Fw: Brava users not satisfied

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----- Original Message ----- From: ~*Patty*~

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Sent: Friday, March 22, 2002 11:07 AM

Subject: Brava users not satisfied

http://southflorida.bizjournals.com/southflorida/stories/2002/01/14/editorial2.html?t=printable

Brava users say device not so swell Since its spring 2001 debut, the Brava System for breast enhancement has received glowing media coverage from ABC's "Good Morning America," "NBC Nightly News," Telemundo, Glamour magazine, the Miami Herald and dozens of other TV, radio and print sources.

But a growing number of women report disappointment with results and problems with the device's technology. Some say they have developed scars, spontaneous lactation and other physical problems. A complaint of false advertising has been filed with the Southeast Florida Better Business Bureau. Some of the women say they are consulting attorneys.

Brava of Coconut Grove is a subsidiary of Canadian firm Bio-Mecanica. The Brava device consists of a sports bra that holds two polyurethane domes that have a tacky silicone gel sealant. A vacuum pump sucks out the air and pulls the breasts forward. Brava says this causes breast tissue to swell as the system is used for 10 hours a day for 10 weeks. A "SmartBox" hooked to an Internet portal keeps track of how many hours the device is worn.

Brava says the $2,500 system is designed for women 18-40 who are cup size AA, A or small B. After 700 hours of effort, breasts are typically one cup larger, the company says.

Developed by Miami plastic surgeon Khouri as an alternative to implant surgery, the Brava device is not regulated by the FDA because Brava does not make medical claims.

"This is a product of compliance more than science," Brava chairman and CEO told the Business Journal last spring. "This technology has been used for a long time for tension-induced cell growth for reconstruction of scars, facial bones and lengthening of limbs."

The FDA division of plastics and reconstructive surgery reviewed the Brava plans on paper but did not test the actual product. The FDA decided to not regulate the device, which means it did not approve or issue cautions about it. A July 16 Reuters story, published in dozens of news outlets, mistakenly said the device had won FDA approval.

Fleming, a plastic surgeon in Beverly Hills, Calif., incorrectly said, "The Brava System is ... FDA approved."

"We did say they could market it," Sharon Snider, FDA spokeswoman, told a Kansas newspaper. "We concluded it was a very low risk and we decided not to actively regulate it."

Clinical trials were held almost three years ago, in Miami, Washington, D.C., and San Francisco. 200 women were tested, but no long-term studies have been released. Disappointed and embarrassed

On the Web, Brav-argh (http://people.ne.mediaone.net/drmomentum/bravargh/) is devoted to Brava customers with frustration stories. The site collects links and comments questioning the device's worth. It features the Brava logo with a Band-Aid over it.

Several women interviewed for this story gave their names and phone numbers to the Business Journal, but requested anonymity in print. The women said they are embarrassed about using the product and "wasting the money."

Names and stories of women who have concerns about Brava are collected on a forum at http://forums.about.com/ab-womenshealth/messages. More than 200 women have posted comments, positive and negative.

A typical message, from `NormajeanB," reads, "Their initial claim of 10 hours/10 weeks for one cup of growth has proven to be vastly exaggerated. The system, while it is working for me, has been incredibly slow and time consuming. I'm just finishing week 32." The woman said she has achieved one-cup size of temporary swelling, but not that much actual growth once the swelling subsides.

These stories were collected through phone interviews.

A 40-year-old computer technician in Kansas said she read about the device, and hoped to increase her size 36 A breasts. She drove three hours to Nebraska to a dermatology clinic that offered the system. She said the dermatologist who fitted her did not know much about the product.

"I knew more about it than they did," she said. "They had no clue what they were doing."

She said the SmartBox data graphs on the Brava Web site did not match her written record, and the LED lights on the smart box modem connection cradle never lit.

She e-mailed Brava president and COO Freyre about her Web site access problems, and said he told her Brava was "working on it, that so many people were trying to access the site, the server kept crashing."

She said she wore the device for 30 weeks but did not see results. She said wearing the device is a "trial of patience."

"I had to prop myself up to keep the seal from breaking, customer service did not help, the domes deteriorate, silicone touches the skin causing a rash, and the recommended cleaning procedure ruined the smart box."

A 36-year-old university instructor in Massachusetts said she wore it for 18 weeks, 17 hours a day, and although she has daily swelling, there has been no growth.

She also experienced problems with the SmartBox. "I cleaned it as directed, which flooded it, and it stopped working. It developed a crack in the box stem," she said.

While wearing the device, she said she developed chafing, open cuts, and a persistent rash, but was told by a customer service representative, "don't worry about it."

A 36-year-old registered nurse in Miami said she was not given a breast exam or asked about a mammogram, but was told she had to go on birth control pills while she wore the device. Brava does not recommend the system for pregnant women. After 10 weeks on the system, she experienced swelling but no growth, and began spontaneously lactating, though she has never given birth. She had a difficult time with the seals of the domes, and was told by a Brava rep to "wrap an Ace bandage" around the $2,500 device.

A registered nurse in Austin, Texas, said she has seen no growth after 18 weeks, and said Brava reps kept increasing the amount of time she was supposed to wear the vacuum system. She said she filed a complaint with the Southeast Florida Better Business Bureau. The BBB's automated phone report offers only Brava's contact information.

"My big problem is their advertising," she said. "When I bought the product, they were saying you'd grow a cup size for every 10 weeks of wear. Brava discovered this was not true. My lawyer will be counseling me on what to do next. I was told by two separate lawyers to start with the BBB." Brava's response

Liz McCarthy, who fielded a phone request for an interview with Brava's officers, said a May 25 Business Journal opinion column about Brava "wasn't balanced," and did not put calls through to , Freyre or Khouri.

"We question the journalistic standard of the article," McCarthy said.

The column, "Needed Lift? Brava System Promises Non-Surgical Breast Growth," won the 2001 Florida Press Club award for best commentary.

Brava's national public relations rep, Tracey Knudsen of Chicago-based Manning Selvage & Lee, said Brava's officers would not meet for an interview or arrange a phone interview, but would answer questions submitted in writing. She said the answers would not be attributed to specific people, but to "a Brava spokesperson."

In its e-mailed response, Brava said there are "thousands" of women using the system, but did not provide numbers.

In response to questions about Web site access problems, Brava wrote, "There are no Web site access problems."

Asked about the SmartBox cracking, Brava wrote, "To eliminate the possibility of this occurring again, all SmartBoxes are now made of a stronger plastic."

Are there concerns about scarring, open cuts, lesions and spontaneous lactation? "Our experience indicates that this is not a widespread occurrence," Brava wrote. "Users are instructed to remove the system at the sign of any skin change."

Several women in the online forum said Brava customer service reps have increased the minimum time needed for growth. Has the recommended wear time officially changed?

"No," Brava wrote. "We will continue collecting data to categorize and tailor the course of treatment for each of these body-type groups. This may result in a decrease or increase to today's recommended protocol."

What about the dozens of women who claim the recommended cleaning procedure ruined the SmartBox?

"We proceeded to develop a filter system that dramatically reduces the need for daily cleaning of the SmartBox and is now an integral part of each kit."

Fabric, a Hollywood plastic surgeon listed on Brava's Web site as a distributor, said Brava works fine.

"The only problem I've seen so far has been skin irritation, a few days of minor discomfort," Fabric said. "They stand by it, fix any problems. It wasn't designed to make Dolly Parton out of an A cup in one night."

Fabric said he is enthusiastic about the device, and "we will be rolling it out in Europe soon."

When asked for clarification about "we," Fabric said he is a shareholder and investor in privately held Brava. Brava copy cats

As Brava grows in popularity, its device is appearing in other forms. One Web site, http://www.usedbrava.com, buys used Brava parts and resells the system for about $1,500.

Gordon Hamm, a manager with Secondary Medical in Utah, which runs the site, said the company buys Brava systems from "doctors who are frustrated with the device" and "women who didn't want it anymore."

Hamm said Secondary Medical buys the used systems, many of which have never been opened by the doctors, for about $750, and resells them for about $1,000 - $1,200.

"Most women we talk to are happy with the device," Hamm said. "They just want to be treated better."

Hamm said he has talked to women who say they have "permanent damage" from using Brava, and that demand for the device has "slowed down dramatically."

"In a year or two, this will be on infommercials," he said.

At the Brav-argh Web site, one woman shares her home-made system, which she said cost about $40 to build. From the plumbing supply department at Lowes, she bought "two faucet protectors, the equivalent of the Brava domes; five feet of RVFD 5/16 OD vinyl clear, flexible tubing; and a `barbed t' to fit the tubing and two single barbed connectors."

To create the vacuum, she bought a "rechargeable quickpump" for about $29.

At the Brav-argh forum, the husband of one user expresses his wife's thoughts on Brava: "My experience with Brava can be summed up in two words: it sucks. It sucks up your time, because you have to have it on for so many hours and are still not guaranteed results. It sucks your attention because you worry whether it's working (especially after you've seen paltry results by week 10). It sucks your mood because you may become depressed when you realize all the effort you've wasted on it. And it sucks out some of the contents of your wallet."

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