Researchers Warn Of Delayed Effects From Cosmetic Skin Fillers

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 Mir??-Mur; Miquel
Vilardell-Tarr?©s

Archives of Dermatology. (2008). 144[5]:637-642.

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Written by: Peter M Crosta