Spanish researchers studying cosmetic skin fillers have found that polyalkylimide implants may lead to potentially severe, adverse immune-related effects that appear months after the procedure. Their research is published in a recent issue of the Archives of Dermatology.
Consisting of a gel and water compound, polyalkylimide implants are designed to augment lips, cheeks, the forehead, and lines that develop between the nose and mouth called nasolabial folds. Researcher Jaume Alijotas-Reig, M.D., Ph.D. (Vall d’Hebron University Hospital and Autonomous University of Barcelona, Spain) and colleagues note that, “According to the manufacturer’s information, polyalkylimide structures do not change over time and do not move or migrate. In the early reports on polyalkylimide implant injections for cosmetic purposes, there were no significant signs of bioincompatibility [rejection of or reaction to the foreign material]. However, more recent evidence refutes these statements, and so the complete safety of polyalkylimide implant gels can no longer be assured.”
The researchers assessed 25 patients who had polyalkylimide implant injections and presented adverse effects at one year or longer after the procedure. The patients showed a variety of reactions such as: swelling, hardening and swollen or tender nodules (skin lesions) around the site of injection, and systemic events such as fever, arthritis and dry eyes or mouth.
The authors found that eight of the patients, “were previously injected with another implant. Tender inflammatory nodules were seen in 24 patients. Systemic or distant manifestations appeared in six 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.”
It is unknown, however, exactly how prevalent these tardy adverse effects are. One reason is that many physicians fail to report negative events, leaving researchers without complete information about patients who underwent similar procedures in the same time period.
“Although infrequent, delayed, moderate to severe immune-mediated adverse effects may be caused by polyalkylimide implants, occasionally with systemic manifestations,” add the authors. “Perhaps in predisposed hosts, the use of more than one source of dermal filler may increase the risk of the onset of delayed immune-mediated reactions related to bioimplants.
“Considering the increased use of polyalkylimide implants in European countries and in the United States, physicians should be aware that intermediate or delayed adverse effects can occur with polyalkylimide implants just as they can with collagen, polyacrylamide, polylactic acid or methacrylate,” they conclude.
Delayed Immune-Mediated Adverse Effects of Polyalkylimide Dermal Fillers: Clinical Findings and Long-term Follow-up
Jaume Alijotas-Reig; Victor Garcia-Gimenez; Francesc Miró-Mur; Miquel Vilardell-Tarrés
Archives of Dermatology. (2008). 144[5]:637-642.
Written by: Peter M Crosta