Certain implantable medical devices from Microval’s Safire, Swift-Sling, Smile, Prolafix, Procur, S-Swift and Gyne-Pro ranges are suspended because they did not have the regulatory CE marking, according to a press release.
“This suspension is not related to a security issue”, pointed out the agency, which did not “To date, no risk to the health of patients who wear one of the implants concerned has been identified”.
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 attending physician and/or the surgeon who fitted them. So now you know what to answer them.
They can also report any adverse effects on the reporting portal, the ANSM said.
With AFP
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