THE ESSENTIAL
- Urinary incontinence, which is the involuntary loss of urine through the urethra, affects at least 2.6 million people over the age of 65. But it can also affect younger people.
- Genito-urinary prolapse is essentially a disease of women. The risk of a woman being operated on for “organ descent” in her lifetime is 11 to 19%.
To treat urinary incontinence and the treatment of prolapse (hernia) of the pelvic organs in women, implants can be prescribed to patients. Among the devices available in France, several can no longer be marketed. In a press release published on February 25the Medicines Agency (ANSM) announced that the sale of several pelvic implants manufactured by the company Microval was suspended.
Regulatory and non-safety reasons
The products concerned by this suspension are those of the Safire, Swift-Sling, Smile ranges, sold between October 27, 2020 and October 12, 2021 and devices from the Prolafix, Procur, S-Swift and Gyne-Pro ranges, marketed between October 21, 2020 and October 12, 2021. January 2021 and October 12, 2021.
According to the health authority, this decision is not linked to a problem of safety but of regulation. The implants will no longer be sold in France because they did not have the valid CE marking. The ANSM has indicated that this suspension will apply until the compliance of these medical devices by the manufacturer, who will proceed with the recall as a precautionary measure of the batches concerned still present in health establishments.
What are the risks ?
“To date, we have not identified any risk to the health of patients who wear one of the implants concerned”, can we read in the press release of the agency. She specified that patients might find out if they were using a device from the batches concerned by this suspension thanks to a document given by the surgeon following the operation. This form must include the brand and batch number of the implant. “In case of doubt or concern, you can contact your doctor and/or the surgeon who fitted the device”, specified the health authority.
What to do in case of side effects?
The ANSM has advised patients who experience adverse effects related to the implanted medical device to consult their treatment doctor or the surgeon who placed the implant. They can also report any side effects on the reporting portal with the device name and lot number. “Regardless of the implant you have had, we recommend that you maintain follow-up as prescribed by your healthcare professional. The compliance issue identified for these implants does not warrant additional follow-up,” added the agency.
