French authorities have suspended sales and imports of ultra-thin condoms made by a Malaysian manufacturer after an investigation found defects that could increase the risk of breakage, which could lead to sexually transmitted infections and unintended pregnancies.
France has ordered the withdrawal and recall of 15 types of condoms across the European market after finding manufacturing defects that could cause the products to burst or rip. The defects could compromise protection against sexually transmitted infections (STIs) and unintended pregnancies, the authorities warned.
ADVERTISEMENT
ADVERTISEMENT
The defects affected ultra-thin condoms manufactured by Malaysian company Richter Rubber Technology, the French consumer watchdog, the Directorate-General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF), said on Friday.
“Some users have reported condom breakages and unwanted pregnancies linked to the sampled batches,” French authorities said in a ministerial order dated 22 October and published in France's Official Journal on 30 October.
French authorities said laboratory tests had identified defects linked to fluctuations in the thickness and quality of the latex film used during manufacturing.
Tested condoms “failed both the pressure and burst volume tests and the tests relating to the absence of perforations,” French authorities added. It is also stated that the manufacturer has “a lack of control over the manufacturing process of its products.”
The products represent approximately 7 million condoms across the European Union, although only a proportion have been sold in France, according to the French economy ministry.
The French government has suspended the sale and import of all ultra-thin condoms made by the manufacturer using the defective production process for one year. The measure can be renewed if necessary.
The decision follows an investigation launched after an initial wave of condom recalls earlier this summer, when around 260,000 condoms were recalled in late May and early August.
Eight users have reported condom breakages since the initial recalls.
EU-wide implications
The recall extends beyond France, with the affected products distributed across the European market under several different brand names.
The French authorities have published a list of the affected products and batches, and ordered their withdrawal from points of sale as well as a recall of products already held by consumers.
French authorities have advised anyone who has used affected condoms to seek screening for sexually transmitted infections at a medical laboratory and to take a pregnancy test if their period is late.
Consumers with concerns have been advised to contact their doctor or a free sexual health screening centre.
The DGCCRF has also urged consumers to report adverse incidents, including condom breakages or perforations during use, through the government's health incident reporting platform.
The French watchdog said it would monitor the effectiveness of the product withdrawal and recall.
