Chronology of systemic disease development in 300 symptomatic recipients of silicone gel-filled breast implants

Aims: To define the time sequence and incremental evolution of the systemic illness manifested by recipients of silicone gel-filled breast implants. Methods: Three hundred patients who became systemically ill following insertion of silicone gel-filled breast implants were examined. Mean age at the time of implantation was 33 years, and the average silicone gel device exposure spanned 12 3/4 years. Results: The onset of systemic disease began on average 2 1/2 years after implant insertion, occurring as early as two weeks after the implant or as late as 18 years afterwards, with 90% of the entire cohort symptomatic after six years. Implant rupture was not the stimulus for disease onset and preceded systemic illness in only nine patients (3%). Subsequent disease progression developed in an exponential manner; eventually encompassing an average of thirty symptoms and signs per patient. Disease acceleration occurred five to six years from the time of implantation, and coincided with failure of the fibrocollagenous capsule. Implant rupture (214 out of 300) served to exacerbate and aggravate any symptoms and signs that were already present but did not alter the rate of sequential disease progression compared to patients who never experienced rupture. Conclusions: In this cohort of symptomatic silicone gel breast implant recipients, the chronology of systemic disease development simulated a self-perpetuating runaway catalytic reaction and was uniquely different from the varied and established evolutions of spontaneous device-free classical connective tissue diseases. This time sequence of disease progression provides strong supportive evidence for the existence of a novel illness, and also offers rational advice for implant removal based primarily on the length of time of device insertion rather than whether or not implants have undergone rupture.