A review of the literature on the etiology of capsular contracture and a pilot study to determine the outcome of capsular contracture interventions.

The etiology of capsular contracture is unclear and probably multifactorial. This review covers the literature on several proposed contracture factors, including filler material, implant placement, surface texture, and bacterial infection. The pilot study's goal was to test the feasibility of a data collection form, which could be used in a scaled-up study analyzing multiple surgeon's records. The goal of the expanded version of this study will be to determine the efficacy of available interventions for capsular contracture, including surveillance. The Breast Implant Public Health Project, LLC (BIPHP), piloted a retrospective review of outcomes in women who had interventions to relieve capsular contracture or had chosen a wait-and-watch approach. An evaluation of the efficacy of various treatments can help women decide if they want to pursue treatment at all and, if so, which treatment might offer them the best solution. BIPHP researchers (E.E.A., M.E.) developed a data collection form after reviewing records of three surgeons (B.C., W.P., V.L.Y.). During the data collection using the same records, we tested a randomization process to identify women with capsular contracture who underwent various interventions, including a wait-and-watch strategy, and those who had no mention of any intervention or waiting approach. Data were gathered on a total of 90 breasts with capsular contracture (scored Baker I-IV or qualitatively), of which 45 underwent a total of 102 interventions for capsular contracture. Interventions were classified as "closed capsulotomy," "surgical," or "watchful waiting." Closed capsulotomy was performed most often (47%), followed by surgery (29%) and watchful waiting (21%). Presurgical Baker scores averaged higher in breasts that underwent surgery (3.1) than for watchful waiting (2.5) or closed capsulotomy (2.3). Though closed capsulotomies had 100% of outcomes scoring "improved" or "same," 58% of the breasts underwent the procedure more than once, suggesting that the favorable outcome was short-lived. The wait-and-watch approach resulted in scores of either "same" or "worse"; surgery (open capsulotomy, repositioning, or capsulectomy) resulted in 79% improved, 16% same, and 5% worse outcomes in breasts with outcomes listed. In all intervention procedure categories, outcomes were frequently unavailable; they were noted only 60% of the time (52/87). The missing 40% may have resulted from the doctor's failure to note it in the chart, satisfied patients not returning for additional treatment, or dissatisfied patients seeking treatment elsewhere. Generally, the data collection forms and procedures were workable; however, we uncovered issues to address in the scale-up of this pilot study: (1) the outcome report rate was 60%; (2) though Baker scores are commonly used to evaluate the degree of capsular contracture, it seems that grade I may have different meanings for different surgeons, which would need to be clarified; (3) participating surgeons will need to divulge standard-of-care items that they may not have included in medical records, but routinely performed (e.g., patient massage, use of prophylactic antibiotics); and (4) records were initially separated by "implant," then researchers realized that a more useful collection would be by "breast." The latter approach captures the history of the breast in one record, which may be more important to contracture than the differences in implants. With the modifications discussed, the study can be scaled up to encompass as many records as necessary to achieve robust statistical power. These data will add to the existing literature regarding factors associated with capsular contracture and identify factors that affect the successful outcome of capsular contracture interventions.