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 form which will be used in a scale-up study analyzing multiple surgeons' records. 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 necessary, target them for screening, surveillance, or intervention. In the pilot study, we compared factors associated with implant rupture in women with and without rupture. Similar studies have considered one or a few factors at a time and, generally, have given little attention to implant generation. We developed a data collection form after reviewing records of three surgeons. A total of 92 records was collected and analyzed. An important feature in the pilot was to compare the results of patients whose implants the surgeons had both implanted and explanted (n = 34) with those of patients whose implants the surgeons had only explanted (n = 55) (unknown = 3). This comparison could show if including all explantation patients in a surgeon's practice 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 collectable on patients whose surgeons both implanted and explanted them (87%) and who had different surgeons for implantation and explantation (84%). Though the data from this limited sample cannot offer firm conclusions on rupture associations, a few factors stood out: size of implants (38. 3% of ruptured versus 15.9% of intact implants were 100-200 cm3), history of mammography (46.8% of ruptured versus 24.4% of intact had mammograms, which is likely due to older women with older implants having more mammograms), and history of closed capsulotomy (85.1% of ruptured versus 68.9% of intact). Interestingly, additional procedures performed on the breast (e.g., scar revision, wound repair, etc.) did not affect rupture: both the ruptured and the intact 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 elsewhere, did not change the results. Though there are not enough data to draw any firm conclusions regarding rupture factors, the collection instrument was rigorously tested and should perform well in an expanded study.
Embrey
M
M
Breast Implant Public Health Project, LLC, Washington, DC 20036, USA.
Adams
E E
EE
Cunningham
B
B
Peters
W
W
Young
V L
VL
Carlo
G L
GL
D019928:Breast Implantation; D018427:Breast Implants; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D010865:Pilot Projects; D011183:Postoperative Complications / Q000453:epidemiology*; D011475:Prosthesis Failure; D012189:Retrospective Studies; D013997:Time Factors