Fw: Clinical Success with Non-Surgical Breast Enlargement

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Martha Murdock, DirectorNational Silicone Implant FoundationDallas, Texas Headquarters

----- Original Message ----- From: S3733@...

S3733@...

Sent: Monday, April 30, 2001 10:23 AM

Subject: Clinical Success with Non-Surgical Breast Enlargement

Medical Researchers Report More Clinical Success with Non-Surgical Breast Enlargement MD's Expect New 'Choice' for Some Women This Year COCONUT GROVE, Fla., April 30 /PRNewswire/ -- Clinical investigators in three U.S. cities today reported data on thirty more women who have succeeded in growing their own breasts by approximately one cup size (120cc) in ten weeks using a new medical system. Led by Dr. J. Baker, former president of the American Society for Aesthetic Plastic Surgery, investigating teams in Miami, San Francisco and Washington, D.C. using identical protocols, reported growth among all participating patients. The team of investigators also reported significant increases in patient self-esteem. This data confirms earlier findings published by Dr. Baker and other colleagues in the June, 2000 edition of Plastic and Reconstructive Surgery. Dr. Baker said he expects the system will be made available to U.S. patients on a limited basis this year. The system has met all the U.S. Food and Drug Administration's marketing requirements. Investigators, now in final stages of market testing, have data on approximately 200 women who have used the Brava® Breast Enhancement and Shaping System developed by Dr. K. Khouri, a renowned plastic and reconstructive surgeon. The Brava System uses a proven scientific principle to stimulate cell reproduction and long-term tissue growth. The system includes two plastic domes, a sports bra and a SmartBox (microprocessor controlled device). It applies a safe, sustained and gentle pull to the breasts. Women must wear the system ten hours a day for ten weeks to achieve long-term growth according to Drs. Baker and Khouri. Physicians and nurses monitor their patients through a combination of regular office visits and a unique, secure on-line data collection system. More than 16 Million U.S. Women Want Larger Breasts; Less than One Percent Per Year Have Surgery According to the American Society for Aesthetic and Plastic Surgery, in 2000, approximately 200,000 women underwent breast implant surgery. Research conducted by Brava found that more than 16 million American women between the ages of 18 and 49 are dissatisfied with their breasts because they are too small. Of these dissatisfied women, 80 percent indicated that they would be content with an increase of one-half to one-full cup size. Drs. Khouri and Baker believe the Brava System will give many of these women and their physicians a new option to consider. "Brava helps a woman grow more breast tissue," said Dr. Khouri. "When she has completed the protocol, she'll have more of her own breast tissue. And that tissue will follow the contours of her own breasts and will be supported by her own vascular and neurological systems." Dr. Baker, who has been a leading plastic surgeon for more than 35 years, said he expects The Brava System to compliment surgical breast enlargement. "Brava provides modest growth. I can see it appealing to a lot of women, but not to the women who want or must have a surgical option. I expect Brava to bring many more women into their doctor's offices over the next few years." System will be Available Through Limited Number of MD's Long-term growth of natural breast tissue requires women to use the Brava Breast Enhancement and Shaping System under their physician's supervision and often with the help of a trained nursing staff. The system requires proper fitting, regular check-ups and patient support systems. Brava will only be available through physicians who have been trained by Brava, LLC. Most women wear the system in the evening while they sleep to comply with the ten-hour daily protocol. Although it is comfortable to wear, some women, as is common in pregnancy, need a few days to adjust their sleeping position if they do not sleep on their back. After only a few days of use, women will begin to see increased fullness to their breasts. Women who completed the initial trial were measured 18 months after they stopped wearing the system. All experienced gradual and lasting breast tissue growth of about 100cc -- approximately one cup size. Proportionate enlargement of both adipose (fat) and fibroglandular (breast) tissue, with no edema (swelling), was confirmed by magnetic resonance imaging (MRI). Women Who Tried the Brava System ... "The growth with Brava was gradual. It added fullness and in the last month, I also noticed lift." (, a 38-year-old clinical trial participant.) "After breastfeeding, I was a double 'A' and didn't completely fill that up. With Brava, I quickly went to an 'A' cup and started filling up a 'B' cup. It's such a nice, natural alternative." (Kathy, another clinical trial participant.) For more information about the Brava System visit www.mybrava.com , or call 1-800-407-5304. Brava, LLC, a subsidiary of Bio-mecanica, Inc., has the exclusive rights on patents, manufacturing, marketing and distribution of the Brava System in the United States and Canada. Brava, LLC is headquartered in Miami, Fla. MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X76154033 SOURCE Brava, LLC CO: Brava, LLC; American Society for Aesthetic Plastic Surgery; U.S. Food and Drug Administration ST: Florida, California, District of Columbia