The BRAVA Breast Enhancement and Shaping System









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		Clinical Trial Results: Safety
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The BRAVA Breast Enhancement and Shaping System has been found to be both safe and effective in enlarging breast tissue. In fact in clinical studies, skin reactions to the product were the only adverse effects reported. The following information will provide you with detailed information about the safety of the BRAVA System.

Skin Irritation:
Some redness and swelling is normal when using the system. Users of the BRAVA System report that there is no discomfort or pain involved when used as directed. Normally, any skin redness will disappear in about an hour. A small amount of swelling to the breast tissue area is expected until the user completes the treatment.

In some cases, a mild to moderate skin irritation can occur when using the BRAVA System. When the BRAVA System is worn and a rash develops, a Brava user will need to discontinue use until the skin irritation is resolved. If a persistent rash or sore develops, and the use is continued without treatment of the skin irritation, a skin rash could develop into blistering and scarring.

To help minimize the chance of any skin irritation, Brava has developed the BRAVA Skin Care Kit which includes creams and lotions that sooth, cleanse and protect the skin throughout the treatment. Each Skin Care Kit comes complete with a body cleanser, a body lotion, a dome cleanser and a choice of skin protection products. The liquid cleanser is used prior to wearing the system to cleanse the breast area, eliminating dead skin cells before they come in contact with the tacky sole of the dome. This protects your skin against irritation and when used to wash the domes, helps to prolong their life by helping to maintain the tacky surface. The dome cleanser is used to clean the domes after use to prolong the longevity of your domes and assist in preventing skin irritation and rashes when used daily. The hydrating lotion is used each day after removing the System to help nourish and care for the sensitive skin of the breast area. For skin protection, the Brava Roll-on Skin Prep or Smith & Nephew's NO STING SKIN PREP™ should be used around the breast area where the domes come in contact with the skin prior to placement of the domes each day. Both of these products create a thin protective barrier between the skin and the domes, reducing the effect of friction the domes exert on your body.

Daily use of the cleansers, lotion and skin prep will extend the effectiveness of the domes; rehydrate the breast; and reduce the chance of developing any skin irritation. These products can be purchased as a complete kit or individually by calling Brava Customer Care at 1-800-407-5304, by visiting our online Brava Storefront (Click here), or by contacting your Brava Authorized Physician.
Allergies:
Although it is extremely rare, some users can develop contact dermatitis, which is as an allergic reaction to the materials used in the construction of the BRAVA System. If itching, blistering, or unusual swelling occurs, you could be allergic to silicone-based products that make up the components of the System. Be sure to consult with your physician prior to using the BRAVA System if skin sensitivity is known. These reactions are uncommon, but if they occur the user should contact their physician immediately.
Hyperpigmentation:
Those who are prone to hyperpigmentation (darkening of the skin) should consult with their dermatologist prior to using the System. Those who develop hyperpigmentation while wearing the BRAVA System should discontinue use immediately and should consult with their dermatologist for treatment.
Costochondritis:
Costochondritis is a rare cause of chest wall pain and is characterized by a painful swelling of the upper costal cartilages of the rib cage (where the ribs connect to the breast bone). Treatment with over-the-counter anti-inflamatories and locally applied heat will usually improve most symptoms. If symptoms persist, discontinue use of the System and see your local Brava Authorized Physician or other health care provider.
Brava and Breast Cancer:
Most importantly, the BRAVA System and the technology of tissue expansion are not associated with cancer.

1- Mechanical forces are protean and omnipresent and have never been implicated as carcinogens:
In the entire cancer research literature, there is no evidence that mechanical forces are remotely, theoretically or in any way associated with cancer causation or growth. In fact, crossing tension, expansion, or mechanical forces with cancer in literature search engine leads to publications on the therapeutic implications of tissue expansion in cancer reconstruction.

2- Experiment of Nature:
Brava effects a distracting force on the breast which is equivalent to the amount of gravity exerted from 4 pound breasts on a large-breasted women. Yet extensive epidemiological research confirms that women with larger breasts that are constantly subjected to the stretching effect of gravity are not at higher cancer risk than small-breasted women. In fact per gram of tissue, large breasts have less cancer incidence than small ones.

3- Clinical Experiment:
Tissue expansion is routinely used for post-mastectomy breast reconstruction. It is well known that even the most radical mastectomy leaves behind some breast tissue. Yet more than three decades of experience on millions of women leave no evidence that expanding that residual cancer prone breast increases the likelihood of cancer growth or recurrence. Furthermore, despite the fact that skin is the most cancer prone organ in the body and skin expansion is routinely used in plastic surgery, there are no reports in the literature of cancer arising in the expanded skin.

4- Animal Experiment:
Published research in animals of the effect of tissue expansion on cancer growth has shown that tissue expansion has an inhibitory effect upon the growth of implanted mammary tumor cells and on the extent of visceral metastasis. (Ref: Plast Reconstr Surg 1991 Jan;87(1):1-7)

5- Cell Biology Experiments:
The cellular mechanisms responsible for tension induced tissue growth involve a highly organized array of sensors, receptors and growth promoting signals. Transformed or cancerous cells typically loose these pathways and acquire an autonomous growth mechanism that is independent of these normal cues. When grown in tissue culture plates, normal cells multiply until they reach confluence; that is when a monolayer fills the plate and "contact inhibition" causes them to cease multiplying. Tissue expansion has been demonstrated in these tissue culture plates; as stretching the plate and the overlying cells causes them to multiply again until they reach the new equilibrium level of confluence. The hallmark of cancerous transformation is the loss of this "contact inhibition". Cancer cells loose the normal clues that make them respond to confluence and tension and will keep on growing autonomously and independently from any additional stretch.

6- The Brava Clinical Experience:
After more than ten years of clinical practice in the United States, as a rule we suggest that all Brava users have a recent breast exam prior to using the System. A mammogram (within one year) may also be recommended as per the guidelines set by the American Cancer Society.

7- Expert Opinions:
We asked two nationally recognized breast cancer experts, one at Vanderbilt University and the other at the MD Anderson Cancer Center to independently review our data, our breast biopsies, and the literature and give us a written opinion as to the cancer risk, if any, associated with Brava. They both unequivocally wrote that there is no evidence whatsoever that it might in any way promote cancer growth or increase cancer risk. Furthermore, there are some in academia that believe that the effects of Brava might actually be cancer protective. Besides the theoretical cell biology evidence (Stretching is good for a cell; Science: May 30, 1997; 276(5317):1345-6), there is evidence from an epidemiological study that showed that women who wear supportive brassieres that annul the lifelong stretch of gravity have a higher incidence of breast cancer.

Finally, Susan Love, M.D., a leading breast cancer expert and professor at UCLA, was quoted in ELLE Magazine's March issue, "The Next Breast Thing" (p. 251) saying "There is no reason to think it causes cancer" and added that, " Compared to most of the fly-by-night things proposed to increase breast size, it actually has some data behind it and seems to pose fewer risks than breast implants or over-the-counter drugs and creams"."