In recent years, many new surgical implants (biological and synthetic) for female urinary incontinence and pelvic organ prolapse (POP) surgery have been launched in Denmark. In the literature, complications have been reported in up to 40% of cases depending on the type of operation, 2-5% as serious complications. An implant can achieve CE-marking if it seems likely that it is substantially equivalent to an implant already on the market. Thus implants can be launched without clinical data.
|Bidragets oversatte titel||[No registration of complications for implants used in gynaecological surgery]|
|Tidsskrift||Ugeskrift for Laeger|
|Status||Udgivet - 22 mar. 2010|