Eight-Year Postmarket Safety Surveillance of Delayed Complications With a Flexible Lip Filler

AbstractTransorbital orbitofrontal penetrating injury by a nonmissile object is uncommon. The presentation of this injury varies. This injury can be easily missed during the initial clinical presentation, because the foreign body is sometimes not visible on local examination, the wound on the orbital skin is small, and very subtle signs are present. The patient can present with delayed complications of the primary injury. Our patient was a 33-year-old male who presented with an orbitofrontal injury with a meat hook. He had minor symptoms at the time of presentation, which were overlooked. Three weeks later, he developed signs and symptoms of raised intracranial pressure (ICP). Brain imaging revealed a peripheral rim of contrast-enhancing mass lesion in the right frontal lobe, extending into the right orbit with perilesional edema suggestive of posttraumatic brain abscess. Via right frontal craniotomy, pus was drained out and abscess wall was excised. The patient made good clinical recovery. A higher index of suspicion and sound knowledge of occult penetrating injury patterns is required in the cases of orbital injuries. Appropriate radiological imaging can lead to an earlier and accurate diagnosis, and can prevent its delayed sequela like brain abscess.

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Nonvascular Complications of Injectable Fillers—Prevention and Management

Indian Journal of Plastic Surgery ◽

10.1055/s-0040-1721872 ◽

2020 ◽

Vol 53 (03) ◽

pp. 335-343

Author(s):

Kuldeep Singh ◽

Shahin Nooreyezdan

Keyword(s):

Early Recognition ◽

Treatment Options ◽

Treatment Strategies ◽

Vascular Complications ◽

Physical Characteristics ◽

Clear Understanding ◽

Type Iv ◽

Acute Infections ◽

Tyndall Effect ◽

Delayed Complications

AbstractInjectable filler treatments have increased in popularity because of enhanced safety profile and improved physical characteristics. ISAPS (International Society of Plastic Surgery) put out global data showing 3.7 million hyaluronic acid (HA) filler procedures in 2018, making it the second most often performed procedure in the world, after botulinum toxin. And these are only ‘those’ performed by qualified plastic surgeons. There was a concomitant increase in both the nonvascular and vascular complications, which coincided with the number and type of filler procedures performed. Filler complications were reviewed from existing literature, and an attempt was made to understand etiology, elucidate clinical features, and clarify optimum treatment strategies for each. Complications can be early or delayed in presentation, early consisting of injection site complications like bruising, edema, and hypersensitivity, Tyndall effect, and intravascular injection. Delayed complications included hypersensitivity type IV, acute infections like cellulitis, abscesses, and herpes and delayed ones like granulomas, biofilms, and atypical mycobacterial infections. These were analyzed and treatment options, protocols, and consensus guidelines were suggested. A clear understanding of facial anatomy, physical characteristics of all fillers used, early recognition, and treatment options of complications will ensure optimum outcomes.

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Imaging strategies for safety surveillance after renal artery denervation

Clinical Research in Cardiology ◽

10.1007/s00392-021-01819-w ◽

2021 ◽

Author(s):

Debbie L. Cohen ◽

Ido Weinberg ◽

Seth Uretsky ◽

Jeffrey J. Popma ◽

Alexandra Almonacid ◽

...

Keyword(s):

Renal Artery ◽

Safety Surveillance ◽

Renal Artery Denervation

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Review of COVID-19 mRNA Vaccines: BNT162b2 and mRNA-1273

Journal of Pharmacy Practice ◽

10.1177/08971900211009650 ◽

2021 ◽

pp. 089719002110096

Author(s):

Shyh Poh Teo

Keyword(s):

Vaccine Development ◽

Safety Data ◽

The United States ◽

Virus Infections ◽

Phase 3 ◽

Vaccination Programs ◽

Safety Surveillance ◽

Mass Immunization ◽

United States Food ◽

States Food

The United States Food and Drug Administration recently issued emergency use authorization for 2 mRNA vaccines for preventing COVID-19 disease caused by SARS-CoV-2 virus infections. BNT162b2 from Pfizer-BioNTech and mRNA-1273 by Moderna are planned for use in mass-immunization programs to curb the pandemic. A brief overview of COVID-19 mRNA vaccines is provided, describing the SARS-CoV-2 RNA, how mRNA vaccines work and the advantages of mRNA over other vaccine platforms. The Pfizer-BioNTech collaboration journey to short-list mRNA vaccine candidates and finally selecting BNT162b2 based on safety data is outlined, followed by the Phase 3 study of BNT162b2 demonstrating 95% efficacy in preventing COVID-19 infections. Studies regarding mRNA-1273 (Moderna) are described, including extended immunogenicity data up to 119 days. The Phase 3 COVE study of mRNA-1273 eventually showed vaccine efficacy of 94.5%. Recommendations for future mRNA vaccine development are provided, including ongoing safety surveillance, evaluation in under-represented groups in previous studies and improving mRNA vaccine thermostability. Finally, further logistical considerations are required for manufacturing, storing, distribution and implementing mass vaccination programs to curb the pandemic.

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GLM-Based Flexible Monitoring Methods: An Application to Real-Time Highway Safety Surveillance

Symmetry ◽

10.3390/sym13020362 ◽

2021 ◽

Vol 13 (2) ◽

pp. 362

Author(s):

Arshad Jamal ◽

Tahir Mahmood ◽

Muhamad Riaz ◽

Hassan M. Al-Ahmadi

Keyword(s):

Real Time ◽

Control Charts ◽

Negative Binomial ◽

Highway Safety ◽

Monitoring Methods ◽

Count Data Models ◽

Crash Data ◽

Safety Surveillance ◽

Study Results ◽

Best Fit

Statistical modeling of historical crash data can provide essential insights to safety managers for proactive highway safety management. While numerous studies have contributed to the advancement from the statistical methodological front, minimal research efforts have been dedicated to real-time monitoring of highway safety situations. This study advocates the use of statistical monitoring methods for real-time highway safety surveillance using three years of crash data for rural highways in Saudi Arabia. First, three well-known count data models (Poisson, negative binomial, and Conway–Maxwell–Poisson) are applied to identify the best fit model for the number of crashes. Conway–Maxwell–Poisson was identified as the best fit model, which was used to find the significant explanatory variables for the number of crashes. The results revealed that the road type and road surface conditions significantly contribute to the number of crashes. From the perspective of real-time highway safety monitoring, generalized linear model (GLM)-based exponentially weighted moving average (EWMA) and cumulative sum (CUSUM) control charts are proposed using the randomized quantile residuals and deviance residuals of Conway–Maxwell (COM)–Poisson regression. A detailed simulation-based study is designed for predictive performance evaluation of the proposed control charts with existing counterparts (i.e., Shewhart charts) in terms of the run-length properties. The study results showed that the EWMA type control charts have better detection ability compared with the CUSUM type and Shewhart control charts under small and/or moderate shift sizes. Finally, the proposed monitoring methods are successfully implemented on actual traffic crash data to highlight the efficacy of the proposed methods. The outcome of this study could provide the analysts with insights to plan sound policy recommendations for achieving desired safety goals.

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