Fw: Elsa on: MD's Expect New 'Choice' for Some Women This Year

[Guest guest]

I'm curious about who manufactures this product! I will continue to

research!

MM / NSIF

Martha Murdock, Director

National Silicone Implant Foundation

Dallas, Texas Headquarters

----- Original Message -----

From: " elsa J. (by way of ilena rose) " <elzaj@...>

<Recipient List Suppressed:>

Sent: Tuesday, May 01, 2001 5:58 PM

Subject: Elsa on: MD's Expect New 'Choice' for Some Women This Year

Ilena, Just wanted to send you a portion of the Brava webpage (notice the

part about the ring being silicone...sigh...this rules me out, since I have

silicone sensitivity. Love, El:

What is the BRAVAÆ System?

The BRAVAÆ Breast Enhancement and Shaping System is the only clinically

proven non-surgical alternative for breast enlargement and shaping. The

BRAVA System is safe, effective and painless. The System applies a gentle

sustained pull to the breast area resulting in the growth of new breast

tissue. This process applies the principle of tension induced tissue growth

that has been widely used in medicine for over 30 years in various

reconstructive procedures.

The BRAVAÆ System is a medical device designed for women, developed and

prescribed by doctors. The System consists of two semi-rigid domes with

specially engineered silicone gel rims, (emphasis MINE) and a

self-regulating microprocessor that creates and regulates the tension within

the domes. The System is held in place by a sports-bra. Women who wore the

system for the 10 hour a day 10-week protocol experienced both a lift and an

increase of approximately one-cup size of their own breast tissue.

New Use of a Proven Medical Concept

Tension induced tissue growth has been widely used by the medical profession

in tissue regeneration for more than 30 years in several procedures

including tissue expansion, limb lengthening and breast reconstruction. The

BRAVA System uses the same principle to apply a gentle three-dimensional

pulling force or tension on the breasts from the outside. This gentle

sustained pull stretches the cells, which respond by replicating until the

resulting gap is filled. The outcome of the treatment period is new breast

tissue growth, and therefore larger and firmer breasts.

Developed by Doctors and Permitted for Sale by the FDA

The BRAVA System was created after a decade of research and development, by

a doctor who wanted to provide women with a safe and effective alternative

to breast augmentation. Consequently, in 1999, the FDA permitted the BRAVA

System as a (510K) Class II medical Device, which is currently being

distributed through doctors in selected metropolitan areas. The System has

been awarded numerous U.S. and corresponding foreign patents.1

1US patents issued: 5,536,233; 5,662,583; 5,676,634; 5,695,445; 5,701,917;

6,083,912 with corresponding foreign patents.

The Clinical Results

Between 1998 and 2001, approximately 200 women between the ages of 18 and 50

years of age have participated in clinical and marketing product trials.

Results show that women who consistently wore the BRAVA System for a 10-week

period, grew an average of 100cc in breast volume, approximately one-cup

size. This true breast enlargement has maintained for more than one year

after discontinued use of the BRAVA System.

All participants were satisfied with their results and felt that their

breasts were lifted and enlarged. MRIs performed on these women revealed

that there was no significant breast edema, abnormal breast tissue

post-treatment or other signs of disease. In addition, there were also no

serious adverse events or dermatological reactions attributed to the use of

the device.

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