The move follows reports from US manufacturer Medtronic of potential serious risks, including cancer, linked to a substance in its soundproofing foam.
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The French National Agency for Medicines (ANSM) requested, on Wednesday July 10, the replacement of respiratory assistance devices for patients at home, following a report from the American manufacturer Medtronic concerning potential serious risks, such as cancers, linked to a substance in the soundproofing foam.
Fewer than 200 units of the ventilator model in question, the Puritan Bennett 500 marketed between 2010 and 2023, remain in use to date, according to an estimate from the manufacturer communicated by the agency. The ANSM recommends on its website “to replace the devices still in use with devices of another brand, within six months”.
The manufacturer Medtronic identified in 2023, during a reassessment of the risks of these devices, that a volatile compound from the sound-absorbing foam exceeded the permitted exposure thresholds after fourteen years of continuous use. This leads to a “potential increased risk of cancer and infertility and, in pregnant women, of congenital malformations or abnormal development of the fetus”specified the ANSM.
According to the manufacturer, these risks have not yet been confirmed in human studies, the agency reported. And no reports of this problem have been reported through market surveillance, it said. The drug agency advises patients not to stop using the ventilators on their own, saying their home health care provider will contact them to inform them and their doctor will prescribe another model.
