Certain 3D printed materials are biocompatible for human implantation
the verdict
SUPPORTED
the evidence backs this
refutedsupported
the weight of evidence
15 sources for · 0 against
Multiple peer-reviewed studies establish that certain 3D-printed materials, including specific polymers like medical-grade PEEK, titanium, and dental resins, exhibit biocompatibility suitable for medical devices and human implantation.
3D printing is a method of manufacturing in which materials, such as plastic or metal, are deposited onto one another in layers to produce a three dimensional object, such as a pair of eye glasses or other 3D objects. This process contrasts with traditional ink-based printers which produce a two dimensional object (ink on paper). To date, 3D printing has primarily been used in engineering to create engineering prototypes. However, recent advances in printing materials have now enabled 3D printers to make objects that are comparable with traditionally manufactured items. In contrast with conventional printers, 3D printing has the potential to enable mass customisation of goods on a large scale and has relevance in medicine including ophthalmology. 3D printing has already been proved viable in several medical applications including the manufacture of eyeglasses, custom prosthetic devices and dental implants. In this review, we discuss the potential for 3D printing to revolutionise manufacturing in the same way as the printing press revolutionised conventional printing. The applications and limitations of 3D printing are discussed; the production process is demonstrated by producing a set of eyeglass frames from 3D blueprints.
<h4>Objective</h4>To present through a systematic review a qualitative analysis of studies published on stereolithography-based 3D printing of restorative materials and their clinical applicability.<h4>Methods</h4>The literature search was conducted based on the question: "What is the state-of-the-art of available restorative materials for 3D printing based on stereolithography?" Online search was conducted in three databases (MEDLINE/PubMed, Scopus and Web of Science) with no restriction for year of publication. Data are reported based on PRISMA, including publication details such as authors and their countries, year and journal of publication, and study design. The synthesis is focused on describing the dental restorative materials and properties evaluated, applied methods, 3D printers used and clinical applicability.<h4>Results</h4>Studies that fit the inclusion criteria were performed in Asia (21), Europe (16) and USA (10), mostly using polymer-based restorative materials (38) for 3D printing constructs. Stereolithographic-printed ceramic-based restorative structures were evaluated by 9 studies. Many studies reported on dimensional accuracy (14), strength (11) and surface morphology (9) of the printed structures. Antibacterial response, cytotoxicity, internal and marginal fit, fracture and wear resistance, density, viscosity, elastic modulus, hardness, structural shrinkage and reliability, degree of conversion, layer cure depth, fatigue, and color were also evaluated by the included studies. Many of them (11) published a proof of concept as an attempt to demonstrate the clinical feasibility and applicability of the technology to print restorative materials, but only 5 studies actually applied the 3D printed restorative structures in patients, which highlights an increasing interest but limited early-stage translation.<h4>Significance</h4>The fast expansion of stereolithographic-based 3D printing has been impressive and represents a great technological progress with significant disruptive potential. Dentistry has demonstrated an incredible willingness to adapt materials, methods and workflows to this promising digital technology. However, esthetic appearance, wear resistance, wet strength and dimensional accuracy are the main current clinical limitations restricting the progression to functional part production with 3D printing, which may explain the absence of clinical trials and reports on permanent/definitive dental restorative materials and structures.
<h4>Purpose</h4>The strength of 3D-printed resins is affected by different factors, but review articles clarifying these factors are limited. This review lists the factors affecting the strength of 3D-printed resins and the possible correlations between them to answer the study question: What are the factors affecting the flexural strength of 3D-printed resins?<h4>Methods</h4>A database search (PubMed, Google Scholar, and Scopus) was performed, limited to English-language publications between 2010 and February 1, 2022. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used for study selection. The modified Consolidated Standards of Reporting Trials (CONSORT) checklist was used to determine the risk of bias of the included studies in this review. The data analysis was descriptive due to the presence of many variables in the included studies.<h4>Results</h4>Out of 123 studies, 26 were reviewed for full-text analysis, and 19 met the inclusion criteria and were thus included in this systematic review. The included studies were divided according to the investigated resin: 5 studies tested provisional restorations, seven tested denture base resins, 2 tested occlusal devices, 3 tested orthodontic appliances, 1 tested denture teeth, and 1 tested surgical guide resins. These studies investigated the flexural strength of 3D-printed resins, with different factors, such as reinforcement with fillers or nanofillers; printing orientation, angulation, and directions; post-polymerization time and temperature; third-party printing (switching between printers and materials); printing layer thickness; and post-printing rinsing time. Most factors significantly affected the flexural strength of 3D-printed resin.<h4>Conclusions</h4>The strength of 3D-printed resins could be improved with one or more of the following factors: filler or nanofiller addition; printing orientation, angulation, or directions; printing layer thickness; and post-polymerization time and temperature. However, further studies combining these factors are recommended.
3D printing, that is, additive manufacturing, has solved many major problems in general manufacturing, such as three-dimensional tissue structure, microenvironment control difficulty, product production efficiency and repeatability, etc., improved the manufacturing speed and precision of personalized bone implants, and provided a lot of support for curing patients with bone injuries. The application of 3D printing technology in the medical field is gradually extensive, especially in orthopedics. The purpose of this review is to provide a report on the related achievements of bone implants based on 3D printing technology in recent years, including materials, molding methods, optimization of implant structure and performance, etc., in order to point out the existing shortcomings of 3D printing bone implants, promote the development of all aspects of bone implants, and make a prospect of 4D printing, hoping to provide some reference for the subsequent research of 3D printing bone implants.
Abstract
The customizability of 3D printing allows for the manufacturing of personalized medical devices such as laryngectomy tubes, but it is vital to establish the biocompatibility of printing materials to ensure that they are safe and durable. The goal of this study was to assess the presence of
S. aureus
biofilms on a variety of 3D printed materials (two surgical guide resins, a photopolymer, an elastomer, and a thermoplastic elastomer filament) as compared to standard, commercially available laryngectomy tubes.
C-shaped discs (15 mm in height, 20 mm in diameter, and 3 mm in thickness) were printed with five different biocompatible 3D printing materials and
S. aureus
growth was compared to Shiley™ laryngectomy tubes made from polyvinyl chloride. Discs of each material were inoculated with
S. aureus
cultures and incubated overnight. All materials were then removed from solution, washed in phosphate-buffered saline to remove planktonic bacteria, and sonicated to detach biofilms. Some solution from each disc was plated and colony-forming units were manually counted the following day. The resulting data was analyzed using a Kruskal-Wallis and Wilcoxon Rank Sum test to determine pairwise significance between the laryngectomy tube material and the 3D printed materials.
The Shiley™ tube grew a median of 320 colonies (IQR 140–520), one surgical guide resin grew a median of 640 colonies (IQR 356–920), the photopolymer grew a median of 340 colonies (IQR 95.5–739), the other surgical guide resin grew a median of 431 colonies (IQR 266.5–735), the thermoplastic elastomer filament grew a median of 188 colonies (IQR 113.5–335), and the elastomer grew a median of 478 colonies (IQR 271–630). Using the Wilcoxon Rank Sum test, manual quantification showed a significant difference between biofilm formation only between the Shiley™ tube and a surgical guide resin (p = 0.018).
This preliminary study demonstrates that bacterial colonization was comparable among most 3D printed materials as compared to the conventionally manufactured device. Continuation of this work with increased replicates will be necessary to determine which 3D printing materials optimally resist biofilm formation.
A patient-specific 3D-printed titanium mandibular implant was developed with an integrated refillable drug storage tank to enable localized cisplatin release. The tank surface geometry and hydrogel formulation were optimized using the Taguchi method and incorporated into anatomically matched implants. In vivo evaluation in six porcine mandibular defect models demonstrated systemic safety over 12 weeks, with plasma platinum levels reduced by more than 60% compared to systemic administration. Hematological and biochemical indicators—including white blood cell count, liver enzymes, and renal function markers—remained within normal ranges throughout the observation period, confirming physiological stability and biocompatibility. No significant complications or implant loosening were observed. Functional validation was further performed on three representative human mandibular large defect models. Finite element analysis revealed implant stresses well below the yield strength of Ti6Al4V (<40%), and four-point bending fatigue tests confirmed structural endurance beyond 1 million loading cycles. This study provides the first functional and biocompatible patient-specific mandibular implant with integrated, refillable drug release, offering a clinically translatable strategy for simultaneous reconstruction and localized chemotherapy in head and neck oncology.
Introduction and Aim: Additive manufacturing has sought a widespread attention and higher rate of development which can also be modeled by processing of the data acquired by medical Computer Tomography scan. The object is built on a built plate of the printer in layers to form a final required model. Thus, a patient-specific model can be created from imaging data set. Materials available for such printing are elastomers, polymers, metals, or ceramics. The polymer, Polyether ether ketone (PEEK) has been used in health care applications, such as medical devices, and implants due to its high strength, biocompatibility, and light weight. Stainless steel (316L) is commonly used due to its strength, bio-tolerance, corrosion resistance and its formability. The aim of this study was to compare the mechanical strength and biocompatibility of medical grade PEEK and stainless steel. Material and Methods: The test sample of PEEK was prepared using unreinforced PEEK (450G-Victrex Plc., Lancashire, UK) at the Prototyping Lab with a 3D-Printer - INTAMSYS - FUNMAT HT. Samples of stainless steel was printed using the iFusion SF1 Metal 3D Printer using Powder Bed Fusion (PBF) technology. The mechanical tests such as compressive, impact, and tensile tests were performed using an electromechanical universal testing machine (UTM) model- Zwick/Roell Z020 with a 20kN load cell. Biocompatibility tests were done using L929 cells to assess the cytotoxicity of the dental materials. Results: The tensile strength of PEEK polymer was 70+1.6 and the impact strength of PEEK polymer was 289 J/m. Conclusion: The tensile strength of stainless steel was higher compared to that of PEEK polymer, and the impact strength of PEEK polymer higher compared to stainless steel. Thus, it can be concluded that both biomaterial such as 316L stainless steel and PEEK are non-toxic to fibroblast.
The biocompatibility of 3D-printed dental resins has become a critical concern in modern dentistry due to the increasing utilization of additive manufacturing (AM) techniques in dental applications. These resins serve as essential materials for fabricating dental prostheses, orthodontic devices, and various dental components. As the clinical adoption of 3D printing in dentistry grows, it is imperative to comprehensively assess the biocompatibility of these materials to ensure patient safety and dental treatment efficacy. This systematic review aimed to evaluate the existing body of literature on the biocompatibility of 3D-printed dental resins, thereby providing valuable insights into the potential biological risks associated with their use. The search strategy to identify relevant papers was implemented across PubMed/MEDLINE, Scopus, Web of Science, Embase, Cochrane Library, CINAHL, and Google Scholar to identify relevant studies. Study selection was not limited to any particular timeframe of publishing. The revised CONSORT criteria were used to ascertain the authenticity and dependability of the review's outcomes. Comprehensive screening and eligibility assessment processes were conducted to select studies meeting predefined criteria. Biocompatibility-related parameters, including toxicity, mechanical properties, cell viability, and other relevant outcomes, were analyzed across selected studies using a standardized variable extraction protocol. A total of 9 studies were included in the systematic review. The findings encompassed various aspects of biocompatibility assessment, including material composition, mechanical properties, cell viability, and cytotoxicity. Some studies revealed significant improvements in flexural strength and cell viability with specific resin formulations, demonstrating their potential for enhanced clinical utility. Conversely, certain resins exhibited cytotoxicity, while others displayed promising biocompatibility profiles. As per the assessed findings, material composition, post-processing techniques, and manufacturing methods emerged as critical factors influencing biocompatibility outcomes. While some resins exhibited favorable biocompatibility profiles, others raised concerns due to cytotoxicity. These findings emphasize the need for careful consideration when selecting and implementing 3D-printed dental resins, with a focus on materials engineering and comprehensive biocompatibility testing. Further research is warranted to elucidate the long-term biocompatibility and clinical implications of these materials.
Abstract The customizability of 3D printing allows for the manufacturing of personalized medical devices such as laryngectomy tubes, but it is vital to establish the biocompatibility of printing materials to ensure that they are safe and durable. The goal of this study was to assess the presence of S. aureus biofilms on a variety of 3D printed materials (two surgical guide resins, a photopolymer, an elastomer, and a thermoplastic elastomer filament) as compared to standard, commercially available laryngectomy tubes. C-shaped discs (15 mm in height, 20 mm in diameter, and 3 mm in thickness) were printed with five different biocompatible 3D printing materials and S. aureus growth was compared to Shiley™ laryngectomy tubes made from polyvinyl chloride. Discs of each material were inoculated with S. aureus cultures and incubated overnight. All materials were then removed from solution, washed in phosphate-buffered saline to remove planktonic bacteria, and sonicated to detach biofilms. Some solution from each disc was plated and colony-forming units were manually counted the following day. The resulting data was analyzed using a Kruskal-Wallis and Wilcoxon Rank Sum test to determine pairwise significance between the laryngectomy tube material and the 3D printed materials. The Shiley™ tube grew a median of 320 colonies (IQR 140–520), one surgical guide resin grew a median of 640 colonies (IQR 356–920), the photopolymer grew a median of 340 colonies (IQR 95.5–739), the other surgical guide resin grew a median of 431 colonies (IQR 266.5–735), the thermoplastic elastomer filament grew a median of 188 colonies (IQR 113.5–335), and the elastomer grew a median of 478 colonies (IQR 271–630). Using the Wilcoxon Rank Sum test, manual quantification showed a significant difference between biofilm formation only between the Shiley™ tube and a surgical guide resin (p = 0.018). This preliminary study demonstrates that bacterial colonization was comparable among most 3D printed materials as compared to the conventionally manufactured device. Continuation of this work with increased replicates will be necessary to determine which 3D printing materials optimally resist biofilm formation.
Thomas D (16 April 2021). "3D printing cross-linkable calcium phosphate biocomposites for biocompatible surgical implantation". Bioprinting. 22 e00141.
Tissue engineering is a biomedical engineering discipline that uses a combination of cells, engineering, materials methods, and suitable biochemical and physicochemical factors to restore, maintain, improve, or replace different types of biological tissues. Tissue engineering often involves the use of cells placed on tissue scaffolds in the formation of new viable tissue for a medical purpose, but
In vitro meat: Edible artificial animal muscle tissue cultured in vitro.
Bioartificial liver device, "Temporary Liver", Extracorporeal Liver Assist Device (ELAD): The human hepatocyte cell line (C3A line) in a hollow fiber bioreactor can mimic the hepatic function of the liver for acute instances of liver failure. A fully capable ELAD would temporarily function as an individual's liver, thus avoiding transplantation and allowing regeneration of their own liver.
Artificial pancreas: Research involves using islet cells to regulate the body's blood sugar, particularly in cases of diabetes . Biochemical factors may be used to cause human pluripotent stem cells to differentiate (turn into) cells that function similarly to beta cells, which are in an islet cell in charge of producing insulin.
Artificial bladders: Anthony Atala (Wake Forest University) has successfully implanted artificial bladders, constructed of cultured cells seeded onto a bladder-shaped scaffold, into seven out of approximately 20 human test subjects as part of a long-term experiment.
Cartilage: lab-grown cartilage, cultured in vitro on a scaffold, was successfully used as an autologous transplant to repair patients' knees.
Scaffold-free cartilage: Cartilage generated without the use of exogenous scaffold material. In this methodology, all material in the construct is cellular produced directly by the cells.
Bioartificial heart: Doris Taylor's lab constructed a biocompatible rat heart by re-cellularising a de-cellularised rat heart. This scaffold and cells were placed in a bioreactor, where it matured to become a partially or fully transplantable organ. the work was called a "landmark". The lab first stripped the cells away from a rat heart (a process called "decellularization") and then injected rat stem cells into the decellularized rat heart.
Tissue-engineered blood vessels: Blood vessels that have been grown in a lab and can be used to repair damaged blood vessels without eliciting an immune response. Tissue engineered blood vessels have been developed by many different approaches. They could be implanted as pre-seeded cellularized blood vessels, as acellular vascular grafts made with…
t 3D printing techniques and their utility in biocompatible material fabrications. The processing conditions including curing process, UV exposure, heat exposure, etc. influencing the properties of biocompatible materials are also discussed. Finally, the testing method of the biocompatible materials is covered. A prospective on the promise of biocompatible polymers, hybrid materials, and new applications is also discussed at the end. Biocompatible and biomedical materials
Biocompatible materials, used for 3D printing biomedically relevant parts/components, are easily categorized into natural polymers, synthetic polymers, and ceramics. [ 7 ] Other classes of materials include metals, alloys, and hybrid materials or composites, although these are not covered in this review. Biocompatible materials have to be absolutely non-cytotoxic and should biodegrade into components that the body can easily get rid of, while maintaining a healthy immune response even after they are implanted. [ 8 ] The biocompatibility of medical devices is discussed thoroughly in ISO 10993, a document detailing the measurement and establishment of biocompatibility. Biodegradation kinetics needs to be fine-tuned in the materials used. If the implanted material is to degrade rapidly, the healing site could suffer collapse, while a material that remains intact for a long period can trigger an inflammatory response. [ 9 ]
Biomaterials as a class of materials have improved drastically over time. The first materials (e.g., stainless steel) to be considered in the surgical setting were chosen due to the suitability of their mechanical properties for the intended use, while causing the least possibility of rejection and non-degradation. The next generation of materials (e.g., titanium and collagen) displayed little bio-corrosivity or is imbibed with bioactive properties such as favorable tissue integration and controlled degradation. Going beyond bioactive properties, the newest crop of biocompatible mat
The popular method of digital light processing 3D printing (DLP) for complex and individual laboratory equipment requires materials that are as inert as possible for use in contact with cells for subsequent investigations. However, the per se incomplete curing of acrylate resins by UV light leaves residuals that are not suitable for cell culture application. Therefore, we evaluated the cytotoxicity of four commercially available acrylate resins with bone marrow‐derived human mesenchymal stromal cells (BM‐hMSC) in an indirect cytotoxicity test. This involved incubating the printed cylinders in Transwell™ inserts for 7 days. While the degree of crosslinking did not increase significantly between freshly printed and stored samples (3 weeks in ambient conditions), the storage improved the material’s performance in terms of cytocompatibility. The DNA amount and LDH activity showed a direct influence of the resin residuals on cell adhesion. The class I acrylate Surgical Guide™ left no adherent cells after 7 days, regardless of previous storage. In comparison, the Basic Ivory™ resin after storage allowed same amount of adherent cells after 7 days as the polystyrene reference. We conclude that resin residuals of certain materials are released, which allows the use of the resins in indirect contact with cells thereafter.
<h4>Purpose</h4>This systematic review aimed to summarize current clinical and experimental applications of Fused Deposition Modeling (FDM) 3D printing in surgery and traumatology.<h4>Methods</h4>Following PRISMA 2020 guidelines, a systematic search was performed in PubMed®, Scopus®, and Web of Science™ for English-language articles published between January 2020 and March 2025. Studies describing the use of FDM printing in surgical or traumatological contexts were included. Data extraction was conducted independently by three reviewers, and inclusion was determined when at least one reviewer supported it.<h4>Results</h4>Out of 1,691 initially identified records, 35 studies met the inclusion criteria. Identified applications clustered into five thematic domains: surgical planning and patient-specific instruments, surgical training and simulation, biomaterials and tissue engineering, device development and prototyping, and comparisons of printing technologies and materials. FDM printing proved effective for preoperative visualization, educational modeling, and rapid prototyping of patient-specific tools, though heterogeneity in methodology and reporting limited direct comparison.<h4>Conclusion</h4>FDM 3D printing represents a versatile and increasingly accessible tool across surgical disciplines. Despite its lower resolution, its cost-effectiveness, ease of use, and expanding range of medical-grade materials make it a practical choice for clinical and educational implementation. Further standardization and validation are essential for broader clinical integration.
<h4>Objectives</h4>Mitral valve disease remains one of the most prevalent and complex cardiac conditions, with treatment strategies varying based on anatomical and pathological factors. The heterogeneity in mitral valve morphology complicates standardized treatment, highlighting the importance of procedural planning and surgical training. This systematic review evaluates current techniques, materials, and clinical applications of 3D printing in mitral valve disease, with a focus on procedural planning and simulation.<h4>Methods</h4>A comprehensive literature search of PubMed and MEDLINE databases was conducted to identify studies published from 1996 to August 2025. A total of 63 studies were included, all involving 3D printing technologies related to mitral valve disease. Extracted data covered imaging modalities, software tools, printing techniques, materials used, total time required for model creation, and clinical applications.<h4>Results</h4>CT, 3D transoesophageal echocardiography, and MRI were the main imaging modalities, with CT being the most common. Data segmentation and model generation were performed using software such as Mimics, 3D Slicer, and Philips QLAB. The primary 3D printing techniques were stereolithography, fused deposition modelling, and PolyJet, using photopolymer resins and thermoplastics. Total processing time-from image acquisition to model completion-ranged from 45 min to 72 h, depending on complexity. Applications included procedural planning, surgical training, and the development of medical and simulation-based educational devices.<h4>Conclusions</h4>3D printing enhances mitral valve surgery by enabling precise planning and training. Although challenges like standardization and accessibility persist, advances in imaging, software, and materials are expected to expand its clinical impact.
Bioresorbable vascular stents (BVSs) offer a transformative therapeutic advantage over permanent metal stents by temporarily supporting the vessel and then fully degrading, thereby restoring natural vasomotion and eliminating long-term complications. However, their clinical translation has been hampered by inherent limitations of conventional manufacturing, including restricted material selection, inflexible design, and limited capability for functional integration. Three-dimensional (3D) printing emerges as a pivotal technology to address these challenges, enabling the fabrication of stents with customized architectures, complex structures, and integrated multifunctionality. This review systematically highlights the latest progress in 3D-printed BVSs, focusing on their evolution toward patient-specific, novel-structured, functional, and smart devices. It assesses advanced printing technologies, presents preclinical outcomes and preliminary clinical evidence of 3D-printed BVSs, discusses current challenges, and also provides some future research directions. By framing the current state of the art, this review aims to accelerate the development of next-generation vascular implants.
Everything we examined (15) — 14 independent sources
This check searched the claim as stated. It did not run a separate search for evidence against it.