An estimation of the biomechanical properties of the continent and incontinent woman bladder via inverse finite element analysis.

Stress urinary incontinence often results from pelvic support structures' weakening or damage. This dysfunction is related to direct injury of the pelvic organ's muscular, ligamentous or connective tissue structures due to aging, vaginal delivery or increase of the intra-abdominal pressure, for example, defecation or due to obesity. Mechanical changes alter the soft tissues' microstructural composition and therefore may affect their biomechanical properties. This study focuses on adapting an inverse finite element analysis to estimate the in vivo bladder's biomechanical properties of two groups of women (continent group (G1) and incontinent group (G2)). These properties were estimated based on MRI, by comparing measurement of the bladder neck's displacements during dynamic MRI acquired in Valsalva maneuver with the results from inverse analysis. For G2, the intra-abdominal pressure was adjusted after applying a 95% impairment to the supporting structures. The material parameters were estimated for the two groups using the Ogden hyperelastic constitutive model. Finite element analysis results showed that the bladder tissue of women with stress urinary incontinence have the highest stiffness (α1 = 0.202 MPa and µ1 = 7.720 MPa) approximately 47% higher when compared to continent women. According to the bladder neck's supero-inferior displacement measured in the MRI, the intra-abdominal pressure values were adjusted for the G2, presenting a difference of 20% (4.0 kPa for G1 and 5.0 kPa for G2). The knowledge of the pelvic structures' biomechanical properties, through this non-invasive methodology, can be crucial in the choice of the synthetic mesh to treat dysfunction when considering personalized options.

Simulation of vaginal uterosacral ligament suspension damage, mimicking a mesh-augmented apical prolapse repair.

Synthetic implants were used for repair of anterior compartment prolapses, which can be caused by direct trauma resulting in damaged pelvic structures. The mechanical properties of these implants may cause complications, namely erosion of the mesh through the vagina. In this study, we evaluated, by modeling, the behavior of implants, during Valsalva maneuver, used to replace damaged uterosacral ligaments (USLs), mimicking a sacrocolpopexy repair. For this purpose, two synthetic implants (A®, for prolapse repair and B®, for Hernia repair) were uniaxially tested, and the mechanical properties obtained were incorporated in the computational models of the implants. The computational model for the implant was incorporated into the model of the female pelvic cavity, in order to mimic the USLs after its total rupture and with 90% and 50% impairment. The total rupture and impairments of the USLs, caused a variation of the supero-inferior displacement and displacement magnitude of the vagina, with higher values for the total rupture. With total rupture of the USLs, when compared to healthy USLs, supero-inferior displacement and displacement magnitude of the vagina increased by 4.98 mm (7.69 mm vs 12.67 mm) and 6.62 mm (9.38 mm vs 16.00 mm), respectively. After implantation (A® and B®) a reduction of the supero-inferior displacements of the anterior vaginal wall occurred, to values found in the case of the model without any impairment or rupture of the ligaments. The simulation was able to mimic the biomechanical response of the USLs, in response to different implants stiffnesses, which can be used in the development of novel meshes.

Melt Electrospinning Writing of Mesh Implants for Pelvic Organ Prolapse Repair.

Over the past decade, melt electrospinning writing has attracted renewed attention. When combined with three-dimensional (3D) printing capabilities, complex 3D structures can be produced, from ultrafine fibers in the absence of toxic solvents, making it particularly attractive to fabricate customized scaffolds and implants for medical applications. This research aimed to develop novel less stiff vaginal mesh implants for pelvic organ prolapse (POP) repair, matching the physiological biomechanics of vaginal tissues. The main objectives, to attain that goal, were: development of a melt electrospinning writing prototype, with additive manufacturing capability, to produce complex structures from micrometer scale fibers, in a direct 3D printing mode; and design and validate new concepts of biodegradable meshes/scaffolds with new geometries, for POP repair. The melt electrospinning writing prototype was built based on different modules. Biodegradable polycaprolactone was used to produce novel implants: three geometries and two fiber configurations were employed. The commercially available Restorelle® (Coloplast) mesh was used as a benchmark. Printed implants were analyzed via scanning electron microscopy (SEM) and uniaxial tensile testing. The SEM images showed that the geometry is generally well produced; however, some minor deviations are visible due to charge interactions. The tensile test results indicated that, regardless of the geometry, the samples showed an elastic behavior for smaller displacements; aplastic behavior dominates later stages. In the physiological range of deformation, the novel meshes (80 µm fiber diameter) matched the tissue properties (p > 0.05). The Restorelle mesh was significantly stiffer than vaginal tissue (p < 0.05) and novel meshes. The precision of the various geometrical patterns and fiber diameters produced highlights the success of the designed and built prototype equipment. Results showed that the biodegradable meshes produced are biomechanically more compatible with native tissue than commercial implants.

Mechanical Performance of Poly Implant Prosthesis (PIP) Breast Implants: A Comparative Study.

BACKGROUND: There is societal concern regarding potential health problems associated with breast implants. Much of this distrust climate was a reaction to the Poly Implant Prosthesis (PIP) scandal. Studying the mechanisms of implant rupture is an important step for their improvement. The mechanical behaviour of breast implant shells was studied on explanted and virgin implants. Implants from both PIP and another brand (brand X), currently in the market, were considered. METHODS: To study the mechanical behaviour of the shell, a total of 940 samples from 11 explants and 5 control implants were analysed. The experimental protocol follows the ISO standards for shell integrity and determination of tensile stress-strain properties. Pearson correlation analyses and the multi-factor ANOVA statistical tests were performed using mechanical test data. RESULTS: Both PIP control and explants had significant variations of stress (P = 0.0001) and shell thickness (P = 0.000) throughout the implant. The stress was directly related to shell thickness. Shell thickness varied significantly for PIP implants, exceeding the manufacturer's specifications. Regarding the other brand, thickness variation was within manufacturer's specifications. CONCLUSIONS: The heterogeneous nature of PIP implants was confirmed. The implant shell thickness should be considered as a relevant parameter during the manufacturing process, for quality control purposes. These results may contribute to dispel mistrust and doubt surrounding breast implants, among the medical community and patients. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .