Table 1.
Summary of Capsular Contracture and Biofilm Studies
| Study Topic | Author | Study Design (n) | Notes | Level of Evidence |
|---|---|---|---|---|
| Presence of Biofilms in Capsular contracture | Virden et al,20 | Case-control (40 patients, 55 implants) | Culture and diagnostic SEM 17 of 27 devices developed CC before 12 months; range 2 mo to 5 yr | 3 |
| Dobke et al,21 | Case-control (87 pts, 150 implants) | Culture only | 3 | |
| Pajkos et al, 200322 | Case-control (16 pts, 27 capsules) | Sonication and diagnostic SEM | 3 | |
| Schreml et al,23 | Case-control (45 pts) | Culture only | 3 | |
| Rieger et al,24 | Case series (13 pts, 22 implants) | Culture only (sonication) | 4 | |
| Rieger et al,24 | Case-control (84 pts, 121 implants) | Culture only (sonication) | 3 | |
| Animal Models of biofilm and Capsular contracture | Shah et al,42 | Animal Study (16 rabbits, 20 implants) | Experimental group inoculated with S epidermidis | 5 |
| Kossovsky et al,82 | Animal Study (10 guinea pigs, 20 implants) | Experimental group inoculated with S aureus, diagnostic SEM | 5 | |
| Tamboto et al,83 | Animal Study (6 pigs, 51 implants) | Experimental group inoculated with S epidermidis, diagnostic sonication and SEM | 5 | |
| Role of implant texture, biofilm formation, and CC | Wong et al,6 | Systematic Review (6 RCTs; 235 patients, 470 breasts total) | Smooth implants more likely to undergo CC at 1, 3, and 7 yr | 1 |
| Schreml et al,23 | Case-control (45 pts) | Culture only, no difference in biofilm formation between textures; no follow-up time recorded | 3 | |
| Stevens et al,100 | Sientra's prospective comparative study (2560 patients, 5109 implants) | Smooth implants more likely to undergo CC; 5 year study | 2 | |
| Spear et al,103 | Allergan Core study (715 patients ) | Smooth and textured implants had similar rates of capsular contracture over 10 year follow-up | 2 | |
| Namnoum et al,101 | Allergan Core, 410 and 410 Continued Access prospective comparative study (4412 patients, 8811 implants) | Smooth implants more likely to undergo CC; mean follow-up 37 months | 2 | |
| Jacombs et al,89 | Animal study (16 pigs, 121 implants) | Experimental groups inoculated with S epidermidis, Diagnostic sonication and SEM, no difference in biofilm formation or CC between textures; 16 weeks at explantation | 5 | |
| Liu et al,102 | Meta-Analysis (16 RCTs, 2 case-control studies; 4486 pts, 8867 implants) | Smooth implants more likely to undergo CC, follow-up range 1-5+ yr | 1 | |
| Role of Implant filler and CC | Schaub et al, 2010 | Systematic review (16 studies) | Unable to draw conclusions based on available data | 2 |
| El-Sheikh et al, 2008 | Meta-analysis (4 prospective studies, 8 retrospective) | Pooled odds ratio = 2.25 for silicone implants developing CC; average scientific quality score range 5-9/14 | 2-3 | |
| Prevention | Wixtrom et al,107 | Case series (32 patients, 63 samples) | 6 month follow-up; 22 pts with shield + positive cultures→no CC; 3 pts with shield + neg. cultures → CC (1 was primary augmentation) | 4 |
| Adams et al,110 | Case series (335 patients) | Mean follow-up 14 months; 1.8% overall CC rate | 4 |