Can Vacuum Bra Double Breast Size Without Surgery? Increase your bust size without surgery with a battery-powered wearable vacuum bra. Physicians are lining up for the chance to offer the Brava Breast Enhancement and Shaping System to their less-endowed female patients.

By Julia Sommerfeld
MSNBC

NEW YORK, May 8, 2001 —  If you suffer from cleavage envy but are averse to scalpels and sacks of saline or silicone, there’s a new option: Hoover-ing your way to a bigger bust with a battery-powered wearable vacuum bra. Physicians are lining up for the chance to offer the Brava Breast Enhancement and Shaping System to their less-endowed female patients.

The bra-like device consists of two hard plastic domes ringed with silicone, a small battery-charged control box and a bra-like covering

IT SOUNDS like a crude joke and looks like a torture device (think Madonna cone bra), but this isn’t some contraption hawked on a late-night infomercial — Brava’s medical advisory board reads like a who’s who list of reputable plastic surgeons.

Physicians gathered here at this week’s meeting of the American Society of Aesthetic Plastic Surgery (ASAPS) were lining up at the Brava booth to learn how to get the product into their practices. But it’s no quick fix: The device must be worn at least 10 continuous hours a day for 10 consecutive weeks, and some experts are doubtful many women are willing or able to make such a time-consuming commitment.

But 37-year-old Marie, who wore it while she slept every night for 12 weeks as part of a clinical trial, says it was well worth it. Now, five months after she stopped wearing it, the San Francisco administrative assistant has maintained a cup-size gain — she went from size AA to a full A bordering on small B. She says the difference is modest but that one cup size is enough for her. “I just wanted to have a woman’s look instead of a little girl,” she said. “This is great for women who aren’t looking for something outrageous like Pamela Lee.”

The bra-like device consists of two hard plastic domes ringed with silicone that fit over the breasts, covered by what looks like a sports bra. With the flick of a switch on a hand-held power box, the air is sucked out of the domes, creating a vacuum that Brava LLC, the product’s manufacturer, says induces the breast tissue to grow approximately one cup size.

Because of the 10-hour requirement, most women who’ve used it in studies have opted to sleep in it, which requires sleeping on one’s back — not the most comfortable position for most people.

The system, which costs about $2,000 to $2,500 (about one-half to two-thirds the cost of traditional breast implants), will be available through select plastic surgeons, gynecologists and cosmetic dermatologists trained by the company to use the system, which has been approved for sale by the FDA as a nonregulated medical device.

The product is now being rolled out and within the past few weeks, about 100 doctors across the country have been trained to use the device. Dr. Roger Khouri, the product’s inventor and the medical director of Brava, says nearly 10,000 doctors have already inquired about the device. The company says the product was designed for small-breasted women. “It’s not for women who already have a C-cup,” Khouri said. “It’s for A’s and B’s who don’t want surgery but want to be a little bigger.”

STUDY DETAILS

In an early study, Miami plastic surgeon Dr. Thomas Baker, who has no financial interest in the company, tested the device on 17 women, only 12 of whom completed the trial. When worn as directed, breast size increased about 100 percent, partly due to swelling. The swelling went down in a few weeks, but the breasts retained a 55 percent increase that has so far been maintained for two years.

Brava was put to the test using strict guidelines and multiple criteria, according to Baker. To assess changes in breast size, he used bead-displacement and chest circumference measurements and plaster torso moulds. Magnetic resonance imaging scans confirmed that the increased volume was in fact due to growth of breast tissue.

But what most patients are really interested in are the before and after photographs — which reveal noticeable but not dramatic results, patients and doctors agree. Baker says he was very skeptical about the product at first but was impressed with the results. “When they wear it like they’re supposed to, everybody gets an increase.”

And all the women in his study reported being satisfied with their results: “A girl who is an A and goes to B is very happy,” he said. The results were published last summer in the peer-reviewed medical journal Plastic and Reconstructive Surgery. Since then, 150 women have completed the process in additional clinical trials.

The company says all the women achieved growth but those results have yet to be published. Baker will start offering the product to women on Monday; he says hundreds of women have already requested it.

Doctors at the ASAPS meeting who examined the device and the research results say they don’t doubt that it the product is safe or that it will give most women some growth — the idea of tension-induced tissue growth has been used in reconstructive surgery for 30 years. But many are concerned about whether their patients will actually comply with the system’s rigorous demands for such subtle results.

The bra-like device consists of two hard plastic domes ringed with silicone, a small battery-charged control box and a bra-like covering. “It’s an idea that works but it’s just too laborious,” Dr. Brian Kinney, a clinical assistant professor of plastic surgery at the University of Southern California and spokesman for the American Society of Aesthetic Plastic Surgery.

Dr. James Baker (no relation to Dr. Thomas Baker) of Winter Park, Fla., a clinical professor of plastic surgery at University of South Florida and head of the breast surgery committee at ASAPS, says he won’t carry the product because he predicts a lot of patient disappointment. “I have concerns people are going to be unrealistic about what will be accomplished and they’ll be disappointed,” he said. “After investing $2,000 in a device that you have to wear for a minimum of 10 hours a day for up to 4 months, your cup size only increases by 3 ounces. That’s not a lot for spending half your day wearing this.”

He also points out that in the study, almost a quarter of patients didn’t complete the trial — some dropped out and others were kicked out for not wearing the device as directed. Outside of a clinical trial, he says, women will be even less likely to comply.

Khouri says he is the first to admit patient compliance poses the biggest hurdle to success with Brava. “This is not for everybody,” Khouri said. “This is for patients with patience.” But the device was free in the trials, he adds, and paying customers aren’t going to want to waste their money.

James Baker disagrees:

“It’s like buying a gym membership or some expensive piece of home exercise equipment. How many of us have done that and only used it a few times?”

Dr. Mark Jewell, a spokesperson for ASAPS, and a plastic surgeon in private practice in Eugene, Ore., is considering using the product in his practice but, like James Baker, worries patients may be disappointed with the results. “The amount of breast volume increase may not satisfy the desires of many women,” Jewell said. “Women who come in for implants usually want to go up two sizes. Plus, many women are going to be unwilling to walk around for that many hours a day wearing essentially breast pumps.” But he says he may be willing to offer it because it does give women who are averse to surgery an option.

SAGGING CONCERNS

Sue, a 40-year-old stay-at-home mother of two teen-agers, participated in the trial. The San Francisco woman had experienced shrinkage and sagging since breast-feeding her children years before and they had never gone back to their pre-motherhood state.

Sue and her doctor were initially worried that the vacuum device might stretch her breasts and result in more sagging. So she was pleased when the top of her breast started filling in. “It made me look like I had a breast lift,” she said. “I’m fuller, it’s what I had always wanted. They’re like the breasts I had before I had children.” Khouri says the device doesn’t cause sagging because it’s not just stretching the skin — it’s stimulating the growth of breast tissue.

As a result, the breast actually looks fuller, not emptier, he said. Sue started the process as an A and ended as a full B. She’s now back in a follow-up clinical trial to find out if she can increase her breast size even further. She says the device was a little cumbersome and it took her a few days to get used to sleeping on her back, but was worth it. “I’m thrilled. I didn’t want surgery. It’s wonderful to know it’s my own breast tissue,” she said.

Her husband was skeptical but supportive. “My husband has a great sense of humor so for him this was joke material — he calls me Barbarella or Vavoom.” As for how wearing this device all night long for several months affects a woman’s sex life, Sue says, “Men can be very creative when they want to be.”

To get the system, women must find a doctor who offers it — listed on Brava’s Web site — and then go in for a consultation, evaluation and fitting. Though the company says there’s no evidence tension-induced tissue growth increases cancer risk, they recommend against use by women who have had breast cancer or who have a family history of the disease.

Source: http://www.msnbc.com/news/570130.asp#BODY

Thursday May 10, 2001 08:52 PM EDT GMA:

Doctors Say Suction Device Increases Breast Size

By ABCNEWS.com

Bras that make women's breasts appear larger have been around a long time, but a team of medical specialists have gone even further: They are testing a bra that actually makes breasts grow.

Women who want a bigger bust have had help over the years from padded bras, push-up bras, and the "Cross Your Heart" bra. Now there's something that actually promises to increase breast size - without implants.

The Brava Breast Enhancement and Shaping System, developed by reconstructive surgeon Dr. Roger Khouri, is said to be the first non-surgical technique for increasing the bust size.

"As soon as you put it on, you see your breasts growing," says Daisy, who asked that her last name not be used. "You have it on for an hour and your breasts are bigger."

Decade in Development

It may sound like one of those ads in the back of women's magazines that boast " GMA Investigates

Good Morning America decided to send its regular "beauty adventurer" Holly Millea to test out the new bra for herself.

"I feel almost like I have plungers on," she said after trying the bra on for the first time. "Like strong men are pulling my breasts away from my chest,"

After a few tingly, tugging minutes, the Smart Box reached maximum pressure, where it will remain for 10 hours a day. Millea will report her own findings on GMA after wearing it for 10 weeks.

The suggested price for the complete system and medical consultation is $2500, though individual doctors may vary that rate. The "Brava" is only available through doctors who have been trained by the developers.

The only negative side effect that researchers report so far is contact dermatitis, an itchy skin condition that results from direct contact with a product that irritates some people's skin.

Pregnant or lactating women, those with a history of breast cancer, or those who have had a mastectomy cannot use the bra.

Source: http://dailynews.yahoo.com/h/abc/20010510/hl/gma010509miracle_bra_1.html

The Brava System is touted as a safe, effective way to increase breast size without surgical implants. (ABCNEWS.com)

N E W Y O R K, May 9, 2001 — Women who want a bigger bust have had help over the years from padded bras, push-up bras, and the "Cross Your Heart" bra. Now there's something that actually promises to increase breast size — without implants.

The Brava Breast Enhancement and Shaping System, developed by reconstructive surgeon Dr. Roger Khouri, is said to be the first non-surgical technique for increasing the bust size. "As soon as you put it on, you see your breasts growing," says Daisy, who asked that her last name not be used. "You have it on for an hour and your breasts are bigger."

Decade in Development

It may sound like one of those ads in the back of women's magazines that boast "bigger bust in just days!" But women who have tried it and the doctors who developed it say in most cases, breasts grow up to one full cup size after 10 weeks of wearing the bra for 10 hours a day.

A board of leading plastic surgeons and tissue engineer who have worked to develop the so-called "suction bra" for more than a decade are conducting clinical trials to demonstrate its legitimacy. Some 200 women have tried the bra in trials in Miami, San Francisco and Washington, D.C.

The bras are now beginning to make their way onto the market via the Brava doctors.

The U.S. Food and Drug Administration has reviewed the bra as a 510(k) Class II Medical Device, and is allowing the sale. Although it met all FDA requirements, however, the agency has decided not to regulate the Brava system at this point.

Domes and Pump

Daisy, a petite data processor, participated in the clinical trials for the device because she wanted her clothes to fit better and did not want breast-enhancement surgery.

For 10 weeks, 10 hours a day, she wears a sports bra containing two plastic domes edged in a sticky silicone gel. Also held in place under the bra is a small rechargeable power pack.

"You'll notice there's a little port on the bottom where tubing fits into, there's a device that we call the 'Smart Box,'" says Dr. Thomas Baker, lead clinical investigator for Brava System. "The Smart Box has a little pump in it, which is battery-activated which creates a negative pressure within the dome between the breast and the wall of the dome."

When the Smart Box is turned on, air is pumped out and the breasts are sucked forward into the dome. Baker says that suction causes the nerves and breast tissue to grow, creating permanent growth of on average one bra cup size when used as directed.

Or at least it seems permanent — researchers have only been following the subjects for 18 months.

"We know that stretching causes new cells to form," says Baker. "So we reason that if we could maintain a pressure over a long period of time we could cause the breast tissue to increase; and indeed that's true."

New Kind of Beauty Sleep

Daisy admits the idea of strapping on the device was a bit daunting.

"At the beginning, when they first told me 10 hours, I thought, 'Wow! Ten hours is a lot of time," she says. "Where am I going to fit the time to wear that?"

Like many of the women in the study, she decided to wear it in her sleep.

"Get in the right position; make sure it's on right, and just pretty much stay there," Daisy recommends. "If you're moving all night, the seal is going to come open and you're going to wait for it to suck out the air again."

GMA Investigates

Good Morning America decided to send its regular "beauty adventurer" Holly Millea to test out the new bra for herself.

"I feel almost like I have plungers on," she said after trying the bra on for the first time. "Like strong men are pulling my breasts away from my chest,"

After a few tingly, tugging minutes, the Smart Box reached maximum pressure, where it will remain for 10 hours a day. Millea will report her own findings on GMA after wearing it for 10 weeks.

The suggested price for the complete system and medical consultation is $2500, though individual doctors may vary that rate. The "Brava" is only available through doctors who have been trained by the developers.

The only negative side effect that researchers report so far is contact dermatitis, an itchy skin condition that results from direct contact with a product that irritates some people's skin.

Pregnant or lactating women, those with a history of breast cancer, or those who have had a mastectomy cannot use the bra.

Source: http://abcnews.go.com/sections/GMA/GoodMorningAmerica/GMA010509Miracle_bra.html#1

Monday July 16, 2001 12:39 PM ET

Vacuum Power Used to Grow Breast Tissue

By Deena Beasley

LOS ANGELES (Reuter) - Women eager to have bigger breasts now have an alternative to surgical implants: a twin-dome device that uses suction to stimulate cell growth. And there is apparently no shortage of candidates.

The annual number of surgical breast augmentations has doubled to 203,310 in 2000 since 1997, according to the American Society of Aesthetic Plastic Surgery, and implants are the second most popular cosmetic surgery after liposuction.

The trade group credits increased social acceptance of plastic surgery for the trend. Others say advertising, lower costs and media coverage of celebrities' surgery contribute to the demand for enhanced breasts.

The new vacuum-powered apparatus, known as Brava, consists of oversize plastic cones fitted under a large zip-up sports bra that has to be worn at least 10 hours a day for a minimum of 10 weeks.

``There is tremendous interest from women who do not want breast implants,'' said Dr. Richard Fleming, a Beverly Hills plastic surgeon who has patients using the Brava system.

Yet some doctors say there are still questions about how much permanent extra breast tissue the new system can deliver.

In initial studies, 200 women using it added a bra cup size to their breasts, according to the Miami company that developed and markets the system. Brava LLC says the idea of using tension to stimulate tissue growth is far from new, but they are the first to use it to trigger breasts to grow.

After being placed over each breast, the system's plastic domes are connected to a machine that draws air out of the domes and pulls on the breast tissue.

CHEAPER THAN IMPLANTS

In addition to avoiding the pain and complications of surgery, the new breast enhancement method, at $2,000 to $2,500, costs a lot less than implants, which run about $5,000 to $6,000, Fleming said.

Surgeons groups estimate that up to 20 million women in the United States want larger breasts, but only a small percentage are willing to undergo surgery to attain their body image.

But Dr. Robert Greenberg, a past president of the California Society of Plastic Surgeons, asked: ``How many women are really willing to wear a suction-cup apparatus for a minimum of 10 hours a day for 10 weeks?''

For all the trouble, the Brava system offers only minimal enhancement, he said, adding: ``It is yet to be determined whether the enlargement will persist for the long term.''

Sara, a 29-year-old patient of Fleming who has been using the Brava system for five weeks, says she is very happy with the results so far. ``There was a lot of swelling during the first week, but now it's a lot less.''

She said she straps the Brava system on at night before going to sleep and, so far, she is up a bra size. ``I was always talking with friends about whether to get a boob job or not, but I've never had surgery before and the idea scared me. Also, I've seen them (implants) and they don't look real,'' she said.

In the early 1990s, thousands of lawsuits were filed against makers of silicone gel breast implants by women alleging that the implants were prone to leakage and raised their risk of developing chronic diseases.

'FULLER, LARGER BREASTS WITHOUT SURGERY'

The U.S. Food and Drug Administration (FDA) banned silicone implants for most women in 1992 and their use is restricted to reconstruction after breast cancer surgery.

Women undergoing breast augmentation now receive saline-filled implants, a silicone shell filled with sterile saltwater, but other types are being tested.

``The Brava system is the first FDA-approved device to offer women the opportunity to have fuller, larger and firmer breasts without undergoing surgery,'' Fleming said.

A spokeswoman for Brava said the FDA reviewed the system for safety and effectiveness but decided not to regulate it.

Fleming and his partner, Dr. Toby Mayer, both specialists in head and neck surgery, are fellows of the American Academy of Facial Plastic & Reconstructive Surgery.

``This is a relatively new procedure that's been tried on a limited number of patients. Its effectiveness has not been answered in a large group of patients,'' Greenberg said.

He noted that there are a great number of women who for various reasons want to have larger breasts. ``Some of them have seen their breast shape change after giving birth and breast-feeding, some were born with small breasts, and some have significant asymmetry,'' the plastic surgeon said.

``In all fairness, women should know that this (the Brava system) is still in its early stages,'' Greenberg added.

Sara said her friends, some of whom have tried pills billed as breast-enhancers that failed to work as advertised, are waiting to see her final results. ``I will go in at the end of 10 weeks and take some pictures,'' she said. ``They've done studies showing that the effect lasts for 1-1/2 years out.''

Source: http://dailynews.yahoo.com/h/nm/20010716/sc/health_breasts_dc.html

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