Dr. Alster: Bruising Affects 67% of Dermal Filler Patients

World-renowned dermatologist Dr. Tina Alster is the founding director of the Washington Institute of Dermatologic Laser Surgery. Dr. Alster has published hundreds of articles and holds leadership and board positions in numerous professional and national organizations. 

Bruising from dermal filler procedures can be a more common side effect than patients anticipate. According to the FDA studies cited in the Juvéderm and Restylane package instructions for use, approximately 67% of all dermal filler patients bruise, with 26% of all patients suffering from bruising that lasted for more than seven days. These FDA clinical trials involved 2,600 patients and were conducted by some of the nation’s top injectors, demonstrating that bruising is prevalent no matter how skilled a practitioner is.

In many cases, recovery depends more on the location for injection than on the injector’s skill. Dermal filler studies around the lips report the highest level of bruising at 80% of patients bruising based on five studies that reviewed a total of more than 700 patients. The average data from four studies of a total of over 530 cheek filler patients reported that 70% of patients bruised. On average, nasolabial fold filler patients experienced bruising the least often—the average data from 12 studies of 1,400 total patients showed that 61% of patients reported bruising.

This data includes four dermal fillers approved in the past two years, which had an average patient-reported bruising rate of 67%. Below are images from the package inserts with the associated links for the four dermal fillers approved by the FDA in the last two years.

 

Table 1: Photo of Package Inserts for Restylane Refyne

In this FDA study, 170 subjects were evaluated in a randomized, double-blinded, split-face trial to compare Restylane Refyne to a non-lidocaine-containing control.

 

Table 2: Photo of Package Inserts for Juvéderm Volbella XC

A multicenter, double-blind clinical trial to evaluate the safety and effectiveness of Juvéderm Volbella XC versus Restylane-L® (control) for lip augmentation and correction of perioral rhytids.

  

 

 

Table 3: Photo of Package Inserts for Restylane Defyne

In this study, 162 subjects were enrolled in a randomized, double-blinded split-face comparison to evaluate the safety and effectiveness of Restylane Defyne vs. a non-lidocaine-containing comparator.

Table 4: Photo of Package Inserts for Juvéderm Vollure XC

In a multicenter, randomized, double-blind controlled clinical trial to evaluate the safety and effectiveness of Juvéderm Volbella XC for the correction of moderate to severe nasolabial folds (NLFs), 123 subjects received treatment with Juvéderm Volbella XC in 1 NLF and control in the other NLF.

To review the data from all Juvéderm and Restylane, the IFUs can be accessed here:

http://hcp.juvederm.com/directionforuse

https://www.restylaneusa.com/hcp

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