- Open Access
- Open Peer Review
Quality evaluation of commercially available male condoms in Rio de Janeiro, Brazil, 2009–2011
© The Author(s). 2016
- Received: 16 October 2015
- Accepted: 9 November 2016
- Published: 7 December 2016
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.
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.
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.
Any nonconforming unit has serious public health implications.
- Male Condoms
- Public Health
- Sanitary Surveillance
The quality of condoms available in Brazil has been widely debated since 1987, when condoms were included in the category of pharmaceuticals. Condoms remain under the jurisdiction of the Brazilian Sanitary Surveillance Agency (Agência Nacional de Vigilância Sanitária: ANVISA) under the Brazilian Ministry of Health. The first Brazilian law, Brazilian National Health Oversight Agency Resolution no. 3 in 2002, repealed by RDC 62/2008, was based on the ISO 4074:2002 standards that established the technical regulation for certification of male condoms of natural rubber latex; it specified that condoms must be certified under the Brazilian Certification System in accordance with the requirements of the indicated technical regulations before their sale or free distribution to consumers.
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 .
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 .
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 .
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 .
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 .
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 .
The objective of the present study was to evaluate the physical quality of condoms marketed in Rio de Janeiro, Brazil.
Criteria established in RDC 62 for the quality control testing of condoms
Number of samples tested
Maximum acceptable non-conforming units
Length, width, thickness
Primary packaging integrity
Bursting volume and bursting pressure
Label and secondary packaging
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) .
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 . Both tests were utilized for evaluating the samples .
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 . 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  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  (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 .
Test results for the twenty condom brands
Dimensions (length, width, thickness)
Freedom from holes
Volumetric capacity and burst pressure
Packaging and labeling
Number of defective samples found by tests in the twenty brands analyzed
Dimensions (length, width, thickness)
Freedom from holes
Volumetric capacity and burst pressure
Packaging and labeling
According to RDC 62/2008, condom width is required to be within 2 mm of the declared nominal width. All brands analyzed had the stated nominal width of 52 mm.
The results show that the B9 brand, although it complies with the criteria of RDC 62/2008, provided two non-conforming units, representing a health risk.
The package integrity analysis predominantly assesses primary sealing of condoms; according to RDC 62/2008, the packaging must be hermetically sealed and opaque to protect the product from contact with oxygen, ozone, moisture, and visible and ultraviolet light that degrade natural rubber. The packaging material must be laminated metallic material, flexible, and waterproof, with inner layers made of plastic (polyethylene). While evaluating package integrity, we found a nonconforming unit (A4) considering the criteria of the Board Resolution (RDC 62). However, the Sanitary Surveillance, in addition to the criteria established by the legislation, shows that non-compliance can lead to product contamination, which may cause damage to the health of users.
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.
JTD conceived the study and participated in its design, carried out the experiments. AECCA participated in the study design SMPA participated in the study design and coordination. All authors read and approved the final manuscript.
The authors declare that they have no competing interests.
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