Early-Onset Gastrointestinal Malignancies: An Investigation into a Rising Concern.

There is growing recognition of early-onset gastrointestinal (GI) malignancies in young adults < 50 years of age. While much of the literature has emphasized colorectal cancer, these also include esophageal, gastric, liver, pancreatic, and biliary tract malignancies. Various factors, including lifestyle, hereditary, and environmental elements, have been proposed to explain the rising incidence of GI malignancies in the younger population. This review aims to provide an overview of the recent literature, including global trends and information regarding genetic and environmental risk factors.

A Review on Endoscopic Management of Acute Cholecystitis: Endoscopic Ultrasound-Guided Gallbladder Drainage and Endoscopic Transpapillary Gallbladder Drainage.

A percutaneous cholecystostomy tube (PCT) is the conventionally favored nonoperative intervention for treating acute cholecystitis. However, PCT is beset by high adverse event rates, need for scheduled reintervention, and inadvertent dislodgement, as well as patient dissatisfaction with a percutaneous drain. Recent advances in endoscopic therapy involve the implementation of endoscopic transpapillary drainage (ETP-GBD) and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD), which are increasingly preferred over PCT due to their favorable technical and clinical success combined with lower complication rates. In this article, we provide a comprehensive review of the literature on EUS-GBD and ETP-GBD, delineating instances when clinicians should opt for endoscopic management and highlighting potential risks associated with each approach.

Powered muscle stimulators: an investigation into newly FDA 510(k) approved devices marketed for muscle toning and esthetic benefit.

Introduction: Powered muscle stimulators have been popularized in recent years due to their muscle toning effects. This study aims to describe marketing trends and reporting of adverse effects of powered muscle stimulators.Methods: We performed a cross-sectional retrospective analysis of records from the United States FDA database for 510(k) premarket approval of powered muscle stimulators between January 1, 2000 and December 31, 2018. The FDA MAUDE database was reviewed for adverse events reported with device usage.Results: One hundred and seventeen devices received 510(k) premarket approval between 2000 and 2018, with the first approval occurring in 2001. Initially, devices were marketed to assist with muscle toning and strengthening, but more recent indications include the treatment of pain, increased local muscle blood circulation, and prevention of post-surgical venous thrombosis. Thirty-six adverse event reports have been submitted and published in the MAUDE database over the past 10 years by 11% of manufacturers.Discussion: Powered muscle stimulators are growing increasingly popular amongst consumers and healthcare providers due to their ease of use and perceived esthetic, muscle strength, and pain relief benefits. Additional investigation to determine optimal treatment parameters and potential adverse effects is necessary due to the growing popularity of these devices.

Low-dose naltrexone: a unique treatment for amyopathic dermatomyositis.

Gottron papules, a heliotrope rash, scalp and extremity erythema, pruritus, and fatigue are the characteristic signs and symptoms of amyopathic dermatomyositis (ADM). Amyopathic dermatomyositis is considered a distinct entity from dermatomyositis (DM) because the characteristic muscle weakness and muscle enzyme elevations of DM are absent in ADM. With respects to treatment, ADM treatments have traditionally included topical corticosteroids and/or systemic immunosuppressants and immunomodulators. Herein we present a patient with refractory ADM that was responsive to low-dose naltrexone therapy.

United States Food and Drug Administration's 510(k) Pathway: Drawing Implications from the Approvals of Brachytherapy Devices.

Introduction Innovations in cancer treatment coupled with an increasing number of cancer patients have led to the growth of brachytherapy devices. The objective of this study is to characterize the development and safety of brachytherapy devices marketed in the United States (US) over the last 15 years. Methods We reviewed records from a public US Food and Drug Administration (FDA) database detailing premarket approval of brachytherapy devices. All 510(k) submissions approved between January 1, 2000 and October 31, 2018 were examined. To assess the safety of these devices, we searched the manufacturer and user facility device experience (MAUDE) database for related adverse events. Results Twenty-two brachytherapy devices received 510(k) premarket approval, with the first device approved in 2005. Of the 22 devices, 20 (91%) were marketed with specific indications. The most common indications include treatment of skin cancers and keloids (n=7), breast cancer (n=4), and gynecologic/rectal cancers (n=2). A review of the MAUDE database revealed 64 reports of adverse events associated with brachytherapy devices. Common adverse effects include poor device design, use error, and device malfunction that led to the delivery of an inaccurate dose of radiation. Discussion Although there are some single-center, short-term studies demonstrating adequate local control and satisfactory cosmesis with brachytherapy, data on long-term outcomes are lacking. Further research is warranted to define appropriate practice guidelines for brachytherapy devices in the treatment of various malignancies.

A review of the FDA's 510(k) approvals process for electromagnetic devices used in body contouring.

Introduction: Greater demand for noninvasive techniques to reduce cellulite and contour the body has led to the growth of electromagnetic and radiofrequency devices. In this study, we aimed to characterize the evolution and safety of electromagnetic devices marketed in the U.S. over the last two decades. Methods: We examined records from a U.S. FDA database documenting premarket approval of electromagnetic devices between January 1, 2000 and October 31, 2018. Additionally, we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports of adverse events. Results: Thirty-one devices were approved from 2012-2018. Initially marketed to temporarily reduce muscle pain and cellulite, indications for these devices have expanded. The MAUDE database revealed 61 reports of adverse events including acute skin damage, dyspigmentation, infection, hair growth, scarring, and others. Discussion: Although electromagnetic devices are gaining increasing public attention and marketed to be safe, the frequency and types of adverse events are not well-documented. Importantly, the MAUDE database has limitations including submission of incomplete, inaccurate, untimely, or unverified data make determining the true number of adverse events difficult. Further investigation is greatly needed to define appropriate parameters and outcomes for the use of electromagnetic devices in body contouring and skin enhancement.