient labeling. The postapproval studies, which will be closely monitored by the FDA, will continue to gather information about the safety and effectiveness of the implants. The FDA anticipates that data from the studies will provide important information for patients and physicians, and may lead to improvements in device labeling.

Source: Xinhua