Women with breast cancer who undergo autologous fat grafting following post-mastectomy breast reconstruction want a breast that looks and feels more natural and say it makes life better psychologically, emotionally, and sexually, according to researchers.
Results from the ongoing Mastectomy Reconstruction Outcomes Consortium (MROC) study now show that fat grafting is effective and safe and that it does not increase risk for breast cancer recurrence or intervene with breast cancer screening.
Importantly, it also boosts patient-reported outcomes (PROs), Jeffrey H. Kozlow, MD, from the University of Michigan Health System in Ann Arbor, and colleagues say in an article published online June 28 in JAMA Surgery.
One year after breast reconstruction, women with breast contour irregularities and volume deficits reported significantly lower breast satisfaction (adjusted mean difference [AMD], −4.74; P = .008), psychosocial well-being (AMD, −3.87; P = .03), and sexual well-being (AMD, −5.59; P = .008) than a control group of women who were satisfied with their initial result.
One year after revision with fat grafting, however, the PROs scores were similar for the two cohorts, with women who underwent fat grafting reporting a similar degree of breast satisfaction (AMD, −0.68; P = .72), psychosocial well-being (AMD, −0.59; P = .73), and sexual well-being (AMD, −2.94; P = .15) as control participants.
“These findings constitute what we believe to be the first evidence from a large, multicenter, prospective outcome study demonstrating the effectiveness of autologous fat grafting for breast reconstruction,” Dr Kozlow and colleagues write.
“We know that not every breast reconstruction is perfect, but by using fat grafting to address contour irregularities, we can improve upon those results and make our breast cancer patients feel better about their reconstruction,” Dr Kozlow said in an email.
Fat grafting made such an improvement for women in this study that they “essentially ‘caught up’ with those patients who were happy with their initial result,” he noted.
Importantly, this study provides evidence to support autologous fat grafting in breast reconstruction following 2014 draft regulations that would give the US Food and Drug Administration (FDA) oversight for the harvesting, storing, and use of human cells, tissues, or cellular or tissue-based products, including autologous fat grafting, the researchers comment. Results are still pending from a public hearing held in September 2016 to discuss the impact of FDA regulation on autologous fat grafting in reconstructive surgery. The study authors point out that “well-designed research assessing the efficacy of fat grafting is essential not only for high-quality patient care, but also to meet growing regulatory concerns over these procedures.”
Multiple previous studies have demonstrated that fat grafting does not interfere with breast imaging and cancer screening, and recent studies have failed to find an association between breast cancer recurrence and fat grafting, the authors note. Newer grafting techniques have addressed previous concerns about reabsorption and fat necrosis.
“By providing multicenter, prospective data confirming the benefits of autologous fat grafting as a useful adjunct in breast reconstruction, we hope that this study will contribute to the ongoing discussion with payers and regulators over the safety and effectiveness of these procedures,” the study authors say. “Our findings should bolster breast reconstruction and that this option should remain available to reconstructive surgeons and to the patients they serve.”
It is our job as plastic surgeons to fight for what is best for our breast reconstruction patients.
Plastic surgeons are supportive of the FDA’s efforts to make sure that only safe and effective procedures are offered to patients, Dr Kozlow told Medscape Medical News. However, he added, “It is our job as plastic surgeons to fight for what is best for our breast reconstruction patients. We believe our study helps support the effectiveness of autologous fat grafting to a reconstructed breast mound and the value of this safe procedure to our breast reconstruction patients.”
Details of the Study Results
For their analysis, the researchers followed 2048 patients who were recruited between February 1, 2012, and July 31, 2016, from 51 plastic surgeons at 11 centers in the United States and Canada that are participating in the MROC study. Launched in 2011, the study is comparing the long-term outcomes of common breast reconstruction techniques in women undergoing first-time breast reconstruction following mastectomy for cancer treatment or prophylaxis.
Participants underwent different breast reconstructions — implant and autologous, delayed and immediate, and unilateral and bilateral. The mean age of the participants was 49 years.
A total of 165 patients (8.1%) underwent fat grafting between years 1 and 2; 1883 patients (91.9%) were satisfied with their initial reconstruction result and did not undergo fat grafting.
PCOs measures were assessed at baseline and again at 1 and 2 years after surgery using the BREAST-Q quality-of-life survey. This tool features domains specific to patients who undergo breast reconstruction. On a 0- to 100-point scale, higher values indicate increased well-being. In addition, survey subscales measured patients’ satisfaction with the reconstructed breast as well as their psychosocial, physical, and sexual well-being following initial surgery and after any subsequent revision procedure between years 1 and 2. Responses were compared between the two groups — those who underwent fat grafting and those who did not.
Improvements in all four BREAST-Q subscale scores between years 1 and 2 were seen in women who underwent fat grafting after their initial reconstructive procedure. Importantly, rates of cancer recurrence were not significantly different between the women who underwent fat grafting and those who did not (1.8% and 2%, respectively), the analysis showed.
This Trial Is “First in the Literature”
This prospective trial is the first in the literature to provide patient-reported outcomes about fat grafting, point out Scott T. Hollenbeck, MD, and E. Shelley Hwang, MD, MPH, from the Department of Surgery at Duke University in Durham, North Carolina, in an accompanying editorial.
“These data support that fat grafting can be a useful adjunct in the reconstructive process and may help those patients struggling with their overall reconstruction,” they add.
Fat grafting may provide more padding over the breast implant or fill contour deformities left by flap positioning, the editorialists write. However, they also note that additional revisions were performed for 75% of the women who underwent fat grafting, thus making it “difficult to ascertain how much of the improvement in breast satisfaction can be attributed to fat grafting itself rather than to the other revisions.” The study findings do not apply to patients who undergo breast reconstruction that consists primarily of fat grafting or to patients who have undergone partial mastectomy, they point out.
“The transfer of fat as either a graft or vascularized DIEP [deep inferior epigastric artery perforator] flap remains a mainstay of reconstructive breast techniques and should be viewed in a similar fashion when delivered by a qualified and responsible clinician,” Dr Hollenbeck confirmed in an email. However, he also warned that clinicians should be careful about overstating the usefulness of fat grafting and should avoid any discussion of the merits of stem cells contained in fat.
“Many tissues that are transferred for reconstruction contain pluripotential cells as part of the larger construct. Fat grafting is not different. However regulatory issues may arise when a clinician makes claims about therapies centered around stem cells,” he told Medscape Medical News.
The Mastectomy Reconstruction Outcomes Consortium study was funded by the National Cancer Institute. The study authors and the editorialists have disclosed no relevant financial relationships.
JAMA Surg. Published online on June 28, 2017. Full text, Editorial
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