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https://www.readbyqxmd.com/read/29133265/critical-under-reporting-of-hernia-mesh-properties-and-development-of-a-novel-package-label
#1
Lindsey G Kahan, Jeffrey A Blatnik
BACKGROUND: With an array of hernia meshes with varying properties, intraoperative decision making for the optimal mesh is critical. While meshes are subjected to regulatory review through the FDA, it is unknown whether mesh properties are visually accessible. To facilitate greater knowledge for the surgeon on mesh choice, we aimed to comprehensively analyze hernia mesh packaging and regulations. STUDY DESIGN: Labeling guidelines and 510(k) requirements across FDA-regulated products were analyzed and compared to mesh packaging...
November 10, 2017: Journal of the American College of Surgeons
https://www.readbyqxmd.com/read/29019097/efficacy-of-conventional-and-liposomal-povidone-iodine-in-infected-mesh-skin-grafts-an-exploratory-study
#2
Peter M Vogt, Joerg Hauser, Stefan Mueller, Bjoern Bosse, Michael Hopp
INTRODUCTION: Infection is a major threat to wound healing and a leading cause of graft loss in patients undergoing meshed skin grafts (MSGs). Therefore, topical antisepsis is important in the overall treatment scheme. METHODS: An exploratory satellite group of 14 patients with infected MSGs were enrolled as part of a prospective, randomized, controlled, parallel-group, open-label, pilot Phase II study that investigated the efficacy and tolerability of 3% liposomal povidone-iodine hydrogel (PVP-ILH, Repithel(®); RepiGel(®)) versus chlorhexidine gauze in non-infected MSGs...
October 10, 2017: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/28882385/lung-deposition-and-systemic-bioavailability-of-different-aerosol-devices-with-and-without-humidification-in-mechanically-ventilated-patients
#3
Islam O F Moustafa, Mohammed R A-A Ali, Moataz Al Hallag, Hoda Rabea, James B Fink, Patricia Dailey, Mohamed E A Abdelrahim
BACKGROUND: During mechanical ventilation medical aerosol delivery has been reported to be upto two fold greater with dry inhaled gas than with heated humidity. Urine levels at 0.5 h post dose (URSAL0.5%) has been confirmed as an index of lung deposition and 24 h (URSAL24%) as index of systemic absorption. Our aim was to determine the effect of humidification and aerosol device type on drug delivery to ventilated patients using urine levels. METHODS: In a randomized crossover design, 36 (18female) mechanically ventilated patients were assigned to one of three groups...
November 2017: Heart & Lung: the Journal of Critical Care
https://www.readbyqxmd.com/read/28876614/significant-clinical-and-patient-reported-outcomes-at-6-months-following-hernia-repair-with-an-absorbable-fixation-device
#4
H Bougard, C Doerhoff, S Bringman, M Chudy, C Romanowski, P Jones
BACKGROUND: Surgeons utilise various mesh fixation methods during hernia repair which may include tacks/straps and/or sutures. One of these tack/strap choices, is an absorbable fixation device, Securestrap® (ETHICON, Somerville, NJ), consisting of polydioxanone and L (-)-lactide/glycolide copolymer. The 6 month clinical results and patient outcomes with Securestrap® fixation are reported. METHOD: The International Hernia Mesh Registry, prospective multi-centre registry, designed to collect patient reported, longitudinal data on hernia mesh products and fixation methods...
September 2017: South African Journal of Surgery. Suid-Afrikaanse Tydskrif Vir Chirurgie
https://www.readbyqxmd.com/read/28808824/gasless-single-incision-laparoscopic-inguinal-hernia-repair-initial-experience
#5
M W V Ng, K C Ng
PURPOSE: Laparoscopic hernioplasty has been gaining its popularity in the past decade for its rapid recovery. Single-incision surgery, as its possible advancement, has also received more attention. Traditional laparoscopic surgery with carbon dioxide insufflation precluded patients with underlying cardiovascular or pulmonary disease from minimal invasive surgery. We report our early experience with gasless single-incision laparoscopic inguinal hernia repair via totally extraperitoneal (TEP) approach...
October 2017: Hernia: the Journal of Hernias and Abdominal Wall Surgery
https://www.readbyqxmd.com/read/28797120/medication-eluting-devices-for-the-field-of-obgyn-medobgyn-3d-printed-biodegradable-hormone-eluting-constructs-a-proof-of-concept-study
#6
Karthik Tappa, Udayabhanu Jammalamadaka, David H Ballard, Todd Bruno, Marissa R Israel, Harika Vemula, J Mark Meacham, David K Mills, Pamela K Woodard, Jeffery A Weisman
3D printing has the potential to deliver personalized implants and devices for obstetric and gynecologic applications. The aim of this study is to engineer customizable and biodegradable 3D printed implant materials that can elute estrogen and/or progesterone. All 3D constructs were printed using polycaprolactone (PCL) biodegradable polymer laden with estrogen or progesterone and were subjected to hormone-release profile studies using ELISA kits. Material thermal properties were tested using thermogravimetric analysis and differential scanning calorimetry...
2017: PloS One
https://www.readbyqxmd.com/read/28770120/laparoscopic-repair-of-a-large-paraesophageal-hernia-with-migration-of-the-stomach-into-the-mediastinum-creating-an-upside-down-stomach
#7
Nasser Sakran, Hadar Nevo, Ron Dar, Asnat Raziel, Dan Hershko
Upside-down stomach is a relatively rare type of a large paraesophageal hernia characterized by the migration of the stomach into the posterior mediastinum. Upside-down stomach is prone to severe complications and therefore surgery is recommended even in asymptomatic patients. A 62-year-old male presented with frequent abdominal pain with nausea and vomiting that persisted for one year. The patient was obese with fatty liver and was treated medically for gastroesophageal reflux disease (GERD) for 4 years. On upper gastrointestinal CT study a level-IV paraesophageal hernia was detected with upside-down stomach, and he was referred for elective surgery...
2017: Case Reports in Surgery
https://www.readbyqxmd.com/read/28746980/single-incision-sling-operations-for-urinary-incontinence-in-women
#8
REVIEW
Arjun Nambiar, June D Cody, Stephen T Jeffery, Patricia Aluko
BACKGROUND: Urinary incontinence has been shown to affect up to 50% of women. Studies in the USA have shown that up to 80% of these women have an element of stress urinary incontinence. This imposes significant health and economic burden on society and the women affected. Colposuspension and now mid-urethral slings have been shown to be effective in treating patients with stress incontinence. However, associated adverse events include bladder and bowel injury, groin pain and haematoma formation...
July 26, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28745703/-creative-surgery-for-hiatal-hernia
#9
O V Galimov, V O Khanov, D Z Mamadaliev, R R Sayfullin, R R Sagitdinov
AIM: To present an experience of surgical treatment of hiatal hernia. MATERIAL AND METHODS: An experience of more than thousand laparoscopic fundoplications in various modifications has been accumulated in the Clinic of Bashkir State Medical University for the period 2001-2016. RESULTS: An original device for intraoperative measurement of hiatal orifice is described. Hiatal orifice repair was indicated in case of its dimension over 3.5 cm...
2017: Khirurgiia
https://www.readbyqxmd.com/read/28733271/telerehabilitation-review-of-the-state-of-the-art-and-areas-of-application
#10
REVIEW
Alessandro Peretti, Francesco Amenta, Seyed Khosrow Tayebati, Giulio Nittari, Syed Sarosh Mahdi
BACKGROUND: Telemedicine applications have been increasing due to the development of new computer science technologies and of more advanced telemedical devices. Various types of telerehabilitation treatments and their relative intensities and duration have been reported. OBJECTIVE: The objective of this review is to provide a detailed overview of the rehabilitation techniques for remote sites (telerehabilitation) and their fields of application, with analysis of the benefits and the drawbacks related to use...
July 21, 2017: JMIR Rehabil Assist Technol
https://www.readbyqxmd.com/read/28627376/inhaled-salbutamol-dose-delivered-by-jet-nebulizer-vibrating-mesh-nebulizer-and-metered-dose-inhaler-with-spacer-during-invasive-mechanical-ventilation
#11
Muhammad H E ElHansy, Marina E Boules, Assem Fouad Mohamed El Essawy, Mohamed Bakry Al-Kholy, Maha M Abdelrahman, Amira S A Said, Raghda R S Hussein, Mohamed E Abdelrahim
BACKGROUND: Patient receiving invasive mechanical ventilation (IMV) may benefit from medical aerosol, but guidance on dosing with different aerosol devices is limited to in-vitro studies. The study was designed to compare aerosol delivery with five different types of aerosol generators during IMV. METHOD: In randomized design, 60 (30 female) mechanically ventilated chronic obstructive pulmonary disease (COPD) patients were assigned to one of 5 groups. Groups 1-4 received 5000 μg salbutamol using Aerogen Pro (PRO), Aerogen Solo (SOLO), NIVO vibrating mesh and jet nebulizers (JN), respectively, while group 5 received 800 μg (8 puffs) of salbutamol via metered dose inhaler with AeroChamber-MV (MDI-AC)...
August 2017: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28616115/management-of-patients-with-stress-urinary-incontinence-after-failed-midurethral-sling
#12
REVIEW
Alex Kavanagh, May Sanaee, Kevin V Carlson, Gregory G Bailly
Surgical failure rates after midurethral sling (MUS) procedures are variable and range from approximately 8-57% at five years of followup. The disparity in long-term failure rates is explained by a lack of long-term followup and lack of a clear definition of what constitutes failure. A recent Cochrane review illustrates that no high-quality data exists to recommend or refute any of the different management strategies for recurrent or persistent stress urinary incontinence (SUI) after failed MUS surgery. Clinical evaluation requires a complete history, physical examination, and establishment of patient goals...
June 2017: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
https://www.readbyqxmd.com/read/28610569/a-novel-tamponade-agent-for-management-of-post-partum-hemorrhage-adaptation-of-the-xstat-mini-sponge-applicator-for-obstetric-use
#13
Maria I Rodriguez, Jeffrey T Jensen, Kenton Gregory, Mary Bullard, Paul Longo, Jerry Heidel, Alison Edelman
BACKGROUND: Although uterine tamponade is an effective treatment for postpartum hemorrhage (PPH), current methods have key limitations in their use, particularly in low resource settings. The XStat™ Mini Sponge Dressing (MSD) is approved for the management of non-compressible wounds in the battlefield/trauma setting. The MSD applies highly compressed medical sponges capable of stopping high-flow arterial bleeding within seconds. The objective of our study was to adopt the MSD for use in managing PPH...
June 13, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28594740/the-importance-of-registries-in-the-postmarketing-surveillance-of-surgical-meshes
#14
Ferdinand Köckerling, Thomas Simon, Martin Hukauf, Achim Hellinger, Rene Fortelny, Wolfgang Reinpold, Reinhard Bittner
OBJECTIVE: To assess the role of registries in the postmarketing surveillance of surgical meshes. BACKGROUND: To date, surgical meshes are classified as group II medical devices. Class II devices do not require premarket clearance by clinical studies. Ethicon initiated a voluntary market withdrawal of Physiomesh for laparoscopic use after an analysis of unpublished data from the 2 large independent hernia registries-Herniamed German Registry and Danish Hernia Database...
June 7, 2017: Annals of Surgery
https://www.readbyqxmd.com/read/28585334/low-eddy-current-rf-shielding-enclosure-designs-for-3t-mr-applications
#15
Brian J Lee, Ronald D Watkins, Chen-Ming Chang, Craig S Levin
PURPOSE: Magnetic resonance-compatible medical devices operate within the MR environment while benefitting from the superior anatomic information of MRI. Avoiding electromagnetic interference between such instrumentation and the MR system is crucial. In this work, various shielding configurations for positron emission tomography (PET) detectors were studied and analyzed regarding radiofrequency (RF) shielding effectiveness and gradient-induced eddy current performances. However, the results of this work apply to shielding considerations for any MR-compatible devices...
June 6, 2017: Magnetic Resonance in Medicine: Official Journal of the Society of Magnetic Resonance in Medicine
https://www.readbyqxmd.com/read/28500861/overview-of-high-risk-medical-device-recalls-in%C3%A2-obstetrics%C3%A2-and-gynecology-from-2002-through-2016-%C3%A2-implications-for-device-safety
#16
Timothy M Janetos, Comeron W Ghobadi, Shuai Xu, Jessica R Walter
The field of women's health has endured numerous recent controversies involving medical devices such as pelvic meshes, laparoscopic morcellators, and a hysteroscopic sterilization device. With the recent passage of the 21st Century Cures Act, new legislation will change how the Food and Drug Administration regulates medical devices. Given these controversies and new changes, we investigated high-risk, class I recalls in women's health from 2002 through 2016. Class I recalls for medical devices are defined by the Food and Drug Administration as the most serious recall events and are designated for situations when there is a reasonable probability of serious adverse health consequences or death...
July 2017: American Journal of Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28470445/ftir-microscopy-contribution-for-comprehension-of-degradation-mechanisms-in-pla-based-implantable-medical-devices
#17
Adrien Leroy, Sofia Ribeiro, Carole Grossiord, Antoine Alves, Robert H Vestberg, Vincent Salles, Céline Brunon, Kerstin Gritsch, Brigitte Grosgogeat, Yves Bayon
The integration and evolution of implantable medical devices made of bioresorbable polymers and used for temporary biomedical applications are crucial criteria in the success of a therapy and means of follow-up after implantation are needed. The objective of this work is to develop and evaluate a method based on microscopic Fourier Transform InfraRed spectroscopy (FTIR) mappings to monitor the degradation of such polymers on tissue explant sections, after implantation. This technique provided information on their location and on both their composition and crystallinity, which is directly linked to their state of degradation induced predominantly by chain scissions...
June 2017: Journal of Materials Science. Materials in Medicine
https://www.readbyqxmd.com/read/28463314/surface-structural-damage-study-in-cortical-bone-due-to-medical-drilling
#18
Cesar G Tavera R, Manuel H De la Torre-I, Jorge M Flores-M, Ma Del Socorro Hernandez M, Fernando Mendoza-Santoyo, Manuel de J Briones-R, Jorge Sanchez-P
A bone's fracture could be produced by an excessive, repetitive, or sudden load. A regular medical practice to heal it is to fix it in two possible ways: external immobilization, using a ferule, or an internal fixation, using a prosthetic device commonly attached to the bone by means of surgical screws. The bone's volume loss due to this drilling modifies its structure either in the presence or absence of a fracture. To observe the bone's surface behavior caused by the drilling effects, a digital holographic interferometer is used to analyze the displacement surface's variations in nonfractured post-mortem porcine femoral bones...
May 1, 2017: Applied Optics
https://www.readbyqxmd.com/read/28441181/inhaled-treprostinil-drug-delivery-during-mechanical-ventilation-and-spontaneous-breathing-using-two-different-nebulizers
#19
Donna K Parker, Shuijie Shen, Jiang Zheng, D Dunbar Ivy, Dave N Crotwell, Justin C Hotz, Robert M DiBlasi
OBJECTIVES: To determine the feasibility of delivering inhaled treprostinil during mechanical ventilation and spontaneous unassisted ventilation using the Tyvaso Inhalation System and the vibrating mesh nebulizer. We sought to compare differences in fine particle fraction, and absolute inhaled treprostinil mass delivered to neonatal, pediatric, and adult models affixed with a face mask, conventional, and high-frequency ventilation between Tyvaso Inhalation System and with different nebulizer locations between Tyvaso Inhalation System and vibrating mesh nebulizer...
June 2017: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/28398930/management-of-mesh-and-graft-complications-in-gynecologic-surgery
#20
(no author information available yet)
This document focuses on the management of complications related to mesh used to correct stress urinary incontinence or pelvic organ prolapse. Persistent vaginal bleeding, vaginal discharge, or recurrent urinary tract infections after mesh placement should prompt an examination and possible further evaluation for exposure or erosion. A careful history and physical examination is essential in the diagnosis of mesh and graft complications. A clear understanding of the location and extent of mesh placement, as well as the patient's symptoms and therapy goals, are necessary to plan treatment approaches...
May 2017: Female Pelvic Medicine & Reconstructive Surgery
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