Novel surfaces aimed at preventing complications related to the textured surface of conventional implants are being developed.

A study reported the development, manufacture, and evaluation of an implant surface obtained from human tissue aimed at biomimicking, with increased compatibility and decreased capsular contracture. This in vitro experimental study used a treated and prepared fat surface of 3 patients fixed with gold and palladium and demonstrated a decreased inflammatory response that was evaluated by cytokine and C-reactive protein levels.

Another study described a modification of the surface with implantation of carbon ionstested in 3 different doses in order to increase biocompatibility. This implantation reduced surface roughness, bacterial adhesion, and capsule formation in an in vitro and in vivo experimental study in 16 rats. The results were more evident with higher doses of carbon ions.

A patent issued in 2017 (registration No. US2017/0049549 A1 by Bayat and contributors - University of Manchester, UK) describes a new biomimetic textured surface topography, with roughness control on macro, micro, and nanoscales simulating the topography (basement membrane and papillary dermis) of human skin. No experimental or clinical trials analyzed this patent.

Another patent (registration No. US0209618 A1 by Mark Anton, 2017) describes a second outer layer of polytetrafluoroethylene (PTFE) to decrease capsular contracture, acting as a reservoir. It utilizes PTFE, rifampicin, verapamil, α-tocopherol (Vitamin E), and methylprednisolone to reduce the risk of infection and biofilm formation, thus forming a third layer with slow or late release, promoting cellular adhesion. It would be used to confer a more natural appearance, similar to natural skin and lighter, because PTFE has a lower density than silicone. It makes use of nanotechnology that repels water (hydrophobia) helping in biocompatibility, with less possibility of capsular contracture. We found no clinical trials analyzing this patent as well.

Nanotechnology in breast silicone implants

Nano and surface microtopography aim at influencing cell polarization, alignment, migration, coupling, adhesion, proliferation, and morphological nature at the nano and micro levels, thus leading to cells reacting more naturally to surrounding structure studies suggest that the inflammatory response in these new models is lower, with better scattered and spindle-shaped fibroblasts and milder surface reactions by macrophages, thus indicating a more favorable foreign body reaction.

In the technological line, some studies describe a breast silicone implant coated with halofuginone nanofibers inhibitors of collagen synthesis type I that interferes with the synthesis of transforming growth factor β (TGF-β) which, in an experimental study using the submuscular plane of 28 rats, showed no systemic reaction; a decrease in histiocytes, CD68 marker (type I collagen), TGF-β, fibroblasts, type I and III collagens; and capsular thickening.

More recently, a clinical study analyzed 5813 breast implants, with a maximum of 3 years of follow-up, using implants with nano and microtextures, built with uniform topography using three-dimensional silicone printing to create optimized biocompatible external surfaces. The manufacturing was described as particle-free and did not use extrusion of foreign material to create the surface geometry, thus allowing a surface of uniform and controlled thickness. Complications such as seroma, infection, hematoma, dehiscence, rupture, and malposition of the implant occurred in 0.36% of the implants with nanotexture surface and in 1.06% of the surface implants with microtexture surface. However, capsular contracture and the eventual incidence of BIA-ALCL could not be evaluated conclusively in a short time period.

Latest technology silicone implants

We identified 4 silicone breast implants utilizing innovative and recent technology:

Ideal Implant^®. It is a structured breast implant approved by the FDA and Health Canada in November 2014 which combines the benefits of saline and gel implants with intercommunicate lumens filled with saline solution, with frontal and posterior valves for filling. It was subjected to screening in 502 patients, 399 undergoing primary augmentation and 103 undergoing implant replacement and used in 35 different cities by 45 certified plastic surgeons with 6-year follow-up in 438 cases (87.3%). The satisfaction reported by the patients was 89.7% in primary cases and 91.6% in cases of implant replacement, and the satisfaction reported by surgeons was 92.6% in primary cases and 94% in cases of implant replacement. Contractures of Baker grades III and IV were observed in 5.7% of primary cases and 11.5% of cases of implant replacement. Rupture/deflation were observed in 1.8% of primary cases and 4.7% of cases of implant replacement.

Microchip or  Microtransponder. Two articles described a 9×2.1-mm sized radiofrequency microchip or microtransponder positioned inside the silicone gel near the center of its base, for identification and postoperative tracking by Radio-Frequency Identification (RFID), with a specific device of the manufacturer Motiva^®. RFID is a technological trend in other specialties such as veterinary. In the field of breast implants, it provides technical information about the implant. It is expected that in the future, RFID can store data from breast exams, hospital data from surgery, and global online updates.

The presence of RFID raised questions about its safety in imaging diagnostic methods, especially magnetic resonance imaging (MRI), with possible interference in the diagnosis of breast neoplasms, because it has a ferrite/copper antenna and iron is a material with great interference with artifacts on MRI. Initial evaluations show that RFID is compatible with clinical MRI, with a magnetic field of 1.5 or 3.0 Tesla, causing temperature increase (3 °C) after 15 minutes of continuous pulse (regular exams rarely exceed 3 minutes), and not showing any RFID displacement or torsion.

Initial evaluations show that an artifact is seen on MRI, being greater in the inner posterior face of the implant with extension to the chest wall, without significantly affecting the breast tissue and subcutaneous tissue. Further studies need to be conducted to evaluate this interference, especially if the RFID migrates to the interior of the implant over the years, and in cases of implant rotation with the base positioned next to the breast tissues.

With Kind Regards,
John Kimberly
Associate Managing Editor
Journal of Women’s Health and Reproductive Medicine