The environmental durability and useful life of a breast implant is of major concern to both the patient and the plastic surgery community. The influence of complex environmental factors, both chemical and physical effects, on the basic properties of breast implants are discussed in this chapter. A large variety of physical-analytical methods were used to determine what change, if any, occurred in a variety of implants prepared by several different manufactures over several generations of implant development. Implants explanted from patients after implantation periods as long as 32 years were directly compared to available control samples. Explants and controls were investigated by a broad combination of mechanical testing, chemical analysis, and scanning electron microscopy.

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.

This study analyzed the shells of single-lumen silicone gel breast implants within the general context of device durability in vivo. The investigation included the major types of gel-filled implants that were manufactured in the United States in a 30-year period. The implants analyzed were Cronin seamed (two explants and one control), Silastic 0 and Silastic I (18 explants and seven controls), and Silastic II (22 explants and 43 controls). The biodurability of the explants was investigated with measurements of the mechanical and chemical properties of the various types of silicone gel control and explanted shells, with implantation times ranging from 3 months to 32 years. The shell properties measured for the controls and explants included the stress-strain relationships, tensile strength, elongation, tear resistance, moduli, cross-link density, and amount of extractable material in the shell. In addition, the mechanical properties of shells that had been extracted with hexane were analyzed for both explants and control implants. The silicone gel explants investigated in this study included some of the oldest explants of the various major types that have been tested to date. For assessment of long-term implantation effects, the data obtained in this study were combined with all known data from other institutions on the various major types of gel implants. The study also addressed the failure mechanisms associated with silicone gel breast implants. The results of the study demonstrated that silicone gel implants have remained intact for 32 years in vivo and that degradation of the shell mechanical and chemical properties is not a primary mechanism for silicone gel breast implant failure.

A study was conducted to investigate the effect of in vivo aging on the physical, mechanical, and chemical properties of Silastic II gel-filled breast implants. In the study, the properties of 16 Silastic II gel-filled explants (retrieved from eight patients), with in vivo duration times ranging from 4 months to 13 years, were compared with lot-matched control (unimplanted) samples. Tensile and tear strength properties were measured for both explant and control shells by using identical testing protocols. The tensile strength properties of shells, which were extracted with hexane to remove non-cross-linked silicones, were also measured. Swelling measurements were used to determine the average molecular weight between cross-links (or entanglements). In addition, scanning electron microscopy was applied in the comparison of the morphological features of the explants and their lot-matched controls. The results of the study suggest that the silicone polymer used to fabricate the shells does not undergo appreciable degradation for up to 13 years in vivo. The study represents an investigation of the world's largest known inventory of explanted breast implants with lot-matched controls.

Changes in the physical and mechanical properties of silica filled silicone elastomeric films were studied as a function of repeated sorption extraction cycling. The sorption of octamethylcyclotetrasiloxane (D4) on the properties of three silicone filled elastomeric films was analyzed. Two of the films, SILASTIC®I and SILASTIC®II, were shells of explanted breast implants and the third, a calendered film, prepared with similar composition to the elastomer used for the breast prosthesis were studied. The as-received (AR) SILASTIC®I and II films contained 20 and 26.5 wt% non-cross-linked material that was removed by extraction with hexane. The failure properties of the extracted films are significantly higher than those of the AR films. The amount of swelling, weight gain, volumetric change, and the stress- and strain-to-fail of the films were measured in the as-received condition, and after a series of extractions and swellings. Repeated cycling (up to 5 cycles) of extraction-swelling had essentially no effect on the failure properties of films when all the diluent was removed. The effect of diluent on the failure properties of all three films was quite large. The stress-to fail of the swollen film was reduced a factor of 6 compared to baseline extracted samples while the corresponding strain values were reduced a factor of 5. The energy to fail of the swollen compared to baseline films was reduced almost a factor of 50. However, the overall mechanical properties of the films are restored when the diluent was removed. The mechanical forces involved in the swelling process do not degrade the polymer even when cycled through five swell-extract cycles.

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. (Plast. Reconstr. Surg. 108: 647, 2001.)

The transport of octamethylcyclotetrasiloxane (D4), one of the major constituents of silicone fluids and rubbers, and low viscosity polydimethylsiloxane oil into a silica filled cross-linked silicone elastomeric rubber was measured as a function of temperature, cross-link density of the rubber, and concentration of the D4 in methanol solution. A small amount of material, approximately 3 wt%, is extracted from the rubber with hexane. The extraction process has a large effect upon D4 solubility in the rubber, increasing from approximately 160 to 180 wt% after extraction. The heats of solution for both penetrants into the rubber are essentially zero and the activation energies for diffusion are small, approximately 8 and 15 kJ mol-1 for D4 and PDMS, respectively. The diffusion process is Fickian and the diffusion coefficient of D4 into silicone/silica rubbers is essentially independent of concentration over the concentration investigated, i.e. from 1 to 100 vol% D4 in methanol. The permeability, i.e. the product of the diffusion coefficient and the solubility, decreases rapidly for D4 concentrations less than 50 vol% (0.1 mol fraction). This suggests that the permeation of D4 out of any encapsulation device, such as a silicone breast implant, is linearly dependent upon the concentration of D4 in the prosthesis. Swelling is isotropic and was measured by dimensional changes in rectangular samples and correlates well with the volume of D4 sorbed.

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.

A study was conducted to examine the physical, mechanical and chemical properties of composite (silicone/silica) breast implants as a function of implantation time. In the study the properties of SILASTC®II gel-filled explants with in vivo duration times ranging from 4 months to 10 years were compared to lot-matched control (unimplanted) samples. Tensile strength properties were measured for both explant and control shells using identical testing protocols. The tensile strength properties of shells which were extracted with hexane to remove non-cross linked silicones were also measured. In addition, swelling measurements were used to determine the average molecular weight between cross-links (and/or entanglements). The tensile strength properties obtained from the present study were correlated with implantation time. The results of the study suggest that the silicone elastomer shells do not undergo appreciable degradation during in vivo aging.

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(R)II gel-filled implants. In the earlier study, the mechanical properties of 34 Dow Coming SILASTIC(R)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.

Titanium matrix composites (TMC) and their behavior under mechanical fatigue loads was the subject of this research. The primary objective was to explain fatigue damage modes in center-notched TMC specimens. Two modes of damage have been observed in continuously reinforced, zero-degree unidirectional, SCS-6/Ti-15V-3Cr-3Al-3Sn (SCS-6/Ti-15-3) laminates. The fatigue specimens were destructively analyzed using optical microscopy to determine where cracks originated and how they grew throughout the specimen. A micromechanical model was developed to explain the fatigue crack patterns observed in the interface region surrounding the fibers of the woven and acrylic-binder TMC material systems. A two-dimensional (2-D) model of a longitudinal lamina with a center hole was used to obtain a set of displacement boundary conditions for an element near the notch, yet within the net section where the spiral crack patterns were observed. These boundary conditions were then used on a three-dimensional (3-D) unit cell model of the fiber, matrix, and interface.

The thermomechanical fatigue properties of Sn-Pb eutectic based solders in a single lap shear configuration were investigated. The development of fatigue cracks through heterogeneously coarsened, Sn enriched, bands near the solder-intermetallic interface were observed in eutectic and solid solution strengthened alloys. Other authors had not previously reported the Sn enrichment of coarsened bands in eutectic solders. However, analysis of micrographs found in published literature found evidence of the development of Sn enriched regions in Sn-Pb eutectic solders with initially globular microstructures. Solder microstructures, which were initially lamellar eutectic, displayed no evidence of Sn enrichment in the coarsened bands, Dispersion strengthening was effective in inhibiting heterogeneous coarsening, and resulted in solders with the greatest thermomechanical fatigue lifetimes.

Young, Leroy V. M.D.; Peters, Walter M.D.; Brandon, Harold J. D.Sc.; Jerina, Kenneth L. D.Sc.; Wolf, Clarence J. Ph.D. Author Information

Extensive microstructural evaluations were performed on two titanium matrix composite (TMC) materials to examine any chemical and/or physical differences which explain fatigue crack growth patterns observed in these materials. These examinations included optical microscopy, scanning electron microscopy (SEM), energy dispersive X-ray (EDX) and Auger analysis. The results of these studies indicate that fatigue damage modes, in addition to being affected by obvious parameters like load and temperature are also affected by the process in which the TMC is consolidated. Fiber surface damage is visible on one of the two TMC systems which may have influenced the observed fatigue damage mode. The fiber surface damage can be traced back to the pressure applied to the laminate during consolidation. This paper provides a detailed explanation for the occurrence of the different fatigue damage modes and, therefore, provides an explanation for the significant difference in fatigue life of the two materials.

Dispersion-strengthened Al-8.5% Fe-1.2% V-1.7% Si alloy was produced by inert gas atomization and atomized melt deposition processes. Differential scanning calorimetry was used to estimate the extent of undercooling in the alloy powders as a function of powder size and in the atomized melt-deposited alloy as a function of process parameters. The estimated undercooling was found to be a strong function of powder size and processing conditions and varied from 380−200 °C. Alloy powders of diameter greater than 180 jam did not experience any undercooling during solidification. X-ray diffraction analysis was performed to study the dependence of supersaturation of alloying elements and metastable phase formation on the extent of undercooling. When the undercooled alloy was heated to about 400 dgC, formation of Al12(Fe, V)3Si phase with b c c crystal structure from the supersaturated matrix was observed.

The slow degradation or deterioration of a material due to the long-term effects of the environment are usually referred to as aging. Aging is an extremely complex process which may represent a myriad of physical and/or chemical processes. In polymeric materials the physical processes accompanying aging range from loss of additives, such as plasticizers or anti-oxidants to swelling by liquids. Chemical aging includes diverse phenomenon such as cross-linking, depolymerization, or reaction with environmental species, such as oxygen, to produce new or different compounds. The aging of silicones is of great interest, particularly with respect to changes which may occur in body implants during long-term implantation.

Deformation characteristics of a rapidly solidified dispersion strengthened Al-8.5% Fe-1.2% V-1.7% Si alloy processed by planar flow casting was studied by tension testing at 25–420°C, compression testing at 25°C and hardness tests. The as-processed alloy shows non-linear elastic behavior, yield drop, low uniform and total elongation, serrated yielding, stress relaxation, flow softening and anomalous strain rate dependence of ductility. The results indicate that greater dynamic recovery due to fine grains (<0.3 μm) and essentially pure aluminum matrix in the as-processed planar flow cast alloy contribute to the observed deformation characteristics. Corroborative evidence for the recovery processes was obtained by differential scanning calorimetry and hardness measurements of cold rolled and annealed samples.