Implant
rupture is a well-known complication of
breast implant surgery that can pass unnoticed by both patient and physician. To date, no prospective study has addressed the possible health implications of
silicone breast implant rupture. The aim of the present study was to evaluate whether untreated
ruptures are associated with changes over time in magnetic resonance imaging findings, serologic markers, or self-reported breast symptoms. A baseline magnetic resonance imaging examination was performed in 1999 on 271 women who were randomly chosen from a larger cohort of women having cosmetic
breast implants for a median period of 12 years (range, 3 to 25 years). A follow-up magnetic resonance imaging examination was carried out in 2001, excluding women who underwent explantation in the period between the two magnetic resonance imaging examinations (n = 44). On the basis of these examinations, the authors identified 64 women who had at least one ruptured implant at the first magnetic resonance imaging examination and, for comparison, all women who had intact implants at both examinations (n = 98). Magnetic resonance images from the two examinations were compared and changes in
rupture configuration were evaluated. Comparisons were also made for self-reported breast symptoms occurring during the study period and for changes in serum values of
antinuclear antibodies,
rheumatoid factor, and
cardiolipin antibodies immunoglobulin G and
immunoglobulin M. The majority of the women with implant
rupture had no visible magnetic resonance imaging changes of their ruptured implants. For 11 implants (11 percent) in 10 women, the authors observed progression of
silicone seepage, either as a conversion from intracapsular into extracapsular
rupture (n = 7), as progression of extra-capsular
silicone (n = 3), or as increasing herniation of the
silicone within the fibrous
capsule (n = 1); however, in most cases, these changes were minor. Some changes could be ascribed to
trauma, but others seemed spontaneous. There was no increase in levels of
autoantibodies during the study period in either study group. Women with untreated implant
ruptures reported a significant increase in nonspecific breast changes (odds ratio, 2.1; 95 percent confidence interval, 1.2 to 3.8) compared with women without
ruptures. On the basis of this first study of women with untreated
silicone breast implant rupture, the authors conclude that implant
rupture is a relatively harmless condition, which only rarely progresses and gives rise to notable symptoms. Even so, because of a small risk of
silicone spread, the authors suggest that women with implant
ruptures be followed clinically, if not operated on. Because implant
ruptures often occur asymptomatically, any woman with
silicone implants, regardless of
rupture status, should be evaluated at regular intervals.