Evaluation of the Biocompatibility of Silicone Gel Implants - Histomorphometric Study

Abstract

CONFLICT OF INTEREST: NONE DECLAREDBreast implants are medical devices that are used to augment breast size or to reconstruct the breast following mastectomy or to correct a congenital abnormality. Breast implants consist of a silicone outer shell and a filler (most commonly silicone gel or saline). Approximately 5 to 10 million women worldwide have breast implants. Histomorphometric study to evaluate the biological tissue compatibility of silicone implants suitable for plastic surgery and the adverse effects and risks of this material. Thirty Wistar white rats received subcutaneous implants and the revestiment of silicone gel Silimed ®®, and randomized into six groups of five animals each, according to the type of implanted material and the time of sacrifice. Eight areas of 60.11mm2 corresponding to the obtained surgical pieces were analyzed, counting mesenchymal cells, eosinophils, and foreign body giant cells, observing an acceptable biocompatibility in all implants, for subsequent statistical analysis by Tukey test. Silicone gel showed inflammation slightly greater than for other groups, with tissue reactions varying from light to moderate, whose result was the formation of a fibrous capsule around the material, recognized by the organism as a foreign body. Despite frequent local complications and adverse outcomes, this research showed that the silicone and top layer presented an acceptable chronic inflammatory reaction, which did not significantly differ from the control group. In general, it is possible to affirm that silicone gel had acceptable levels of biocompatibility, confirmed the rare presence of foreign body giant cells, and when of the rupture, formed a fibrous capsule around the material, separating the material of the organism.

Evaluation of Local Tissue Reaction After the Application of a 3D Printed Novel Holdfast Device for Left Atrial Appendage Exclusion

“…11,25,29 The degree of the organism's immune reaction depends on a product's properties, including its structure, shape, chemical composition, porosity and coarseness as well as the contact duration, material degradation and sterility. 12,25 Therefore, based on our results, we can clearly state that the reported holdfast device meets all the biocompatibility criteria specified in PN-EN ISO 10993-6_2009E recommendations.…”

“…When new biomaterials are used in any living organism, it is crucial to verify whether they can be biocompatible with the surrounding tissues to prevent any pathological postoperative reactions. 11,12,25,28 Two elements should be considered: biological safety and biofunctionality. Firstly, this means the material should be tested to ensure that it does not cause any harm.…”

“…This idea has been a challenge for many scientific centers. 1,12,28,29 The point of contact between the material and native tissue is the most important place at which the intracellular sequence initiates the autoand paracrine response of the host's tissue. Therefore, the material's surface structures, both spatial and chemical, are crucial elements for reducing the undesirable host immune response.…”

Chronic Pulmonary Silicone Embolism from Breast Augmentation Is Not a Common Finding in Explanted Lungs

“…Since then, breast implantation has evolved considerably, and breast implants are composed of an outer elastomer shell of silicone and an inner filler, which can be either silicone gel or saline. Silicone used in breast implants is polydimethylsiloxane (PDMS) and is considered safe [ 2 ]. Acute pulmonary silicone embolism (APSE) from cosmetic silicone injections is well known to cause lung disease [ 3 – 8 ].…”

Characterization of the foreign body response to common surgical biomaterials in a murine model

“…breast implants and maxillofacial prosthetic materials. 17,18 Here, we evaluate the FBR to different biomedical implants and the possible utilization of these materials to be used as fibrosis models to further study diagnostic and therapeutic applications.…”