Ingen registrering af komplikationer til implantater ved gynaekologiske operationer

Helle Christina Sørensen; Gunnar Lose; Pia Sander; Karl Møller Bek; Lars Alling-Møller

Ingen registrering af komplikationer til implantater ved gynaekologiske operationer

Helle Christina Sørensen, Gunnar Lose, Pia Sander, Karl Møller Bek, Lars Alling-Møller

Kvindesygdomme, Graviditet og Fødsler

Abstract

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]
Originalsprog	Dansk
Tidsskrift	Ugeskrift for Laeger
Vol/bind	172
Udgave nummer	12
Sider (fra-til)	964-7
Antal sider	4
Status	Udgivet - 22 mar. 2010

Citationsformater

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abstract = "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.",

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T1 - Ingen registrering af komplikationer til implantater ved gynaekologiske operationer

AU - Sørensen, Helle Christina

AU - Lose, Gunnar

AU - Sander, Pia

AU - Bek, Karl Møller

AU - Alling-Møller, Lars

PY - 2010/3/22

Y1 - 2010/3/22

N2 - 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.

AB - 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.

M3 - Tidsskriftartikel

C2 - 20334798

SN - 1399-4174

VL - 172

SP - 964

EP - 967

JO - Ugeskrift for Laeger

JF - Ugeskrift for Laeger

IS - 12

ER -

Ingen registrering af komplikationer til implantater ved gynaekologiske operationer

Abstract

Fingeraftryk

Citationsformater