BRAVA Nonsurgical Breast Augmentation - From Yes They're Fake!

The information below is strictly from the BRAVA-provided information -- to speak with real BRAVA patients visit: The Unofficial BRAVA Support Group

"New Use For A Proven Technique". For centuries various cultures have applied the principle of cell growth through tissue expansion to enlarge various body parts. The molecular basis of cell growth continues to be the subject of intensive research. This phenomenon is widely reported and has been studied at leading medical institutions for many years. The creators of the BRAVA System have applied these scientific principles to the breast and developed a safe and effective system that actually grows breast tissue naturally.

Understanding the Science Behind the Brava System
The BRAVA System is based on a scientifically proven principle that all types of body tissue will grow and generate new, normal tissue when gentle, sustained, uniform tension is applied. This tension, or stretching, is good for skin cells, and is in fact the mechanism involved in normal growth, regeneration, and normal balance of human tissue. This principle when applied to all types of tissues, including skin, bone, nerves, skeletal muscle, heart tissue and smooth muscle, will grow and regenerate normal tissue.
Tissue growth can be achieved by using an implanted device or by using an externally placed device. In the first process, breast tissue is encouraged to grow by placing a medical device inside of the breast area, such as the type used in post-mastectomy reconstruction surgery. The placement of the device generates a sustained "pushing" or tension, which causes tissue to grow.
This same process also applies by using external forces. In this process, sustained tension or "pulling" is applied to the area by an externally placed medical device. The device gently and gradually draws the tissue forward causing it to grow.

How Does The Brava System Work?
All living cells sense mechanical forces. Whenever tension is applied, cells respond by multiplying which expands the tissue. This expansion in volume relieves the tension and restores the cells to their normal state. Within the BRAVA System, the cells in the breast tissue are kept under constant tension, which motivates the cells to continue to multiply and expand the breast volume. As long as the cells are kept under constant tension they will continue to multiply.

The BRAVA Breast Enhancement and Shaping System consists of two plastic domes that fit comfortably over each breast. The domes are attached to a small rechargeable SmartBox™, all held securely in place with an attractive sports bra.

The SmartBox is a small computer that regulates the gentle pulling action of the system and records your wear pattern. When activated, the SmartBox draws air out of the domes and the breasts are gently drawn forward. The mild pulling action inside each dome, which is actually less than the pressure you experience inside a commercial airliner, gradually causes the breast tissue to expand and grow.

How You Use the Brava System
For the best results, the BRAVA Breast Enhancement and Shaping System should be worn an average of 10 hours a day for 10 weeks. Most women have chosen to wear the system in the evening while sleeping, although it can be worn during the day.

The BRAVA System is safe and effective due to its patented design and the materials used in its construction. The System has been engineered to conform to the physiology and biomechanics of the breast. The pressure inside the System's domes is evenly distributed, which avoids pressure points, making this a painless and gentle process. In addition, all materials used are hypoallergenic and biocompatible.

What Happens To Your Body?
The BRAVA Breast Enhancement and Shaping System uses gentle, three-dimensional negative pressure to grow breast tissue. In fact, today, the medical profession uses the same technique for several medical procedures including breast reconstruction and lengthening of limbs. The creators of the BRAVA System have taken this principle and developed patented processes and designs to apply it to the soft tissue of the breast. Clinical research indicates that women who comply with the procedure experience increase in breast volume during Weeks 1 through 10. This initial increase is made up of both true tissue growth and swelling, which is painless. During the initial phase, the observed change in volume is due to swelling rather than true tissue growth. However, with continued use of the BRAVA System, true tissue growth begins to take place so that by the end of Week 10, there is a greater proportion of true tissue growth to swelling.

What Results Can You Expect?
When the system is worn as directed - an average of 10 hours per day over a 10-week period - most women initially experience a doubling of breast volume, followed by a period of reduction in size as swelling diminishes. The increase in breast volume stabilizes with an increase of approximately 100cc or approximately one-cup size.

Frequently Asked Questions

Q. What is the product?

A. 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 non-surgical way to grow breast tissue.

Q. Did the U. S. Food and Drug Administration (FDA) review this product?

A. 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.

Q. How much tissue growth can women expect?

A. 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.

Q. Will the "new" breast tissue feel different than the original breast?

A. No, it's the person's own tissue that is growing.

Q. What do women think about the BRAVA System?

A. 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.

Q. How long does the enhancement last?

A. 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.

Q. What effect does it have on women that have breast-fed and have some level of sagging?

A. 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.

Q. Do the breasts grow in proportion or does one grow faster than the other?

A. Both breasts will grow in proportion when used as directed.

Q. Are the cells in the breast really growing or are they just stretching?

A. 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.

Q. When do I use the BRAVA Breast Enhancement and Shaping System?

A. 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.

Q. How does the BRAVA System feel?

A. 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.

Q. Is the BRAVA System heavy?

A. 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™, which is a small computer that regulates and records your wear pattern; and a sports bra, that is designed for both comfort and support.

Q. Other than wearing the device for 10 hours every day for 10 weeks, what else must I do?

A. 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.

Q. What happens if the BRAVA System is worn for more than 10-weeks?

A. Your breasts will continue to grow. The rule of thumb is that a woman grows one-cup size for each 10 weeks of wear. However, depending on how large she becomes, she may outgrow the largest available dome size.

Q. Why are frequent doctor visits required?

A. 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.

Q. What happens if one or more days are skipped during a treatment?

A. 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.

Q. What if my breasts get too big and I don't like the look?

A. One of the most important attributes of the system is that it provides you with a preview of what you will probably look like. In most women, by the fifth week of active use, the breasts are markedly enlarged, providing a preview of the size at which growth will stabilize if treatment continues through the 10-week protocol. If, for example, at the fifth week, you do not like what you see, you can cease wearing the device and your breasts will return to a size close to that with which you began the process. This reversible enlargement is due to the initial action of the system and some edema or swelling. In fact, you always have the ability to stop wearing the device at any point you are not comfortable with the look. There will always be some retraction between when you stop using the device and when the tissue stabilizes.

Q. How much will the BRAVA Breast Enhancement and Shaping System cost?

A. The exact cost has not been set yet. However, it is expected that the device coupled with physician fees will cost between $2000 and $2500.

Q. When will it be available?

A. The device will be available in late 2000 after additional clinical trials are conducted and additional product design refinements are made to the system.

Q. How can women get the BRAVA System and from whom?

A. 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.

Q. What risks, if any, are there from using the system?

A. The risks associated with the device are contact dermatitis, that is, an allergic reaction to the materials used in the device.

Q. Are there women who should not use the system?

A. 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).

Q. Will it cause cancer?

A. 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.

Q. Can you describe the clinical trials?

A. 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 trail due to noncompliance. The women's initial cup sizes were AA, A, or B. 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. Brava, LLC will be conducting much larger clinical trials this summer in three major metropolitan areas around the country involving approximately 200 women.

Q. Will the System cause stretch marks?

A. 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.

Editorial
What do I think? I think it's worth a shot if you truly do not want breast implants or use supplements. In my opinion I believe that even women who have very little breast tissue but are wanting implants anyway, could possibly use the system beforehand to gain a cup size in tissue. I know it would be more expensive in the long run due to buying the system AND getting implants - but the more tissue to cover the implants, the better. I am hoping that eventually BRAVA, LLC conducts clinical tests with women who wish to go this route. Reason being, I would like to know the amount of lost tissue due to the pressure of the implant once placed in the body. I know that I personally had loss of tissue within a year but regained some due to hormones (birth control pills). I suspect when I cease taking this form of hormone I will lose the tissue regardless all over again. It's tough being a woman, isn't it?

Update! 10/25/01: Two surgeons that I know have reported abrasions, blisters and soreness in several cases when their patients wear the system. It is unknown if these patients wore their systems incorrectly, for too long, etc but I do know that said surgeons stopped offering the system at their practice. They also advised a lot of women had too high expectations and were only disappointed with the results.

Update! 12/02/01: I spoke with a lady who developed blisters and some type of contact dermatitis resulting in the need for hydrocortisone. The patient developed a sore which held "us. Also a few mornings the patient advised she woke up only to discover no suction or "hissing" (pressurizing) when she removed the device. She was very angry that all the time she was spending in the uncomfortable device without a good night's rest -- and no suction. I will attempt to obtain a statement or journal from her and wish her much luck! I have heard the same from too many visitors who have written me after using the BRAVA system. This isn't to say the product is a dud, however facts are facts.

Update! 12/8/01: I have seen the light. Please visit this The Unofficial BRAVA Support Group - a group of women discussing the reality of the BRAVA system. You will learn A LOT. RECOMMENDED!

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