Katelyn G Bennett1, Ji Qi1, Hyungjin M Kim2,3, Jennifer B Hamill1, Edwin G Wilkins1, Babak J Mehrara4, Jeffrey H Kozlow1. 1. Section of Plastic Surgery, Department of Surgery, University of Michigan Health System, Ann Arbor. 2. Center for Statistical Consultation and Research, University of Michigan, Ann Arbor. 3. Department of Biostatistics, University of Michigan, Ann Arbor. 4. Plastic and Reconstructive Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York.
Abstract
IMPORTANCE: Fat grafting has proven to be a useful adjunct to breast reconstruction for the treatment of contour irregularities and volume deficits, but the proposed US Food and Drug Administration regulations may severely limit the ability of plastic surgeons to continue its use in this clinical context. OBJECTIVE: To determine whether fat grafting is associated with patient-reported outcomes (PROs) in patients undergoing breast reconstruction. DESIGN, SETTING, AND PARTICIPANTS: A longitudinal, multicenter, prospective cohort study was conducted between February 1, 2012, and July 31, 2016, at the 11 sites associated with the Mastectomy Reconstruction Outcomes Consortium Study. Eligible patients included women 18 years or older presenting for breast reconstruction after mastectomy with 2 years or more of follow-up. All primary procedure types (implant based and flap based) were eligible. Patients were excluded if they had not completed breast mound reconstruction by 1 year after starting reconstruction. INTERVENTIONS: Fat grafting as an adjunct to breast mound reconstruction. MAIN OUTCOMES AND MEASURES: Primary end points were patient-reported outcome measures as assessed by the validated BREAST-Q survey, with higher scores on a 0- to 100-point scale indicating better health-related quality of life. Survey subscales included breast satisfaction, as well as psychosocial, physical, and sexual well-being. Patient-reported outcomes were compared between those who received and did not receive fat grafting. RESULTS: A total of 2048 women were included (mean [SD] age, 49.4 [10] years), with 165 (8.1%) undergoing fat grafting between years 1 and 2. One year postoperatively, patients who later underwent fat grafting reported significantly lower breast satisfaction (adjusted mean difference [AMD], -4.74; 95% CI, -8.21 to -1.28; P = .008), psychosocial well-being (AMD, -3.87; 95% CI, -7.33 to -0.40; P = .03), and sexual well-being (AMD, -5.59; 95% CI, -9.70 to -1.47; P = .008), compared with those who did not receive subsequent fat grafting. Following the procedure, the fat-grafted cohort reported similar breast satisfaction (AMD, -0.68; 95% CI, -4.42 to 3.06; P = .72), psychosocial well-being (AMD, -0.59; 95% CI, -3.92 to 2.74; P = .73), and sexual well-being (AMD, -2.94; 95% CI, -7.01 to 1.12; P = .15) 2 years postoperatively. CONCLUSIONS AND RELEVANCE: Fat grafting may improve breast satisfaction, psychosocial well-being, and sexual well-being in patients undergoing breast reconstruction.
IMPORTANCE: Fat grafting has proven to be a useful adjunct to breast reconstruction for the treatment of contour irregularities and volume deficits, but the proposed US Food and Drug Administration regulations may severely limit the ability of plastic surgeons to continue its use in this clinical context. OBJECTIVE: To determine whether fat grafting is associated with patient-reported outcomes (PROs) in patients undergoing breast reconstruction. DESIGN, SETTING, AND PARTICIPANTS: A longitudinal, multicenter, prospective cohort study was conducted between February 1, 2012, and July 31, 2016, at the 11 sites associated with the Mastectomy Reconstruction Outcomes Consortium Study. Eligible patients included women 18 years or older presenting for breast reconstruction after mastectomy with 2 years or more of follow-up. All primary procedure types (implant based and flap based) were eligible. Patients were excluded if they had not completed breast mound reconstruction by 1 year after starting reconstruction. INTERVENTIONS: Fat grafting as an adjunct to breast mound reconstruction. MAIN OUTCOMES AND MEASURES: Primary end points were patient-reported outcome measures as assessed by the validated BREAST-Q survey, with higher scores on a 0- to 100-point scale indicating better health-related quality of life. Survey subscales included breast satisfaction, as well as psychosocial, physical, and sexual well-being. Patient-reported outcomes were compared between those who received and did not receive fat grafting. RESULTS: A total of 2048 women were included (mean [SD] age, 49.4 [10] years), with 165 (8.1%) undergoing fat grafting between years 1 and 2. One year postoperatively, patients who later underwent fat grafting reported significantly lower breast satisfaction (adjusted mean difference [AMD], -4.74; 95% CI, -8.21 to -1.28; P = .008), psychosocial well-being (AMD, -3.87; 95% CI, -7.33 to -0.40; P = .03), and sexual well-being (AMD, -5.59; 95% CI, -9.70 to -1.47; P = .008), compared with those who did not receive subsequent fat grafting. Following the procedure, the fat-grafted cohort reported similar breast satisfaction (AMD, -0.68; 95% CI, -4.42 to 3.06; P = .72), psychosocial well-being (AMD, -0.59; 95% CI, -3.92 to 2.74; P = .73), and sexual well-being (AMD, -2.94; 95% CI, -7.01 to 1.12; P = .15) 2 years postoperatively. CONCLUSIONS AND RELEVANCE: Fat grafting may improve breast satisfaction, psychosocial well-being, and sexual well-being in patients undergoing breast reconstruction.
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