Quality fears as condoms fail safety tests

When it comes to quality, manufacturers of condoms are not expected to leave room for error. The scourge of HIV and Aids demands that condoms be manufactured as the ultimate guard against transmission.

They are also designed to serve as a form of contraception. However, recent condom recalls have raised concerns on the quality, and the protective surety of those on sale in Kenya.

Last week, a brand of condoms known as Sure was recalled by the Kenya Medical Supplies Authority (Kemsa) over quality issues. A corresponding statement from the Pharmacy and Poisons Board (PPB) listed the affected batches of Sure condoms as 17DN754 and 17DN052, and LP8058, P48045, P48001, L48037, P48027, L48110, and 1601957422. This was in addition to the two batches 17DN754 and 17DN052 that had been listed for recall by Kemsa.

The recalled condoms had been manufactured with expiry dates of between December 2021 and December 2022. Sure, which is manufactured by Thailand-based condom brand Innolatex Ltd, was supplied through Kemsa. Following the recall, the regulatory board issued a statement to clarify that the recall had only affected specific batches. “The non-compliance (of the Sure lubricated condoms) is batch specific. It does not impact on the entire product of Sure condoms,” the PPB said. The quality issues that resulted in the recall were, however, not revealed.

Nonetheless, questions over the quality of condoms on the shelves are bound to persist. This is because the recall of Sure condoms came barely nine months after the government recalled two male condoms known as Fiesta Stamina and Fiesta Big Black for failing quality tests. These two condoms were recalled in December 2018. According to the regulatory board, the two condoms failed the ‘Freedom from holes’ and ‘thickness’ tests.

These condoms are manufactured by the India-based male and female condom manufacturer, Cupid Ltd. Following these two recalls, the regulatory board advised buyers to check the condom packet and foil wrapping in order to check if the condoms are fit for use.

FAIL TEST

The 2010 WHO and UNFPA Male Latex Condom Specification, Prequalification and Guidelines for Procurement has made it mandatory for the manufacturing requirements for male condoms to include quality natural rubber latex as the main material.

Alarmingly, these are not the only condom recalls that have taken place in the recent past. In April this year, leading condom manufacturer, Reckitt Benckiser Group, recalled its popular Durex condoms over fears that they were prone to tear or burst. The Durex Real Feel and the Durex Latex Free products were recalled after failing pressure tests. They were manufactured with expiry dates of between January and February 2021.

Anxiety over these condom recalls has now been compounded by the proliferation of fake condoms in the market. Last year, Population Services Kenya (PS Kenya) raised alarm that fake studded condoms had entered the local market. PS Kenya distributes the Trust brand of condoms.

In Kenya, condoms have gained popularity as an affordable method of contraception and protection against sexually transmitted diseases. “Condoms, when used correctly and consistently, are safe and highly effective in preventing unwanted pregnancy and sexually transmitted infections, including HIV,” says WHO.