PMID- 25399626
OWN - NLM
STAT- MEDLINE
DCOM- 20150714
LR  - 20220331
IS  - 1473-2165 (Electronic)
IS  - 1473-2130 (Linking)
VI  - 13
IP  - 4
DP  - 2014 Dec
TI  - Review of the safety profile for microfocused ultrasound with visualization.
PG  - 329-35
LID - 10.1111/jocd.12111 [doi]
AB  - The Safety of Microfocused Ultrasound with Visualization (MFU-V) has been well 
      established in both controlled clinical studies and in clinical use, showing only 
      mild and transient anticipated side effects and only rare unanticipated adverse 
      events (AEs). This publication discusses the safety profile of MFU-V based on 
      data from a variety of sources. Reports of side effects and AEs were obtained 
      from published peer-reviewed medical literature, clinical studies, in-market use 
      reports (AEs reported to the manufacturer), and retrospective chart reviews of 
      patient treatments. Events that were typical included tenderness, redness, and 
      slight edema. Rare events included bruising, welting, and nerve-related effects 
      (paresthesia and paresis). Rare incidence of surface thermal effects was seen in 
      some cases where improper technique was used. In all cases where the device was 
      uses properly, the safety events reported tended to be transient, mild in nature, 
      and resolved without sequelae. In general, unexpected and rare AEs could be 
      attributed to incorrect treatment technique or classified as unrelated to MFU-V 
      treatment. Side effects that do occur are generally mild and transient in nature. 
      MFU-V consistently allows for safe treatment when correct treatment technique is 
      used.
CI  - (c) 2014 The Authors Journal of Cosmetic Dermatology Published by Wiley 
      Periodicals, Inc.
FAU - Hitchcock, Thomas M
AU  - Hitchcock TM
AD  - Ulthera, Inc., Mesa, AZ, USA.
FAU - Dobke, Marek K
AU  - Dobke MK
LA  - eng
PT  - Journal Article
PL  - England
TA  - J Cosmet Dermatol
JT  - Journal of cosmetic dermatology
JID - 101130964
RN  - 0 (Anesthetics, Local)
RN  - 98PI200987 (Lidocaine)
SB  - IM
MH  - Anesthetics, Local/administration & dosage
MH  - Clinical Trials as Topic
MH  - Contusions/etiology
MH  - Edema/etiology
MH  - Erythema/etiology
MH  - Humans
MH  - Lidocaine/administration & dosage
MH  - Product Surveillance, Postmarketing
MH  - Review Literature as Topic
MH  - *Skin Aging
MH  - Ultrasonic Therapy/*adverse effects
OTO - NOTNLM
OT  - microfocused ultrasound
OT  - safety
OT  - tissue lifting
EDAT- 2014/11/18 06:00
MHDA- 2015/07/15 06:00
CRDT- 2014/11/18 06:00
PHST- 2014/04/13 00:00 [accepted]
PHST- 2014/11/18 06:00 [entrez]
PHST- 2014/11/18 06:00 [pubmed]
PHST- 2015/07/15 06:00 [medline]
AID - 10.1111/jocd.12111 [doi]
PST - ppublish
SO  - J Cosmet Dermatol. 2014 Dec;13(4):329-35. doi: 10.1111/jocd.12111.