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

Male condoms serve a dual function by protecting against both pregnancy and sexually transmitted infections (STIs) [1‐4]. The incidence of STIs has increased in Brazil and now represents a significant public health issue. This increase is predominantly due to low socioeconomic status, poor cultural conditions, and lack of adequate sex education, particularly among young individuals. Today, STIs are among the most common diseases worldwide [5, 6]. For example, of the 656.701 cases of AIDS in Brazil identified from 1980 to June 2012, 61.400 (9.3%) were reported per the case definition for death criteria consisting of 41.459 (67.5%) males and 19.933 (32.5%) females [6]. Figure 1 shows percentage distribution of AIDS cases by region of residence (Brazil, 1980–2011).

A critical analysis of the Brazilian response to fight HIV/AIDS emphasized the importance of integrating prevention, care, and treatment under the Unified Health System [Sistema Único de Saúde (SUS)] with reference to human rights [7].

Globally, the health impact of STIs has led to the allocation of substantial funds for treatment of young individuals in a range of countries. The World Health Organization (WHO) estimated the rise in incidence of curable STIs in Brazil from 10 million to 12 million annually, covering the age group of 15–49 years [8].

In Brazil, the use of condoms remains an important prevention policy. The Ministry of Health, in response to the increase in cases of STIs and the consideration of the potential consequences, evaluated inconsistencies in the quality of condoms and the disinterest in the use of condoms throughout the population. To remedy this, postexposure prophylaxis has been introduced for the treatment of all high-risk individuals following sexual intercourse (vaginal, anal and oral) since October 2010. This involves the administration of medications up to 72 h after sexual intercourse if condoms were not used or had failed during intercourse [9].

The quality of latex condoms may vary according to the lot, differences in manufacturing technology and the batch of manufacture, resulting in considerable quality variation. From the point of view of contraception, the condom would fail on the order of 15 to 100 on the Pearl Index, i.e., 15 pregnancies in 100 women who use the method each year [10].

The tests established in RDC 62/2008 for the evaluation of condoms include the measurement of dimensional properties (length, width, and thickness), bursting volume, and bursting pressure, in addition to inspection for the detection of holes or other defects. Labeling accuracy and packaging integrity were additionally evaluated. Sampling procedures were performed according to the ISO 2859–1 sampling plans for inspection by attributes through the lot size, the number of units to be evaluated, the acceptance criteria, and the acceptable quality level of acceptable qualities for each type of test, in addition to inspection levels [11].

The male condom is a simple, inexpensive, and widely used material used to prevent unwanted pregnancy and transmission of STIs, but it requires sophisticated oversight by governmental institutions to ensure quality. In this regard, the actions of sanitary surveillance post-marketing have become essential in monitoring condoms for reducing potential public health risks [12].

The objective of the present study was to evaluate the physical quality of condoms marketed in Rio de Janeiro, Brazil.

One out of 600 units from each brand was collected for the post-marketing surveillance, and we evaluated 20 domestic and imported condom brands per lot from eight manufacturers marketed in Rio de Janeiro. The condoms were anonymized by marking them with the letters A through H corresponding to each manufacturer and the numbers 1 through 20 for each brand. Condoms were tested according to the standards established by the Brazilian National Health Oversight Agency Resolution no. RDC 62/2008 [11]. Table 1 shows the number of samples necessary to carry out each test, the acceptable quality level from each test and the criteria established in RDC 62 for the quality control testing of condoms. The ISO 2859–1 sampling procedures for inspection by attributes define the acceptance criteria, the level of inspection (I, II, or III) and the inspection regime based on the size of the lot [13].

Evaluated dimensional properties include condom length, width and thickness, which generally range from 160 to 200, 45 to 60 and 0.03 to 0.09 mm, respectively. Condom width defines condom size and is primarily determined by the circumference (twice the flat width) [11].

Of all the tests performed, the absence of holes is considered the most important and can be performed using an electrical or visual method. The electrical method involves the filling of suspended condoms with an electrolytic aqueous solution of sodium hydroxide, and then the passage of an electric current is used to indicate the presence of holes. The visual method involves filling suspended condoms with water and detecting leaks. Both methods provide equivalent results [14]. Both tests were utilized for evaluating the samples [15].

The bursting volume must be ≥ 16.0 dm³ for condoms with a width ≤ 50.0 mm; ≥ 18.0 dm³ for condoms with a width > 50.0 and ≥ 22.0 dm³ for condoms with a width ≥ 56.0. The bursting pressure must be ≥ 1 kPa regardless of the width [11]. Bursting volumes and pressure were measured using an eight-head automated inflation system (Enersol, Sydney, Australia). Condoms were inflated with the latex film stretched until rupture as a measure of maximum resistance. The inflation system is accompanied by software [16] that records the bursting volumes and pressure. The compressed air that supplies the system is generated by an oil-free air compressor. The flow of compressed air was set at 24–30 dm³ min⁻¹ for all evaluations, as defined in the standards. For each condom, the bursting pressure and bursting volume were recorded with EInflation3 software [15] (Enersol’s head office is in Sydney Australia). For label and packaging inspection, we evaluated all items according to Appendix A of RDC 62/2008 [11].

We observed noncompliance in at least one of the analyses performed on the 17 brands. The bursting volume and bursting pressure tests identified 13 noncompliant brands, with three noncompliant brands identified during the holes check analysis. These results demonstrate that the main objectives of the use of condoms in preventing STIs and protecting against pregnancy are not guaranteed.

The result of this study showed two shortfalls of the criteria laid down in legislation. However, any non-compliance from the point of view of surveillance, even within the legally established limits, can pose serious public health implications.