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

Ramião, Nilza; Martins, Pedro; Barroso, Maria da Luz; Dm, Santos; Pereira, Francisco Bulhosa da Rocha; Fernandes, A. A.

doi:10.1007/s00266-017-0776-4

Cited by 6 publications

(12 citation statements)

References 21 publications

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“…These findings suggest a lack of chemical degradation during the implantation time. The new peak (2025 cm 21 ) found in the spectra from Pa10 shows that the gel did absorb mesoporous silica compounds. These compounds are widely used as catalysts for drug delivery reagents and imaging [32,33].…”

Section: Discussionmentioning

confidence: 95%

“…In the literature, shell thickness variations have already been identified as one of several factors that may affect the integrity of the shell [15,21]. In a previous work, the authors concluded that shell thickness may play a role in the process of implant failure, with thinner implants displaying lower tensile strengths [21]. For example, for Pa04's ruptured implant specimens, the authors found that 0.63 mm of thickness corresponded to 7 MPa stress, and 1.0 mm corresponded to 11 MPa.…”

Section: Discussionmentioning

confidence: 99%

“…The 22 explants (11 intact and 11 ruptured) and three control PIP implants were prepared for testing by removing the gel from shell. The sample preparation and testing followed a previously developed protocol [21]. Each implant was characterized in all its regions (anterior, equatorial and posterior).…”

Section: Testing Protocolmentioning

confidence: 99%

“…Each sample was measured four times in two different locations, corresponding to the central area and the two fillet areas, respectively. The samples were tested until failure with a displacement rate of 20 mm min 21 , in one direction. A mechanical testing machine prototype was used (with biaxial capabilities), which was developed at INEGI Biomechanics Laboratory (Porto, Portugal).…”

Section: Testing Protocolmentioning

confidence: 99%

“…The chemical composition of the surfaces and gels of 22 PIP implants were analysed using a Cary 630 FTIR Spectrometer (Agilent Technologies, USA) equipped with a diamond attenuated total reflectance (ATR) accessory. The tests were carried out at INEGI's tribology laboratory (CETRIB): spectra were acquired over 20 scans with wavelengths ranging from 600 to 4000 cm 21 , with a resolution of 4 cm 21 . A background scan was performed before each sample measurement.…”

Section: Fourier Transform Infrared Spectroscopy Characterizationmentioning

confidence: 99%

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Biomechanical analysis of intact versus ruptured Poly Implant Prothèse breast implants

et al. 2019

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Despite there being many studies that have evaluated breast implant rupture, there is no consensus about causes and incidence. Most studies lack a multifactorial analysis of what causes breast implants to rupture. To fill this gap, an experimental protocol was developed to compare ruptured and intact Poly Implant Prothèse (PIP) breast implants from the same woman. These conditions guarantee that the physical/biological variables are the same for each pair of ruptured and intact implants. A total of 1008 samples from 22 PIP explants (11 intact and 11 ruptured) and three control PIP implants were analysed. The mechanical properties (tensile strength) of the ruptured and intact implants were compared according to brand, lot, implantation time and demographic conditions. In general, statistically significant differences were found between the intact and ruptured PIP implants. Ruptured implants were thinner (0.73 ± 0.10 mm versus 0.91 ± 0.11 mm) and weaker (7.42 ± 2.65 MPa versus 9.59 ± 2.37 MPa) than intact implants. Intact and ruptured implants have shown distinct mechanical behaviours and variations in thickness. Our understanding is that these differences may be associated with the typical manufacturing process of breast implant shells. These results stress the importance of thorough control of the shell thickness. Given its relevance, shell thickness should be used as a quality control measure for homologation purposes. Thus, the homogeneity of the shell should be considered as a relevant parameter during the manufacturing process. This will translate into an improved quality of life for patients and will potentiate safer and longer lasting products.

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Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 99%

Section: Testing Protocolmentioning

confidence: 99%

Section: Testing Protocolmentioning

confidence: 99%

Section: Fourier Transform Infrared Spectroscopy Characterizationmentioning

confidence: 99%

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Biomechanical analysis of intact versus ruptured Poly Implant Prothèse breast implants

et al. 2019

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Physical properties of Scarpa's fascia

et al. 2023

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Preservation of Scarpa's fascia has improved clinical outcomes in abdominoplasty procedures and in other body contour surgeries. However, the physical properties of Scarpa's fascia have not yet been described, and grafts are still underexplored. Fresh surgical specimens from five female patients subjected to classical abdominoplasty were dissected and analyzed. A grid was drawn on the fascia surface, dividing it into equal upper and lower halves; four Scarpa's fascia samples (30 × 10 mm) were collected from each half, 40 mm apart. The thickness was measured with a caliper. A strain/stress universal testing machine was used for mechanical tests. Twenty‐five samples were obtained (nine from the upper half, 16 from the lower). The average thickness was 0.56 ± 0.11 mm. The average values for stretch, stress, strain, and Young's Modulus were, respectively, 1.436, 4.198 MPa, 43.6%, and 23.14 MPa. The upper half showed significantly greater thickness and strain values (p = 0.020 and p = 0.048; Student's t‐test). The physical and biomechanical properties of Scarpa's fascia can make it a donor area for fascial grafts as an alternative to fascia lata, as it is always available and has minimal donor‐site morbidity. Further studies are needed to validate this statement. It seems advantageous to use the lower half of the abdomen instead of the upper part as a donor site.

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Mechanical and surface chemical analysis of retrieved breast implants from a single centre

Magill

Tanska

Keshtgar

et al. 2019

Journal of the Mechanical Behavior of Biomedical Materials

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Introduction: Breast implants are associated with complications such as capsular contracture, implant rupture and leakage often necessitating further corrective surgery. Re-operation rates have been reported to occur in up to 15.4% of primary augmentation patients and up to 27% in primary reconstructions patients within the first three years [1]. The aim of this study was to examine the mechanical and surface chemical properties as well as the fibroblast response of retrieved breast implants in our unit to determine the in vivo changes which occur over time. Methods: Ethical approval was obtained. 21 implants were retrieved. Implantation time ranged from 5 months-300 months (Mean 133.4 months). Tensile strength, elongation, Young's modulus and tear strength properties were measured using Instron 5565 tensiometer on anterior and posterior aspects of the implant. Attenuated total reflectance-fourier transform infra-red spectroscopy (ATR-FTIR), wettability and scanning electron microscopy (SEM) analysis was performed on the shell surfaces. Bicinchoninic acid assay was performed to determine shell protein content. The fibroblast response was determined by seeding HDFa cells on the retrieved implants and cell metabolism measured using Alamar Blue™ assay. Results: Mechanical properties fall with increasing duration of implantation. There were no significant changes in ATR-FTIR spectra between ruptured and intact implants nor significant changes in wettability in implants grouped into 5 year categories. SEM imaging reveals surface degradation changes with increasing duration of implantation. Conclusions: With increasing duration of implantation, mechanical properties of the breast implants fall. However this was not associated with surface chemical changes as determined by ATR-FTIR and wettability nor protein content of the shells. Thus the reduction in mechanical properties is associated with breast implant failure but further research is required to elucidate the mechanisms.

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

Abstract: 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 .

Cited by 6 publications

References 21 publications

Biomechanical analysis of intact versus ruptured Poly Implant Prothèse breast implants

Biomechanical analysis of intact versus ruptured Poly Implant Prothèse breast implants

Physical properties of Scarpa's fascia

Mechanical and surface chemical analysis of retrieved breast implants from a single centre

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