The study, performed in Birmingham, Alabama, involved women who had their first breast implant before 1988. The majority of the 907 women in this study had silicone gel-filled breast implants. MRI allows the radiologist to see the breast implant while it is still inside the breast. FDA conducted this study because of concerns about the frequency and results of rupture. The relationship of free silicone to development or progression of disease is unknown.
Rupture is a device failure the implant is no longer performing as intended.
Protocol Women in this study were identified because they had been in a National Cancer Institute study on women with breast implants. Women who responded to a questionnaire in the NCI study were eligible for this study. This cohort included only women who were patients at two plastic surgery practices. The 907 women in this study were a subset of 1247 women in the Birmingham, Ala., area who were part of an NCI study on breast implants. The rupture study had two parts.