The clinical course of immediate breast implant reconstruction after breast cancer

Figures & data

Figure 1. Breast implant reconstructions registered in the Danish Registry for Plastic Surgery of the Breast in the period 1999–2006.

Table I. Characteristics of permanent implants; primary implantation for the one-stage and exchange operation for the two-stage procedures (Implant level).

	One-stage procedures (n = 40)
	Double lumen expandable^&	Saline, expandable^§	Cohesive silicone
McGhan (n = 12)	8 (67%)		4 (33%)
Mentor (n = 17)	8 (47%)	6 (35%)	3 (18%)
Eurosilicone (n = 10)			10 (100%)
Missing (n = 1)
	Two-stage procedures, permanent implant (n = 125)
	Cohesive, type I^£	Cohesive, type II*	Cohesive, type III^#
McGhan (n = 37)		1 (3%)	36 (97%)
Mentor (n = 81)	4 (5%)	1 (1%)	76 (94%)
Eurosilicone (n = 1)		1 (100%)
Missing (n = 6)

^&Saline in inner chamber, silicone in outer.

^§Saline implants used as expandable implants were of the type Siltex Contour Profile Spectrum.

^£Cohesive, type I corresponds to McGhan style 110 Responsive Gel, Mentor Silicone Gel Breast Implants Cohesive I.

*Cohesive, type II corresponds to McGhan style 410 Soft Touch, Mentor Silicone Gel Breast Implants Cohesive II and Eurosilicone Cristalline Aptex Paragel E.S. 101N.

^#Cohesive, type III corresponds to McGhan style 410 Cohesive Gel and Mentor Silicone Gel Breast Implants Cohesive III.

Table II. Cumulative incidence of complications adjusted for competing risks according to time since operation for all immediate implant reconstructions (Implant level, n = 189).

Outcome	N^£	1 Year Risk (95% CI)	2 Year Risk (95% CI)	5 Year Risk (95% CI)	8 Year Risk (95% CI)
Any complication**	144	52.4 (48.7;56.0)	67.2 (63.8;70.6)	75.7 (72.6;78.8)	76.4 (73.3;79.5)
Infection^¤	38	19.0 (16.2;21.9)	19.6 (16.7;22.5)	20.1 (17.2;23.0)	20.1 (17.2;23.0)
Hematoma	23	11.1 (8.8;13.4)	12.2 (9.8;14.6)	12.2 (9.8;14.6)	12.2 (9.8;14.6)
Seroma	23	12.2 (9.8;14.5)	12.2 (9.8;14.5)	12.2 (9.8;14.5)	12.2 (9.8;14.5)
Capsular Contracture^#	10	2.1 (1.1;3.2)	4.2 (2.8;5.7)	5.3 (3.7;7.0)	5.3 (3.7;7.0)
Extrusion of the implant	11	5.8 (4.1;7.5)	5.8 (4.1;7.5)	5.8 (4.1;7.5)	5.8 (4.1;7.5)
Rupture^@	3	1.6 (0.7;2.5)	1.6 (0.7;2.5)	1.6 (0.7;2.5)	1.6 (0.7;2.5)
Displacement/asymmetry	55	14.8 (12.2;17.4)	23.8 (20.7;26.9)	28.7 (25.4;32.0)	29.5 (26.1;32.9)

^£N is number of events and accounts for all events in the given category.

**Any complication included all registered unintended postoperative adverse events ranging from minor events not requiring treatment to surgery-requiring complications.

^¤Including clinical suspicion of both superficial- and periprosthetic infections.

^#Capsular contracture includes severe contractures (modified Baker III-IV).

^@Rupture is suspicion of implant rupture based on clinical findings.

Table III. Cumulative incidence of reoperation adjusted for competing risks according to time since operation (Implant level)^#.

	N^£	1 Year Risk (95% CI)	2 Year Risk (95% CI)	5 Year Risk (95% CI)	8 Year Risk (95% CI)
Reoperation, all (n = 189)	74	23.3 (20.2;26.4)	33.9 (30.4;37.3)	38.3 (34.7;41.8)	40.6 (36.8;44.3)
One stage (n = 40)^$	23	50.0 (42.1;57.9)	57.5 (49.7;65.3)	57.5 (49.7;65.3)	57.5 (49.7;65.3)
Two stage (n = 149)^$	51(19)	16.1 (13.1;19.1)	27.5 (23.9;31.2)	33.2 (29.3;37.0)	36.3 (32.0;40.7)

^#Reoperations were defined as operations not included in the planned reconstructive procedure, where the implant capsule space was accessed.

^£N is number of events and accounts for all events in the given category within the full study period of 10 years – for two-stage procedures the brackets indicate the part concerning the expander.

^$The difference between risk of reoperation for the two procedures was statistically significant, p = 0.002.

Table IV. Cumulative incidence of complications adjusted for competing risks according to time since operation stratified by expansion period and period after second surgery (Implant level).

	Expansion period (N = 149)		Period after second surgery (N = 125)
Outcome	N^£	6 Months Risk (95% CI)	N^£	1 Year Risk (95% CI)	8 Years Risk (95% CI)
Reoperation^#	19	13.5 (10.3;16.6)	32	16.0 (12.8;19.3)	28.1 (23.5;32.7)
Any complication**	72	54.1 (49.0;59.3)	71	40.0 (35.6;44.4)	57.6 (53.1;62.1)
Infection^¤	24	16.9 (13.7;20.2)	7	4.8 (2.9;6.7)	5.6 (3.5;7.7)
Hematoma	17	11.4 (8.8;14.0)	3	1.6 (0.5;2.7)	2.4 (1.0;3.8)
Seroma	19	12.8 (10.0;15.5)	2	1.6 (0.5;2.7)	1.6 (0.5;2.7)
Capsular Contracture^$	5	1.8 (0.5;3.2)	4	2.4 (1.0;3.8)	3.2 (1.6;4.8)
Extrusion of the implant	3	2.0 (0.9;3.1)	1	0.8 (0.0;1.6)	0.8 (0.0;1.6)
Rupture^@	2	1.9 (0.5;3.3)	1	0.8 (0.0;1.6)	0.8 (0.0;1.6)
Displacement/asymmetry	11	13.0 (8.8;17.2)	36	19.2 (15.7;22.7)	29.4 (25.2;33.6)

^£N is number of events and accounts for all events throughout the period with the expander in place or after second surgery.

^#Reoperations were defined as operations not included in the planned reconstructive procedure, where the implant capsule space was accessed.

**Any complication included all registered unintended postoperative adverse events ranging from minor events not requiring treatment to surgery-requiring complications.

^¤Including clinical suspicion of both superficial- and periprosthetic infections. For the expander period 75% were treated with antibiotics and no surgery and 21% with explantation, after the second surgery is was 86% and 14%, respectively.

^$Capsular contracture includes severe contractures only (modified Baker III-IV).

^@Rupture is suspicion of implant rupture based on clinical finding.

Table V. Cumulative incidence of complications adjusted for competing risks according to time since operation comparing two-stage immediate and two-stage delayed procedures (Implant level).

	Immediate Breast Reconstruction (N = 149)			Delayed Breast Reconstruction (N = 353)
Outcome	N^£	1 Year Risk (95% CI)	8 Year Risk (95% CI)	N^£	1 Year Risk (95% CI)	8 Year Risk (95% CI	p-value
Reoperation^#	51 (19)	16.1 (13.1;19.1)	36.3 (32.0;40.7)	107 (26)	15.9 (13.9;17.8)	30.5 (28.0;33.0)	0.410
Any complication**	113 (72)	51.7 (47.6;55.8)	76.2 (72.6;79.7)	233 (100)	44.5 (41.8;47.1)	67.2 (64.5;69.9)	0.021
Infection^¤	31 (24)	19.5 (16.2;22.7)	20.8 (17.5;24.1)	51 (34)	13.6 (11.8;15.4)	14.4 (12.6;16.3)	0.099
Hematoma	20 (17)	12.1 (9.4;14.8)	13.4 (10.6;16.2)	25 (18)	7.1 (5.7;8.4)	7.1 (5.7;8.4)	0.044
Seroma	21 (19)	14.1 (11.2;16.9)	14.1 (11.2;16.9)	24 (20)	6.5 (5.2;7.8)	6.5 (5.2;7.8)	0.017
Capsular Contracture^$	8 (5)	1.3 (0.4;2.3)	5.4 (3.6;7.3)	27 (7)	4.2 (3.2;5.3)	8.2 (6.6;9.8)	0.268
Extrusion of the implant	4 (3)	2.7 (1.4;4.0)	2.7 (1.4;4.0)	11 (10)	3.1 (2.2;4.0)	3.1 (2.2;4.0)	0.765
Rupture^@	3 (2)	2.0 (0.9;3.2)	2.0 (0.9;3.2)	8 (7)	2.0 (1.2;2.7)	3.4 (1.8;4.9)	0.946
Displacement/asymmetry	43 (11)	13.4 (10.6;16.2)	29.5 (25.6;32.3)	113 (18)	19.0 (16.9;21.1)	32.5 (29.9;35.0)	0.363

^£Number of events account for all events throughout the full study period after the second surgery. Numbers in brackets indicate the part concerning the expander period for two-stage procedures.

^#Reoperations were defined as operations not included in the planned reconstructive procedure, where the implant capsule space was accessed.

**Any complication included all registered unintended postoperative adverse events ranging from minor events not requiring treatment to surgery-requiring complications.

^¤Including clinical suspicion of both superficial- and periprosthetic infections. For the immediate procedures 77% were treated with antibiotics and no surgery and 19% with explantation, for the delayed procedures is was 92% and 8%, respectively.

^$Capsular contracture includes severe contractures (modified Baker III-IV).

^@Rupture is suspicion of implant rupture based on clinical findings.