Translation of a-t 2021; 52: 70
 

IN BRIEF

IUB BALLERINE use stopped

The use of the copper bead ball IUB BALLERINE is stopped until further notice. The risk assessment by the Federal Institute for Drugs and Medical Devices (BfArM) had not yet been completed at the time of the editorial deadline. The provider, Dr. Schittenhelm GmbH, has ceased delivery for the time being (2) as requested by BfArM (1). The open questions linked to a suspended CE certificate* for the medical device, which was dismissed by a lawyer for Ocon Healthcare as "administrative inconsistencies" therefore were not "cleared up soon" (see a-t 2021; 52: 60). In response to our question of how specialist circles had been informed of the request not to use the product, Schittenhelm stated that "confidential documents...are fundamentally not provided to third parties" (3) and made reference to the Israeli manufacturer, Ocon. The European representative of the company, however, indicated that their "willingness to collaborate" was "significantly harmed" by our note in a-t 8/21 and that they had "no legal obligation to provide" (4) the information we requested. The question of whether and if so in what form the specialist circles have been informed therefore remains open. Pharmaceutical providers have now broadly recognised that even and in particular with regard to issues of safety an open and transparent information policy can mitigate damage. It is our opinion that the medical device providers Dr. Schittenhelm/Ocon are very much lagging behind on this realisation, -Ed.

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