Abstract
BACKGROUND: Some of the millions of women with silicone breast implants (SBIs) report a pattern of systemic complaints, known as ASIA syndrome. However, the association between these complaints and breast implants remains uncertain. OBJECTIVES: This study aimed to evaluate the prevalence of complaints in women with breast implants and healthy controls, and to compare their health-related quality of life. METHODS: Four groups of subjects were requested to fill in a general and a diagnostic questionnaire, and the Short Form 36. Group 1 was recruited from the Dutch foundation for breast implant illness (BII). Two groups were recruited from Dutch hospitals, where they had been augmented or reconstructed with SBIs (group 2) or saline-filled and hydrogel implants (group 3). A control group without breast implants was recruited from friends of subjects from group 2. RESULTS: In total, 238 women completed the questionnaires. ASIA manifestations appeared in the majority of the respondents (72.3%-98.8%), with a latency period of 0 to 35 years. Adjusted for age, smoking, and comorbidities, typical symptoms only occurred significantly more frequently in group 1. The presence of a chronic disease was an independent predictor for ASIA syndrome. The health-related quality of life was lower in women with SBIs than in women without breast implants. CONCLUSIONS: The adjusted prevalence of BII manifestations is not significantly higher in women with SBIs than in women without implants. The findings of this study suggest that results on BII are subject to selection bias. Further studies are needed to prove an association between self-reported complaints and SBIs.