[Traceability of a resorbable implant for lipoatrophy: why should it be traced and how should this be done? Example of polylactic acid (Newfill)].

Med Mal Infect

Service de pharmacie, hôpital Saint-Louis, APHP, 1, avenue Claude-Vellefaux, 75475 Paris cedex 10, France.

Published: December 2007

Facial lipoatrophy is a frequent adverse effect of HIV-infected patients due to antiretroviral therapy. Intradermal injection of polylactic acid (Newfill) is one of the currently available treatments. Newfill is a resorbable implant and follow-up has to be rigorous. The Pharmacy and the Infectious Diseases units at the Saint-Louis hospital implemented a follow-up procedure. A follow-up of treated patients was made for 20 months. 127 patients were included. The rate of traceability was 100%. Such traceability is therefore feasible and will have to be implemented for the follow-up of patients treated with future filling products.

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http://dx.doi.org/10.1016/j.medmal.2007.09.006DOI Listing

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