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

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.32 no.1
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• pp.60-64
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• 2006

Backgrounds: Though they are considered as reliable devices, titanium plates and screws have limitations due to some potential problems. To overcome these problems, researches on bioabsorbable materials for internal fixation have been continuing. Recently, there are many clinical trials to apply biodegradable internal fixation devices in oral and maxillofacial surgery. The purpose of this study was to evaluate the clinical results of application of bioabsorbable plates and screws in orthognathic surgery. Methods: Fifty-four patients with dentofacial deformity (17 male patients and 37 female patients) were selected in this study. The patients were treated by internal fixation using bioabsorbable plates and 2.4-mm, 2.0-mm pretapped screws (Biosorb FX, Bionix Implants, Inc., Finland). The patients were evaluated for complications during the follow-up period. Results: Five patients (9.3%) experienced complications. All complications in these cases were infection. No other complications related with physical or mechanical properties of bioabsorbable plates were found such as malunion or nonunion, fractures of plates and loosening of screws. All complications were minor and adequately managed with drainage and supportive care with antibiotics coverage. Conclusions: From the results, the use of these fixation systems in orthognathic surgery will provide a promising alternative titanium fixation in appropriate cases.

• Archives of Craniofacial Surgery
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• v.19 no.2
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• pp.143-147
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• 2018

We present a patient who showed a sterile abscess after facial bone fixation with bioabsorbable plates and screws. He had zygomaticomaxillary complex and periorbital fracture due to falling down. The displaced bones were treated by open reduction and internal fixation successfully using bioabsorbable plate system. However, at postoperative 11 months, abrupt painless swelling was noted on the previous operation sites, left lateral eyebrow and lower eyelid. By surgical exploration, pus-like discharge and degraded materials were observed and debrided. The pathologic analysis revealed foreign body reaction with sterile abscess. This complication followed by bioabsorbable device implantation on maxillofacial bone surgery has been rarely reported in which we call attention to the maxillofacial plastic surgeons.

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

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

• Journal of Korean Foot and Ankle Society
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• v.24 no.3
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• pp.107-112
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• 2020

Purpose: Hallux valgus (HV) is a common foot deformity that causes pain in the first metatarsophalangeal joint. Distal metatarsal osteotomies are commonly performed as a treatment. This retrospective study compared the clinical and radiological results of bioabsorbable magnesium (Mg) versus titanium (Ti) screw fixation for modified distal chevron osteotomy in HV. Materials and Methods: Forty-nine patients, who underwent modified distal chevron osteotomy for HV in 2018 and 2019, were reviewed retrospectively. Bioabsorbable Mg screw fixation was applied in 20 patients (22 feet), and a traditional Ti compression screw was applied in 29 patients (40 feet). The patients were followed up for at least six months. The clinical results were evaluated using the American Orthopaedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal (AOFAS-MTP-IP) scale and a visual analogue scale (VAS). The hallux valgus angle (HVA), intermetatarsal angle (IMA), and distal metatarsal articular angle (DMAA) were measured before, after surgery, and at the six months follow-up. Results: The AOFAS-MTP-IP scale and VAS points were improved in both groups, with no significant difference between them. At the six-month follow-up, HVA, IMA, and DMAA were similar. Bone union was confirmed in both groups, and there were no significant major complications in both groups. Four people in the Ti screw group underwent implant removal surgery. Conclusion: Bioabsorbable Mg screws showed comparable clinical, radiologic results to Ti standard screws six months after distal modified chevron osteotomy. These screws are an alternative fixation material that can be used safely and avoid the need for implant removal operations.

• Archives of Plastic Surgery
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• v.39 no.5
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• pp.561-564
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• 2012

Nasal bone fractures are often accompanied by septal fractures or deformity. Posttraumatic nasal deformity is usually caused by septal fractures. Submucosal resection and septoplasty are commonly used surgical techniques for the correction of septal deviation. However, septal perforation or saddle nose deformity is a known complication of submucosal resection. Hence, we chose to perform septoplasty, which is a less invasive procedure, as the primary treatment for nasal bone fractures accompanied by septal fractures. During septoplasty, we used a bioabsorbable mesh as an internal splint. We used the endonasal approach and inserted the mesh bilaterally between the mucoperichondrial flap and the septal cartilage. The treatment outcomes were evaluated by computed tomography (CT) and the nasal obstruction symptom evaluation (NOSE) scale. The CT scans demonstrated a significant improvement in the septal deviation postoperatively. The symptomatic improvement rated by the NOSE scale was greater at 1 month and 6 months after surgery compared to the preoperative status. There were no cases of extrusion or infection of the implant. In cases of moderate or severe septal deviation without dislocation from the vomerine groove on the CT scan, our technique should be considered one of the treatments of choice.

• Journal of Veterinary Clinics
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• v.24 no.2
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• pp.182-191
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• 2007

Bioabsorbable devices have been utilized and experimented in many aspects of orthopaedic surgery. Depending upon their constituent polymers, these materials can be tailored to provide sufficient rigidity to allow bone healing, retain mechanical strength for certain period of time, and then eventually begin to undergo degradation. The objective of this study was to estimate extent in which Poly-L-latic acid (PLLA) implants had bioabsorbability and biocompatibility with bone and soft tissue in dogs and also to develop bioabsorbable, biocompatible materials with the appropriate strength and degradation characteristics to allow for regular clinical use for treating orthopedic problems in humans as well as animals. Eighteen dogs were used as experimental animals and were inserted two types of PLLA implants. PLLA rods were inserted into subcutaneous tissue of back or the abdomen wall. And the rods were tested for material properties including viscosity, molecular weight, melting point, melting temperature, crystallinity, flexural strength, and flexural modulus over time. PLLA screws were inserted through cortical bone into bone marrow in the femur of the dogs and stainless steel screw was inserted in the same femur. Radiographs were taken after surgery to observe locations of screw. Histological variations including cortical bone response, muscular response, bone marrow response were analyzed over the time for 62weeks. The physical properties of PLLA rods had delicate balances between mechanical, thermal and viscoelastic factors. PLLA screws did not induce any harmful effects and clinical complications on bone and soft tissue for degradation period. These results suggest that PLLA implants could be suitable for clinical use.

• Archives of Plastic Surgery
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• v.41 no.5
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• pp.571-575
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• 2014

Background Disulfiram implantation is a widely used treatment alternative for alcohol abuse, yet reports on the surgical aspect of disulfiram implantation with respect to patient and drug-related treatment efficacy and wound complications are very limited. We present our clinical experiences with disulfiram implantation and discuss the surgical outcomes obtained with different anatomical planes for implantation. Methods Medical records of all patients referred to our clinic from the psychiatry department between 2007 and 2013 for disulfiram implantation were retrospectively analyzed. Implantation was carried out using 10 sterile Disulfiram tablets (WZF Polfa S.A.), each tablet containing 100 mg of disulfiram. The procedure was carried out by implanting the tablets randomly in either a subcutaneous or an intramuscular plane. The location and the plane of implantation and the complications were recorded for each patient and compared to determine the differences in the outcomes. Results A total of 32 implantation procedures were evaluated for this study. Twenty-five implants were placed in the intramuscular plane (78.2%), while seven implants were placed subcutaneously (21.8%). Exposure was encountered in three of the seven subcutaneous implants (42.9%), while no exposure was seen with the intramuscular implants. Incomplete absorption of the tablets was encountered in one patient with a previous subcutaneous implant who presented 1 year later for re-implantation as part of the continuation of therapy. Conclusions To overcome the issue of treatment continuation in the case of disulfiram therapy, which may be ceased due to frequently encountered wound complications, we believe that implantation in the subscapular intramuscular plane allows both uneventful healing and an out-of-reach implant location.