Anti-hernia implants: health authorities increase vigilance after reported adverse effects

So-called "parietal reinforcement" implants, used against certain hernias, will be subject to increased monitoring following a series of adverse events, the drug agency announced on Friday, February 21.

"Recent reports of adverse events by patients, as well as publications at the international level, may raise questions about the associated risks," reported the ANSM in a press release .

The implants in question are called "parietal reinforcement implants". "They come in the form of flexible plates, most often made of synthetic material and non-resorbable, (and) are used to treat hernias in the abdomen (abdominal hernia, eventration) or the groin (inguinal hernia)," the drug agency specified.

The adverse effects reported in 2024 included persistent pain, "which can sometimes affect quality of life," according to the ANSM. In this context, the agency says it launched a "market surveillance" action in August 2024, through which it requested information from implant manufacturers, but also from distributors and importers.

The analysis of this data should give rise to a meeting in mid-2025 between the ANSM, patients and the caregivers concerned, in order to take stock of the risks and develop "courses of action to best guarantee patient safety".

The agency specifies that reports are rare - less than thirty per year between 2020 and 2024 for some 200,000 implants sold each year on average - while acknowledging that problems linked to medical devices are often under-reported.

In addition, the ANSM stressed that it was exercising "enhanced surveillance" on other types of implants (non-resorbable flexible plates or strips), such as pelvic reinforcements and suburethral strips. In the event of adverse effects, patients and healthcare professionals are encouraged to report them on the reporting portal.