$2000 device for minimal enlargement?
In June 2000 Miami surgeon Roger Khouri reports in the journal Plastic and Reconstructive Surgery his experience with his invention The BRAVA system.
“The non- surgical breast-enlargement system incorporates two semi rigid plastic domes, each slightly larger in volume than the corresponding breast to be enlarged. A brassiere garment supports the two domes, and the device is worn like a brassiere. Each dome has an outlet port for vacuum application and a gel-filled bladder at the rim that circumscribes the outer margins of the breast. An adhesive, hypoallergenic silicone gel applied to the skin-contact surface of each bladder maintains a vacuum seal with the skin. A battery-powered, microcomputer-controlled vacuum pump is connected to outlet ports on each dome by plastic tubing. Pressure sensors and relief valves are used to maintain a vacuum pressure of 15 to 25 mmHg. To document protocol compliance, the microcomputer records temperature and pressure every 10 minutes and stores the data in its memory.
Participants were required to wear the breast-enlargement system for 10 to 12 hours per day every day for 10 weeks.”
Dr. Khourdi reported his endorsement for his device.
“All participants were very pleased with the outcome and reported that the device was comfortable to wear. No adverse events were recorded during the use of the device or after treatment. We conclude that true breast enlargement can be achieved with the daily use of an appropriately designed external expansion system. This nonsurgical and noninvasive alternative for breast enlargement is effective and well tolerated.”
I the November 2002 issue of the same journal Seattle surgeon Curran Smith reports on his disappointments with the system.
“For the past 6 months I have been using the new Brava system (Brava, LLC, Coconut Grove, Fla.) of nonsurgical breast enhancement. My initial results with the system have been inconsistent with the results reported by Khouri et al.,and I believe it to be important to share this information with plastic surgeons who might be considering promoting the product. I was attracted to the system by the Journal’s publication of the excellent study of Khouri et al., the endorsement of the product by a number of prestigious members of our organization, and my frustration over the years with the challenge of treating the very small-breasted woman who wants only a very minimal enlargement with an implant because of the implant’s narrow diameter. The Brava Company provides the physician dispensing their product with a fitting kit that contains a silicone mold equivalent to the shape of a 100-cc increase in breast tissue that the patient places on her breast to judge the anticipated average result. That potential improvement has met the objectives of almost all of the women investigating the Brava system seeking the elusive minimal enlargement. Here, I thought, was the answer to my dilemma.”
It has also become readily apparent from my experience, and the experience shared with me by others, that the recommended minimal wear-time of 10 hours a day for 10 weeks is insufficient for most women, with the actual wear-time requirement closer to 12 to 14 hours a day and, possibly, 12 to 14 weeks. I have provided the system to over 25 women since July of 2001, with 13 far enough along in their treatment to be able to judge their response. My initial findings included the following:
1. Six were pleased with the outcome and seven were displeased.
2. None described the device as comfortable.
3. Two patients had significant adverse events requiring discontinuation of therapy. One developed a systemic allergic skin reaction to the silicone domes and the other developed a tender, hard, nonsuppurative subcutaneous mass from dome pressure-fortunately, there was no skin breakdown and the mass is spontaneously resolving.
As a final observation and admonition, the physician should not tell the patient that the device “can…be worn during the day while at work,” as claimed by the company on their Web site. The smallest set of domes might be worn discreetly under loose clothing, but the large and extra-large units certainly cannot. In addition, the SmartBox motor is designed to periodically turn on if the pressure drops below a certain level, and even with the alarm system turned off the motor can be easily heard. Not only would the patient be wearing conspicuously large devices under her blouse but her breasts might also periodically “hum.”
Certainly, I have had satisfied patients who did obtain a minimal but noticeable increase in size that pleased us both. It seems to me that the Brava system has merit and does work for selected patients. Nevertheless, an even more accurate predictor of those patients who are suitable candidates, both psychologically and physically, is needed. Patients also must be more accurately informed of the reasonable probability that they will indeed be “very pleased.”
“It is safe to predict that in the future I shall still not find patients who have paid approximately $2000 for the Brava system telling me that they are “very pleased” after achieving only a 15 percent increase in breast volume.”
Khouri , R. K., Schlenz , I., Murphy , B. J., and Baker , T. J. Nonsurgical breast enlargement using an external soft-tissue expansion system. Plast. Reconst. Surg. 105: 2500, 2000.
Curran J. Smith, M.D .. Plast. Reconst. Surg. 110:1593, 2002.
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