Patient and Implant Characteristics Stratified into Tertiles Based on Amount of Silicone Leakage
| . | Breasts, n . | ||||
|---|---|---|---|---|---|
| . | . | Silicone leakage tertiles . | . | ||
| . | Total (n = 1147) . | Low leakage (n = 383) . | Moderate leakage (n = 382) . | High leakage (n = 382) . | P-valuea . |
| Amount of silicone, median (IQR), mL | 0.10 (0.00-0.90) | 0.00 (0.00-0.00) | 0.10 (0.04-0.23) | 2.20 (0.92-5.39) | |
| Patients, nb | 657 | 293 | 322 | 296 | |
| Age, median (IQR), years | 47.2 (38.5-55.4) | 42.6 (34.7-52.5) | 46.9 (38.5-54.5) | 50.4 (42.2-57.4) | <.001 |
| BMI, median (IQR), kg/m2 | 22.6 (20.5-24.9) | 22.2 (20.5-24.5) | 22.5 (20.4-24.6) | 22.9 (20.7-25.4) | .027 |
| Smoking (%) | |||||
| No | 514 (78) | 235 (80) | 258 (80) | 227 (77) | .48 |
| Yes | 143 (22) | 58 (20) | 64 (20) | 69 (23) | |
| ASA classification (%) | |||||
| I | 390 (60) | 183 (63) | 197 (61) | 162 (55) | .30 |
| II | 249 (38) | 102 (35) | 119 (37) | 125 (42) | |
| ≥III | 18 (2.7) | 8 (2.7) | 6 (1.9) | 9 (3.0) | |
| Indication for primary surgery (%) | |||||
| Breast reconstruction | 122 (19) | 60 (20) | 52 (16) | 30 (10) | .002 |
| Breast augmentation | 535 (81) | 233 (80) | 270 (84) | 266 (90) | |
| Indication for revisional surgery (%) | |||||
| Capsular contracture | 250 (38) | 84 (29) | 112 (35) | 142 (48) | <.001 |
| Cosmetic | 256 (39) | 157 (54) | 128 (40) | 58 (20) | |
| Implant age | 45 (6.8) | 24 (8.2) | 27 (8.4) | 11 (3.7) | |
| Suspected BIA-ALCL | 10 (1.5) | 3 (1.0) | 6 (1.9) | 5 (1.7) | |
| Suspected BII | 8 (1.2) | 5 (1.7) | 5 (1.6) | 3 (1.0) | |
| Suspected rupture | 88 (13) | 20 (6.8) | 44 (14) | 77 (26) | |
| Time of implantation, median (IQR), years | 14.0 (7.1-19.7) | 9.0 (3.3-14.0) | 14.0 (7.1-18.0) | 18.0 (14.0-22.0) | <.001 |
| Rupture (%) | |||||
| No | 909 (79) | 380 (99) | 359 (94) | 170 (44) | <.001 |
| Yes | 238 (21) | 3 (0.8) | 23 (6.0) | 212 (56) | |
| Previous implant replacement (%) | |||||
| No | 963 (84) | 328 (86) | 324 (85) | 311 (81) | .24 |
| Yes | 184 (16) | 55 (14) | 58 (15) | 71 (19) | |
| Implant volume, median (IQR), mL | 320.0 (275.0-375.0) | 320.0 (280.0-375.0) | 320.0 (275.0-378.8) | 320.0 (275.0-350.0) | .11 |
| Implant surface (%) | |||||
| Smooth | 48 (4.2) | 5 (1.3) | 19 (5.0) | 24 (6.3) | <.001 |
| Motiva SmoothSilk | 46 (4.0) | 24 (6.3) | 14 (3.7) | 8 (2.1) | |
| Mentor Siltex | 498 (43) | 210 (55) | 164 (43) | 124 (33) | |
| Eurosilicone Cristalline | 218 (19) | 78 (20) | 76 (20) | 64 (17) | |
| CUI Microcell | 35 (3.1) | 10 (2.6) | 13 (3.4) | 12 (3.1) | |
| Allergan Biocell | 107 (9.3) | 11 (2.9) | 39 (10) | 57 (15) | |
| Other texturesc | 195 (17) | 45 (12) | 57 (15) | 93 (24) | |
| Silicone cohesiveness (%)d | |||||
| Low cohesive | 645 (56) | 184 (48) | 229 (60) | 232 (61) | <.001 |
| Highly cohesive | 312 (27) | 159 (42) | 99 (26) | 54 (14) | |
| Unknown | 190 (17) | 40 (10) | 54 (14) | 96 (25) | |
| Implant plane (%) | |||||
| Prepectoral | 169 (15) | 63 (16) | 59 (15) | 47 (12) | .24 |
| Subpectoral | 978 (85) | 320 (84) | 323 (85) | 335 (88) | |
| Radiotherapy (%) | |||||
| No | 1118 (98) | 370 (97) | 372 (97) | 376 (98) | .27 |
| Yes | 29 (2.5) | 13 (3.4) | 10 (2.6) | 6 (1.6) | |
| Chemotherapy (%) | |||||
| No | 599 (91) | 261 (89) | 300 (94) | 285 (96) | .005 |
| Neoadjuvant | 24 (3.7) | 16 (5.5) | 6 (1.9) | 5 (1.7) | |
| Adjuvant | 34 (5.2) | 16 (5.5) | 16 (5.0) | 6 (2.0) | |
| . | Breasts, n . | ||||
|---|---|---|---|---|---|
| . | . | Silicone leakage tertiles . | . | ||
| . | Total (n = 1147) . | Low leakage (n = 383) . | Moderate leakage (n = 382) . | High leakage (n = 382) . | P-valuea . |
| Amount of silicone, median (IQR), mL | 0.10 (0.00-0.90) | 0.00 (0.00-0.00) | 0.10 (0.04-0.23) | 2.20 (0.92-5.39) | |
| Patients, nb | 657 | 293 | 322 | 296 | |
| Age, median (IQR), years | 47.2 (38.5-55.4) | 42.6 (34.7-52.5) | 46.9 (38.5-54.5) | 50.4 (42.2-57.4) | <.001 |
| BMI, median (IQR), kg/m2 | 22.6 (20.5-24.9) | 22.2 (20.5-24.5) | 22.5 (20.4-24.6) | 22.9 (20.7-25.4) | .027 |
| Smoking (%) | |||||
| No | 514 (78) | 235 (80) | 258 (80) | 227 (77) | .48 |
| Yes | 143 (22) | 58 (20) | 64 (20) | 69 (23) | |
| ASA classification (%) | |||||
| I | 390 (60) | 183 (63) | 197 (61) | 162 (55) | .30 |
| II | 249 (38) | 102 (35) | 119 (37) | 125 (42) | |
| ≥III | 18 (2.7) | 8 (2.7) | 6 (1.9) | 9 (3.0) | |
| Indication for primary surgery (%) | |||||
| Breast reconstruction | 122 (19) | 60 (20) | 52 (16) | 30 (10) | .002 |
| Breast augmentation | 535 (81) | 233 (80) | 270 (84) | 266 (90) | |
| Indication for revisional surgery (%) | |||||
| Capsular contracture | 250 (38) | 84 (29) | 112 (35) | 142 (48) | <.001 |
| Cosmetic | 256 (39) | 157 (54) | 128 (40) | 58 (20) | |
| Implant age | 45 (6.8) | 24 (8.2) | 27 (8.4) | 11 (3.7) | |
| Suspected BIA-ALCL | 10 (1.5) | 3 (1.0) | 6 (1.9) | 5 (1.7) | |
| Suspected BII | 8 (1.2) | 5 (1.7) | 5 (1.6) | 3 (1.0) | |
| Suspected rupture | 88 (13) | 20 (6.8) | 44 (14) | 77 (26) | |
| Time of implantation, median (IQR), years | 14.0 (7.1-19.7) | 9.0 (3.3-14.0) | 14.0 (7.1-18.0) | 18.0 (14.0-22.0) | <.001 |
| Rupture (%) | |||||
| No | 909 (79) | 380 (99) | 359 (94) | 170 (44) | <.001 |
| Yes | 238 (21) | 3 (0.8) | 23 (6.0) | 212 (56) | |
| Previous implant replacement (%) | |||||
| No | 963 (84) | 328 (86) | 324 (85) | 311 (81) | .24 |
| Yes | 184 (16) | 55 (14) | 58 (15) | 71 (19) | |
| Implant volume, median (IQR), mL | 320.0 (275.0-375.0) | 320.0 (280.0-375.0) | 320.0 (275.0-378.8) | 320.0 (275.0-350.0) | .11 |
| Implant surface (%) | |||||
| Smooth | 48 (4.2) | 5 (1.3) | 19 (5.0) | 24 (6.3) | <.001 |
| Motiva SmoothSilk | 46 (4.0) | 24 (6.3) | 14 (3.7) | 8 (2.1) | |
| Mentor Siltex | 498 (43) | 210 (55) | 164 (43) | 124 (33) | |
| Eurosilicone Cristalline | 218 (19) | 78 (20) | 76 (20) | 64 (17) | |
| CUI Microcell | 35 (3.1) | 10 (2.6) | 13 (3.4) | 12 (3.1) | |
| Allergan Biocell | 107 (9.3) | 11 (2.9) | 39 (10) | 57 (15) | |
| Other texturesc | 195 (17) | 45 (12) | 57 (15) | 93 (24) | |
| Silicone cohesiveness (%)d | |||||
| Low cohesive | 645 (56) | 184 (48) | 229 (60) | 232 (61) | <.001 |
| Highly cohesive | 312 (27) | 159 (42) | 99 (26) | 54 (14) | |
| Unknown | 190 (17) | 40 (10) | 54 (14) | 96 (25) | |
| Implant plane (%) | |||||
| Prepectoral | 169 (15) | 63 (16) | 59 (15) | 47 (12) | .24 |
| Subpectoral | 978 (85) | 320 (84) | 323 (85) | 335 (88) | |
| Radiotherapy (%) | |||||
| No | 1118 (98) | 370 (97) | 372 (97) | 376 (98) | .27 |
| Yes | 29 (2.5) | 13 (3.4) | 10 (2.6) | 6 (1.6) | |
| Chemotherapy (%) | |||||
| No | 599 (91) | 261 (89) | 300 (94) | 285 (96) | .005 |
| Neoadjuvant | 24 (3.7) | 16 (5.5) | 6 (1.9) | 5 (1.7) | |
| Adjuvant | 34 (5.2) | 16 (5.5) | 16 (5.0) | 6 (2.0) | |
Age, BMI, smoking, ASA classification, indication for primary surgery, indication for revisional surgery, and chemotherapy were reported per patient and did not sum up to the per breast total. ASA, American Society of Anesthesiologists; IQR, interquartile range. aP-values shown are for Kruskal–Wallis rank sum tests, or Pearson χ2 tests depending on variable type. bPatients undergoing bilateral surgery can contribute to 2 different silicone leakage groups. cIncluding Polytech POLYtxt (Dieburg, Germany), Silimed Biodesign (Rio de Janeiro, Brazil), Nagor Nagortex (GC Aesthetics, Sandyford, Dublin), and implants with unknown texture. dLow-cohesive implants include Allergan SoftTouch (Irvine, CA), CUI Responsive (Allergan), Eurosilicone Soft (Apt, France), Mentor Cohesive I (Mentor Worldwide LLC, Irvine, CA), Motiva ProgressiveGel Ultima (Establishment Labs Holdings, Inc., Alajuela, Costa Rica), Nagor Impleo. Highly cohesive implants include Allergan 410 Highly Cohesive, CUI Cohesive, Eurosilicone Natural, Mentor Cohesive II and III, Motiva ProgressiveGel PLUS, Nagor CoGel.
Patient and Implant Characteristics Stratified into Tertiles Based on Amount of Silicone Leakage
| . | Breasts, n . | ||||
|---|---|---|---|---|---|
| . | . | Silicone leakage tertiles . | . | ||
| . | Total (n = 1147) . | Low leakage (n = 383) . | Moderate leakage (n = 382) . | High leakage (n = 382) . | P-valuea . |
| Amount of silicone, median (IQR), mL | 0.10 (0.00-0.90) | 0.00 (0.00-0.00) | 0.10 (0.04-0.23) | 2.20 (0.92-5.39) | |
| Patients, nb | 657 | 293 | 322 | 296 | |
| Age, median (IQR), years | 47.2 (38.5-55.4) | 42.6 (34.7-52.5) | 46.9 (38.5-54.5) | 50.4 (42.2-57.4) | <.001 |
| BMI, median (IQR), kg/m2 | 22.6 (20.5-24.9) | 22.2 (20.5-24.5) | 22.5 (20.4-24.6) | 22.9 (20.7-25.4) | .027 |
| Smoking (%) | |||||
| No | 514 (78) | 235 (80) | 258 (80) | 227 (77) | .48 |
| Yes | 143 (22) | 58 (20) | 64 (20) | 69 (23) | |
| ASA classification (%) | |||||
| I | 390 (60) | 183 (63) | 197 (61) | 162 (55) | .30 |
| II | 249 (38) | 102 (35) | 119 (37) | 125 (42) | |
| ≥III | 18 (2.7) | 8 (2.7) | 6 (1.9) | 9 (3.0) | |
| Indication for primary surgery (%) | |||||
| Breast reconstruction | 122 (19) | 60 (20) | 52 (16) | 30 (10) | .002 |
| Breast augmentation | 535 (81) | 233 (80) | 270 (84) | 266 (90) | |
| Indication for revisional surgery (%) | |||||
| Capsular contracture | 250 (38) | 84 (29) | 112 (35) | 142 (48) | <.001 |
| Cosmetic | 256 (39) | 157 (54) | 128 (40) | 58 (20) | |
| Implant age | 45 (6.8) | 24 (8.2) | 27 (8.4) | 11 (3.7) | |
| Suspected BIA-ALCL | 10 (1.5) | 3 (1.0) | 6 (1.9) | 5 (1.7) | |
| Suspected BII | 8 (1.2) | 5 (1.7) | 5 (1.6) | 3 (1.0) | |
| Suspected rupture | 88 (13) | 20 (6.8) | 44 (14) | 77 (26) | |
| Time of implantation, median (IQR), years | 14.0 (7.1-19.7) | 9.0 (3.3-14.0) | 14.0 (7.1-18.0) | 18.0 (14.0-22.0) | <.001 |
| Rupture (%) | |||||
| No | 909 (79) | 380 (99) | 359 (94) | 170 (44) | <.001 |
| Yes | 238 (21) | 3 (0.8) | 23 (6.0) | 212 (56) | |
| Previous implant replacement (%) | |||||
| No | 963 (84) | 328 (86) | 324 (85) | 311 (81) | .24 |
| Yes | 184 (16) | 55 (14) | 58 (15) | 71 (19) | |
| Implant volume, median (IQR), mL | 320.0 (275.0-375.0) | 320.0 (280.0-375.0) | 320.0 (275.0-378.8) | 320.0 (275.0-350.0) | .11 |
| Implant surface (%) | |||||
| Smooth | 48 (4.2) | 5 (1.3) | 19 (5.0) | 24 (6.3) | <.001 |
| Motiva SmoothSilk | 46 (4.0) | 24 (6.3) | 14 (3.7) | 8 (2.1) | |
| Mentor Siltex | 498 (43) | 210 (55) | 164 (43) | 124 (33) | |
| Eurosilicone Cristalline | 218 (19) | 78 (20) | 76 (20) | 64 (17) | |
| CUI Microcell | 35 (3.1) | 10 (2.6) | 13 (3.4) | 12 (3.1) | |
| Allergan Biocell | 107 (9.3) | 11 (2.9) | 39 (10) | 57 (15) | |
| Other texturesc | 195 (17) | 45 (12) | 57 (15) | 93 (24) | |
| Silicone cohesiveness (%)d | |||||
| Low cohesive | 645 (56) | 184 (48) | 229 (60) | 232 (61) | <.001 |
| Highly cohesive | 312 (27) | 159 (42) | 99 (26) | 54 (14) | |
| Unknown | 190 (17) | 40 (10) | 54 (14) | 96 (25) | |
| Implant plane (%) | |||||
| Prepectoral | 169 (15) | 63 (16) | 59 (15) | 47 (12) | .24 |
| Subpectoral | 978 (85) | 320 (84) | 323 (85) | 335 (88) | |
| Radiotherapy (%) | |||||
| No | 1118 (98) | 370 (97) | 372 (97) | 376 (98) | .27 |
| Yes | 29 (2.5) | 13 (3.4) | 10 (2.6) | 6 (1.6) | |
| Chemotherapy (%) | |||||
| No | 599 (91) | 261 (89) | 300 (94) | 285 (96) | .005 |
| Neoadjuvant | 24 (3.7) | 16 (5.5) | 6 (1.9) | 5 (1.7) | |
| Adjuvant | 34 (5.2) | 16 (5.5) | 16 (5.0) | 6 (2.0) | |
| . | Breasts, n . | ||||
|---|---|---|---|---|---|
| . | . | Silicone leakage tertiles . | . | ||
| . | Total (n = 1147) . | Low leakage (n = 383) . | Moderate leakage (n = 382) . | High leakage (n = 382) . | P-valuea . |
| Amount of silicone, median (IQR), mL | 0.10 (0.00-0.90) | 0.00 (0.00-0.00) | 0.10 (0.04-0.23) | 2.20 (0.92-5.39) | |
| Patients, nb | 657 | 293 | 322 | 296 | |
| Age, median (IQR), years | 47.2 (38.5-55.4) | 42.6 (34.7-52.5) | 46.9 (38.5-54.5) | 50.4 (42.2-57.4) | <.001 |
| BMI, median (IQR), kg/m2 | 22.6 (20.5-24.9) | 22.2 (20.5-24.5) | 22.5 (20.4-24.6) | 22.9 (20.7-25.4) | .027 |
| Smoking (%) | |||||
| No | 514 (78) | 235 (80) | 258 (80) | 227 (77) | .48 |
| Yes | 143 (22) | 58 (20) | 64 (20) | 69 (23) | |
| ASA classification (%) | |||||
| I | 390 (60) | 183 (63) | 197 (61) | 162 (55) | .30 |
| II | 249 (38) | 102 (35) | 119 (37) | 125 (42) | |
| ≥III | 18 (2.7) | 8 (2.7) | 6 (1.9) | 9 (3.0) | |
| Indication for primary surgery (%) | |||||
| Breast reconstruction | 122 (19) | 60 (20) | 52 (16) | 30 (10) | .002 |
| Breast augmentation | 535 (81) | 233 (80) | 270 (84) | 266 (90) | |
| Indication for revisional surgery (%) | |||||
| Capsular contracture | 250 (38) | 84 (29) | 112 (35) | 142 (48) | <.001 |
| Cosmetic | 256 (39) | 157 (54) | 128 (40) | 58 (20) | |
| Implant age | 45 (6.8) | 24 (8.2) | 27 (8.4) | 11 (3.7) | |
| Suspected BIA-ALCL | 10 (1.5) | 3 (1.0) | 6 (1.9) | 5 (1.7) | |
| Suspected BII | 8 (1.2) | 5 (1.7) | 5 (1.6) | 3 (1.0) | |
| Suspected rupture | 88 (13) | 20 (6.8) | 44 (14) | 77 (26) | |
| Time of implantation, median (IQR), years | 14.0 (7.1-19.7) | 9.0 (3.3-14.0) | 14.0 (7.1-18.0) | 18.0 (14.0-22.0) | <.001 |
| Rupture (%) | |||||
| No | 909 (79) | 380 (99) | 359 (94) | 170 (44) | <.001 |
| Yes | 238 (21) | 3 (0.8) | 23 (6.0) | 212 (56) | |
| Previous implant replacement (%) | |||||
| No | 963 (84) | 328 (86) | 324 (85) | 311 (81) | .24 |
| Yes | 184 (16) | 55 (14) | 58 (15) | 71 (19) | |
| Implant volume, median (IQR), mL | 320.0 (275.0-375.0) | 320.0 (280.0-375.0) | 320.0 (275.0-378.8) | 320.0 (275.0-350.0) | .11 |
| Implant surface (%) | |||||
| Smooth | 48 (4.2) | 5 (1.3) | 19 (5.0) | 24 (6.3) | <.001 |
| Motiva SmoothSilk | 46 (4.0) | 24 (6.3) | 14 (3.7) | 8 (2.1) | |
| Mentor Siltex | 498 (43) | 210 (55) | 164 (43) | 124 (33) | |
| Eurosilicone Cristalline | 218 (19) | 78 (20) | 76 (20) | 64 (17) | |
| CUI Microcell | 35 (3.1) | 10 (2.6) | 13 (3.4) | 12 (3.1) | |
| Allergan Biocell | 107 (9.3) | 11 (2.9) | 39 (10) | 57 (15) | |
| Other texturesc | 195 (17) | 45 (12) | 57 (15) | 93 (24) | |
| Silicone cohesiveness (%)d | |||||
| Low cohesive | 645 (56) | 184 (48) | 229 (60) | 232 (61) | <.001 |
| Highly cohesive | 312 (27) | 159 (42) | 99 (26) | 54 (14) | |
| Unknown | 190 (17) | 40 (10) | 54 (14) | 96 (25) | |
| Implant plane (%) | |||||
| Prepectoral | 169 (15) | 63 (16) | 59 (15) | 47 (12) | .24 |
| Subpectoral | 978 (85) | 320 (84) | 323 (85) | 335 (88) | |
| Radiotherapy (%) | |||||
| No | 1118 (98) | 370 (97) | 372 (97) | 376 (98) | .27 |
| Yes | 29 (2.5) | 13 (3.4) | 10 (2.6) | 6 (1.6) | |
| Chemotherapy (%) | |||||
| No | 599 (91) | 261 (89) | 300 (94) | 285 (96) | .005 |
| Neoadjuvant | 24 (3.7) | 16 (5.5) | 6 (1.9) | 5 (1.7) | |
| Adjuvant | 34 (5.2) | 16 (5.5) | 16 (5.0) | 6 (2.0) | |
Age, BMI, smoking, ASA classification, indication for primary surgery, indication for revisional surgery, and chemotherapy were reported per patient and did not sum up to the per breast total. ASA, American Society of Anesthesiologists; IQR, interquartile range. aP-values shown are for Kruskal–Wallis rank sum tests, or Pearson χ2 tests depending on variable type. bPatients undergoing bilateral surgery can contribute to 2 different silicone leakage groups. cIncluding Polytech POLYtxt (Dieburg, Germany), Silimed Biodesign (Rio de Janeiro, Brazil), Nagor Nagortex (GC Aesthetics, Sandyford, Dublin), and implants with unknown texture. dLow-cohesive implants include Allergan SoftTouch (Irvine, CA), CUI Responsive (Allergan), Eurosilicone Soft (Apt, France), Mentor Cohesive I (Mentor Worldwide LLC, Irvine, CA), Motiva ProgressiveGel Ultima (Establishment Labs Holdings, Inc., Alajuela, Costa Rica), Nagor Impleo. Highly cohesive implants include Allergan 410 Highly Cohesive, CUI Cohesive, Eurosilicone Natural, Mentor Cohesive II and III, Motiva ProgressiveGel PLUS, Nagor CoGel.
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