Breast Enlargement Fort Worth - Brava System
Breast enlargement without surgery—this is an idea that has captured the attention of women everywhere! The Brava system has received a great deal of publicity in the United States and has been marketed extensively. The early studies suggest that using this suction device every day for an extended period of time will actually cause a woman's breast to grow.
This is good news to some women. However, the amount of enlargement is small and most women who want larger, fuller breasts would not be happy with the degree of enlargement provided by Brava. This is why breast augmentation remains one of the most popular cosmetic procedures performed today.
When performing breast augmentation surgery, it is unusual to use an implant smaller than 250cc—and most women prefer larger implants. A small 250cc breast implant still produces 2 1/2 times the amount of enlargement (100cc) reported for the average woman who used the Brava system. Hence, it is unlikely that the Brava device will replace breast augmentation surgery.
Instead, the Brava system seems to complement breast augmentation surgery by providing women with another choice. It is very important for a woman to understand that the degree of enlargement she should expect with this device will be small and it will occur slowly over months of continued use. Wearing two large suction cups on one's chest for 10 hours every night for at least 10 consecutive weeks (2 1/2 months) requires a highly motivated woman. Although the manufacturer of the Brava device initially recommended wearing it for 10 weeks, many physicians now recommend at least 14 weeks (3 1/2 months) of continued use.
At USA Plastic Surgery, we now offer the Brava system as an option to our patients who desire breast enlargement. The vast majority of women still prefer breast augmentation surgery to achieve the look they desire. The Brava system is probably most appealing to those women who would be content with a small increase in breast size and those who are opposed to surgery.
Brava works through the principle of "tension-induced tissue growth." The human body has been shown to grow in response to mechanical force. The Brava device works by creating suction on the breast to stimulate its growth. By wearing the Brava system-two plastic domes connected to a suction device 10 hours a day for at least 10 weeks-women have been shown to grow their breasts by an average of 100cc or approximately one cup size.
The following "frequently asked questions" are provided by the company that makes the Brava device. It is interesting to note that the company reports 5 of the 17 women in the initial clinical trials were dropped due to non-compliance (i.e. failure to use it for the required 10 hours a day for 10 consecutive weeks). This represents almost 1/3 of the patients in this trial. This seems to suggest that because of the burden of having to use it every day for months, many women eventually give up. Hence, we believe its use should be primarily for those women who are both highly motivated and content with a small increase in breast size.
These photos were provided by the creators of the Brava system. These two patients demonstrate an increase in breast size from an A cup to a B cup after using the Brava system for 10 weeks.
What is the product?
The BRAVA Breast Enhancement and Shaping System is a well-researched, clinically tested medical device that has been in development for 10 years. Invented by a renowned plastic surgeon, it provides a lasting, safe, effective, and nonsurgical way to grow breast tissue.
Did the U. S. Food and Drug Administration (FDA) review this product?
Yes. After reviewing the system as a 510(k) Class II Medical Device, the U.S. Food and Drug Administration (FDA) responded by allowing the sale of the BRAVA System. The system has met all FDA requirements, and the FDA has decided against regulating the system at this time.
How much tissue growth can women expect?
Women can expect approximately 100 cc of lasting tissue growth, an increase of up to one-cup size. During the 10-week period, women do experience a certain amount of edema (swelling), which will diminish when the device is not in use and after completing the regimen.
Will the "new" breast tissue feel different than the original breast?
No, it's the person's own tissue that is growing.
What do women think about the BRAVA System?
The women who participated in the clinical trials reported that they were pleased with the results commenting most on the lift and fullness that developed. Many noted that their self-confidence increased and they became more aware of their bodies. Physicians noted that self-esteem increased in many women involved in the clinical trials leading to weight loss following new exercise and diet routines. The gradual nature of the enhancement also gave women time to adjust to the change personally and did not overtly announce to the world that something had been done.
How long does the enhancement last?
After completing the 10-hour per day, 10-week period, there is an initial regression that ends with women maintaining approximately a one-cup (100 cc) growth in the size of their breasts. Upon 18-month follow-up, the women had maintained their increase.
What effect does it have on women that have breast-fed and have some level of sagging?
Clinical data demonstrates that one of the most noticeable effects of the device is that it both develops breast tissue and offers a lift to the tissue as well.
Do the breasts grow in proportion or does one grow faster than the other?
Both breasts will grow in proportion when used as directed.
Are the cells in the breast really growing or are they just stretching?
Cells are first stretched and then grow. The device creates a sustained mechanical tension, which is translated to the cell via biochemical signals. A gentle pull is placed on the breast tissue, the cells respond by developing new generated breast tissue growth. Normal balance is restored and breast size is increased. MRI analysis of clinical participants indicated an overall proportional even increase in all elements (i.e., fat, fibroglandular tissue, etc.) of breast tissue.
When do I use the BRAVA Breast Enhancement and Shaping System?
Most women prefer to wear the system in the evening while they sleep. It can, however, be worn during the day while at work, wherever you are most comfortable. You will need to be able to wear the system for 10 consecutive hours.
How does the BRAVA System feel?
Women who use the System in clinical trials said that it did not cause any pain or significant discomfort. In fact, the pressure inside the BRAVA System's domes is insignificant compared to the forces exerted on the body in everyday life. The pressure developed inside the BRAVA System's domes is equivalent to the pressure change experienced prior to a storm or when climbing to the top of a high tower.
Is the BRAVA System heavy?
No. The BRAVA System's weight will vary due to the multiple sizes available to accommodate differing body types and breast size. The system weight ranges at around 1 to 2 pounds. The system consists of two domes; a SmartBox(tm), which is a small computer that regulates and records your wear pattern; and a sports bra, that is designed for both comfort and support.
Other than wearing the device for 10 hours every day for 10 weeks, what else must I do?
Nothing. Other than cleaning the BRAVA System domes and bra with soap and water and recharging the SmartBox's battery, you should go about your daily routine normally.
Why are frequent doctor visits required?
Initially your doctor will ensure that there is not a medical condition that would prevent you from wearing the device. You will also be sized and instructed on how to properly use and maintain the BRAVA System. Subsequent visits are to monitor change, ensure that you are wearing the device appropriately and moving to deeper domes as necessary. During these visits, measurements can be taken and data downloaded for wear pattern analysis, if necessary.
What happens if one or more days are skipped during a treatment?
Skipped or missed days, especially at the beginning of treatment, cause major setbacks. Missing wear time is not recommended. Because of the way the process works, growth takes place only after sustained tension is exerted on tissue. When tension is not applied for significant periods of time, e.g., 48 hours, cell memory causes the tissue to regress to its original state eliminating much of the previous benefit gained from having worn the device. As the wearer enters the 5th and 6th week of the wear, a skipped day does not create the complete loss of growth that it would during the beginning of the treatment, although future growth does slow.
How much will the BRAVA Breast Enhancement and Shaping System cost?
The suggested retail price of the BRAVA System including the physician's service is approximately US $2,500.
How can women get the BRAVA System and from whom?
Women will be able to purchase the system through physicians and will need to be supervised and counseled on its proper use to achieve the greatest benefit.
What risks, if any, are there from using the system?
The risks associated with the device are contact dermatitis, that is, an allergic reaction to the materials used in the device.
Are there women who should not use the system?
Most healthy women can wear the system. Women who should not use the BRAVA System include pregnant and lactating women, those with a history of breast cancer, those who have had a mastectomy, and those under the age of 18 years (or those whose natural breast development is not complete).
Will it cause cancer?
Mechanical forces have not been associated with causing cancer. There are numerous medical references that indicate that tension-induced tissue growth does not stimulate the growth of cancer.
Can you describe the clinical trials?
The initial clinical trials involved 17 women ranging in age from 18 to 40. Some were mothers and others had never had children. Five women were dropped from the trial due to noncompliance with the visitation protocol. Their initial cup sizes were AA, A, or B. All of the women grew approximately one-cup size and they were satisfied with their results. They agreed to use a medically accepted birth control method for the duration of the study and comply with stringent protocol requirements. Volunteers were excluded from the study for the following reasons: positive urine test for pregnancy; breastfeeding; a history of breast surgery or disease; severe breast tenderness and swelling related to menstruation, trauma or pain; presence of a breast mass; severe drooping of the breast; history of chronic dermatitis, and use of hormonal therapy besides birth control pills.
A second study consisting of approximately 150 women has been conducted. This study was undertaken to test the BRAVA System's product attributes. An initial wave of participants completed the study. They experienced the same positive results obtained in the original clinical trial. The remaining volunteers will be completing the study within the next several months. Women can now purchase the BRAVA System through BRAVA Authorized Physicians.
Will the System cause stretch marks?
No. The BRAVA System is very gentle. It applies a minimal amount pressure to the breast area. The resulting growth, of approximately one-cup size, is a gradual process that occurs over a 10-week period. Due to this gentle method of action, no evidence of stretch marks has been observed.
Frequently Asked Questions © Brava, LLC a subsidiary of Bio-mecanica, Inc.
STEVEN J WHITE, MD
PRESBYTERIAN HOSPITAL OF DALLAS
TEXAS HEALTH PRESBYTERIAN DALLAS
PROFESSIONAL BUILDING 3, SUITE 814
8230 WALNUT HILL, DALLAS, TX 75231-4485
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