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The ANSM warns about the suspension of implants against urinary incontinence and prolapse manufactured by the company Microval. What risk? How do you know if you are affected?
The National Medicines Agency announces the recall and suspension of several pelvic implants manufactured by the company Microval. “These implantable medical devices are used for the treatment of female urinary incontinence and the treatment of prolapse (hernias) of the pelvic organs in women, by upper surgery”, the statement said. The suspension of these implants is due to the lack of valid CE certification. She “is not related to a security issue”, reassure the authors.
The problem is that these implants have been marketed and perhaps implanted in patients. In order to recognize them, here are the references of the product batches:
- Implants from the Safire, Swift-Sling, Smile range, marketed between October 27, 2020 and October 12, 2021;
- Implants of the Prolafix, Procur, S-Swift and Gyne-Pro family marketed between January 21 and 12. 2021;
“This suspension will apply until the manufacturer brings these medical devices back into conformity”, specifies the ANSM. How to check the reference of your implant? After the implantation operation, you should normally be given a small card with the brand and references of the implant you have. “You can then refer to the list of batch numbers of implants manufactured and placed on the market over the period concerned.”
What if you have one of these implants?
If you are indeed concerned by one of the suspended lots, don’t panic. As a reminder, until today there is no safety problem identified in connection with one of these implants, it is just a lack of valid CE marking from the manufacturer. “Microval will proceed with the recall as a precautionary measure of the affected batches still present in health establishments.”, specifies the ANSM. A priori, no withdrawal is envisaged for people carrying a batch concerned, but it is advisable to warn their doctor or surgeon all the same so that they decide for themselves or start a follow-up.
Stay alert to the slightest side effect
Even if no danger has been identified or reported, we must remain vigilant. The ANSM recommends that patients remain vigilant and consult their doctor at the slightest side effect or in case of doubt. “You can also report any side effects on the reporting portalspecifying as much information as possible, such as the commercial name and batch number of the device, the name of the manufacturer, the date and place of implantation, the date of explantation if applicable.