25-12-2010, 15:55
Independent Assessment of Brava system
April 14 2006 at 10:58 AM
Jennelle (Login Jenneelle)
EVE MEMBERS
--------------------------------------------------------------------------------
Here's an independent assessment of brava from a cosmetic surgeon in Seattle (published in a medical journal):
"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.
The women in Khouri et al.'s study obtained an average increase of 55 percent of their breast volume (range, 115 percent down to 15 percent), representing approximately one cup size for the small cup-sized woman. Khouri et al.'s summary of their results following the treatment of 12 women (five of the original 17 excluded because of noncompliance) included the following observations:
1. "All participants were very pleased with the outcome…."
2. "…the device was comfortable to wear."
3. "No adverse events were recorded…."
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.
Why the striking difference in the percentage of "very pleased" individuals between my group and Khouri et al.'s? That is easy to explain. They did not consider the opinions of the five women excluded from their original 17 participants, their focus was appropriately on the objective scientific measurement of the efficacy of the device, and they provided the device free of charge. Conversely, when the physician in clinical practice assesses the success rate of a treatment method he or she does not have the luxury of simply ignoring the noncompliant individuals; the focus, by necessity, is on the subjective perception of the fulfillment of a perceived goal by the individual under treatment; and a fee is charged. Khouri et al.'s determination of being pleased was based on a short multi-question test measuring self-image. My determination was based on the simple, age-old single question test, "Would you recommend the Brava system to a friend?" The individuals in their group were "participants," whereas mine were patients. 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.
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.
The concept of enlarging the breasts using a vacuum device is not new, but the technologic innovation called the SmartBox, which maintains the constant vacuum and by means of a computer chip records the patient wear-time and average pressure, is an ingenious concept. The patient downloads the data weekly by modem into the Brava central computer where it can then be accessed using an individual code by the patient, physician, and company. The objective is to confirm patient compliance (or noncompliance) with less than 9 hours of continuous wear-time constituting a missed day, which requires an additional week of wear-time. Unfortunately, the monitoring system does not work as intended because the device divides continuous wear-time into 2 separate days at midnight. One might think that it would all even out, and it would were the device to be worn at the same time each day, but that is impractical. One patient's husband cleverly charted the actual daily wear-time and the total hours divided into each 24-hour period, which clearly demonstrated why that when his wife wore it the required minimum of 10 hours every day, the Brava computer would frequently and erroneously identify her as noncompliant. This would seem to be a correctable glitch.
There were also issues of product reliability and performance and customer service. Although there have been frequent breakdowns of the device components, I have been very impressed with the company's ready willingness to promptly provide replacement parts for our patients and by the continued improvement in their customer support. This new company seems intent on resolving the predictable growing problems as they arise.
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."
Author Reply
Sally Anne
(Login sally.anne)
SENIOR MEMBER Re: Independent Assessment of Brava system April 17 2006, 7:19 AM
That's a very interesting read. I would say it's the best thing I've ever found to read about Brava. Does the clinic in question still supply it?
Jennelle
(Login Jenneelle)
EVE MEMBERS Re: Independent Assessment of Brava system April 25 2006, 10:48 AM
No, they said they no longer supply the brava system because the results that their patients obtained were not consistent with what they expected from the glowing reports that were published in the original study.
Annette
(no login) Re: Independent Assessment of Brava system May 21 2006, 7:47 PM
I've noticed there are a number of clinics which have stopped selling Brava.
April 14 2006 at 10:58 AM
Jennelle (Login Jenneelle)
EVE MEMBERS
--------------------------------------------------------------------------------
Here's an independent assessment of brava from a cosmetic surgeon in Seattle (published in a medical journal):
"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.
The women in Khouri et al.'s study obtained an average increase of 55 percent of their breast volume (range, 115 percent down to 15 percent), representing approximately one cup size for the small cup-sized woman. Khouri et al.'s summary of their results following the treatment of 12 women (five of the original 17 excluded because of noncompliance) included the following observations:
1. "All participants were very pleased with the outcome…."
2. "…the device was comfortable to wear."
3. "No adverse events were recorded…."
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.
Why the striking difference in the percentage of "very pleased" individuals between my group and Khouri et al.'s? That is easy to explain. They did not consider the opinions of the five women excluded from their original 17 participants, their focus was appropriately on the objective scientific measurement of the efficacy of the device, and they provided the device free of charge. Conversely, when the physician in clinical practice assesses the success rate of a treatment method he or she does not have the luxury of simply ignoring the noncompliant individuals; the focus, by necessity, is on the subjective perception of the fulfillment of a perceived goal by the individual under treatment; and a fee is charged. Khouri et al.'s determination of being pleased was based on a short multi-question test measuring self-image. My determination was based on the simple, age-old single question test, "Would you recommend the Brava system to a friend?" The individuals in their group were "participants," whereas mine were patients. 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.
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.
The concept of enlarging the breasts using a vacuum device is not new, but the technologic innovation called the SmartBox, which maintains the constant vacuum and by means of a computer chip records the patient wear-time and average pressure, is an ingenious concept. The patient downloads the data weekly by modem into the Brava central computer where it can then be accessed using an individual code by the patient, physician, and company. The objective is to confirm patient compliance (or noncompliance) with less than 9 hours of continuous wear-time constituting a missed day, which requires an additional week of wear-time. Unfortunately, the monitoring system does not work as intended because the device divides continuous wear-time into 2 separate days at midnight. One might think that it would all even out, and it would were the device to be worn at the same time each day, but that is impractical. One patient's husband cleverly charted the actual daily wear-time and the total hours divided into each 24-hour period, which clearly demonstrated why that when his wife wore it the required minimum of 10 hours every day, the Brava computer would frequently and erroneously identify her as noncompliant. This would seem to be a correctable glitch.
There were also issues of product reliability and performance and customer service. Although there have been frequent breakdowns of the device components, I have been very impressed with the company's ready willingness to promptly provide replacement parts for our patients and by the continued improvement in their customer support. This new company seems intent on resolving the predictable growing problems as they arise.
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."
Author Reply
Sally Anne
(Login sally.anne)
SENIOR MEMBER Re: Independent Assessment of Brava system April 17 2006, 7:19 AM
That's a very interesting read. I would say it's the best thing I've ever found to read about Brava. Does the clinic in question still supply it?
Jennelle
(Login Jenneelle)
EVE MEMBERS Re: Independent Assessment of Brava system April 25 2006, 10:48 AM
No, they said they no longer supply the brava system because the results that their patients obtained were not consistent with what they expected from the glowing reports that were published in the original study.
Annette
(no login) Re: Independent Assessment of Brava system May 21 2006, 7:47 PM
I've noticed there are a number of clinics which have stopped selling Brava.