The first night she pulled out her new breast enhancement system, a motorized contraption with large, clear plastic domes resembling something only a space-age sex symbol might wear, Linda Langer wondered aloud: "What am I \o7 doing\f7 ?"
The new vacuum-based system, known as Brava, is worn beneath a large zip-up sports bra at least 10 hours a day for a minimum of 10 weeks. It isn't for the weak of will.
But nearly two weeks into the regimen, Langer is a believer. "I definitely see a change," she says. "My breasts are much fuller and they're not saggy."
The brainchild of Miami plastic surgeon Dr. Roger K. Khouri, Brava has no national advertising campaign but is catching on through word of mouth. Since March 26, when the product went on sale, more than 1,000 women have been fitted, even though so far the system is sold by only 200 U.S. doctors--for $2,500 each.
Early results, which claim an average gain of less than a cup size, look promising. But other doctors are carefully watching the trend, sensitive to the breast being a delicate, disease-prone organ. Some are concerned about the lack of long-term data--and whether any increase in breast size will actually hold up over time.
Khouri insists the program is safe--and effective. The vacuum pressures, he says, exert a constant pull on the breasts, stimulating reproduction of the breast's glandular and fat cells. He says he based his work on the tissue expanders that stretch skin and fat for breast cancer patients being fitted with implants. Khouri also cites bone-lengthening devices that use pressure to stimulate growth of new tissue, nerves, muscle and bone.
He even submitted the device to the federal Food and Drug Administration for marketing approval. But the agency considered the system "very low risk" and decided against regulating it. The FDA didn't review its effectiveness.
Khouri published results on 17 women in the June 2000 issue of the peer-reviewed journal Plastic & Reconstructive Surgery, including tissue growth verification by magnetic resonance imaging and core biopsies. He also has unpublished findings on 200 women he's followed more than two years.
Dr. William Shaw, chief of plastic and reconstructive surgery at UCLA, has kept tabs on Khouri's work and believes the device is safe.
"Basically, it's fairly innocuous," said Shaw, a friend of Khouri's with no financial interest in Brava.
