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 bacter ial 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 multip le surgeon's records. The goal of the expanded version of this study will b e to determine the efficacy of available interventions for capsular contrac ture, including surveillance. The Breast Implant Public Health Project, LLC (BIPHP), piloted a retrospective review of outcomes in women who had inter ventions to relieve capsular contracture or had chosen a wait-and-watch app roach. An evaluation of the efficacy of various treatments can help women d ecide if they want to pursue treatment at all and, if so, which treatment m ight offer them the best solution. BIPHP researchers (E.E.A., M.E.) develop ed 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 un derwent various interventions, including a wait-and-watch strategy, and tho se who had no mention of any intervention or waiting approach. Data were ga thered on a total of 90 breasts with capsular contracture (scored Baker I-I V 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%). Presurg ical Baker scores averaged higher in breasts that underwent surgery (3.1) t han for watchful waiting (2.5) or closed capsulotomy (2.3). Though closed c apsulotomies had 100% of outcomes scoring "improved" or "same," 58% of the breasts underwent the procedure more than once, suggesting that the favorab le outcome was short-lived. The wait-and-watch approach resulted in scores of either "same" or;"worse"; surgery (open capsulotomy, repsoitioning, or c apsulectomy) resulted in 79% improved, 16% same, and 5% worse outcomes in b reasts with outcomes listed. In all intervention procedure categories, outc omes 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, o r dissatisfied patients seeking treatment elsewhere. Generally, the data co llection forms and procedures were workable; however, we uncovered issues t o 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 o f capsulaar 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 hav e included in medical records, but routinely performed (e.g., patient massa ge, use of prophylactic antibiotics); and (4) records were initially separa ted by "implant," then researchers realized that a more useful collection w ould be by "breast." The latter approach captures the history of the breast in one record, which may be more important to contracture than the differe nces 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.