Implantation in the USA:We don’t have FDA approval!

Dear patients, surgeons, and FTM community in the United States:

ZSI has participated in many international urology conferences held in the United States, presenting its implants designed for biological males.

US laws require us to announce in a visible way that we do not have certification from the FDA (US Food and Drug Administration), which is required to promote or sell products like ours in the United States. Thus we’ve been able to present our products to surgeons from all parts of the world except the United States. In fact, lacking FDA certification, we’re prohibited from making any commercial presentation to the public in the United States.

Of course we comply with this requirement by posting on our booths that we do not have FDA certification, and we inform our US audience of that fact.

We receive many messages regarding our FTM implants from patients and surgeons in the United States, asking us to present our products. Of course we would be interested in introducing and promoting our products in US cities, but it’s not possible to do so legally without the approval of the FDA.

With respect to our current digital marketing initiatives and the creation of a blog for the FTM community, we don’t know how US law applies. To avoid any unintentional error, we are officially announcing that our commercial and informational initiatives are not intended for the US audience.

ZSI is the only European manufacturer of artificial urinary sphincters and of malleable and inflatable penile implants, as solutions for male urological problems (incontinence), sexual complications (Erectile Dysfunction), and gender identity procedures (prostheses for trans men and women).

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