Prevalence of Silicone Breast Implant Rupture among Danish Women

Abstract

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.

Incidence of Silicone Breast Implant Rupture

“…The MRI machine at center 3 was not used for the second MRI study because it could not generate silicone-excited sequences, which in some cases improve the sensitivity. 4 The study subjects from centers 1 and 2 were examined using the same machine for both MRI examinations: center 1, Siemens Vision 1.5 Tesla (Siemens AG, Erlangen, Germany); center 2, Philips NT5 (Philips Medical Systems BV, Best, the Netherlands). Both scanners were equipped with a dedicated breast coil.…”

“…By contrast, silicone gel implant rupture often remains unnoticed by both patient and physician because the leaking silicone is kept in place by the surrounding fibrous scar membrane and no visible reabsorption occurs. 3,4 Several clinical studies have estimated the prevalence of implant rupture based on findings at explantation, [5][6][7][8][9][10][11][12][13] and attempts to estimate implant survival based on pooling of explantation data have been made.14-17 However, because these studies are mainly based on symptomatic women seeking surgery, they constitute a biased selection of women with breast implants, presumably resulting in overestimation of rupture frequency. Recently, 2 studies using magnetic resonance imaging (MRI) in women with cosmetic silicone breast implants, randomly selected from larger cohorts of women with implants, reported rupture prevalences of 26% for implants with a median time in situ of 12 years 4 and 55% for implants with a median time in situ of 16.4 years.…”

“…[14][15][16][17] However, because these studies are mainly based on symptomatic women seeking surgery, they constitute a biased selection of women with breast implants, presumably resulting in overestimation of rupture frequency. Recently, 2 studies using magnetic resonance imaging (MRI) in women with cosmetic silicone breast implants, randomly selected from larger cohorts of women with implants, reported rupture prevalences of 26% for implants with a median time in situ of 12 years 4 and 55% for implants with a median time in situ of 16.4 years. 18 However, rupture prevalence can only be used, at best, as a surrogate measure for incidence, 19 and to our knowledge no study has directly examined the incidence rate of implant rupture.…”

The Use of Medical Devices in Italy and Europe: Between Legal Obligations, Operational Obstacles and Possible Responsibilities

“…A Swedish study that examined 106 women, who had been implanted with 109 prostheses reports that after 11 years the percentage of breakage was about 8%. Analogously with such results, a Danish study monitored and analysed 533 prosthetic mammary implants, between 1973 and 1997, reports that after 16-20 years from implantation, the percentage of malfunctioning prostheses is around 26% [27][28][29][30]. Recently, on the professionalism are not exercised.…”

"Doctor, tengo un bulto en la axila". Adenomegalia siliconomatosa postmamoplastia de aumento: a propósito de ocho casos

“…El tiempo trascurrido desde los años 60 ha hecho que las prótesis mamarias rellenas de silicona evolucionen mejorando el continente y contenido de las mismas (10). En la práctica hemos pasado de los 90 al 2007 de la 2ª-3ª generación de prótesis a la 6ª-7ª y hoy las prótesis son de una cubierta de silicona multicapa con mínima o nula capacidad de filtración, superficie lisa o rugosa, con un contenido de silicona en forma de gel más o menos cohesivo y con diseños más adaptables a la estructura anatómica.…”