Why has ANSM suspended the sale of many implants?

primary

  • Urinary incontinence, the involuntary loss of urine through the urethra, affects 2.6 million people over the age of 65. But it can also affect young adults.
  • Urogenital prolapse is primarily a female disease. The risk of a woman having surgery due to ‘organ descent’ in her lifetime is 11 to 19%.

For the treatment of urinary incontinence and for the treatment of prolapse (hernia) of the pelvic organs in women, patients may be prescribed implants. Among the devices available in France, many can no longer be marketed. at Press release published on February 25The Agency for Medicines (ANSM) has announced that the sale of several pelvic implants manufactured by Microval has been suspended.

Regulatory and non-safety reasons

The products involved in this comment are the Safire, Swift-Sling and Smile ranges, sold between October 27, 2020 and October 12, 2021 and devices from the Prolafix, Procur, S-Swift and Gyne-Pro ranges, which were marketed between October 21, 2020 and 12 October 2021. January 2021 and October 12, 2021.

According to the health authority, this decision is not related to a safety issue but to a regulation issue. The implants will no longer be sold in France because they do not have a valid CE mark. ANSM indicated that this suspension will apply until the compliance of the manufacturer of these medical devices, which will continue the refund process as a precaution for the respective batches that are still in health institutions.

What are the risks?

“So far, we have not identified any health risk to patients wearing one of the implants in question,” Can we read the agency’s press release? It specified that patients could tell if they were using a device from the batches involved in this suspension thanks to a document the surgeon provided after the operation. This form must include the brand and batch number of the implant. “If in doubt or worried, you can contact your doctor and/or the surgeon who installed the device,” Health Authority identified.

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What do you do in case of side effects?

ANSM advises patients who experience adverse effects related to the implanted medical device to consult the treating physician or the surgeon who placed the implant. They can also report any side effects on the reporting portal using the device name and operating number. “Regardless of which implant you received, we recommend that you continue as prescribed by your healthcare professional. The compliance issue specific to these implants does not require additional follow-up,” Agency added.

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