• Archives of Plastic Surgery
• /
• v.43 no.1
• /
• pp.40-45
• /
• 2016

Background Bioabsorbable plates and screws are commonly used to reduce maxillofacial bones, particularly in pediatric patients because they degrade completely without complications after bone healing. In this study, we encountered eight cases of a delayed foreign body reaction after surgical fixation with bioabsorbable plates and screws. Methods A total of 234 patients with a maxillofacial fracture underwent surgical treatment from March 2006 to October 2013, in which rigid fixation was achieved with the Inion CPS (Inion, Tampere, Finland) plating system in 173 patients and Rapidsorb (Synthes, West Chester, PA, USA) in 61 patients. Their mean age was 35.2 years (range, 15-84 years). Most patients were stabilized with two- or three-point fixation at the frontozygomatic suture, infraorbital rim, and anterior wall of the maxilla. Results Complications occurred in eight (3.4%) of 234 patients, including palpable, fixed masses in six patients and focal swelling in two patients. The period from surgical fixation to the onset of symptoms was 9-23 months. Six patients with a mass underwent secondary surgery for mass removal. The masses contained fibrous tissue with a yellow, grainy, cloudy fluid and remnants of an incompletely degraded bioabsorbable plate and screws. Their histological findings demonstrated a foreign body reaction. Conclusions Inadequate degradation of bioabsorbable plates caused a delayed inflammatory foreign body reaction requiring secondary surgery. Therefore, it is prudent to consider the possibility of delayed complications when using bioabsorbable plates and surgeons must conduct longer and closer follow-up observations.

• Journal of Korean Foot and Ankle Society
• /
• v.19 no.3
• /
• pp.97-101
• /
• 2015

Purpose: The purpose of this study was to analyze the clinical results of application of bioabsorbable screws in hallux valgus surgery using modified Mau osteotomy. Materials and Methods: We retrospectively reviewed medical records of 25 patients. Operations were performed between May 2013 and January 2014. We performed 33 modified Mau osteotomies and fixed using bioabsorbable screws. Mean age of patients was 52 years (range 19 to 71). Mean follow up duration was 13.2 months (range 12.3 to 18.9). The clinical evaluations included pain visual analogue scale (VAS) score, American Orthopaedic Foot and Ankle Society (AOFAS) score, and satisfaction score. Weight bearing anteroposterior radiographs were taken for measurement of hallux valgus angle (HVA), intermetatarsal angle (IMA), and distal metatarsal articular angle (DMAA). All radiographs were evaluated in order to detect complications related to bioabsorbable screws such as osteolysis, cyst formation, and fixation failure. Results: The mean pre- and postoperative pain VAS scores were 4.0 and 1.7 (p<0.05). The mean AOFAS score improved from 52.6 to 82.8 (p<0.05). Preoperative HVA and IMA were 31.2 and 13.9, respectively. Postoperative HVA and IMA were 5.2 and 6.2 (p<0.05). The DMAA increased from 7.8 to 9.9 (p<0.05). There was one case of superficial wound infection and one loss of correction, and no case of osteolysis, cystic formation around the screw, or deep infection. All patients showed union without fixation failure. Conclusion: The clinical and radiological evaluation of this study demonstrates reliable results without fixation failure or allergic reaction. The use of bioabsorbable screw appears not to be inferior to metal screw fixation in hallux valgus surgery.

• Journal of Biomedical Engineering Research
• /
• v.44 no.6
• /
• pp.414-427
• /
• 2023

Implantable bioabsorbable combination products undergo inherent degradation and systemic absorption within the physiological environment, thereby streamlining the therapeutic regimen and obviating the imperative for invasive extraction procedures. This inherent property not only enhances patient convenience and therapeutic efficacy but also underpins a paradigm of support characterized by heightened safety parameters. Within the regulatory landscapes of Korea, the United States, and Europe, implantable bioabsorbable combination products are meticulously classified into distinct categories, either as pharmaceutical implants or as implantable medical devices, depending on their primary mode of action. This scholarly investigation systematically examines the regulatory frameworks governing implantable bioabsorbable combination products in South Korea, the United States, and Europe. Notable discrepancies across national jurisdictions emerge concerning regulatory specifics, including terminology, product classification, and product name associated with these products. The conspicuous absence of standardized approval regulations presents a formidable barrier to the commercialization of these advanced medical devices. This academic discourse passionately emphasizes the critical need for formulating and implementing a sophisticated regulatory framework capable of streamlining the product approval process, thereby paving the way for a seamless path to commercializing implantable bioabsorbable combination products.

• Archives of Craniofacial Surgery
• /
• v.17 no.3
• /
• pp.135-139
• /
• 2016

Background: The ultimate goal of craniofacial reconstructive surgery is to achieve the most complete restoration of facial functions. A bioabsorbable fixation system which does not need secondary operation for implant removal has been developed in the last decade. The purpose of this study is to share the experience of authors and to demonstrate the efficacy of bioabsorbable mesh in a variety of craniofacial trauma operations. Methods: Between October 2008 and February 2015, bioabsorbable meshes were used to reconstruct various types of craniofacial bone fractures in 611 patients. Any displaced bone fragments were detached from the fracture site and fixed to the mesh. The resulting bone-mesh complex was designed and molded into an appropriate shape by the immersion in warm saline. The mesh was molded once again under simultaneous warm saline irrigation and suction. Results: In all patients, contour deformities were restored completely, and bone segments were fixed properly. The authors found that the bioabsorbable mesh provided rigid fixation without any evidence of integrity loss on postoperative computed tomography scans. Conclusion: Because bioabsorbable meshes are more flexible than bioabsorbable plates, they can be molded and could easily reconstruct the facial bone in three dimensions. Additionally, it is easy to attach bone fragments to the mesh. Bioabsorbable mesh and screws is effective and can be easily applied for fixation in various craniofacial trauma reconstructive scenarios.

• Composites Research
• /
• v.14 no.4
• /
• pp.15-26
• /
• 2001

Interfacial properties and microfailure degradation mechanisms of the bioabsorbable composites fur implant materials were investigated using micromechanical technique and nondestructive acoustic emission (AE). As hydrolysis time increased, the tensile strength, the modulus and the elongation of poly(ester-amide) (PEA) and bioactive glass fibers decreased, whereas these of chitosan fiber almost did not change. Interfacial shear strength (IFSS) between bioactive glass fiber and poly-L-lactide (PLLA) was much higher than PEA or chitosan fiber/PLLA systems using dual matrix composite (DMC) specimen. The decreasing rate of IFSS was the fastest in bioactive glass fiber/PLLA composites whereas that of chitosan fiber/PLLA composites was the slowest. AE amplitude and AE energy of PEA fiber decreased gradually, and their distributions became narrower than those in the initial state with hydrolysis time. In case of bioactive glass fiber, AE amplitude and AE energy in tensile failure were much higher than in compression. In addition, AE parameters at the initial state were much higher than those after degradation under both tensile and compressive tests. In this work, interfacial properties and microfailure degradation mechanisms can be important factors to control bioabsorbable composite performance.

• Journal of Periodontal and Implant Science
• /
• v.32 no.3
• /
• pp.631-642
• /
• 2002

The present study evaluated of regeneration effect of platelet rich plasma on the treatment of classII furcation involvement, with allograft in humans. The control was treated without bioabsorbable membrane, and the test was treated with bioabsorbable membrane. Pocket depth, clinical attachment level, and gingival recession were measured at baseline, postoperative 3, 6months. Both groups were statistically analyzed by Wilcoxon signed Ranks Test & Mann-whitney Test using SPSS program (5% significance level). The results were as follows: 1. The change of pocket depth and clinical attachment level in both groups was decreased significantly at 3, 6months.(p<0.05) 2. The change of gingival recession in both groups was increased significantly at 3, 6months than at baseline.(p (0.05) 3. The change of pocket depth and clinical attachment level in both groups was increased significantly at 3, 6months, but there were no statistically or clinically significant differences with both groups. 4. The change of gingival recession in both groups was increased significantly at 3, 6months, but there were no statistically or clinically significant differences with both groups. 5. The significant reduction of the pocket depth and clinical attachment level exhibited marked changes at 3 months in both groups. In conclusion, the results of this study suggest that there are no statistically or clinically significant differences between with and without bioabsorbable membrane on treatment of classII furcations using allograft and PRP

• Proceedings of the Korean Society For Composite Materials Conference
• /
• 2001.05a
• /
• pp.263-267
• /
• 2001

The changes of interfacial properties and microfailure degradation mechanisms of bioabsorbable composites with hydrolysis were investigated using micromechanical test and acoustic emission (AE). As hydrolysis time increased, the tensile strength, the modulus and the elongation of PEA and bioactive glass fibers decreased, whereas those of chitosan fiber changed little. Interfacial shear strength (IFSS) of bioactive glass fiber/poly-L-lactide (PLLA) composite was significantly higher than that two other systems. The decreasing rate of IFSS was the fastest in bioactive glass fiber/PLLA composite, whereas that of chitosan fiber/PLLA composite was the slowest. With increasing hydrolysis time, distribution of AE amplitude was narrow, and AE energy decreased gradually.

• Transactions of the Korean Society of Mechanical Engineers A
• /
• v.31 no.7 s.262
• /
• pp.732-738
• /
• 2007

Effects of melt-mixing conditions on fracture properties of hydroxyapatite filled bioabsorbable poly(L-lactic acid)(HA/PLLA) composites was investigated by measuring the firacture toughness value of HA/PLLA composites prepared under different mixing time and rotor speed. The fracture surface morphology was also examined by profile measurement and scanning electron microscopies. It was found that the fracture toughness of HA/PLLA composites decreases due to decrease of ductile deformation of PLLA matrix and debonding of interfaces with increase of the rotor speed and mixing time. Effect of mixing process on neat PLLA was also assessed, and it was found that the fracture toughness of PLLA decreases due to disappearance of multiple craze formation and increase of defects. Such thermal and shear-stress degradation were found to be the primary mechanisms of the degradation of HA/PLLA composites during melt-mixing process.

• Maxillofacial Plastic and Reconstructive Surgery
• /
• v.36 no.4
• /
• pp.178-183
• /
• 2014

Lip canting is associated with facial asymmetry, and is one of the most challenging problems in surgical correction of facial deformities. The author corrected lip canting using bioabsorbable devices during orthognathic surgery. Soft tissue suspension procedures were performed on four patients with facial asymmetry. Lip lines improved for all patients. Over an observation period of five years, no complications were noted, nor did any late relapse develop. Furthermore, as time past, the effect of the Endotine suspension procedure increased probably due to induction of fibrosis on surrounding soft tissues.

• Journal of Adhesion and Interface
• /
• v.3 no.2
• /
• pp.17-29
• /
• 2002

Interfacial properties and microfailure degradation mechanisms of the bioabsorbable composites for implant materials were investigated using micromechanical technique and measurement of surface wettability. As hydrolysis time increased, the tensile strength, the modulus and the elongation of poly(ester-amide) (PEA) and bioactive glass fibers decreased, whereas those of chitosan fiber almost did not change. Interfacial shear strength (IFSS) between bioactive glass fiber and poly-L-lactide (PLLA) was much higher than PEA or chitosan fiber/PLLA systems using dual matrix composite (DMC) specimen. The decreasing rate of IFSS was the fastest in bioactive glass fiber/PLLA composites whereas that of chitosan fiber/PLLA composites was the slowest. Work of adhesion, $W_a$ between bioactive glass fiber and PLLA was the highest, and the wettability results were consistent with the IFSS. Interfacial properties and microfailure degradation mechanisms can be important factors to control bioabsorbable composite performance.