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Breast implant strength and durability is presently an important topic in biomaterials science. Research studies are being conducted to determine the mechanisms and rates of failure in order to assess the in vivo performance of breast implants. Fatigue life is a measure of breast implant durability since fatigue failure is a potential in vivo failure mechanism. This study describes the characterization of the fracture surface morphology of breast implant shell regions that have failed due to cyclic fatigue. Saline breast implants were fatigue tested to failure using a laboratory apparatus in which flat plates cyclically compressed the implants. The implants were unimplanted control devices of both textured and smooth saline implants. The failure surfaces of the fatigued shells were examined using scanning electron microscopy (SEM). The morphological features of the failure surfaces are described for implants with short and long fatigue lifetimes. The details of both the inside and outside surfaces of the shell at the failure location are described. Two different modes of failure were observed in both the textured and smooth shells. These modes depend on the magnitude of the cyclic load and corresponding number of fatigue cycles at failure. The first mode is a tear in the shell of about 18 mm in length, and the second mode is a pinhole approximately 1 mm in diameter. Details of the surface morphology for these two types of failure modes and shell thickness data are presented herein. There was no significant change in the crosslink density of the shell as a result of fatigue.

Several generations of silicone gel breast implants have been produced by implant manufacturers. The primary material usually viewed as the base material in the manufacture of implants is polydimethylsiloxane. Polymeric reactions are notorious for their variability and nonuniformity. The elastomer used in different types of implants can have vastly different properties. Furthermore, the material properties associated with a particular type of implant can vary considerably from one lot to the next. Considering the various designs, styles, and manufacturing techniques associated with silicone gel implants, knowledge of the original properties of the implants before implantation is important in determining the effects of aging in vivo. This study was conducted to investigate differences in key mechanical and chemical properties of silicone gel breast implant materials. The two types of implants chosen for analysis were Silastic I and Silastic II control implants. Material property data were determined for both types of controls and significant differences were found in their values. Lot-to-lot variability was also investigated and found to be significant.

In this article, mechanisms of breast-implant failure caused by surgical instruments commonly used to perform implantation, breast biopsies, needle localization procedures, cyst aspirations, and explantation are described. Failure was artificially induced in breast-implant shells using various types of surgical instruments, including scalpels, suture needles, hypodermic needles, hemostats, and Adson forceps. Field-emission scanning electron microscopy (SEM) was used to document the morphology of the failure sites produced by these instruments. Micrographs were used to categorize failure according to a specific type of surgical instrument. SEM micrographs were also obtained on explants that failed in situ, and the morphology of the corresponding failure sites was examined. The study was designed to document a range of failure mechanisms associated with gel-filled, saline-filled, double-lumen (saline-gel), and soybean oil-filled implants. The results of the study also demonstrate that SEM can often be used to determine the cause of breast-implant failure.

The reasons for the failure of silicone gel breast implants are unclear. One potential failure mechanism is the weakening of the implant shell during its insertion into the breast. Such local weakening could eventually lead to implant failure. We recently reported on the effect of implant surgery on the overall mechanical properties of SILASTIC II gel-filled implants. In the earlier study, the mechanical properties of 34 Dow Corning SILASTIC II gel-filled breast implants from the same manufacturing lot were measured. Twenty of the thirty four implants were not implanted but were evaluated to establish a baseline of control data. The other fourteen lot-matched implants were inserted into a subglandular pocket through an inframammary incision in a cadaver breast and then removed. The experimental augmentation scenario was designed to represent actual breast implantation as closely as possible. The mechanical properties of the anterior and posterior sides of the control implants (not implanted) and explants (implanted in a cadaver) were measured and compared to determine whether differences existed between the explant and control groups. We found that the implantation surgery process did slightly reduce the average tensile strength. Although not as statistically significant, other mechanical properties such as breaking energy and moduli were less for the explants than the controls. The reduction was a relatively small percentage in the context of overall shell properties. Elongation and tear resistance were unaffected. Our findings suggested that the surgical act of implanting a breast implant has a small but detectable weakening effect on the average tensile strength, breaking energy and moduli of the elastomeric shell of the device. The present study is an extension of the previous investigation. Here we have analyzed the explant shell region where the surgeon's fingers forced the implant through the incision. Our results indicate that the implant shell can be locally damaged due to the implantation process.

The chemical and biomechanical properties of explanted implants whose time of implantation ranged from zero to 21 years were measured. The properties appear to decrease with time. However it is important to note that proper controls have yet to be tested. The consistency of the gel varied considerably with manufacturer and date of manufacture. The data will be correlated with control samples when they become available. The data are consistent with the hypothesis that in some instances, the gel does affect the cross-linking, i.e., strength, of the silicone rubber shell. At the present time only a limited number of samples have been tested in this on-going program. One of our major objectives, to determine the influence of the physiological environment of the human body on the durability of the silicone implant, has yet to be quantified.