Effect of Implantation Surgery on the Strength Properties of Silastic® II Silicone Gel Breast Implants☆, ☆☆, ★, ★★

Autor: Clarence J. Wolf, K.L. Jerina, V.Leroy Young, Harold J. Brandon
Rok vydání: 1999
Předmět:
Zdroj: Aesthetic Surgery Journal. 19:197-204
ISSN: 1090-820X
DOI: 10.1016/s1090-820x(99)70036-1
Popis: Background: The causes of silicone gel–filled breast implant rupture are uncertain, and little research has been directed toward characterizing or quantifying the multiple factors that may contribute to device failure. Breast implants are subjected to some degree of stress and deformation during the surgical procedures of insertion. Thus implantation surgery itself could be a factor in affecting the durability of breast implants. Objective: The purpose of this study was to investigate whether the surgical procedure of insertion affects the mechanical properties of the silicone elastomer shell of gel–filled implants. We wanted to determine whether the procedure of inserting a breast implant might cause a decrease in the strength properties of the shell. Methods: Thirty-four Silastic ® II gel–filled breast implants manufactured by Dow Corning were tested. All implants were from the same lot and had a volume of 300 cc. Twenty of 34 implants were tested without implantation to investigate variability within a lot and establish a baseline of control data for comparison with implanted implants. Fourteen of the 34 implants were implanted through an inframammary incision in the right breast of a cadaver. The effect of implantation surgery was investigated by comparing the mechanical properties of the anterior and posterior sides of the cadaver explants with those of the controls. Results: Statistical analysis of the data indicated that the mechanical properties of elongation and tear resistance were essentially unaffected by implantation surgery. However, the average tensile strength of the explants was reduced 4.9% to 6.2% (for shells extracted with hexane and unextracted shells, respectively) compared with the controls. Breaking energy averages for the explants were also reduced 7.8% to 5.9% (for extracted and unextracted shells, respectively) when compared with the controls and average moduli decreased by a similar magnitude. Conclusions: The surgical procedure of implanting a breast implant has a small but statistically significant effect on the average strength properties of the elastomer shell of the implant. It is unlikely that this small reduction is sufficient to be a factor in implant durability.
Databáze: OpenAIRE