The BRAVA Breast Enhancement and Shaping System

Because we care about your health, this section is designed to help inform you of breast health issues and your options for breast enlargement. Below are important facts you should know regarding breast awareness and, if you are deciding which breast enlargement option is right for you, the following information may be helpful in making an informed decision.

1. What are my options for breast enlargement?

Truths & Myths of Breast Enlargement

What are my options? (5)	Brava® Breast Enhancement & Shaping System	Surgical Breast Augmentation	Pills	Creams	Padded Bras/Curves®

What will I need to do?	Must wear System a minimum of 10 hours a day for 10 to 16 weeks. Compliance is key to growth. Once final growth results are achieved, there is no need to wear the system further to maintain growth.	You will need to undergo a surgical procedure and anesthesia. Recovery time is estimated at 2 months with no heavy lifting and 4 to 6 months for final results to be achieved.	Ingest pills daily to sustain the temporary engorgement	Apply daily to breast area	Place on as needed for appearance of larger breasts

What results can I expect?	Increase in your own breast tissue from 1/2 to 2 cup sizes in as little as 10 consecutive weeks of use. Results vary with the use and biological variability. The more you wear BRAVA, the more you will grow.	Results are immediate following surgery. You can choose amount of increase you desire. Results can be great. It depends on the technique of your surgeon and the amount of breast tissue you have to start with. In most cases, the more breast tissue the better the result.	Unproven to enlarge breasts. Results, if any, are a temporary engorgement of breast milk ducts. Consumerlab.com, an independent lab that tests supplements said, "There is no hard evidence that any current herbal breast supplement works. Herbal supplements often tout the so-called estrogen effect of some herbs, but this is unlikely because doses are so small." Click here to view article, COMPANY (ISIS) AGREES TO STOP SELLING BREAST-ENHANCEMENT PRODUCT	Unproven to enlarge breasts	Gives the appearance of larger breasts as long as they are worn.

Who should not use this method?	Any one under 18 years of age, those who have breasts larger than a small C cup, those who are pregnant or lactating, those prone to hypertrophic scars (thickening of scar), those who are over age 40 and have not had a mammogram within the year, those who have had an abnormal mammogram, those who have chronic dermatitis of the chest area or those who have a history of radiation of the breasts (other than routine x-rays) If any other history of breast abnormalities, please consult a physician prior to use.	Those patient under 18 years of age, those with bleeding diathesis (bleeding disorder), those who are medically unstable for surgery, those who are pregnant and/or breastfeeding, those who have current infection or breast malignancy.	Those who may be allergic to the herbal compounds found in these products.	Those who may be allergic to the herbal compounds found in these products.	Anyone can use these methods

How long will results last?	Results are long lasting. In clinical trials after 10 to 16 weeks of wear, growth maintained 22 months post-wear without re-use.	Implants last on average 7 to 10 years. Further revisional surgery is usually needed	If any results are visible, they manifest themselves only while ingesting the pill. Temporary growth is lost when use is discontinued.	No growth has been noted.	The appearance of larger breasts while the bra/Curve is worn.

How will they look and feel?	BRAVA grows more of your own breast tissue, so the increase is natural breast tissue that follows the natural contours of your body. Most users note an increase to the upper part of their breast giving them cleavage. As CRYSTAL Magazine says, "The real deal". They feel like real breasts because they are.	Breast implants allows you to increase your breasts to any size you like. If the woman has a lot of breast tissue to begin with, the results can look very natural. If there is little to no breast tissue, the breasts will have the appearance of "round balls" on the chest. You sometimes may notice the edge of the implant on certain women. In cold temperatures the breasts will feel cooler than the rest of the body. Saline filled implants can at times give a ripple effect and are not as natural feeling as the silicone implants of earlier years. Results are usually better when a plastic surgeon specializing in cosmetic breast surgery is selected. See www.surgery.org for a listing of doctors certified by the American Board of Plastic Surgery. CRYSTAL Magazine says, "All-natural plastic".	If any increase is seen at all, it is a temporary engorgement of the milk ducts. Many of these herbal products claim to increase the breast with "hormone like" effects similar to birth control pills. (See the recent HORMONE review by the US government in the questions below.) You may see a temporary increase similar to the increase seen during menstrual cycles.	No growth has been noted.	Padded bras such as the WonderBra® or products likes Curves® can be very effective in accentuating the breast tissue you already have by pushing you inward & upward. The padding or jelly-like forms make the breast appear rounder and fuller by giving you cleavage. These are often touted as "Hollywood's best kept secret", but if there is no breast tissue the results are disappointing. CRYSTAL Magazine says, "Look don't touch�great until you take it off."

How much does it cost?	In the U.S., the Brava System comes as either a complete system (2 domes) or as a BRAVA Starter or Brava Sport Systems (1 set of domes). The cost of the system ranges from 1/3 to 1/6 the cost of breast augmentation surgery depending on the product configuration selected. When you buy the System from an authorized physician and results are documented, a money back guarantee is available. Payment plans, for as little as $167.00 a month, are available when purchasing from Brava direct. An additional set of domes may be purchased as needed.	The average cost for breast augmentation surgery in the U.S. is $5,000.00. Costs vary by region. You may pay more for a doctor who is known as a "the breast implant specialist" in your area.	You pay by the day for as long as you want the increase, if any, to last. Costs for breast pills range from $84.00 to $111.00 a month depending on quantity purchased. (i.e. 12 months x $84.00 = $1008.00 per year.) In five years you will spend $5,040.00 or more than surgery and five times the cost of BRAVA.	Daily use is also needed, yet results are unproven. Most of the creams are sold in combination with pills. Cost range from $45.00 each to $95.00 for both products per month. (i.e. 12 months x $45.00 = $540.00 a year). In five years you will spend $2,700.00 or almost three times the cost of BRAVA.	Padded bras retail for around $26.00. Curves� cost $99.00 a set. Both are available in leading department stores.

Where can I get it?	In the U.S., the Brava System is available from an authorized physician near you or direct from the company. To locate a doctor near you go to How to Buy Brava; to buy direct call: 1-800-422-5350 M-F 8:30am to 8:00pm.	From plastic surgeons worldwide. In the US you can find a plastic surgeon certified by the American Board of Plastic Surgery by visiting www.surgery.org	Sold through internet sites and telemarketers.	Sold through internet sites and telemarketers.	Available from leading department stores.

Are there any risks associated with this option?	Skin reactions are the most common adverse effects reported. Most skin irritations are from either contact dermatitis, or a heat rash caused by improper cleaning of the domes. Go to BRAVA SAFETY for more information.	Risks with surgery include: capsular contracture (hardening), deflation/rupture/leakage, additional surgeries, pain, scarring, infection, hematoma/seroma, change in nipple sensation, calcium deposits in tissue around the implant, delayed wound healing, extrusion, necrosis, galactorrhea, mammography interference. For complete information, see the complete report written by the U.S. Food and Drug Administration by contacting them at 1-888-info-FDA or by visiting www.fda.gov/ cdrh/breastimplants/	Effects from daily absorption are unknown and have not been studied. However, recent warnings indicate that the effect of estrogen like substances, which are usually the ingredients touted in the product's literature have come under recent scrutiny due to their unknown carcinogenic effect on the person. Furthermore, recent warnings also indicate interference with other medications could prove harmful to a woman's health. Reported allergic reactions.	Risks are unknown and have not been studied. Absorption is very minimal. Allergic reactions. Click here to view article, COMPANY (ISIS) AGREES TO STOP SELLING BREAST-ENHANCEMENT PRODUCT	None

Has this been tested in clinical trials?	Yes. Two clinical studies were conducted that involved approximately 200 women. Results from the initial clinical trials were published in the journal of PLASTIC & RECONSTRUCTIVE SURGERY and were reviewed by the US Food & Drug Administration.	Yes. Many studies have been done since introduction in the 1970's. Studies are ongoing of each new type of implant designed. The FDA reviews all data as implants are used for both augmentation and reconstruction. MENTOR notes, "Most women experienced at least one complication over a 3 year period. Most women were satisfied with their implants. The chance of additional surgery for augmentation is 1 in 8, with implant removal and replacement as the most common reason for the additional surgery."	Independent studies have been conducted and have proven these products are ineffective in offering breast enlargement. Click here to view article, COMPANY (ISIS) AGREES TO STOP SELLING BREAST-ENHANCEMENT PRODUCT	No studies have been conducted and published in any medical journal as to the efficacy of these herbal products.	Not applicable

Has this been FDA reviewed?	Brava submitted to the U.S. Food & Drug Administration a premarket notification for a 510(k) Class II Medical Device, the U.S. Food and Drug Administration (FDA) has chosen not to regulate the Brava System when used for breast augmentation at this time.	Yes. Implants are a regulated medical product that is reviewed by the US Food and Drug Administration.	No. The FDA has not reviewed these products.	No. The FDA has not reviewed these products.	Not applicable

2. What gives breasts their shape?

A. Breasts are made up of skin, milk ducts, glands, connective tissue and fatty tissue. The breasts are supported by your rib cage and your chest muscles (the pectoralis major and minor).

3. Is there a website where I can find more information on cosmetic breast surgery?

Yes, there are great free resources. The ASAPS (American Society for Aesthetic Plastic Surgeons) is a good place to start. Go to http://www.surgery.org/ Another is Mentor Corporation's web site. It is a very comprehensive. You can see a listing of frequently asked questions about surgical augmentation at: http://www.mentorcorp.com/cs/ba/cs_ba_aa_faq.htm To help you make an informed decision about breast augmentations, Mentor also suggests you visit: http://www.mentorcorp.com/pdf/FinalInformedConsent.pdf. You can also call MENTOR at: 1-800-MENTOR8.

To learn of the risks associated with breast implants, you can also see the complete report written by the US Food and Drug Administration by calling 1-888-info-FDA or by visiting: http://www.fda.gov/cdrh/breastimplants/

4. Why do our breasts sag anyway?

A. Breast sagging (drooping) or ptosis as it is commonly referred to, occurs for several different reasons - multiple pregnancies, breast feeding, rapid weight loss, genetics, gravity and age. Just as all body tissues are susceptible to the effects of gravity over time, the breast, because it is an external organ and not protected from external forces, also undergoes changes over time. The connective tissues supporting the breast are always under constant stretch due to the effects of gravity on the weight of the breast, this effect eventually causes the relaxation of these supporting ligaments creating the sagging effect.

5. Why should I do a self-breast exam?

A. By examining your breasts regularly, you will become familiar with what is normal for your body. By becoming familiar with what is normal, you will also be able to recognize changes promptly. Any change should be brought to the attention of your doctor. Please remember, breast self-exams are only one part of good breast health care. A regular yearly breast exam by a qualified physician is an important part of the screening process, as well as, indicated mammograms (see recommendations by the American Cancer Society).

6. When and how do I do a self-breast exam?

A. The most opportune time to perform a self-breast exam is when you are showering. First using a mirror and good lighting, perform a visual exam of both breast with your hands on your hips and then placed over your head. Look for any skin dimpling, discoloration, or abnormal skin growths. Look for symmetry. You may notice one breast larger than the other, this is considered normal for the most part. However if there is change from one month to the other please contact your doctor. Next, begin examining the breast with the flat portion of you fingers, Start by pushing the breast tissue down to your chest wall and in a circular pattern examine the breast from outside to inside feeling for any lumps or noticeable changes from the month before. You may use soap or skin lotion to enhance your exam. Next, check under the armpits for any lumps and then squeeze the nipples to check for any nipple discharge. Any abnormalities should be reported to your personal doctor immediately.

7. When should I begin mammogram screening?

A. Mammogram screening should begin when a woman is 40 years of age then every 1-2 years thereafter. At age 50 women should begin routine yearly mammogram screening. If there is a family history of premenopausal breast cancer, you may want to start mammogram screening at an earlier age.

8. Can supplements (pills) increase my breasts?

In November 2002, ABC TV Affiliates around the US reported on an independent study conducted to test the efficacy of three different herbal supplements that claimed to increase breast tissue up to three-cup sizes. Researchers found that none of the women tested showed an increase in breast size. It was also found that there are no herbal supplements registered or evaluated by the U.S. Food and Drug Administration. Computerlab.com located in White Plains, New York, which conducts tests on all kinds of supplements said that there was "NO HARD EVIDENCE" that any current breast supplement works. They also indicated that herbal supplements which often tout the "so-called estrogen effect of some herbs" are unlikely to provide any effect due to the fact that the dose is so small.

9. Are hormone supplements safe?

Here is a press release from the U.S. government released on December 11, 2002 entitled, "U.S. lists hormone therapy as carcinogen":

WASHINGTON, Dec 11 (Reuters) - Estrogen replacement therapy joined the official U.S. government list of cancer-causing agents on Wednesday, along with wood dust and ultraviolet light.

A big study published in July showed that hormone replacement therapy increases the risk of several kinds of cancer, including breast cancer, although it seems to lower the risk of colon cancer. It also raises the risk of heart disease.

The report also lists wood dust as a "known human carcinogen." The report, part of the National Toxicology Program's biennial report on cancer-causing agents, says unprotected workers in sawmills, furniture factories and similar places have a higher risk of cancers of the nasal cavities and sinuses.

And it lists broad-spectrum ultraviolet light, both naturally produced by the sun and the light made by tanning beds and lamps, as a known cause of cancer in people.

The various separate kinds of UV light, such as UVA, UVB and UVC, are listed as probable carcinogens because it is not clear whether each one on its own alone could cause cancer.

"This and 15 other new listings bring the total of substances in the report, 'known' or 'reasonably anticipated' to pose a cancer risk, to 228," the Department of Health and Human Services said in a statement.

The NTP, part of the National Institute of Environmental Health Sciences, one of the National Institutes of Health, updates its list of known and suspected cancer-causing agents after lengthy study and scientific reviews by three expert panels of government and non-government scientists.

Also new to the list are nickel compounds and beryllium and its compounds commonly used in industry. Beryllium was previously listed as "reasonably anticipated to be a human carcinogen."

"About 800,000 workers are exposed via inhalation of beryllium dust or dermal (skin) contact with products containing beryllium," the department statement said.

"Workers with the highest potential for exposure include beryllium miners, beryllium alloy makers and fabricators, ceramics workers, missile technicians, nuclear reactor workers, electric and electronic equipment workers, and jewelers."

Joining the list of reasonable cancer suspects are IQ, or 2-amino-3-methylimidazo(4,5-f)quinoline, which is formed during direct cooking with high heat of foods such as meat and eggs and which is also found in cigarette smoke.

10. Is there anything I can do to help reverse the effects of gravity on my breasts?

A. Yes, in fact just by wearing a bra that offers good support or a sports bras while exercising can help reduce or even slow the downward pull of gravity. Gravity actually causes our breasts to grow downward. Stay in shape. Excessive weight gain contributes as well as genetic factors.

11. Are there any new clinical trials offering options for breast reconstruction following a mastectomy or lumptectomy?

Yes, The Brava System is presently being used in a major clinical study by leading Plastic Surgeons in the U.S. and Europe, to assist in the transfer of Autologous Fat from other parts of the body (e.g. stomach and thighs) to the breasts.

This revolutionary study is on-going with encouraging preliminary results. The scientific theory is that the Brava System helps enhance the endurance and the survival of the new cells that are grafted into the breasts from other parts of the body. The Brava System also allows for a greater size increase in the breasts by allowing a greater amount of cells to survive the fat transplant due to better blood circulation to the area and the expansion of tissue in the breast area that will accommodate the transfer of the new Autogolgous Fat cells.

The preliminary results have been presented at a major medical conference and the study is presently being submitted for publication in a major medical journal. To learn more about this clinical trial study, http://www.clinicaltrials.gov/ct/show/NCT00466765?order=1.

Learn more about Fat Grafting to the Breasts:
http://www.youtube.com/watch?v=syx1guRVfmM
http://www.youtube.com/watch?v=H2_cK-ddpnw
http://www.plasticsurgerypa.com/index.cfm?event=ProductView&CategoryID=33&SubcategoryID=29&ProductID=337
http://www.plasticsurgerypa.com/index.cfm?event=ProductView&CategoryID=33&SubcategoryID=29&ProductID=503

12. Are there any videos that I can watch to give me an idea of how Brava works and how to use it?

Yes, you can view this information on YOU TUBE.
http://www.youtube.com/watch?v=kIHubAQJpCk
http://www.youtube.com/watch?v=YZ4-94N7gL0

13. I saw the Evening News and a doctor named Roger Khouri, MD showed a device that grows breast tissue, was that Brava?

Yes. We found a copy of it on You Tube. It aired on CBS Channel 4 in Miami interviewed Dr. Roger Khouri and one of his patients.
http://www.youtube.com/watch?v=ug5TxfW8BHg

14. What do doctors say about Brava? Do they think it works?

In a Brava, LLC-sponsored study¹, Brava was tested by a leading team of plastic surgeons in clinical trials across the U.S. and the results found Brava to be an effective non-surgical alternative for breast enlargement.
The published article concluded, " In summary, this System offers women a means of enlarging their breasts without the pain and risk of surgery or the perceived long term health risks associated with surgical implants. The process is slow and gradual; the arbitrarily chosen 10-week course does not match the immediate size gain that follows the insertion of an average sized breast implant. Additional�use beyond 10 weeks is required to achieve further growth. This gradual process gives women more control over the change in their appearance. Because the tissue growth is local and autogenous, the result is more natural looking, as opposed to the artifical appearance that can often accompany breast implants."

1. Khouri, RK, Schlenz, I, Murphy, BJ, Baker, TJ. Nonsurgical breast enlargement using an external soft tissue expansion system. Plast Reconstr Surg. 2000;105(7):2500-2514.

�NOTE: To view abstract, go to http://www.brava.com/professional-publications.asp

REALSELF.com asked some leading physicians, "Are there any alternatives to breast implants?"
See their responses at http://www.realself.com/question/there-any-alternatives-breast-augmentation

For more physicians comments, see http://www.brava.com/what-leading-doctors-say.asp

15. Are there any new options being developed for breast augmentation?

Yes, there are many innovations that are being examined around the world as new alternatives for breast augmentation. Cosmetic Surgery Times (October 2008), offers an overview of these advances in the article, �A look at global trends in breast augmentation� authored by Karen Donley-Hayes. http://cosmeticsurgerytimes.modernmedicine.com/cosmeticsurgerytimes/article/articleDetail.jsp?id=553790

These developments include alternate types of implants, injectable products, stem cell alternatives and the use of a vacuum assisted device with fat injections to the breasts. (This technique is also referred to as Brava enhanced fat grafting to the breasts.)

In it, Dr. Eisenmann-Klein explains a new technique, pioneered by BRAVA developer Dr. Roger Khouri, which "combine the device (Brava) with fat injections into the subcutaneous tissue of the breast". Dr. Eisenmann-Klein notes that this technique offers �impressive results�. In this procedure small amounts of fat (only 3 cc or less) are injected into multiple channels in the subcutaneous tissue after gaining the fat by liposuction in the same session. Altogether, up to 300 cc of fat per breast can be injected in one session. The patient wears the BRAVA device for 12 hours per day, beginning 10 days prior to surgery and again from her first postoperative day for 10 days, 12 hours per day." The device increases the volume of the subcutaneous tissue and enables an 80 percent take of the fat grafts on average, Dr. Eisenmann-Klein explains. She notes that a collaborate exchange of ideas between Dr. Khouri and Dr. Rigotti has lead to the development of a �safe and effective technique� that �will be the future" of breast augmentation.

Also, in the The New York Times article by Catherine Saint Louis (December 3, 2009),"Your Own Fat Relocated', two leading physicians specializing in Fat Grafting to the breasts, Dr. Roger Khouri (Miami, FL) and Dr. Sydney Coleman (New York, NY) were interviewed. The article notes, fat grafting to the breasts is now considered a "safe method of augmentation" by the ASPS Task Force. Dr. Khouri's long term study results, presented at the October Meeting of The American Society of Plastic Surgeons, indicated that liposuctioned fat is "a viable alternative to breast implants". To read the complete article, go to http://www.nytimes.com/2009/12/03/fashion/03skin.html.

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