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40
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Text
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<a href="http://doi.org/10.1080/09546634.2019.1587148" target="_blank" rel="noreferrer noopener">http://doi.org/10.1080/09546634.2019.1587148</a>
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Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
Pages
1-4
NEOMED College
NEOMED College of Medicine
NEOMED Department
NEOMED Student Publications
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
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Powered muscle stimulators: an investigation into newly FDA 510(k) approved devices marketed for muscle toning and esthetic benefit.
Publisher
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The Journal of dermatological treatment
Date
A point or period of time associated with an event in the lifecycle of the resource
2019
2019-02
Subject
The topic of the resource
premarket approval; 510(k); abdominal muscles; MAUDE; muscle blood flow; Muscle conditioning; muscle toning; pain relief; slendertone; transcutaneous electrical muscle stimulation
Creator
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Manudhane Albert P; Wang Sophie; Ezaldein Harib H; Scott Jeffrey F
Description
An account of the resource
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.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1080/09546634.2019.1587148" target="_blank" rel="noreferrer noopener">10.1080/09546634.2019.1587148</a>
2019
510(k)
abdominal muscles
Ezaldein Harib H
Manudhane Albert P
MAUDE
muscle blood flow
Muscle conditioning
muscle toning
NEOMED College of Medicine Student
NEOMED Student Publications
pain relief
premarket approval
Scott Jeffrey F
slendertone
The Journal of dermatological treatment
transcutaneous electrical muscle stimulation
Wang Sophie
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.7759/cureus.4230" target="_blank" rel="noreferrer noopener">http://doi.org/10.7759/cureus.4230</a>
Pages
5
Issue
3
Volume
11
ISSN
2168-8184
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Title
A name given to the resource
United States Food and Drug Administration's 510(k) Pathway: Drawing Implications from the Approvals of Brachytherapy Devices
Publisher
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Cureus
Date
A point or period of time associated with an event in the lifecycle of the resource
2019
2019-03
Subject
The topic of the resource
premarket approval; adverse events; cancer; General & Internal Medicine; radiotherapy; brachytherapy; radiation therapy; device malfunction; keloids; medical devices
Creator
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Wang S; Manudhane A; Ezaldein H H; Scott J F
Description
An account of the resource
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.
Identifier
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<a href="http://doi.org/10.7759/cureus.4230" target="_blank" rel="noreferrer noopener">10.7759/cureus.4230</a>
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Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2019
adverse events
brachytherapy
Cancer
Cureus
device malfunction
Ezaldein H H
General & Internal Medicine
June 2019 Update
keloids
Manudhane A
medical devices
NEOMED College of Medicine
NEOMED College of Medicine Student
NEOMED Student Publications
premarket approval
radiation therapy
Radiotherapy
Scott J F
Wang S
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1080/09546634.2019.1566589" target="_blank" rel="noreferrer noopener">http://doi.org/10.1080/09546634.2019.1566589</a>
Rights
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
Pages
1-3
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
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A review of the FDA's 510(k) approvals process for electromagnetic devices used in body contouring
Publisher
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The Journal of Dermatological Treatment
Date
A point or period of time associated with an event in the lifecycle of the resource
2019
2019-06
Subject
The topic of the resource
acne vulgaris; cellulite; cutaneous lesions; Electromagnetic devices; facial wrinkles; Google Trends; hair reduction; laser skin resurfacing; pigmented lesions; premarket approval; RF energy; vascular lesions
Creator
An entity primarily responsible for making the resource
Wang Sophie; Manudhane Albert; Ezaldein Harib H; Scott Jeffrey F
Description
An account of the resource
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.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1080/09546634.2019.1566589" target="_blank" rel="noreferrer noopener">10.1080/09546634.2019.1566589</a>
2019
Acne Vulgaris
cellulite
cutaneous lesions
electromagnetic devices
Ezaldein Harib H
facial wrinkles
Google Trends
hair reduction
June 2019 Update
laser skin resurfacing
Manudhane Albert
NEOMED College of Medicine
NEOMED College of Medicine Student
NEOMED Student Publications
pigmented lesions
premarket approval
RF energy
Scott Jeffrey F
The Journal of dermatological treatment
vascular lesions
Wang Sophie