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

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 aesthetic, 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. PMID: 30799667 [PubMed - as supplied by publisher]
Source: Journal of Dermatological Treatment - Category: Dermatology Tags: J Dermatolog Treat Source Type: research

Related Links:

ConclusionPortal and mesenteric venous thrombosis after laparoscopic sleeve gastrectomy is an unusual complication but it has life threatening consequences if it is not diagnosed early and treated adequately. The patients with porto-mesenteric venous thrombosis (PMVT) usually present themselves with vague abdominal symptoms. As so, the physicians should have high index of suspicion to recommend computed tomography (CT) abdomen to confirm diagnosis and start adequate treatment.
Source: International Journal of Surgery Case Reports - Category: Surgery Source Type: research
CONCLUSION: Despite early diagnosis and management of this rare injury, the prognosis for functional recovery is guarded and largely dictated by the extent of neurological injury in the setting of concomitant brachial plexopathy. Brachial plexopathy is highly associated with axillary artery injury and its impact often underestimated in comparison due to its non-limb-threatening nature in the acute setting. Future studies should focus on the long-term prognosis for functional recovery in patients with this rare injury pattern. PMID: 31525793 [PubMed - as supplied by publisher]
Source: Zeitschrift fur Orthopadie und Unfallchirurgie - Category: Orthopaedics Tags: Z Orthop Unfall Source Type: research
CONCLUSIONS: There is very low-certainty evidence regarding the use of GECS for treatment of PTS as assessed by two small studies of short duration. One study reported beneficial haemodynamic effects, while one found no benefits on PTS severity compared to control/placebo stockings. There is very limited evidence for adverse effects, patient satisfaction, QoL, and compliance rates. There is low-certainty evidence favouring use of intermittent pneumatic compression devices compared to a control device for the treatment of severity owing to different measurements used by the studies reporting on this outcome and small studie...
Source: Cochrane Database of Systematic Reviews - Category: General Medicine Authors: Tags: Cochrane Database Syst Rev Source Type: research
A 40-something male with no PMH of any kind presented  to urgent care on a weekend (cath team is at home) with cough starting 2 weeks prior and SOB one week prior.He underwent a chest x-ray:As this was consistent with " pulmonary edema vs. viral infection, " and he was transferred to the EDThe faculty physician did an immediate cardiac and lung ultrasound:Many B lines (probable pulmonary edema)Parasternal short axis cardiac ultrasound:The anterior wall is closest to the transducer and shows an obvious wall motion abnormalityFurther history:The patient denied chest pain but stated that he had had ab...
Source: Dr. Smith's ECG Blog - Category: Cardiology Authors: Source Type: blogs
The patient is an 49-year-old male who was referred to our tertiary centre for management of a large left renal mass. He had been   evaluated elsewhere for vague left side abdominal pain and contrast enhanced computed tomography (CT) of his abdomen had revealed a large left renal mass with level III inferior vena caval (IVC) thrombus and regional adenopathy(Figure 1A,B). He denied any history of recent acute weight loss and h is body mass index was 26.4 Kg/m2.Review of the CT images showed that the left renal vein which had the tumour thrombus was retro-aortic in position .
Source: Urology - Category: Urology & Nephrology Authors: Tags: Invited grand rounds Source Type: research
r M Abstract OBJECTIVE: Fast track concepts are used to reduce the risk of perioperative and postoperative complications after total knee arthroplasty. INDICATIONS: The described concepts are used for patients with indications for the implantation of a total knee prosthesis. CONTRAINDICATIONS: Contraindications for fast track concepts are aged patients, dementia, American Society of Anesthesiologists (ASA) grade IV and implantation of large revision or tumor prostheses. Contraindications for tranexamic acid are bleeding in the urinary tract, caution in cases of known epilepsy, individual risk assessment ...
Source: Operative Orthopadie und Traumatologie - Category: Orthopaedics Authors: Tags: Oper Orthop Traumatol Source Type: research
We report a case of intolerance to warfarin. A 20-year-old woman with toe pain was diagnosed as myxoma with multiple systemic embolism. She was prescribed warfarin for remaining embolic pain after myxoma excision and mitral annuloplasty. Even on 1 mg of warfarin, INR was much increased. The patient have the Cytochrome P450 2C9 (CYP2C9)*3/*3 and vitamin K epoxide reductase complex subunit 1 (VKORC1) 1639AA genotype, extremely rare in Koreans. Based on this result, we assessed the potential risks and benefits of warfarin, and decided to switch to aspirin because the risk of bleeding was considered to be too high.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
We describe two Japanese brothers with immunoglobulin-A vasculitis (IgAV) who met the diagnostic criteria of LAHPS. They presented with palpable purpura and abdominal pain, and had a prolonged activated partial thromboplastin time (APTT) and prothrombin deficiency with the presence of lupus anticoagulant. Pediatric LAHPS was reviewed in abstracts from the Japan Medical Abstracts Society that were written in Japanese and PubMed or Web of Science-listed articles in English between 1996 and 2019. Including our cases, pediatric LAHPS has been reported in 40 Japanese and 46 non-Japanese patients. We summarized the clinical and ...
Source: Rheumatology International - Category: Rheumatology Source Type: research
We report a case of intolerance to warfarin. A 20-year-old woman with toe pain was diagnosed as myxoma with multiple systemic embolism. She was prescribed warfarin for remaining embolic pain after myxoma excision and mitral annuloplasty. Even on 1 mg of warfarin, INR was much increased. The patient have the Cytochrome P450 2C9 (CYP2C9)*3/*3 and vitamin K epoxide reductase complex subunit 1 (VKORC1) 1639AA genotype, extremely rare in Koreans. Based on this result, we assessed the potential risks and benefits of warfarin, and decided to switch to aspirin because the risk of bleeding was considered to be too high. PMID: ...
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Ann Thorac Surg Source Type: research
Publication date: Available online 5 September 2019Source: Urology Case ReportsAuthor(s): William Ong Lay Keat (MBBS, Shamsuddin Omar(FRCS), Han Pei Kwong (FRCS)Abstract:Acute scrotal pain is a common urological emergency where clinical judgement plays pivotal role in making the diagnosis. Scrotal pain secondary to spontaneous pampiniform plexus thrombosis is rare, and we are the first who report in the Asian region.
Source: Urology Case Reports - Category: Urology & Nephrology Source Type: research
More News: Databases & Libraries | Dermatology | Marketing | Pain | Skin | Study | Thrombosis | USA Health