Comparisons of Therapeutic and Aesthetic Effects of One-Stage Implant-Based Breast Reconstruction with and without Biological Matrix

Figures & data

Figure 1 Unilateral, left nipple-sparing mastectomy and one-stage implant-based breast reconstruction with SIS matrix. A 40-year-old woman who was diagnosed with invasive carcinoma and she was treated with neoadjuvant chemotherapy before surgery (above). Photos at 1 year postoperatively (below).

Figure 2 Bilateral nipple-sparing mastectomy and one-stage implant-based breast reconstruction without matrix. A 27-year-old woman with bilateral invasive carcinoma and axillary lymph node metastasis before surgery (above). Photos at 1year postoperatively (below).

Table 1 Baseline Characteristics of the Included Patients Who Received Breast Reconstruction Surgeries

Characteristics	SIS Mesh (n=79)	No-Mesh (n=76)	P value
Mean age, years (SD)	41.14(7.03)	39.43(7.23)	0.139
Mean BMI, kg/m2 (SD)	21.73(2.20)	21.91(2.21)	0.617
Mean implant volume, cc (SD)	231.58(53.27)	237.70(56.45)	0.489
Unilateral reconstruction, n (%)			0.332
Right	37(46.8)	29(38.2)
Left	42(53.2)	46(60.5)
Bilateral reconstruction, n (%)	0(0)	1(1.3)	0.194
Histology, n (%)			0.048
DCIS	16(20.3)	8(10.5)
Invasive carcinoma	20 (25.3)	25(32.9)
Carcinoma and DCIS	40(50.6)	37(48.7)
Others	3(3.8)	6(7.9)
Axillary resection, n (%)	32(40.5)	21(27.6)	0.127
Sentinel node	52(65.8)	58(76.3)	0.161
Surgical type, n (%)			0.446
NSM	59(74.7)	61(80.3)
SSM	20(25.3)	15(19.7)
Days to drain removal, days (SD)	21.08(9.53)	16.52(7.61)	0.001
Good-fitting sports bra condition, n (%)			0.002
Non-wore	30(38.0)	12(15.8)
wore	49(62.0)	64(84.2)
Smoking status, n (%)
Former	4(5.1)	1(1.3)	0.367
Current	0	0
Diabetes mellitus, n (%)	0	0
Treatment
Neoadjuvant chemotherapy, n (%)	9(11.4)	4(5.3)	0.274
Adjuvant Chemotherapy, n (%)	46(58.2)	48(63.2)	0.622
Radiotherapy status, n (%)	16(20.3)	12(15.8)	0.534
Hormone therapy, n (%)	52(65.8)	44(57.9)	0.326
Targeted therapy, n (%)	20(25.3)	17(22.4)	0.709
Mean Duration of Follow-Up at Time of BREAST-Q, Months (SD)	17.55(4.83)	33.37(16.65)	0.000

Table 2 Postoperative Scales of BREAST-Q Version 2.0

Items	SIS Mesh	No-Mesh	P value
Available questionnaires, n	68(86.1%) of 79	63(82.9%) of 76	0.660
Psychosocial well-being
Data available, n (%) of N	68(86.1%) of 79	63(82.9%) of 76
Mean (SD)	73.52(19.96)	72.22 (18.8)	0.703
Satisfaction with breast
Data available, n (%) of N	68(86.1%) of 79	63(82.9%) of 76
Mean (SD)	60.27(17.71)	54.49 (14.76)	0.045
Satisfaction with implants
Data available, n (%) of N	68(86.1%) of 79	63(82.9%) of 76
Mean (SD)	6.04(1.44)	5.84 (1.57)	0.443
Physical well-being: chest
Data available, n (%) of N	68(86.1%) of 79	63(82.9%) of 76
Mean (SD)	39.60(17.39)	36.83 (20.29)	0.406
Sexual well-being
Data available, n (%) of N	40(50.6%) of 79	40(52.6%) of 76
Mean (SD)	50.95(26.47)	48.1 (18.21)	0.577
Satisfaction with surgeon
Data available, n (%) of N	68(86.1%) of 79	63(82.9%) of 76
Mean (SD)	85.49(21.38)	81.81 (23.07)	0.348

Table 3 Univariate Analysis Results of the Complications Between SIS Matrix-Assisted One-Stage IBBR Group and No-Matrix-Assisted One-Stage IBBR Group

Complications	SIS Mesh (n=79)	No-Mesh (n=76)	P value
Major complications	5(6.3)	3(3.9)	0.720
Minor complications	9(11.4)	5(6.6)	0.403
Seroma	6 (7.6)	2(2.6)	0.277
Infections	4(5.1)	0(0)	0.120
Implant loss	5(6.3)	2(2.6)	0.443
Recurrence/metastasis	0(0)	1(1.3)	0.490
Dehiscence	2(2.5)	2(2.6)	1.000
Capsular contracture	0(0)	2(2.6)	0.239
NAC necrosis	2(2.5)	1(1.3)	1.000
Prosthesis malposition	0(0)	1(1.3)	0.490
Chronic pain	2(2.5)	1(1.3)	1.000

Table 4 Multivariate Logistic Analysis of Patient and Surgery-Related Characteristics as Risk Factors for Postoperative Complications (Major + Minor) in the Whole Series

Characteristics	OR	95% CI	P value
Mean age, years, n (%)	3.314	1.012–10.854	0.048
>40
≤40
BMI, kg/m^2, (SD)	3.607	0.754–17.266	0.108
>25
≤25
Mean implant volume, cc (SD)	0.993	0.983–1.004	0.211
Histology, n (%)	0.676	0.156–2.938	0.601
DCIS
Invasive carcinoma and others
Axillary resection, n (%)	0.803	0.252–2.556	0.711
Surgical type, n (%)	0.363	0.110–1.201	0.097
NSM
SSM
Days to drain removal, days (SD)	0.964	0.896–1.037	0.321
Good-fitting sports bra condition, n (%)	1.116	0.323–3.857	0.862
Wore
No wore
Smoking status, n (%)	0.000	0.000–0.000	0.999
Treatments
Adjuvant chemotherapy, n (%)	2.737	0.545–13.735	0.221
Chemotherapy, n (%)	0.767	0.216–2.723	0.682
Radiotherapy status, n (%)	1.497	0.327–6.863	0.604
Endocrine therapy, n (%)	0.260	0.092–0.736	0.011
Targeted therapy, n (%)	1.872	0.519–6.754	0.338

Table 5 Studies Regarding Biological Matrices or Synthetic Meshes Based on One-Stage IBBR or Two-Stage IBBR

Author	Year	Journal	Country	Sample Size	Trial Phase	Matrix/Mesh Type	Reconstruction Type	Key Findings	Ref.
Vera Lidwina Negenborn	2018	Lancet Oncol	Netherlands	One-stage IBBR with ADM group: 60 patients; two-stage IBBR group: 61 patients.	Prospective randomized controlled trial	One-stage IBBR with ADM (strattice^®) and two-stage IBBR	One-stage ADM-assisted IBBR and two-stage IBBR	(1) One-stage IBBR with ADM does not yield superior results in terms of patient-reported QOL compared with two-stage IBBR. (2) Risks for adverse outcomes are significantly higher in the one-stage ADM group.	[^Citation31]
Michael Scheflan	2018	Plast reconstr surg	Israel	111 patients	Retrospective study	Bovine-derived ADM: SurgiMend^® prs	One-stage or two-stage ADM-assisted IBBR	The results support the value of SurgiMend^® in implant-based breast reconstruction.	[^Citation6]
Michael Sorkin	2017	Plast reconstr surg	USA	Expander reconstruction with ADM: 655 patients; Expander reconstruction without ADM: 642 patients.	Prospective cohort study	ADMs	Two-stage IBBR with and without ADM	There is no significant ADM effects on complications, time to exchange or PRO in immediate expander/implant breast reconstruction.	[^Citation26]
D. Gschwantler-Kaulich	2016	Eur j surg oncol	Austria	Protexa^® group: 23 patients; Tiloop^® bra group: 25 patients	Prospective randomized controlled trial	ADM (Protexa^®) and titanized mesh (Tiloop^® bra)	One-stage ADM/mesh-assisted IBBR	(1) the use of Tiloop^® bra or Protexa^® in IBBR is feasible leading to good cosmetic outcomes and high patient satisfaction. (2) Protexa^® group has higher failure rates but requires a larger data trial.	[^Citation25]
Max Dieterich	2013	Plast reconstr surg	Germany	207 patients	Retrospective study	Titanium-coated polypropylene mesh (TCPM): Tiloop^® bra	One-stage or two-stage mesh-assisted IBBR	This TCPM shows acceptable com- plication rates and is a helpful device in IBBR.	[^Citation24]
Colleen M. McCarthy	2012	Plast reconstr surg	USA	Two-stage IBBR with ADM group: 36 patients; Two-stage IBBR in a completely submuscular position: 34 patients.	Retrospective study	Human ADM: Alloderm^®	Two-stage IBBR with and without ADM	The use of ADM in the setting of two-stage IBBR neither reduces post-operative pain nor accelerates the rate of post-operative expansion.	[^Citation27]
C. Andrew Salzberg	2011	Plast reconstr surg	USA	260 patients	Retrospective study	Human ADM: Alloderm^®	One-stage ADM-assisted IBBR	Human ADM-assisted direct-to-implant breast reconstruction following mastectomy is safe and reliable, with a low overall long-term complication rate.	[^Citation28]

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