What is Being Reported About Vaginal “Lasers”?: An Examination of Adverse Events Reported to the Food and Drug Administration on Energy-Based Devices

Background Description of energy-based genitourinary non-surgical devices (energy-based devices) safety data is outlined given their rapid adoption. Objectives To describe adverse events (AEs) for energy-based devices in the Manufacturer and User Facility Device Experience (MAUDE) database, and to compare to similar devices and other subspecialty applications. We hypothesized that products with genitourinary applications had similar AEs to dermatologic or general surgery applications. Methods Reed Tech™ Navigator compiled AE reports for all registered energy-based devices. Individual AE reports associated with 1) non-ablative, 2) fractionated, 3) unfractionated 4) radiofrequency, and 5) hybrid laser technologies were categorized. AE characteristics were compared among genitourinary applications (n=39) and other subspecialty applications within the same devices (n=79). Results Eighteen manufacturers were identified, which collectively manufacture 43 products with genitourinary applications. Thirty-nine genitourinary AEs were reported and isolated to 6 manufacturers with 11 products, of which 82% (n=32) were injuries, 15% (n=6) were device malfunction, and 3% (n=1) related to improper maintenance. Local treatment reactions were the most commonly reported injury (62%, n=21). AEs varied by device type with CO2 lasers having more burns and radiofrequency devices having higher rates of sensation loss. When comparing similar technology types, genitourinary energy-based devices had the least AE reports per device in MAUDE database. Conclusions AEs were reported on a quarter of the products currently available, and most were local treatment reactions. The reporting of AEs is equal to that of other subspecialties suggesting similar risk profiles. Improved reporting is needed to fully evaluate the safety of individual energy-based devices.

Short-segment myelitis presenting as Brown-Séquard-plus syndrome as the initial attack of multiple sclerosis.

Brown-Séquard syndrome is an uncommon condition accounting incomplete spinal cord injury, manifesting as ipsilateral weakness and proprioception loss, associated with contralateral pain and temperature sensation loss. Brown-Séquard-plus syndrome (BSPS) has not quite a well-stablished definition, but usually is defined as a Brown-Séquard syndrome associated with clinical findings compatible with another spinal cord tract. We present a pearls & oysters article naming the most relevant findings and aspects to evaluate in this pathology, throughout a clinical case where a patient presents a Brown-Séquard-plus syndrome as the initial attack in multiple sclerosis.

A Pharmacognostical and Pharmaceutical evaluation of Dhanyamla

Introduction: Dhanyamla is a medicated liquid preparation produced by fermentation process of various grains. Dhanyamla is cold at perception by its nature as it is a sour liquid and Ayurvedic classics opine that amla rasa is of cold nature if used externally. It is commonly used for management of Diabetic Polyneuropathy which commonly presents with burning sensation, loss of strength, loss of balance, loss of sensation, numbness etc. especially of feet. Materials and methods: Raw drugs of Dhanyamla as per the reference in Sahasrayogam were purchased from the local market of Jamnagar, Gujarat. It was prepared as per the standard preparation procedure at Department of Rasa shastra and Bhaishajya kalpana, IPGT&RA, GAU, Jamnagar. The final product was then subjected to pharmacognostical and pharmaceutical analysis. Pharmacognosy of Dhanyamla was carried out by preparing a slide made with glass slide and cover slip. Then this slide was observed under the Carl Zeiss Trinocular microscope. Organoleptic characters and physico-chemical parameters were noted. HPTLC was performed and observed under short UV (254 nm) and long UV (366 nm). Results: Pharmacognosy study of Dhanyamla revealed presence of starch content and oil globules. Analytical study of Dhanyamla showed 14 spots and 20 spots at 254 nm and 366 nm respectively. Specific Gravity, pH and total solid contents were 1.0033, 3.257 and 55.334 respectively. Discussion and conclusion: The presence of both carbohydrate and oil content would have been the reason of having soothing and mild nourishing effect.

Complete spinal cord injury following computed tomography–guided biopsy of the thoracic spine: A case report

Computed tomography–guided spine biopsy is a routine procedure in diagnosing vertebral infection or tumor. Following a thoracic intervertebral disc biopsy for presumed osteodiscitis, a patient immediately presented with flaccid paralysis and loss of temperature and pinprick sensation below biopsy level, followed rapidly by complete sensation loss. There was no evidence of direct injury during the biopsy, and emergent post-biopsy magnetic resonance imaging revealed no cord signal abnormality or compression. Later magnetic resonance imaging demonstrated corresponding-level cord edema, presumed secondary to transient cord ischemia during the procedures. Despite frequent utility, authors recommend caution in utilization of computed tomography–guided spine biopsy.

New technics for removal of intradural spinal tumours

Introduction. Neuronavigation is a computer-assisted technology based on pre- and intraoperative images that permit neurosurgeons to have a better approach of the brain and intradural spinal tumors. The neuronavigation systems have been a significant progress in neurosurgery. These systems allow neurosurgeons to evaluate surgical risks, select the best interventional method, localize better the tumors in order to improve the accuracy of the resection and decide on the optimal trajectory for the surgical procedure, resulting in decreased patient morbidity and mortality. Material: Spinal cord tumors are rare and uncommon lesions. Their growth result in compression of the spinal cord, which can cause severe neurologic deficits such as limb dysfunction, motor and sensation loss with the possibility of leading to death. We present o short report of a study publicated by Stefini et al. in 2018 regarding the use of neuronavigation for removal of intradural spinal tumors. Conclusion: The benefits of using neuronavigation in resection of the intradural spinal tumors include decreased risk of bad localization of the tumor, minimal invasive surgery technique and reduction of bone removal.

A Smart Device to Substitute the Neurothesiometer

This paper presents a patented smart point-of-care testing (POCT) system for the diagnosis and grading of peripheral neuropathy at the patient’s home or care center. The device aims to detect changes or worsening of a patient’s neuropathy. Our system utilizes the vibration motor within a smartphone, applied through a 3D printed probe attachment to detect sensation loss in vibration sensitivity threshold (VST). A smartphone app displays several neuropathy questionnaires to the user to identify and monitor changes in their condition. This paper presents results from comparison between the new smart device and the gold standard Neurothesiometer. Results suggest that the new device performs closely to the gold standard in terms of the frequency and amplitude of vibration.