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anses

French Agency for Food, Environmental and Occupational Health & Safety

Incontinence pads: ANSES publishes the results of its health risk assessment

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News of 23/06/2020

Today, ANSES is publishing its risk assessment report on chemicals in heavy incontinence pads. In its expert appraisal, the Agency identified cases where the health thresholds for several chemical substances were exceeded for people with skin lesions who have to wear these protective products on a long-term basis. ANSES recommends that manufacturers eliminate or minimise the presence of these chemicals in incontinence pads. It also advises healthcare professionals, carers and users to make every effort to prevent the occurrence of skin lesions.

Incontinence pads are medical products whose purpose is to absorb and retain the urine and stools of people suffering from incontinence, while keeping their skin dry and healthy. Since the 1980s, the incontinence market has grown considerably, due to an increase in the number of dependent people, a growing trend towards home care, and a decrease in the stigma associated with these products.

In 2018, ANSES received a formal request from the Directorate General for Health and the Directorate General for Competition Policy, Consumer Affairs and Fraud Control to assess the safety of these products in terms of the risks of allergy, infection or intolerance, as well as the chemical risks, from contact with the skin or mucous membranes.

 

Several chemicals found in incontinence pads exceeded the health thresholds in the event of skin lesions

Tests carried out on four heavy incontinence pads commercially available in 2017-2018 revealed the presence of various hazardous chemicals (dioxins, furans, DL‑PCBs and formaldehyde). They seem to come from contamination of raw materials or the manufacturing processes used. In particular, these substances can migrate into urine and come into prolonged contact with the skin. The risk assessment carried out by ANSES concluded that as long as the skin remains healthy, the health thresholds are not exceeded.

However, given the fact that the health thresholds for some substances were exceeded, the expert appraisal showed that for "elderly" and "young" populations suffering from skin lesions on the buttocks and genital area, wearing these pads over the long term – constantly for more than one year – can lead to a health risk. And these lesions tend to appear more often when these products are worn for long periods of time or almost continuously.

 

ANSES's recommendations: limit chemicals in incontinence pads and prevent the occurrence of skin lesions in users.

In light of the results of this expert appraisal, ANSES is recommending:

  • For manufacturers of incontinence pads:
    • Eliminate the use of all fragrances in the composition of incontinence pads, with priority being given to those with skin irritating or sensitising effects;
    • Improve control over the origin of natural raw materials that can become contaminated, even before manufacture;
    • Improve manufacturing processes to minimise the presence of undesirable chemicals in the materials that make up the entire pad;
    • Better document the nature of the raw materials used in these products and mention them on the packaging, to inform users.

 

  • For the public authorities:
    • Monitor the presence of hazardous substances in incontinence pads through measurement campaigns covering all products on the market;
    • Make it easier for healthcare professionals to access the exact detailed composition of products, as part of medical device vigilance.
    •  
  • For healthcare professionals, carers or users:
    • Ensure compliance with good practice in the use of these pads (frequent changes, keeping skin clean and dry, etc.) to minimise the risks of irritation of the skin on the buttocks and genital area;
    • Report any adverse effects due to wearing incontinence pads to the French Health Products Safety Agency (ANSM) via the adverse health event reporting portal