Factors associated with breast implant rupture: Pilot of a retrospective analysis

This pilot study's goal was to test the feasibility of a data collection fo rm which will be used in a scale-up study analyzing multiple surgeons' reco rds. The goal of this expanded study will be to develop identifying factors for women who are at greater risk for having ruptured implants and, if nec essary, target them for screening, surveillance, or intervention. In the pi lot study, we compared factors associated with implant rupture in women wit h and without rupture. Similar studies have considered one or a few factors at a time and, generally, have given little attention to implant generatio n. We developed a data collection form after reviewing records of three sur geons. A total of 92 records was collected and analyzed. An important featu re in the pilot was to compare the results of patients whose implants the s urgeons had both implanted and explanted (n = 34) with those of patients wh ose implants the surgeons had only explanted(n = 55) (unknown = 3). This co mparison could show if including all explantation patients in a surgeon's p ractice would bias the sample; however, based on this pilot data, concerns regarding this type of bias seem to be minimal. Similar amounts of data (e. g., implant information, history of capsular contracture, etc.) were collec tible on patients whose surgeons both implanted and explanted them (87%) an d who had different surgeons for implantation and explantation (84%). Thoug h the data from this limited sample cannot offer firm conclusions on ruptur e associations, a few factors stood out: size of implants (38.3% of rupture d versus 15.9% of intact implants were 100-200 cm(3)), history of mammograp hy (46.8% of ruptured versus 24.4% of intact had mammograms, which is likel y due to older women with older implants having more mammograms), and histo ry of closed capsulotomy (85.1% of ruptured versus 68.9% of intact). Intere stingly, additional procedures performed on the breast (e.g., scar revision , wound repair, etc.) did not affect rupture: both the ruptured and the int act groups had an average of 1.7 procedures performed. The data collection form tested very well in this pilot study. Also, including all patients in the study sample, instead of excluding those who received their implants el sewhere, did not change the results. Though there are not enough data to dr aw any firm conclusions regarding rupture factors, the collection instrumen t was rigorously tested and should perform well in an expanded study.