Quality evaluation of commercially available male condoms in Rio de Janeiro, Brazil, 2009-2011

Abstract

Background: The increased incidence of sexually transmitted infections (STIs) in Brazil represents a significant public health issue. This issue has raised awareness among health authorities regarding the quality of condoms. In Brazil, male condoms need to be certified. The certification process evaluates in detail the manufacturing and quality of the final product; however, post-market surveillance is not part of the normal certification practice. Methods: From 2009 to 2011, we evaluated 20 male condoms brands per lot of 8 manufactures-both domestic and imported-marketed in Rio de Janeiro, Brazil. Sampling was performed per ISO 2859-1, and the condoms were evaluated on length, width, thickness, holes, integrity of primary packaging, bursting volume, bursting pressure, label and secondary packaging, following the criteria established in the Brazilian National Health Oversight Agency Resolution no. RDC 62/2008. Results: Of the 20 evaluated brands, 17 brands were found to be noncompliant with the guidelines of the Brazilian National Health Oversight Agency Resolution no. RDC 62/2008 in at least one of the analyses performed. Conclusions: Any nonconforming unit has serious public health implications.