The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions.
San Francisco, CA (PRWEB) November 20, 2006
Following the United States Food and Drug Administration's approval on Friday November 17th 2006 of silicone breast implants for use in cosmetic breast augmentation surgery, San Francisco Board-Certified Plastic Surgeon Dr. Scott W. Mosser announced that he will begin immediately offering the newly approved implants as an option for all his patients seeking this type of cosmetic surgery.
This is good news for Bay Area women who may be considering breast augmentation. They now can consider silicone implants in addition to the commonly used saline filled implants currently being used for cosmetic surgery.
Dr. Mosser, who specializes in breast surgery, has used the improved silicone implants for some time for reconstructive breast surgery following mastectectomy and for corrective surgery for medical reasons. The FDA's 14-year ban on silicone implants did not extend to their use in breast augmentation surgery for medical reasons. He now anticipates a greatly increased demand for cosmetic reasons.
Dr. Mosser, whose office is located in the historic 450 Sutter Building, in San Francisco's Union Square, performs a wide range of plastic surgery procedures in his clinic and in various other Bay Area institutions including California Pacific Medical Center, St. Mary's Medical Center and Seton Medical Center in San Francisco.
In announcing the approval, the FDA stated, "The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions."
This newer form of silicone implants -- with a thicker, cohesive gel -- has been widely used in the US for some time for breast surgery designated as "reconstructive"; that is, anything from breast lifts combined with implants to post-cancer restoration.
The new silicone implant gel technology is cohesive, which means that it defies diffusion when rupture occurs, behaving more like a viscous gel than a liquid. Would a leak to happen, this material are designed to be less likely to seep into local tissues and cause inflammation.
The FDA has approved the implants for use in cosmetic surgery on women over the age of 22 after carefully reviewing safety data over the past decade. The FDA has also stipulated that the manufacturers must continue follow up safety studies. As a condition of the implants' approval, each company agreed to conduct a study tracking 40,000 women for ten years after receiving silicone implants and must also continue lab studies on implant failures.
This development, coupled with recent studies disproving any link between silicone implants and systemic disease, have now lessened the fear and greatly broadened the options available to any woman seeking cosmetic breast augmentation.
In an interview with Dr. Scott W. Mosser at his San Francisco office, Dr. Mosser cautioned, "The decision of whether to use saline or silicone implants is still one which should be made by a Board-Certified Plastic Surgeon and should be tailored specifically to the individual patient. Every patient is unique and the choice of type of implant and surgical procedure used is a very personal and carefully weighed decision. The FDA's approval is a positive development and broadens our surgical options."
Throughout its turbulent history, one fact remains clear: breast augmentation has retained its place as the highest-rated plastic surgery in terms of patient satisfaction.