Delayed immune-mediated adverse effects of polyalkylimide dermal fillers -: Clinical findings and long-term follow-up

Objective: To evaluate the clinical complaints, laboratory data, treatment, and follow-up of patients with delayed adverse effects related to polyalkylimide implants (PAIs). Design: Prospective case series of patients injected with PAIs. Setting: A university tertiary teaching hospital. Patients: A prospectively acquired series of 25 patients with severe and/or persistent delayed adverse effects after PAI injection. The patients underwent clinical follow-up, a battery of blood tests, and when possible, biopsy and chest radiography. Main Outcome Measures: Clinical evaluation of granulomas, skin manifestations, and other local and systemic immune-mediated disorders possibly related to PAIs. Results: The average latency period for onset of symptoms was 13.4 months. Eight patients were previously injected with another implant. Tender inflammatory nodules were seen in 24 patients. Systemic or distant manifestations appeared in 6 cases. Laboratory abnormalities were found in 20 cases. After an average of 21.3 months of follow-up, 11 patients appeared to be free of adverse effects, and 10 still had recurrent bouts. Conclusion: Although infrequent, delayed and recurrent chronic inflammatory and granulomatous reactions may complicate PAI fillers.