Plastic Surgery Articles

A small research project conducted by Spanish physicians has raised concerns about the use of polyalkylimide gel as cosmetic filler material for facial improvements.  This particular filler is used primarily in Europe, although it is seeing increased use in the United States. 

Like the popular fillers used for cosmetic facial purposes in the United States, the purpose of polyalkylimide injections is to smooth out the wrinkles and lines formed naturally through the aging process.  However unlike collagen or Botox which dissipate over a period of months, polyalkylimide gel is meant to be a permanent implant.  The manufacturers claim polyalkylimide to have greater stability, better integration with living tissues and simple removal if required. It is non-biodegradable.

The gel’s manufacturer claims that polyalkylimide gel does not change its chemical structure over time and will not move or migrate once implanted.  While there have not been many reports of injection recipients having difficulty with the results immediately, the study in Spain has turned up a pattern of delayed reactions to the injections that are characterized by “immune related” adverse affects.  Further, the report asserts that a small but significant number of cases showed distant reactions to the gel, indicating systemic adverse impacts of the procedure.

The physicians conducted a thorough analysis of twenty five patients who had received polyalkylimide injections and had developed adverse reactions over twelve months (an average of 13.4 months) after the procedure.  Reactions included hardening of the material and swollen or tender lesions near the injection site.  Systemic reactions included dry eyes or mouth; fever, and arthritic symptoms.

All of these suggest to the physicians that the body’s autoimmune function was attempting to reject the implants.  Twenty of the patients exhibited tender or inflamed lesions; six of them had some sort of systemic reaction to the gel.  None of them had exhibited adverse reactions to the implants for the first year following the injection procedures.  After a twenty one month period of follow-up observation, eleven of the patients had lost the symptoms of adverse reaction while ten were still having “recurrent bouts.”

The immediate conclusion of the report is that polyalkylimide gel may not be the safe and permanent choice for cosmetic injections that its manufacturers purport it to be.  Beyond that, there are only educated guesses.  There is general agreement that the reactions to the material, because of the delayed reaction, are probably induced by the immune system.  The fact that there were reactions unrelated to the injection site suggest that there is potential for systemic reaction, if not actual movement of the injection material.

The doctors acknowledge that theirs is a very small sample, but they consider the severity and (in some cases) systemic reactions to be important signals of a potential health problem with the polyalkylimide facial injection procedures.  The delayed reaction suggests some complex physiological occurrences; these injections are perhaps not the simple insertion of a benign artificial filler material.

Their report does not take into account the total number of these cosmetic facial procedures that were administered during the period that their study participants were treated.  For that reason, they suggest that while the immune-related and systemic reactions to this material may be infrequent, it is nonetheless an established possibility.  They also note that collagen and other cosmetic facial fillers are known to induce adverse reactions in some recipients.

The study was conducted by Dr. Jaume Alijotas-Reig, MD, PhD, of Vall d’Hebron University Hospital and Autonomous University of Barcelona, Spain and colleagues practicing in the area.  The report was published in the May issue of Archives of Dermatology; a summary of the document was also put out as a press release by the Journal of the American Medical Association.