Between Jan. 1, 1997 and Dec. 31, 2001, 276 consecutive primary augmentation patients (552 breasts) received saline implants with a variety of fill volumes. These patients are being prospectively followed to collect data on a variety of variables related to the patients, breasts, and implants. As part of the study, all local complications, reoperations, and explantations are tracked to determine their frequency and possible causes. The subset of data presented describes the relationship between complications and implant size.

The very large breast implants size makes chance an unlikely explanation for the results, but bias due to differential overreporting of connective-tissue diseases or selective participation by affected women with breast implants remains a plausible alternative explanation. The major contribution of this and other observational analytic studies has been to exclude large risks of connective-tissue diseases following breast implants.