Brava and autologous fat transfer, an efficient alternative to breast augmentation with silicone implants: Results: 6 years 81pacienti, prospective multicenter
Roger K. Khouri, M. D. Marita Eisenmann-Klein, M. D. Eufemiano Cardoso, M. D. Brian C. Cooley, Ph.D. Daniel Kacher, M.S.Eva Gombos, M. D. Thomas J. Baker, M. D.
Key Biscayne; Miami, Fla .; Regensburg, Germany; Milwaukee, Wis .; Boston, Mass
Breast augmentation by autologous fat transfer is an attractive therapeutic alternative and this study attempts to assess the scientific value of the method.
Methods: In a prospective multicenter study, 81 women (age range, 17 to 63 years) wore Brava device, a bra that can achieve negative pressures, operating as a foreign tissue expander for 4 weeks and then practiced using autologous fat transfer 10 to 14 puncture needle for each breast, fat is injected through special cannulas (277 ml volume injected into each breast). Patients, surgery resumed wearing the Brava system for 24 hours over a period of 7 or more days. Pre and post-treatment were made by magnetic resonance imaging tests (IM) and the results were compared with analysis of six published cases of breast augmentation autologous fat transfer without external expander. Tracking cases between 12 months and 6 years (average 3.7 years).
Results: Breast volume was unchanged between 3 and 6 months. For 71 of the women who wore the Brava, were able to inject 233 ml of fat, compared to those who did not wear BRAVA and who were able to inject only 134 ml of autologous fat. Graft survival was 82: 18%, compared to 55: 18%, without Brava. There was a strong linear correlation between the expansion Brava before breast enlargement and augmentation result. There has been developing cystic fibrosis or nodules. Magnetic resonance imaging revealed a 16% incidence of fat necrosis easily identified from 1-year mammographic evaluation.
Conclusion: Wearing Brava device before autologous fat transplantation resulted in a significantly greater increase in the volume of the breast, with a greater amount of fat graft, higher rates of graft maintenance with minimal tissue necrosis autologous and without complications, demonstrating a high degree of safety and efficacy for the procedure.
Autologous fat transfer to the breast has a long and controversial istorie.1 2 In 1987, a statement of the American Society of Plastic Surgery has blocked this procedure arguing that the transferred fat tissue will not survive and can cause calcification that could not be differentiated from existing breast imaging techniques.
However, today’s radiologists are able to differentiate the neoplastic processes for fat necrosis, with technological advance and recorded in the imagisticii.Prin result, in 2007, the American Society of Plastic Surgeons found that autologous fat transfer could be used for breast, “the techniques and results may vary … need high quality trials”
Breast augmentation with fat lipoaspirat was limited by two components: the amount of fat that can be transferred in one session and the percentage of graft survival. In fact, there seems to be an inverse relationship between the two (eg more fat transferred lower survival rate) Efforts to overcome this focused on harvesting techniques, handling of fat and stem cells the way in which it was injected. Until now, most studies have shown a survival rate of 50-60% to a 100 ml augmentation long term, none have attempted to improve space “receiver” of the breast.
To ensure transplant fat to be dispersed in the form of micro-droplets. In small breasts, which will be augmented, there is enough physical space without cluttering not too much micro-drops, so we postulated the idea that it would require an external expansion to create the necessary space.
The Brava was used in the market for over 10 years as an external expansion device for soft tissue and had modest results in long-term breast augmentation. Using Brava short caused a marked temporary increase breast and fibro-vascular generation of networks, which is an ideal bed container fat grafts (Khouri RK, personal observation). So we decided to make this multicentre, prospective, MRI documented that determine the safety and efficacy of autologous fat transplantation in a single step from people who wore Brava.
PATIENTS AND METHODS
This study was designed to optimize all potential options. This includes an atraumatic technique of liposuction, minimal handling fat graft and graft in the form of microdroplets. Ethical reasons (patients subjected to surgical procedures less effective), the results were compared with those of recent studies on the use of fat grafts in breast augmentation without external expansion.
After approval of the study (Concordia Clinical Research, Inc .; Breast Augmentation with Brava Re- construction tion and au tologous Enhanced Micro Fat grafting Protocol No. 2004-2, IRB COMM. No. 167), the 81 enrolled women (Miami breast Center, Key Biscayne, Fla., n 59, Caritas St. Josef Kran- kenhaus, Regensburg, Germany, n 12; Harley Medical Center, London, United KING- dom, n 10) who wanted breast augmentation, were against silicone implants and tolerate 20 – minute Brava device. We conducted 77 bilateral and 4 unilateral transfers transfers of autologous fat in 170 breasts. Age of patients ranged from 17 to 63 years, body mass index varied from 15 to 28 (average 19.8). Smokers were excluded. All patients were grafted, despite large variations in terms of compliance wearing Brava, 4 patients were not compliant, and 6 patients presented no su MRI monitoring visits, post grafting. Six of the patients later conducted another transfer s0 has not taken into account only results from the first grafting. Figure 1 shows a breakdown of the groups of patients treated.
Before Brava expansion and function of menstrual cycle, each woman was investigated with magnetic resonance imaging and contrast agent iv Patients were asked to wear the Brava system external tissue expansion of the breast 10 hours / day for 4 weeks. This period increases vascularization preexpansionala bed “receiver”. In the last 36-48 hours, they were asked to maintain uninterrupted expansion this device and come to the gym, preoperative, wearing Brava to induce an immediate three-dimensional matrix expansion periglandular subcutaneous tissue.
Sampling was performed Lipografter fat, a device for harvesting, processing and fat grafting dark (KVAC syringe and AT Gates, Lipocosm, LLC, Miami, Florida).
The fat was aspirated with fine cannula of 2.7 mm with 12 holes (Marina Medical, Sunrise, Florida), attached to a syringe KVAC with a constant pressure of 300 mm Hg vacuum. The fat was aspirated directly transferred to the collection bag 3 through a valve opening and centrifuged at 15 g for 3 minutes, then re-injected into the bag with the syringe directly from 3-5 ml of 2.4-mm blunt-tipped cannula. Through a variety of periglandulare and periareolar puncture, no more than 1 ml of fat during extraction cannula on 5cm long. The fat was injected in three planes subdermal, subglandular and subpectoral. I carefully avoided the collection overgrafting localized tissue turgor evaluated. At the end of the procedure patients wear a compression bandage properly.
Within 24 hours after the procedure, patients are all dressings removed after local and general restroom resume wearing Brava device for the next 48 to 72 hours uninterrupted for a better engraftment and vascularization. 3rd postoperative day were encouraged to return to their normal life style and wear the Brava device only at night for 4 days. . At the 3 months after the grafting, a second MRI examination were obtained in the first 24 patients, and all the six and 12 months. All women older than 40 years have done one full year mammogram ultrasound examination whenever it was indicated by the radiologist. Two independent teams of radiologists reviewed the MRI place and all exams and mammograms cross.
Initial and final measurements were obtained by MRI imaging in axial orientation with standard Digital Imaging in breast medicina.Zona was bounded by sections of 1-mm intervals from the inner edge of Sipan leather, limited by anatomical landmarks (eg , sternum, pectoral, shoulder). The areas were summed to obtain an estimate for each breast volume, measured in ml. The maximum volume expansion was derived by comparing photographic standard set three positions obtained at the time of maximum expansion the day of surgery, with two sets of three in the same position taken at baseline and at the end of volume measurements by MRI. Injection volumes were recorded during the procedure.
Statistical analysis was carried out on three parameters: the volume augmentation, defined as the final volume of the breast measuring; augmentation rate, defined as [volume augmented / reference], 100; and graft survival, defined as [augmented volume / volume injected graft] 100 data extracted from six studies published recently, which uses expansion before autologous fat transfer were combined and used as a control group (sample total N 335). Of these, four (N 280) reported augmentation with autologous fat transfer using various means of harvest and fat separation, and two (N 55) cell activation technology (which involves the addition of concentrated stem cells in fat processed) . Table 1 shows the retention rates of graft based on the results of these studies, with an average of 55% graft retention. Our data series are compared using the paired t test (pre-treatment to post-treatment). For comparison the percentage augmentation previously published Centralized control group, we used t-test for two independent variables.
A dose-response curve was developed to measure the effect of the amount of fat preexpansion transferred using a paired t test. All women enrolled were asked to use the Brava device for 10 hours / day for 4 weeks. However, some were more compliant than others, and some with breasts and leave atrophic had tissues more flexible than young, nulliparous. Thus, we observed considerable variability in the amount of expansion of the breast pregrefat which allowed us to construct a dose-response curve of expansion to augmentation.
In order to analyze the relationship between the expansion augmentation, a regression analysis was performed on the sample of 75 women. The data were normalized by dividing the volume of both the reference variable. Expansion weight / volume basis was used as an independent variable and augmentation / volume basis was used as a dependent variable. Descriptive statistics were calculated and their relationship analyzed using MATLAB 7.8.0 (MathWorks, Natick, Mass) and the “cftool.”
Of the 84 women evaluated for enrollment in the study, three (3.6 percent) were not enrolled because of inability to pass Brava outpatient tolerance test. I gradually increased the amount transferred with training method. 20 women were first grafted with an average of 190 ml of the breast, resulting in graft survival of 90%, while the remaining 20 were grafted with an average of 360 ml of the breast, with a 78% graft survival. The operating time for the first 20 cases, on average, 4 hours later, decreased to 2 hours, in spite of the larger volume. There were no complications related to operatie.Pacientele were watched by an average of 3.7 years (between 12 and 75 months). Except for some small bruises and superficial skin blisters which healed without complications, all returned to The activities of the sedentary women at 3 to 4 days and have resumed full activities on 1 week. One patient developed late (2 months postoperatively), atypical mycobacterial infection successfully treated with oral antibiotics and minor incisions and drainage. Six women had unplanned pregnancies, within 6 months after grafting. They all had normal birth and could nurse. One year postalaptare have received breast MRI control, no patient developed clinically suspicious masses or noduozitati. Although some women had minor fluctuations in weight during the study, mean BMI did not change. All were very pleased to expand and improve the appearance of their breasts and lipo-suctioned donor area.
The MRI Outbreaks of fat necrosis in 12 of 75 women. At 1 year, only the same 12 women (16 percent) showed some calcifications on mammography. All were clearly recognized as benign. Since it was found that these calcifications are benign, not requiring further intervention.
Free fat transfer is a procedure known and accepted for interventions on the face, where small amounts are placed in an area “receiving” well vascularized and buttocks, where larger volumes of fat are transferred to a larger area and where nodules and calcifications are not so disturbing. However, fat transfer to the breasts is controversial because of two main reasons: (1) our inability to transfer large amounts of fat in a small breast with a high rate of graft survival and (2) the impossibility calcifications or fat nodules differentiation of breast cancers. The inability to resolve these problems elicit a broad experimental and scientific interest. Our data show that external expansion device Brava breast before and after the transfer, allows the physician to achieve an increase in volume and graft survival significantly, which is not achieved without Brava Poteau. Statistical analysis shows that preoperative expansion is a major determinant of the final volume augmentation.
The expansion creates a matrix pre-operative more and better vascularized bed, which allows the fat to be transferred uniformly dispersed. Some surgeons have shown acceptable results using a variety of collection and preparation of fat, often opposite each. Interestingly, the analysis control studies in this article using different methods for the preparation of graft, including stem cells enriched with fat to produce similar results. Our staff From the point of view limiting factor in the transfer of large autologous fat is the “receiver” and not grafted material or method of harvesting and preparation.
Transmission of large autologous fat grafting involves a three-dimensional, a new concept that is similar to the “sowing of land.” To produce the best culture, we need to optimize the following four components, each of which can be rate limiting:
Seeds (eg, graft, quality, sustainability, capacity Inductive fat).
The method of planting (for example, the surgical technique diffuse, uniform and atraumatic in order to avoid graft lymph collections).
Plot (e.g., the tissue “receiver”, its size, its vascularization, the presence or absence of growth factors).
Growing seedlings after planting (eg, postoperative care, restraint, boosting).
If only one of the above components is low, even if all the other is maximized, the final yield is not satisfactory. Least these four components optimized factor bottleneck becomes the limiting factor and the final result.
“Before sowing, the farmer prepares the ground for seeds in the soil to accept” .Brava works in a similar way. When the device is worn before the procedure, there is an expansion, plans to separate tissue increases parenchymal space, and reducing interstitial pressure of the breast for a certain amount of fat injected. Without pre-expansion period, fat plays a double role: graft that requires a proper bed with a good blood supply to survive and internal tissue expander. This poses no problems when it is injected in small amounts as small quantities does not significantly affect physiological interstitial pressure and the grafting techniques can keep oxygen and nutrients adequately disseminate the first zile.Cu However, even with the most meticulous grafting techniques, large volumes grafted at least two negative effects: (1) increased interstitial pressure leading to decreased tissue perfusion and potential grafting and (2) by filling the bed of grafting, which was previously unexpanded lead the collections, which subsequently lead to necrosis / apoptosis fat that is fed right. By increasing the volume of the breast parenchymal to overcome these two limitations Brava volume / graft. Instead of being used as internal expanders, grafted cells are deposited in an extensive fibrovascular network that subsequently populate. In addition, as demonstrated closures vacuum-assisted, vacuum and mechanical force expansion and the development promotes angiogenesis and stimulate local growth factors. This increased vascularity enhances grafted tissue to feed and survive. It is well established that the muscle with high capillary density is an excellent bed “receptor” May cateste graft and the blood supply to the receiver is greater than both the graft survival. Therefore, the preparation has a beneficial effect Brava prelipofilling twofold: (1) a physical effect to increase the space filling reduce agglomeration of the graft and pressure, and generates a “scaffold” receptor, and (2) a biological effect that stimulates the production of angiogenic cytokines that enhance engraftment.
After preparing the soil, the farmer selects the best seeds to plant them. Just as the farmer must have the best seeds, harvesting, processing, and reinjection adipocyte be made carefully. In an attempt to improve these processes largest energy and resources have been spent in the last 20 years. However, no matter how much these areas are enhanced with new tools, methods and technologies probably will not offset the constraints related to the interstitial pressure in the receiving area, and graft revascularization. These blocks will remain.
Finally, “after land preparation and sowing good seeds, they must be fed.” Reapply’s vacuum after the grafting procedure plays an important role in fat grafts immobilized to allow the development of neo-vasculature and stimulates their proliferation. From experience fat transfer to the face is well known that fat graft periorbital region (furniture) has the same success as fat grafts from other areas less mobile. Using Brava postoperative low pressure and constant help vascularization by securing a stent graft, protecting it from external injuries and keeping open the millions of tiny “room for growth Morrison” that have been shown experimentally to stimulate the growth of fat graft . Moreover, as has been reported, unless the vasculature is taking place in a relatively short period, cells can not survive.
Our study reveals a strong prospective multicenter dose-dependent effect on the expansion prelipofilling and outcome. Statistics revealed that more than 80% of the final cazurirezultatul will be about 70% of peak expansion Brava. This takes away the unpredictable factor that keeps autologous fat transfer. The patient becomes responsible for the outcome and it’s stimulating to comply with Brava. Women may be compliant implant the augmentations comparable in one step (2 hours), using a procedure without bisturiu.Procedura produce a natural-looking breast with the capability to correct the deformation and the shape of the breast implant much better than any “anatomical”.
Using the Brava is painless. Pain is an alarm linked to a tissue pain and any patient developing it is advised to remove the device. The Brava was criticized as being hard to wear a device and surgeons maneuver promoted autologous fat transfer, free Brava, especially in women with breast atrophy Unfortunately, they did not understand the importance of creating a three-dimensional space above concept farmer . Small breasts is a recipient bed with a small volume which will inevitably lead to congestion and graft loss. To avoid congestion, interstitial space must be large and well vascularized, so it is recommended to use the device Brava. Of course, let breasts are more mobile and respond very effective mechanical expansion Brava. In order to give these women the best result possible in a single session, it is best to persuade them of the benefits of Brava and to provide encouragement and support during the enlargement process. A very compliant patient with highly compliant tissues can expand by 150% in 10 to 14 days and is expected to double the initial breast volume, augmentation with autologous tissue 300 ml in a single procedure without scalpel outpatient in less than 2 hours. In 2007, Del Vecchio visited our center and reproduced, then our results independently. Using a different protocol cuBrava pre-expansion and fat transfer, he coauthored the recently published Bucky this initial experience that supports our findings.
Wearing Brava system requires discipline and commitment. If a woman is willing to wear the Brava device a few weeks, then surgical alternatives are: (1) autologous fat free Brava modest 100 -150 ml; (2) more sessions to reach lipofilling as possible in one procedure wearing Brava, and (3) silicone implant. Usually, patients who opt for Brava plus autologous fat transfer are disciplined and increased education degree; they are crucial for compliance bigger. It is no surprise, therefore, 86% of women in our series had at least college and 20% are medical or family physicians and four are radiologists.
Liposuction and breast augmentation is the most common procedures in cosmetic surgery. Plus autologous fat transfer is a procedure Brava 2 in 1: Remove excess fat from unwanted places and transfers where necessary, also be a procedure without incisions.
Regarding the issue of patient safety paramount in the 6 years of experience with augmented breasts Brava 170 plus autologous fat transfer, our main complication was an atypical bacterial infection, which was treated successfully and cured without significant sequelae. I also had a magnetic resonance imaging scan, which showed a clear lesion that was removed at the next scan. This 1.3 percent (one of 75) false-positive rate is anticipated breast MRI. It is important to note that although there were several outbreaks of necrotic fat, they were easily identified and that none of the patients had suspicious lesions requiring biopsy. This confirms that the new breast imaging technology can almost always distinguish necrotic fat nodules of neoplastic lesions. Radiologists are now assured that contrary to expectations autologous fat transfer breast overshadows but gives no radiolucent and makes it less dense.
Of course some skeptics have raised the alarm about the possibility of breast cancer and autologous fat transfer. In humans, there is absolutely no scientific support for this claim, even teoretic.Societatea American plastic surgeons have found, and it would be absurd to claim that autologous fat transfer is carcinogenic. A study in which they were transferred large amounts of fat in the immediate post-mastectomy local metastases, and there has been no trace of evidence that this leads to an increase in the rate of recurrence; also status post neck dissection followed by irradiation even after 10 years revealed no recurrence. Oncologic standpoint autologous fat transfer is a safe. Although women should continuously monitor their breasts and this should not be a problem and to discourage acceptance of this alternative breast enhancement very rewarding and at the same time representing the most natural method of breast enhancement.
After more than 20 years since the American Society of Plastic Surgeons banned autologous fat transfer breast, debates and controversies surrounding this procedure can be put aside. Our study shows that breast expansion method Brava device allows the transfer of large volumes of autologous fat breast in one session safe and effective at the same time, with a very high success rate with comparable volume augmentation of implants and with the added benefit of a look and a more natural sensation.