Analysis of U.S. Food and Drug Administration Data on Soft-Tissue Filler Complications

2020 ◽  
Vol 46 (7) ◽  
pp. 958-961 ◽  
Author(s):  
Arisa E. Ortiz ◽  
Jusleen Ahluwalia ◽  
Silvia S. Song ◽  
Mathew M. Avram

2020 ◽  
Author(s):  
Heather R. Faulkner

The preferred methods for facial rejuvenation have been changing over the past decade, with operative procedures on the decline and minimally invasive, office-based procedures on the rise. As a result, it is critical for plastic surgery practitioners to understand the intricacies of the use of neuromodulators and soft tissue fillers in this milieu. While these procedures are usually performed in an office, without general anesthesia, the risk of significant complications still exists. The knowledge of facial anatomy, techniques, and pitfalls is essential for achieving high quality, predictable, and reproducible results. Likewise, when a complication arises, prompt recognition and appropriate treatment is paramount. In this chapter, the history, purpose, technical guidelines, and complications of adjunctive techniques for facial rejuvenation are reviewed in detail. This review contains 2 tables, and 52 references. Keywords: facial rejuvenation, neuromodulator, soft tissue filler, botulinum toxin, dermal filler, aging face, facial rhytids, filler complications, glabellar lines, nasolabial fold 



2009 ◽  
Vol 35 ◽  
pp. 1672-1680 ◽  
Author(s):  
ANTHONY P. SCLAFANI ◽  
STEVEN FAGIEN


2002 ◽  
Vol 30 (3) ◽  
pp. 474-476

In a rare step, the U.S. Food and Drug Administration (FDA) in August ordered Cryolife Corporation to recall all human soft tissue it had processed since October of last year, stating that the safety of Cryolife products could not be assured. Although a subsequent agreement between the FDA and Cryolife led to a limited relaxation on the recall order for “medically urgent uses when alternative therapies are exhausted or unavailable,” the sale of Cryolife soft tissue remains severely restricted. Cryolife insists that its procedures are safe and that its overall rates of infection are extremely low, and is appealing the FDA recall?Cryolife is the nation’s largest processor of donated human tissue, and supplies 15 to 20 percent of the market for soft tissue implants. Such implants are widely used in elective orthopedic surgery: about 650,000 Americans have surgery involving soft tissue implants each year. Cryolife also processes 70 percent of the country’s heart valves.



2010 ◽  
Vol 125 (4) ◽  
pp. 1250-1256 ◽  
Author(s):  
Rod J. Rohrich ◽  
Gary Monheit ◽  
Alexander T. Nguyen ◽  
Spencer A. Brown ◽  
Steven Fagien






2018 ◽  
Vol 42 (2) ◽  
pp. 498-510 ◽  
Author(s):  
Fernando Urdiales-Gálvez ◽  
Nuria Escoda Delgado ◽  
Vitor Figueiredo ◽  
José V. Lajo-Plaza ◽  
Mar Mira ◽  
...  


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