Some implantable medical devices have been suspended from Microval’s Safire, Swift-Sling, Smile, Prolafix, Procur, S-Swift and Gyne-Pro ranges because they did not carry the regulatory CE marking, according to a press release.
“This comment has nothing to do with a security issue,” The agency indicated that you did not “So far, no health risk to patients wearing one of the implants in question has been identified.”
The products in question were marketed between October 27, 2020 and October 12, 2021 for those affiliated with the Safire, Swift-Sling and Smile domains, between January 21, 2021 and October 12, 2021 for those affiliated with Prolafix, Procur, and S-scopes of 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 initiate a preemptive recall of affected batches still in healthcare facilities.
In case of doubt or concern, Women who have one of these implants are invited to contact the attending physician and/or the surgeon who installed them. So now you know what to answer them.
ANSM said they can also report any negative effects to the reporting portal.
with AFP
