Breast Fat Grafting in Sydney – Evidence

What is the evidence behind breast fat grafting in Sydney?

In compiling this page, Dr Gavin Sandercoe has performed a literature search on the available published data on the procedure in mid August 2012 (when the the directory page on fat grafting was initially created) and then updated it with articles that he has collected over the next four years to June 2016. They are in order of most recent to oldest article, so reverse numbered. These are the key articles and their take home message.

18. 2015 Post Mastectomy Fat Graft/Fat Transfer  ASPS Guiding Principles

• Consensus opinion from American Society of Plastic Surgery Fat Grafting Task Force
• Most evidence is level B (Case Series), but there is consistency in outcomes when fat is transferred into a mastectomy site
• Most patients gain an improvement in aesthetic results
• Breast cancer recurrence is not increased by fat transfer to a mastectomy site
• Complication rate is related to surgical technique
• Fat transfer improves post mastectomy pain syndrome
• Radiation therapy does not increase complication rates of fat transfer to mastectomy sites
• Most patients require more than 1 session to be satisfied with their result

17. A Case Controlled Study of the Oncologic Safety of Fat Grafting

Gale et al, PRS 135(5): 1263-75, May 2015

• 328 patients had fat grafting after breast cancer, complete data available for 211
• Average follow up was 4.5 years after breast cancer surgery, and 32 months after fat grafting
• Coleman technique with no stem cell or growth factor enhancement
• Average 1.28 procedures (range 1-4)
• Case controls matched 2:1 for comparison, with end points being breast cancer recurrence and death
• No excessive (statistically significant) cancer events were noted in regards to local/regional/distant recurrences
• Systematic review of literature reveals a loco regional recurrence rate of 0.95%/year after fat transfer to breast in breast cancer surgery

16. Aesthetic Applications of Brava Assisted Megavolume Fat Grafting to the Breasts: A 9 year, 476 patient multi centre experience

Khouri et al, PRS 133(4):796-807, April 2014

• 476 patients across 9 years between 2 hospitals, 565 sessions in total (73 patients had 2 procedures, 8 patients had 3 procedures – most multiple procedures were seen in implant to fat conversion patients)
• Average age 37.6 (range 16-60), BMI average 21.6 (range 16.2-29.2)
• Exclusion criteria included smoking, unrealistic expectations, excess bleeding tendency, multiple prior liposuction procedures (decreased available fat to transfer)
• Range of cosmetic and reconstructive cases (294 patients for aesthetic breast augmentation, 45 patients for congenital deformity, 43 patients for complication correction, 6 patients for implant-fat conversion. 88 patients had implant to fat conversion without Brava)
• Average follow up 3.5 years (range 6 months to 9 years)
• Average volume grafted was 346ml/breast and average 6 month volume increase was 266ml/breast (23% volume loss)
• Complications
  • One pneumothorax
  • 19% fat necrosis rate on follow up MRI
  • 13/295 patients with post operative MRI had areas that mimicked breast cancer – all were eventually diagnosed as benign
  • Minor infection treated with antibiotics in 7/476 patients
• No patients diagnosed with breast cancer. Expected incidence of breast cancer in 476 women across 3.5 years is 1-2 patients. In reality, the short follow up time of 3.5 years is not enough to ensure oncologic safety across a patient’s lifetime

15. Magnetic Resonance Imaging & Ultrasound Evaluation after Breast Autologous Fat Grafting with Platelet Rich Plasma

Fiaschetti et al, PRS 132(4): 498e-509e, October 2013

• 24 breasts (15 patients), across 2.5 years, BMI 19-25, mostly breast reconstruction or replacing breast implants with fat transfer
• Mammograms, ultrasound & MRI performed pre-operatively and at timed intervals up until 12 months after the last session of fat transfer
• Of note, this study used high speed centrifugation and enhancement with platelet rich plasma (uncommon in most other studies)
• Oil cysts noted on ultrasound at rates up to 70% (3 months after last fat transfer session) but decreased with time, MRI at the same time intervals reported oil cysts at 8% (2/24 breasts)
• Fat necrosis >20mm diameter rates were essentially stable from 3 months after first fat grafting session, but increased slightly with time
• Micro calcifications were found in 20% patients
• Volumetric assessment showed an average of 30% volume loss at 12 months (15% at 6 months)

14. Mammographic Changes After Fat Transfer to the Breast Compared with Changes after Breast Reduction: A Blinded Study

Rubin JP et al, PRS 129(5): 1029-38, May 2012

• 27 women with normal preop mammograms underwent stem cell enhanced autologous fat grafting (average volume 527cc), and had a mammogram 12 months post op
• Control group of 23 women having breast reduction surgery
• Each mammogram was read by 8 independent radiologists
• Postoperative mammography found higher rates of oil cysts, scarring, benign calcifications and distortion warranting biopsy in the breast reduction group. The breast fat grafting group was higher (4.6 vs. 1.6%) for calcifications warranting biopsy
• Fat grafting of the breast results in lower rates of mammographic abnormalities than the accepted procedure of breast reduction surgery

13. Brava and Autologous Fat Transfer Is a Safe and Effective Breast Augmentation Alternative: Results of a 6 year, 81 patient, Prospective Multicenter Study

Khouri RK et al, PRS 129(3): 1173-87, March 2012

• 81 patients over 6 years
• BRAVA device worn for 10 hours/day for 4 weeks preop, and constantly for the last 36-48 hours
• Harvested and processed fat using Lipografter. Fat placed using microdroplet technique
• BRAVA device replaced within 24 hours, for 48-72 hours uninterrupted, then at night for 4 more days
• Average grafted volume of 282ml with 78% graft survival, followed up for average 3.7 years
• 3 and 6 month MRI were essentially unchanged – proves stability by 3 months
• 12 women (16%) had visible fat necrosis on MRI, and these were the only women with calcifications on mammography at 1 year. Calcifications clearly recognizable as benign fat necrotic foci. One-year mammogram equally sensitive to 3 or 6 month MRI.

12. The Oncologic Outcome and Immediate Surgical Complications of Lipofilling in Breast Cancer Patients: A Multicenter Study–-Milan-Paris-Lyon Experience of 646 Lipofilling Procedures

Petit JY, Delay E et al, PRS 128(2): 341-6, August 2011

• 3 institutions with 513 consecutive patients (646 procedures) for breast cancer reconstruction using autologous fat transfer from December 2000 to March 2010
• Coleman technique harvesting, low-g centrifuge processing. No data on graft survival
• 18.1% required more than one fat transfer procedure
• 2.8% complication rate mostly fat necrosis (2.0%) but also local infections, seroma, pneumothorax
• Of the 13 patients with fat necrosis, 9 of them received post operative radiotherapy in some form
• Systematic yearly mammogram follow up of the 119 breast conserving surgery cases
• 12 post op mammograms had abnormalities. 7 showed benign calcifications, 2 benign opacities, 3 suspicious lesions. Of the 12, 7 were biopsied and there were 5 benign lesions (fat necrosis 2, scarring 2, fibrocystic lesion 1), and 2 cancer local relapses
• Autologous fat transfer for breast cancer reconstruction has a very low rate of complications, but does not provide definitive proof of the safety of the technique in terms of cancer recurrence or distant metastases.

11. Breast augmentation using Pre-Expansion and Autologous Fat Transplantation: A Clinical Radiographic Study

Del Vecchio et al, PRS 127(6): 2441-50, June 2011

• 25 patients, 46 breasts with  from 2007-9
• 3 weeks pre-expansion with Brava device
• Fat processed with low-g force centrifugation
• “Megavolume” (>300cc) fat transfer
• 2-4 weeks post operative ‘splinting’ with Brava on low suction, begun at 24-48 hours post operatively
• Compared pre and 6 month post operative 3D imaging and MRI to quantify breast volume (12 patients completed protocol)
• Average 100% increase in breast volume at 6 months post-operatively (range 60-200%)
• Post operative MRI showed that all increase in breast volume was due to viable fat cells
• No new cysts, fat necrosis or breast masses on 6 month MRI (no discussion about calcifications)

10. Clinical Analyses of Clustered Microcalcifications after Autologous Fat Injection for Breast Augmentation

Wang CF et al, PRS 127(4): 1669-76, April 2011

• 48 patients with autologous fat grafting for breast augmentation over 10 years with mammography at 18-72 months post op (Beijing)
• ? variation of Coleman technique to harvest, process and reinject fat
• 8 patients with a total of 10 microcalcifications, unable to be distinguished as benign by radiologists
• Histopathology confirmed that all lumps were fat necrosis
• Authors concluded “clustered microcalcifications … cannot be distinguished from malignant calcifications …. And the method should continue to be prohibited”
• Discussion paper noted the variation in fat grafting technique and radiographic techniques used when compared to other papers

9. Adipose tissue grafting to post-mastectomy irradiated chest wall: Preparing the ground for implant reconstruction

Sarfati et al, JPRAS 64:1161-6, 2011

• Fat transfer to the breast improves skin quality, so was used as an initial stage in breast reconstruction to improve implant coverage
• 28 patients over 2 years
• Fat transfer began 6 months after radiotherapy ended
• Average number of fat transfer sessions was 2 (some patients had 3 sessions)
• Average volume of injection was 115cc (range 70-275cc) each time
• Average 17 month (range 4-34 months) follow up with 3 minor complications (seromas)
• Cosmetic results rated good to very good in >80% cases by both patient and surgical team

8. Breast Augmentation Using Preexpansion and Autologous Fat Transplantation: A Clinical Radiographic Study

Del Vecchio DA & Bucky LP, PRS 127(6): 2441-50, June 2011

• 25 patients from 2007-9
• BRAVA suction device to prepare the breasts for large volume (220-550cc, average 430cc) fat grafting in a single procedure
• Fat harvesting technique not specified. Fat processed using a low-g centrifuge
• Patients had pre and post op 3D volumetric imaging or MRI to quantify breast volume changes. Average 106% increase in total breast volume, or 64% graft take

7. Radiographic Findings after Breast Augmentation by Autologous Fat Transfer

Veber M, Delay E et al, PRS 127(3):  1289-99, March 2011

• 76 patients (113 procedures) from 2000 to 2008 with autologous fat transfer to the breast (all non cancer reconstructions or cosmetic augmentations)
• Coleman technique (minor modifications) for harvesting, processing and grafting
• Compared 20 patients’ preop and post op mammograms. Found no statistical significance between groups when comparing breast density and standardized Breast Imaging classification. This means that there is no reason for mammogram analysis difficulties after autologous fat transfer to the breast. Acknowledges the need for radiology interpretation by a radiologist trained in breast surgery radiology
• 31/76 patients had post op mammograms (> 1 year post op) analysed. The other 45 patients did not meet inclusion criteria for this part of the study
  • 17/31 (54%) had no radiological abnormality
  • 8/31 (26%) had cystic lesions, likely oil cysts
  • 5/31 (16%) had benign microcalcifications
  • 3/31 (9%) had macrocalcifications
  • 4/31 (12%) had visible scarring associated with nipple lift scars in the breast
• Large areas of fat necrosis are likely due to technical weakness of operator

6. Determining the Oncological Risk of Autologous Lipoaspirate Grafting for Post-Mastectomy Breast Reconstruction

Rigotti et al, Aesth Past Surg 34:475-80, 2010

• 137 patients underwent fat grafting after a modified radical mastectomy, in two distinct time windows
• Mean follow up time was 7.6 years
• No control group
• Local and regional recurrence rates were comparable to published data from patients that had not had fat grafting after their mastectomy
• “Although further conformation is needed from multi centre randomised clinical trials, our results support the hypothesis that autologous lipoaspirate transplant combines striking regenerative properties with no or marginal effects on the probability of post-mastectomy loco regional recurrence of breast cancer”

5. Autologous Fat Grafts Harvested and Refined by the Coleman Technique: A Comparative Study

Pu, Coleman et al, PRS 122(3): 932-7, September 2008

• Lab study comparing viability of fat cells harvested and processed by Coleman technique when compared to conventional liposuction
• Coleman technique likely provides about 60% more viable cells than standard liposuction

4. Fat Grafting to the Breast Revisited: Safety & Efficacy

Coleman & Saboeiro, PRS 119(3): 775-85, March 2007

• 17 patients with fat grafting to the breast (Coleman technique) over 5 years
• One to three sessions with average volume of 280cc fat grafted
• Average 4 year follow up with mammogram at least 1 year after procedure
• Mammographic changes consistent with any type of breast surgery

3. Structural Fat Grafting: More Than a Permanent Filler

Coleman, PRS 118(S): 108-120, 2006

• Fat grafting survival is technique dependent. Up to 90% survival with Coleman technique
• Grafted fat affects the tissue into which it is transplanted, which may be mediated by stem cells

2. Current applications and safety of autologous fat grafts: A report of the ASPS Fat Graft Task Force

PRS 124: 272, 2009

Referenced 111 articles, compiled in March 2008

• Fat grafting of the breast results are dependent on technique and surgeon expertise. Longevity of graft is unknown, so additional treatments may be required. Fluctuations in body weight can affect graft volume over time
• Fat grafting of the breast is a safe technique, but infection is a primary concern so the need for sterile conditions needs to be emphasized
• Surgeons should exercise caution when considering autologous fat grafting for patients at high risk for breast cancer
• Discussed applications, efficacy, risks and complications of the published reports

 1. ASERNIP-S  – Autologous fat transfer for cosmetic and reconstructive breast augmentation

Australian Safety and Efficacy Register of New Interventional Procedures – Surgical. Royal Australian College of Surgeons watch dog to ensure that new techniques are fully evaluated prior to introduction as a mainstream procedure.

Reviewed all articles from January 2001 to January 2009, 35 met inclusion criteria

• Articles generally considered poor quality (on scientific merit)
• Breast fat grafting is at least as safe as comparator procedures