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By Mara Levy Published: 2007-12-10 19:54
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By Sylvia Coleman
Published: Wednesday, January 3, 2007 - 20:16

Just a few years ago, the media was plagued with reports of silicone breast implants gone awry. Now, in a controversial move, the U.S. Food and Drug Administration (FDA) has approved the implants that once wreaked havoc in the lives of so many females. But, will women seeking breast augmentation be so receptive to silicone impants? Experts from the American Society for Aesthetic Plastic Surgery (ASPS) and the American Society of Plastic Surgeons (ASAPS) say they should.

"This is a great day for American women and the plastic surgeons who care for them," says Roxanne Guy, M.D., ASPS president. "Silicone breast implants have been scrutinized more than any medical device, and we applaud the FDA for making its well thought-out decision and allowing American women to make informed choices about their health care."

The scrutiny Dr. Guy refers to are the independent clinical studies conducted by Allergen Corp, in Irvine, Calif., and Mentor Corp., Santa Barbara, Calif. Although some of the study's participants reported breast pain, change in nipple sensation, implant rupture, and hardening of the area around the implant, the majority of women in these studies said they were satisfied with their implants. After careful review of each study and the manufacturing plants of both companies, the FDA gave the two pharmaceuticals the green light, making them the only two companies approved by the FDA to market the implants after a selective14-year ban. However, the FDA stamp of approval comes with some mandatory stipulations.

"We're requiring that each company conducts a large 10-year study on approximately 40,000 women who receive the implants," says Donna-Bea Tillman, Ph.D., director, Office of Device Evaluation, Center for Devices and Radiological Health, FDA.

According to the ASAPS, approximately 300,000 women chose breast augmentation in 2005, while nearly 58,000 women had breast reconstruction in 2005. Both breast augmentation and reconstruction, notes ASAPS, have been proven in numerous studies to have psychological and physical benefits for women who choose these procedures. This may be particularly good news for women left disfigured from such diseases as breast cancer.

As of 2004, ASAPS research indicated that a whopping 83.4 percent of respondents used saline implants, while only 16.6 percent used the silicone implant. Only time will tell if the FDA approval is enough to change the nations current trend toward saline.