Opinion on the use of heterologous materials in operations for pelvic descensus

Opinion of the Urogynological Society of the Czech Republic and the Section of Urogynecology of the CGPS

Utilization of heterologous materials in operations for pelvic organ descensus

Dear colleagues,

As you have seen, there is a gradual reduction in the sales and distribution of networks for vaginal surgery of pelvic organ descents in the world. This is mainly due to the increasing number of actions for complications related to implantation of foreign material. The last step that has been taken is to ban these products on the US market for two companies - Boston Scientific and Coloplast.

The situation in Europe is somewhat different from the US market. There has not been such a massive "abuse" of operating methods, in most countries the operation is concentrated in the hands of experts, including our republic. Also thanks to the Register of Operations and Complications, we are certainly on top level. Just as we review our operational procedures, we will respect the decisions of the European Union on the safety of the materials used.

Therefore, the Committee of both companies recommends that anyone using these materials in their operations carefully consider their use and correctly indicate them. In particular, it is essential to assess the latest conclusions of the EBM. Informing the patient about possible complications and signing the right informed consent is essential. In case of complications it is necessary to cooperate with the most specialized centers.

The Committees continue to monitor the situation and, in the case of further legislative steps, we are ready to enter into further negotiations.

Lukáš Horčička June 13, 2019

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