Silicon Analysis of Breast and Periprosthetic Capsular Tissue from Patients with Saline or Silicone Gel Breast Implants

Abstract

The ubiquitousness of silicon is well known. Recent work has demonstrated measurable baseline levels of silicon in nonaugmented cadavers, subsequent to numerous reports of significant elevations of such levels within patients with silicone breast implants and even more reports alleging a causal relation between silicone gel prostheses and connective-tissue diseases. Despite the lack of scientifically substantiated data that such a relation exists, the calamitous silicone breast implant controversy has ensued. Saline-filled breast implants are constructed with a silicone elastomer envelope that remains in direct contact with periprosthetic capsular tissue following implantation. Although there is no evidence to link saline implants with any disorders, it is important to know if saline breast implants contribute any silicon to human body baseline silicon levels. The present study measured tissue silicon levels in 28 breasts of 16 patients with saline-filled implants to determine if the silicone envelope of these prostheses can contribute to the elevation of such levels. These data were compared with data from 116 breasts of 65 patients with silicone gel-filled prostheses as well as breast tissue from 17 patients (controls) who had never been exposed to either type of implant. Samples of breast tissue and periprosthetic capsular tissue were obtained from patients with both intact and ruptured implants. Silicon levels of breast tissue specimens from patients with saline-filled implants were within the range of the controls if the implants were intact. Silicon levels in periprosthetic capsular tissue from patients with intact saline-filled implants were significantly higher than controls (p < 0.02); however, they were still 100-fold less than capsular tissue levels from patients with intact gel-filled implants. Silicon levels measured in both types of tissue were significantly elevated in patients with silicone gel-filled implants compared with controls (p < 0.01). In the case of ruptured gel implants, breast tissue demonstrated higher silicon levels than did similar specimens from patients with intact implants (p < 0.054); periprosthetic capsular tissue levels also were elevated, although the differences were not statistically significant (p = 0.54). These findings are independent of the implant brand or length of exposure to the particular prosthesis. The finding of elevated levels of silicon in both breast and periprosthetic capsular tissue in patients with silicone gel-filled implants in no way implies or substantiates any claim of a causal relationship between silicone and any reported illnesses.

Analysis of periprosthetic capsular tissue from women with silicone breast implants by magic-angle spinning NMR

“…In this study, no correlation was found between the amount of silicon measured in the capsular tissue surrounding the implant and the length of implantation time, as determined by linear regression (r 2 ϭ 0.02) and Pearson correlation test (r ϭ 0.22). Several studies have shown an increase in the concentration of silicon in tissue with increasing implantation time (27,28). This is supported by estimates of the mean-life time of a breast implant, about 10 to 12 years (5,6).…”

“…Measurements performed on different portions of the same capsule varied by as much as a factor of two (see Table 1). Atomic absorption studies have also shown high levels of silicon in capsular tissue (26)(27)(28); however, the identity of the compound containing the silicon could not be confirmed because of the inability of the technique to determine chemical structure. The lowest concentration of silicon calculated was 0.05%.…”

Determination of Silicon in Breast and Capsular Tissue From Patients With Breast Implants Performed by Inductively Coupled Plasma Emission Spectroscopy:Comparison With Tissue Histology

“…35 That document addresses in detail the differences in silicon concentrations observed in tissues surrounding saline and silicone gel-filled implants from different manufacturers and the clinical implications of this work. Here, we discuss the analytical issues involved in the development and evaluation of the method for silicon analysis in tissue and compare tissue silicon concentrations with histologic parameters.…”

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

“…Las roturas protésicas extracapsulares tienen un alto potencial de migración o captación linfática de la silicona pudiendo producirse granulomas en el área tóraco-mamaria y/o adenopatías axiliares siliconomatosas. Schnur et al(1996) (9), encuentran que los niveles de silicona en el tejido capsular periprotésico son significativamente elevados en las pacientes portadoras de implantes mamarios rellenos de silicona aunque las prótesis se encuentren indemnes; si existe una rotura intracapsular los niveles de silicona están elevados también en el tejido mamario. Holmich y colaboradores (2001) (10), hallan que inicialmente 3 de cada 4 rupturas (75%) son intracapsulares y 1 de cada 4 (25%) son extracapsulares.…”

“…Estos dos últimos hechos, tamaño y dinámica, producen un aumento en la fatiga del material con un mayor desgaste de la superficie de la prótesis (fricción dinámica) y liberación de partículas de silicona desde la superficie de la misma. Quienes han recambiado prótesis mamarias seguramente habrán observado, ocasionalmente, en algunas partes de la cubierta un mayor desgaste de la superficie de la misma con desaparición parcial de la texturixación, lo que es un indicador de microliberación de partículas de silicona (9). El rozamiento y la basculación de la prótesis producidos por el movimiento muscular (repetición y carga) pueden, además de suavizar la texturización y modificar el posicionamiento (giros en el eje vertical y horizontal de la prótesis), inducir un encapsulamiento más rígido, pliegues en la próte-sis, seroma tardío, rotura protésica y adenitis siliconomatosa.…”