International classification of abdominal wall planes (ICAP) to describe mesh insertion for ventral hernia repair.

BACKGROUND: Nomenclature for mesh insertion during ventral hernia repair is inconsistent and confusing. Several terms, including 'inlay', 'sublay' and 'underlay', can refer to the same anatomical planes in the indexed literature. This frustrates comparisons of surgical practice and may invalidate meta-analyses comparing surgical outcomes. The aim of this study was to establish an international classification of abdominal wall planes. METHODS: A Delphi study was conducted involving 20 internationally recognized abdominal wall surgeons. Different terms describing anterior abdominal wall planes were identified via literature review and expert consensus. The initial list comprised 59 possible terms. Panellists completed a questionnaire that suggested a list of options for individual abdominal wall planes. Consensus on a term was predefined as occurring if selected by at least 80 per cent of panellists. Terms scoring less than 20 per cent were removed. RESULTS: Voting started August 2018 and was completed by January 2019. In round 1, 43 terms (73 per cent) were selected by less than 20 per cent of panellists and 37 new terms were suggested, leaving 53 terms for round 2. Four planes reached consensus in round 2, with the terms 'onlay', 'inlay', 'preperitoneal' and 'intraperitoneal'. Thirty-five terms (66 per cent) were selected by less than 20 per cent of panellists and were removed. After round 3, consensus was achieved for 'anterectus', 'interoblique', 'retro-oblique' and 'retromuscular'. Default consensus was achieved for the 'retrorectus' and 'transversalis fascial' planes. CONCLUSION: Consensus concerning abdominal wall planes was agreed by 20 internationally recognized surgeons. Adoption should improve communication and comparison among surgeons and research studies.

ANTECEDENTES: La nomenclatura de la inserción de una malla para la reparación de una hernia incisional ventral (ventral hernia, VH) es inconsistente y confusa. En la literatura indexada se usan varios términos, tales como 'inlay', 'sublay', y 'underlay' que pueden referirse a los mismos planos anatómicos. Este hecho frustra las comparaciones de técnicas quirúrgicas e invalida los metaanálisis que comparan resultados quirúrgicos en función del plano de inserción de la malla. En consecuencia, el objetivo de este estudio fue establecer una clasificación internacional de los planos de la pared abdominal (International Classification of Abdominal Wall Planes, ICAP). MÉTODOS: Se realizó un estudio Delphi, en el que participaron 20 cirujanos de pared abdominal reconocidos internacionalmente. Se identificaron diferentes términos que describían los planos de la pared abdominal anterior mediante la revisión de la literatura y el consenso de expertos. La lista inicial incluía 59 términos posibles. Los panelistas completaron un cuestionario que sugería una lista de opciones para los planos individuales de la pared abdominal. El consenso sobre un término fue predefinido cuando dicho término había sido seleccionado por ≥ 80% de panelistas. Se eliminaron los términos con una puntuación < 20%. RESULTADOS: La votación comenzó en agosto de 2018 y se completó en enero de 2019. Durante la Ronda 1, 43 (73%) términos fueron seleccionados por < 20% de los panelistas y se sugirieron 37 términos nuevos, dejando 53 términos para la Ronda 2. Cuatro planos alcanzaron un consenso en la Ronda 2 con los términos 'onlay', 'inlay', 'pre-peritoneal' e 'intra-peritoneal'. Treinta y cinco (66%) términos fueron seleccionados por < 20% de los panelistas y fueron eliminados. Después de la Ronda 3, se logró un consenso para 'anterectus' (ante-recto), 'interoblique' (inter-oblicuo), 'retrooblique' (retro-oblicuo) y 'retromuscular'. Se alcanzó un consenso por defecto para los planos 'retrorectus' (retro-recto) y 'transversalis fascial' (fascial transverso). CONCLUSIÓN: La ICAP ha sido desarrollada por el consenso de 20 cirujanos reconocidos internacionalmente. Su implementación debería mejorar la comunicación y la comparación entre cirujanos y estudios de investigación.

Medical Devices; Ear, Nose, and Throat Devices; Classification of the Active Implantable Bone Conduction Hearing System. Final order.

The Food and Drug Administration (FDA or we) is classifying the active implantable bone conduction hearing system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the active implantable bone conduction hearing system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Soft and Firm Alloplastic Implants in Rhinoplasty: Why, When and How to Use Them: A Review of 311 Cases.

BACKGROUND: Modern rhinoplasty is not just a reduction procedure. An optimal nasal esthetic result occasionally requires augmenting the nasal tip, the dorsum or the lateral wall with autografts or alloplasts. A large number of nasal implant types have been reported in the medical literature. OBJECTIVE: The goal of this article is to demystify the role and indications of nasal implants in rhinoplasty. As well, it offers both the novice and experienced nasal surgeon a basic, simplified and organized approach to the use of soft and firm nasal implants in rhinoplasty. METHODS: This article presents the authors experience with 311 rhinoplasties using both soft and firm alloplastic implants. The indications for both types of alloplasts are discussed, the surgical technique detailed and the outcomes analyzed. RESULTS: A total of 311 nasal implant cases were reviewed. This series revealed a low incidence of postoperative infection (5.57% for soft implants and 0.1% for the firm ones). The revision rate was 2.7% for the soft implants group and 7.1% for the firm implants group. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery. Final order.

The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the pressure wedge for the reduction of cesarean delivery's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

[Comparative analysis of corneal aberrations after intrastromal segments and MyoRing implantation using femtosecond laser in patients with keratoconus]. / Sravnitel'nyi analiz rogovichnykh aberratsii posle femtolazernoi implantatsii intrastromal'nykh segmentov i kolets pri keratokonuse.

AIM: to comparatively analyze corneal aberrations after intrastromal corneal segments (ICS) and MyoRing implantation using femtosecond laser in patients with stage II-III keratoconus (KC) by Pentacam examination. MATERIAL AND METHODS: We have operated on 135 patients (145 eyes) with stage II or III KC. Depending on surgical technique, all patients were divided into two groups. Group I consisted of patients with KC, who received optimized femtosecond laser-assisted MyoRing implantation, group II - of those, who received femtosecond laser-assisted ICS implantation. Depending on the stage of the disease, each group was further divided into two subgroups, for stage II and stage III KC, respectively. Before and after surgery, all patients underwent visometry, biomicroscopy, corneal topography, and corneal aberrations measurement under photopic and mesopic conditions on Pentacam. The follow-up period averaged 30 months (from 6 to 34 months). RESULTS: In both groups corneal aberrations significantly decreased after surgery, which was confirmed by an improvement in parameters of refraction and keratometry readings. CONCLUSION: Implantation of intrastromal MyoRings leads to a greater reduction in the total corneal aberration, higher-order aberrations under photopic and mesopic conditions, and spherical aberration under photopic conditions as compared to ICS in patients with stage III KC; a comparable reduction in the total corneal, higher-order, and spherical aberrations under photopic conditions as compared to ICS in patients with stage II KC; a comparable increase in spherical aberration under mesopic conditions as compared to ICS in patients with stage III KC.

[A modified implant for upper eyelid ptosis correction in frontalis suspension surgery]. / Primenenie modifitsirovannogo implantata dlia ustraneniia ptoza verkhnego veka podveshivaniem.

AIM: to develop a modified implant to correct ptosis through brow suspension and to evaluate its effectiveness. MATERIAL AND METHODS: The clinical group consisted of 20 patients (29 eyes) aged 23 to 69 years (45±5.3 years on the average) and the comparison group - of 20 patients (33 eyes) aged 19 to 77 years (47±9.5 years on the average). All patients were operated on for severe ptosis of the upper eyelid, which implied stitching their eyelids to the eyebrows. In the main group, an original implant was introduced as suspensory material - a 200 µm thick porous polytetrafluoroethylene tape, length 13 cm, width 6 mm, round staggered perforation pattern, 1.5 mm holes, 3.5 mm pitch. In the comparison group, Mersilene mesh strips were used. The article contains a detailed description of the surgical technique. Checkups were performed at 1, 6, and 12 months. Follow-up periods were up to 4 years (1.7 years on the average) in the main group and up to 7 years (5.1 years on the average) - in the controls. RESULTS: Were evaluated by the width of the palpebral fissure at raised eyebrows, marginal reflex distance (MRD, which is the distance between the center of the pupil and the upper eyelid margin), presence and depth of the upper eyelid crease, and residual lagophthalmos. Examinations held at months 1, 6, and 12 after surgery showed that the results were positive and stable in all cases. Neither signs of recurrence, nor statistically significant differences between the groups were found. CONCLUSION: The use of the original modified implant during frontalis suspension surgery provides high and stable cosmetic result and expands the possibilities of ophthalmic plastic surgery.

The implant infection paradox: why do some succeed when others fail? Opinion and discussion paper.

Biomaterial-implants are frequently used to restore function and form of human anatomy. However, the presence of implanted biomaterials dramatically elevates infection risk. Paradoxically, dental-implants placed in a bacteria-laden milieu experience moderate failure-rates, due to infection (0.0-1.1%), similar to the ones of joint-arthroplasties placed in a near-sterile environment (0.1-1.3%). Transcutaneous bone-fixation pins breach the immune-barrier of the epidermis, exposing underlying sterile-tissue to an unsterile external environment. In contrast to dental-implants, also placed in a highly unsterile environment, these pins give rise to relatively high infection-associated failure-rates of up to 23.0%. Herein, we attempt to identify causes as to why dental-implants so often succeed, where others fail. The major part of all implants considered are metal-made, with similar surface-finishes. Material choice was therefore discarded as underlying the paradox. Antimicrobial activity of saliva has also been suggested as a cause for the success of dental-implants, but was discarded because saliva is the implant-site-fluid from which viable bacteria adhere. Crevicular fluid was discarded as it is largely analogous to serum. Instead, we attribute the relative success of dental-implants to (1) ability of oral tissues to heal rapidly in the continuous presence of commensal bacteria and opportunistic pathogens, and (2) tolerance of the oral immune-system. Inability of local tissue to adhere, spread and grow in presence of bacteria and an intolerant immune-system are identified as the likely main causes explaining the susceptibility of other implants to infection-associated failure. In conclusion, it is the authors' belief that new anti-infection strategies for a wide range of biomaterial-implants may be derived from the relative success of dental-implants.

[Orthopaedic implants. Application outside of patient care?]. / Orthopädisch-Unfallchirurgische Implantate. Verwendungsmöglichkeiten außerhalb der Patientenversorgung?

Internal fracture fixation represents a widespread concept for the treatment of fractures. As the number of implants increases, person tracking may be possible. In spring 2010 near Rostock (Germany), human remains including a stainless steel nail were found. Forensic analysis considered the parts of skeleton to belong to a man of medium height, exposed to outdoor conditions for several years to a few decades. The tibial nail was analysed and according to the product identification number possible hospitals of implant placement and transportation paths were determined and screened. Furthermore a match analysis of the database of missing individuals of the last 15 years was undertaken and a DNA match analysis identified a local individual who had been missing since winter 2003. Equipped with the actual patient's identity, out of academic interest a survey of clinical documents such as discharge letters and operative reports was performed, but was inconclusive. Although technically feasible, tracking the patient in this case based on the implant product number itself was unsuccessful. In this case report, the feasibility, validity and efficiency of this option are presented and discussed.

Scaffolds for partial meniscal replacement: an updated systematic review.

INTRODUCTION: Meniscectomy, a most common orthopaedic procedure, results in increased contact area of the articular surfaces of tibia and femur leading to early osteoarthritis. We systematically review the literature on clinical outcomes following partial meniscal replacement using different scaffolds. SOURCES OF DATA: We performed a comprehensive search of Medline, CINAHL, Embase and the Cochrane Central Registry of Controlled Trials. The reference lists of the selected articles were then examined by hand. Only studies focusing on investigation of clinical outcomes on patients undergoing a partial meniscal replacement using a scaffold were selected. We then evaluated the methodological quality of each article using the Coleman methodology score (CMS), a 10 criteria scoring list assessing the methodological quality of the selected studies (CMS). AREAS OF AGREEMENT: Fifteen studies were included, all prospective studies, but only 2 were randomized controlled trials. Biological scaffolds were involved in 12 studies, 2 studies investigated synthetic scaffolds, whereas 1 remaining article presented data from the use of both classes of device. The mean modified CMS was 64.6. AREAS OF CONTROVERSY: Several demographic and biomechanical factors could influence the outcomes of this treatment modality. GROWING POINTS: Partial replacement using both classes of scaffolds achieves significant and encouraging improved clinical results when compared with baseline values or with controls when present, without no adverse reaction related to the device. RESEARCH: There is a need for more and better designed randomized trials, to confirm with a stronger level of evidence the promising preliminary results achieved by the current research.

[The ultrasound semiotics of uncomplicated wound healing after inguinal mesh plastics].

Dynamic ultrasound (US) investigation was performed in 89 patients operated on inguinal hernia with the use of meshes of various type. The US scanning proved to be a highly informative means of visualization, allowing the objective postoperative assessment of muscular and aponeurotic structures as well as the implant form and position. The study showed, that the mesh implantation was always accompanied by the exudative tissue reaction, which was determined by the physico-chemical characteristics of the implant.

[Comparative assessment of national and foreign endoprostheses for hernioplasty].

The used foreign endoprostheses have redundant strength, and great number and stiffness of implanted material might be a cause of complications and result in patients' discomfort associated with decreased mobility of the anterior abdominal wall. Less material consumption of endoprostheses results in increased porosity and less thickness facilitating rapid integration of the grid into the elastic and strong connective tissue scar. Company "Lintex" has developed and produced endoprostheses from polypropylene and polyvinylenfluoride monothreads in heavy, standard and light version, which allows their choice with a glance to the particular surgical situation.

[Testing of initial contamination for three kinds of surgical implants producted in Beijing].

The initial contamination of femoral head, femoral stem and femoral component producted by seven factories in Beijing is tested, all of the initial contamination values are 580 in total. Then these data is analyzed on statistics. The result indicates that the initial contamination values of three kinds of products according with normal distribution; The initial contamination values have not significant difference between femoral head and femoral component of the same factory; and the season has not significant effect on initial contamination in Beijing. According to the experimental data, the level of initial contamination is undulatory, so the factories should control the initial contamination and maintain the stability of initial contamination.

Management of erosion of graft materials in pelvic floor reconstruction.

We present an overview of the current literature and management techniques for vaginal extrusion or urinary tract erosion of graft materials used in pelvic floor reconstruction. A MEDLINE search was performed to identify literature pertaining to the incidence and management of vaginal or urinary tract exposure of graft materials commonly used in anti-incontinence and pelvic floor reconstructive procedures. Dependent on the type of mesh material used, a vaginal extrusion rate of up to 77% has been reported. The currently accepted, loosely woven, monofilament type I polypropylene meshes appear to have acceptable lower exposure rates in the range of 1-3% for slings, but with the larger area of mesh used in prolapse repairs, the rate increases to up to 10%. With the current widespread use of graft materials to reinforce pelvic floor reconstructive techniques, it is imperative for surgeons to be familiar with potential complications related to the materials and proper management of these complications. Although it is beginning to appear that the benefit of using some synthetic materials may outweigh the risks, proper management and understanding of the risks is important in order to counsel our patients appropriately and responsibly prior to their surgeries.

Ear epistheses as an alternative to autogenous reconstruction.

An ear episthesis is an artificial substitute for the auricle. The term EAR PROSTHESIS is used synonymously. The breakthrough came with the introduction of the modern silicones and their colorings. Although there are still indications for noninvasive methods of retention such as medical adhesives, the best and most reliable method of fixation is by bone anchorage. Long-lasting osseointegration with reaction-free skin penetration can be achieved with titanium implants. The first system used extraorally was the Brånemark flange fixture. Later, different solitary titanium implants were introduced, such as the ITI system. A different strategy used the titanium grids (Epitec) or plates (Epiplating) derived from osteosynthesis systems. These systems are fixed subperiosteally with several bone screws and are therefore also labeled as grouped implants. With these modern developments, secure retention can be achieved also in unfavorable anatomic situations. The grouped systems are resistant to torque with abutment insertion. The latest development is the subcutaneously implanted double magnet without skin penetration. The advantages of implant retained ear epistheses include optimal camouflage, predictable cosmetic results, fast rehabilitation, no donor site morbidity, and early detection of tumor recurrence. Depending on the clinical setting, prosthetic rehabilitation may be more than just an alternative to plastic reconstructive surgery.

The classification of implants: class I, II, III.

Medical implants fall under the larger category of medical devices, which are defined as products used for medical purposes in patients, in diagnosis and/or treatment. There are three classes of devices that are controlled by the Food and Drug Administration (FDA). Class I devices present the lowest safety risk and are only subject to general controls; Class II devices require general and special controls involving labeling requirements, mandatory performance standards and adequate surveillance; Class III devices must have the same general and special controls as Class I and II devices, and undergo scientific review. Class III is the most scientifically rigorous classification of medical devices and encompasses most of the orthopedic implants on the market today. In this paper, different categories of orthopedic implants will be discussed, including the development of artificial anterior cruciate ligament (ACL) grafts and FDA approval of alumina ceramic-on-ceramic (COC) total hip prostheses.

Experience of left atrial appendage occlusion with the WATCHMAN device in Chinese patients.

OBJECTIVE: Little is known about left atrial appendage occlusion (LAAO) with WATCHMAN device in patients with atrial fibrillation (AF) in China. The aim of the present study was to evaluate the acute procedural performance and complication rate of LAAO procedures and patient selection in China. METHODS: A total of 658 consecutive Chinese patients who were referred to receive LAAO procedures with the WATCHMAN device between 2014 and 2017 were retrospectively included in the study. Patients were divided into four groups according to the year of procedures: Group 2014, Group 2015, Group 2016, and Group 2017. The procedural success, complication rates, and characteristics of Chinese patients, as well as the trends of patients' selection and management, were analyzed. RESULTS: The average age of the patients was 67.7+-9.2 years, the CHA2DS2-VASc score was 3.7+-1.6, and the HAS-BLED score was 2.5+-1.1. Both scores of patients in different years show obvious increasing trends (r=0.126, p=0.001 and r=0.145, p<0.001, respectively). Indications for LAAO included increased bleeding risk (45.6%), recent bleeding under oral anticoagulation (OAC) (9.0%), and non-compliance with OAC (51.4%). The implantation was successful in 643 (97.7%) patients, with a procedural complication rate of 0.6%. Approximately 80.1% of the patients received OAC after LAAO. CONCLUSION: In China, LAAO with WATCHMAN devices in patients with AF can be performed successfully with a low complication rate. Most of the target population had increased bleeding risk or non-compliance for OAC as indications and received OAC for antithrombotic therapy after the procedure.

Three-Dimensional Optical Coherence Tomography Imaging For Glaucoma Associated With Boston Keratoprosthesis Type I and II.

PRECIS: Three-dimensional (3D) spectral domain optical coherence tomography (OCT) volume scans of the optic nerve head (ONH) and the peripapillary area are useful in the management of glaucoma in patients with a type I or II Boston Keratoprosthesis (KPro). PURPOSE: The purpose of this study was to report the use of spectral domain OCT in the management of glaucoma in patients with a type I or II Boston KPro. MATERIALS AND METHODS: This study is an observational case series. Four consecutive patients with KPro implants were referred for glaucoma evaluation. A comprehensive eye examination was performed which included disc photography, visual field testing, and high-density spectral domain OCT volume scans of the ONH and the peripapillary area. 2D and 3D parameters were calculated using custom-designed segmentation algorithms developed for glaucoma management. RESULTS: Spectral domain OCT parameters provided useful information in the diagnosis and management of 4 KPro patients. OCT parameters which can be used in KPro patients included 2D retinal nerve fiber layer (RNFL) thickness, 3D peripapillary RNFL volume, 3D peripapillary retinal thickness and volume, 3D cup volume, and 3D neuroretinal rim thickness and volume. In 3 of 4 cases where the traditional 2D RNFL thickness scan was limited by artifacts, 3D spectral domain OCT volume scans provided useful quantitative objective measurements of the ONH and peripapillary region. Therefore, 3D parameters derived from high-density volume scans as well as radial scans of the ONH can be used to overcome the limitations and artifacts associated with 2D RNFL thickness scans. CONCLUSIONS: Spectral domain OCT volume scans offer the possibility to enhance the evaluation of KPro patients with glaucoma by using both 2D and 3D diagnostic parameters that are easily obtained in a clinic setting.

[Implantable medical devices]. / Dispositifs médicaux implantables.

Medical devices have been individualized to include a category of implantable medical devices, "designed to be totally implanted in the human body or to replace an epithelial surface or a surface of the eye, through surgery, and remain in place after the intervention" (directive 93/42/CEE and decree of 20 April 206). Each implantable medical device has a common name and a commercial name for precise identification of the model (type/references). The users' service and the implanting physician should be clearly identified. There are a number of rules concerning health traceability to rapidly identify patients exposed to risks in which the implantable medical devices of a particular batch or series were used and to monitor the consequences. The traceability data should be preserved 10 years and the patient's medical file for 20 years.

Classification of posterior dynamic stabilization devices.

Numerous new posterior dynamic stabilization (PDS) devices have been developed for the treatment of disorders of the lumbar spine. In this report the authors provide a classification scheme for these devices and describe several clinical situations in which the instrumentation may be expected to play a role. By using this classification, the PDSs that are now available and those developed in the future can be uniformly categorized.