Hylaform Side Effects Center

SIDE EFFECTS

Clinical Evaluation of Hylaform Gel

In a randomized, controlled clinical trial to evaluate the safety and effectiveness of Hylaform gel as a dermal filler for nasolabial folds, 261 patients 30 to 55 years of age were randomized between the treatment (Hylaform) and the control (Zyplast) implant. During the initial phase of the study, each patient was injected with the respective dermal filler in the nasolabial folds for wrinkle correction. Patients were followed for 12 weeks. Following completion of the initial phase, each of the patients who initially received Hylaform gel treatment was offered repeat treatment with Hylaform products in both nasolabial folds and evaluated for safety for an additional 4 weeks.

Initial Treatment Phase

Adverse events reported during the 12 weeks following treatment were categorized according to the reported severity (see Table 1).

Table 1 : Injection Procedure Related Adverse Events by Maximum Severity Occurring in > 5% of Patients [Number (%) of Patients]

Table 2: Duration of Procedure or Device Related Events Occurring in Greater thaii 5% of Patients

Device related adverse events occurred infrequently in both groups and were primarily of mild intensity; 2 patients (2%) experienced 3 events in the Hylaform group, and 9 patients (7%) experienced 14 events in the Zyplast group. The Hylaform device related adverse events were erythema, induration and pruritus.

Clinical trial adverse events unrelated to the injection procedure reported in the Hylaform treatment group occurring in greater than 1% of patients (n=133) were nasopharyngitis (5.3%), headache (4.5%), influenza (3.8%), rash (3%), conjunctivitis (1.5%), and sinusitis (1.5%).

Repeat Treatment Phase

During the initial and repeat treatment phases of the study, hylan B IgG antibody titers were measured at baseline and throughout treatment. Only one patient exhibited a positive antibody response after treatment with hylan B. This patient experienced adverse events of injection site bruising and headache lasting 11 days and 2 days after initial treatment, respectively. These adverse events were not reported as device-related and were not considered to be associated with the increased antibody titer level. None of the other study patients developed similar increases in antibody titer levels during the initial or repeat study phases.

Of the 133 patients treated with Hylaform gel during the initial phase, 96 underwent repeat treatment with Hylaform products and were followed for up to 4 weeks for safety. The types of adverse events seen after repeat treatment with Hylaform products were similar to those seen during the initial clinical evaluation. The most frequently reported adverse events included injection site erythema, bruising, swelling, pain, nodules, pruritus and tenderness. Device-related adverse events were reported in 3 patients during repeat treatment with Hylaform gel and included involuntary muscle contraction described as eye fasciculations in one patient and dizziness in another. A third patient experienced bilateral aseptic abscess formation at the site of injection, but did not develop increased hylan B antibody titers throughout either the initial or repeat phase of the study.

Surveillance outside the US

Hylaform post market safety surveillance in countries outside of the United States indicates that the most frequently reported adverse events include: injection site erythema, nodule, swelling, and induration. These adverse events are similar in frequency and duration to what has been noted during clinical trials.

Read the entire FDA prescribing information for Hylaform (Hylan B Dermal Filler Gel)