Poor quality male latex condoms found in Dominican Republic: Quality assurance evaluation and public health impact.

Abstract

Male condoms are important to prevent transmission of HIV (and other STIs) and unwanted pregnancies. Research was conducted to evaluate the quality of male condoms available in the Dominican Republic market based on preliminary concerns of suspect product. Based on international testing standards (ISO 4074 and ASTM D 3492-08), condoms were sampled across ten prominent brands within the market and evaluated for airburst pressure / volume, freedom from holes, visual defects, package seal integrity, packaging and marking, lubricant quantity, and dimensions. Five of the brands were found to have extensive quality problems, where holes were found in 5.7% to 17.5% of the condoms (depending on the brand). Between 5.1% and 30.5% of these condoms failed to meet the requirements for airburst properties, and violations in regulatory labeling where observed. Three additional brands were compliant for the other tests, but were found to have the same challenges with labeling violations as the previous five brands. Two brands were found to be fully compliant with all aspects of the evaluation. The level of defects observed in these samples would greatly increase the risk of HIV transmission (and other STIs) and unwanted pregnancies. When projected on the annual market of male condoms sold in the Dominican Republic (~26 million), potentially over 1 million condoms could be estimated to adversely impact the health risk of the end-user. These results prompted action by the Dominican Republic regulatory authorities to investigate and remove poor quality product from the market. This research study emphasizes the need for continued vigilance towards increased regulatory and market surveillance efforts to better protect public health interests.