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Incidence of late reactions to Juvéderm Volbella higher than expected

Patients in Israel who received injections of Juvéderm Volbella in the tear trough area or lips had a higher than expected incidence of late cutaneous reactions, according to study results.

Researchers examined the medical records of 400 patients (360 women; average age, 49.6 years) who were treated with Juvéderm Volbella (hyaluronic acid; HA-Vb) filler at four medical centers in Israel. There were 350 patients who had the filler injected in the tear trough area or lips. The patients were injected with other hyaluronic acid-based products in other areas of the face. 

Seventeen patients (4.25%) developed inflammatory cutaneous reactions to HA-Vb. The overall period of reaction ranged from1.5 months to 11 months, and patients experienced an average of 3.17 recurrences. The average onset of the reaction was 8.41 weeks after the injection. The patients were generally healthy and did not have a history of autoimmune disease or former injections of permanent filler.

Eight patients were treated with one product besides HA-Vb, four patients were treated with two additional products and three patients with three additional products. All products were injected at the same time in 11 patients, whereas in the remaining patients, HA-Vb filler was injected up to 6 months after treatment with different fillers.

The 17 patients were treated with oral ciprofloxacin (500mg to 750 mg twice a day) for 3 to 4 weeks. All symptoms receded in six patients, but 11 patients developed recurrent inflammatory reactions.

“The reaction rate was higher (17 of 400 [4.25%]) than the accepted safety threshold of 0.02% for [hyaluronic acid]-based fillers and much her than previously experienced by the authors in previous years,” the researchers wrote.

“Although the incidence of late-onset reactions to [hyaluronic acid]-based fillers is reportedly low, the authors believe that prevalence of such reactions is higher and is influenced by several parameters, including the number and volume of [hyaluronic acid]-based gel injections, the nature of product injected, and possibly individual factors,” the researchers concluded. “The authors believe HA-Vb to be more immunogenic than other [hyaluronic acid]-based gels and the same time more resistant to degradation by hyaluronidase.” – by Bruce Thiel

Disclosure: The researchers report no relevant financial disclosures.