PIP implants should be removed for preventative reasons
Breast implants manufactured by Poly Implant Prothèse (PIP) have a poorer mechanical durability and, in a number of cases, contain an irritant substance in significantly higher levels than other silicone breast implants. The Medical Products Agency and the National Board of Health and Welfare therefore recommend that clinics that have, in the past, used PIP implants inform the women affected of these risks and also that PIP implants should be removed for preventative reasons, except in individual cases where there are medical reasons for not doing so. (Source: MPA RSS news -)
Source: MPA RSS news - - June 4, 2013 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: news
Information on Single assessment and Worksharing for periodic safety update reporting
Updated information on the EURD list and worksharing is available on the MPA website. (Source: MPA RSS news -)
Source: MPA RSS news - - April 26, 2013 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: news
Pharmaceutical ingredients in one out of three eyelash serums
The Swedish Medical Products Agency’s analyses of eyelash serums/eyelash growth products have now been completed. Prostaglandin analogues were found in as many as nine of the 26 products in total. In three of the products prostaglandin analogues were not declared on the packaging. Prostaglandin analogues are added to stimulate eyelash and eyebrow growth. The Swedish Medical Products Agency advises consumers not to use products containing prostaglandin analogues, as this may lead to serious side effects. (Source: MPA RSS news -)
Source: MPA RSS news - - April 15, 2013 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: news
Registry study confirms increased risk of narcolepsy after vaccination with Pandemrix in children and adolescents and shows an increased risk in young adults
A large Swedish registry study confirms the increased risk of narcolepsy after vaccination with Pandemrix in subjects 20 years and younger. The study also shows an increased risk in young adults (21-30 years). The risk declines gradually with increasing age. No associations with increased risks were concluded for any of the other studied neurological and immune related diseases. (Source: MPA RSS news -)
Source: MPA RSS news - - March 26, 2013 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: news
The MPA focuses on eyelash growth serum
The Swedish Medical Products Agency is concerned by the fact that eyelash growth products may contain prohibited substances known as prostaglandin analogues. This type of substance may give rise to serious side effects and there is a keen interest among consumers to buy and use this type of products. Consequently, the MPA will take a broader approach during 2013, by mapping the Swedish market, acquiring and analysing relevant products and communicating analysis results. (Source: MPA RSS news -)
Source: MPA RSS news - - March 5, 2013 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: news
Guidance for qualification and classification of Medical Information Systems
Standalone software with a medical purpose has a central role in health care. Depending on the application, they may be subject to the requirements of the medical device regulation. MPA has developed a guide for standalone software with medical purposes in support of manufacturers, health care providers and government agencies. (Source: MPA RSS news -)
Source: MPA RSS news - - January 31, 2013 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: news
