The National Medicines Safety Agency (ANSM) on Friday suspended the marketing of several implants manufactured by the company Microval.
These are implants intended for the treatment of female urinary incontinence and pelvic hernias.
The suspension of these implantable medical devices is not linked to security reasons, but purely regulatory ones.
The latter did not have the regulatory CE marking, according to a press release from the agency, which has “not identified to date any risk to the health of patients who wear one of the implants concerned”.
Recall of products in healthcare establishments
The products concerned were marketed between October 27, 2020 and October 12, 2021 for those belonging to the Safire, Swift-Sling, Smile ranges, between January 21, 2021 and October 12, 2021 for those belonging to the Prolafix, Procur, S-ranges. Swift and Gyne-Pro, is it specified in the press release.
The suspension will apply until the manufacturer brings these medical devices back into conformity.
Microval will proceed with a precautionary recall of the affected batches still present in healthcare establishments.
“In case of doubt or concern”, women with one of these implants are invited to contact their doctor and/or the surgeon who fitted them.
They can also report any adverse effects on the reporting portal, the ANSM said.
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