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ABSTRACT: Prevalence of Silicone Breast Implant Rupture among Danish Women
[09/12/2001; Plastic and Reconstructive Surgery]
The durability of silicone gel-filled breast implants is
of concern, but there are few epidemiological studies on this
issue. To date, most of the relevant findings are derived from
studies of explantation, which suffer from bias by including
women with symptoms or concerns about their implants.
As part
of a long-term magnetic resonance imaging study of the incidence
of rupture, this study involved 271 women with 533 cosmetic breast
implants who were randomly selected from among women who underwent
cosmetic breast implantation from 1973 through 1997 at one public
and three private plastic-surgery clinics in Denmark.
The prevalence
of rupture was determined from the first magnetic resonance screening.
The images were evaluated by four independent readers, using
a standardized, validated form. The outcomes under study were
rupture, possible rupture, and intact implant.
Ruptures were
categorized as intracapsular or extracapsular. Overall, 26 percent
of implants in 36 percent of the women examined were found to
be ruptured, and an additional 6 percent were possibly ruptured.
Of the ruptured implants, 22 percent were extracapsular. In multiple
regression analyses, age of implant was significantly associated
with rupture among second- and third-generation implants, with
a 12-fold increased prevalence odds ratio for rupture of implants
that were between 16 and 20 years of age, compared with implants
between 3 and 5 years of age.
Surgitek implants (Medical Engineering
Corporation, Racine, Wis.) had a significantly increased prevalence
odds ratio of 2.6 for rupture, compared with the reference implants.
No significant association was found with the position (subglandular
or submuscular) or the type of implant (single- or double-lumen).
Extracapsular ruptures were significantly associated with a history
of closed capsulotomy (p = 0.001).
In the future, the authors
plan to examine the women in their cohort with a second magnetic
resonance imaging scan to establish the incidence of rupture,
a parameter unknown to date in the literature, and to further
characterize those factors associated with the actual risk of
rupture.
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