Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process.

ABSTRACT:

Introduction

Transvaginal mesh devices are approved in the USA by the Food and Drug Administration (FDA), through the 510(k) system. However, there is uncertainty about the benefit to harm balance of mesh approved for pelvic organ prolapse. We, therefore, assessed the evidence at the time of approval for transvaginal mesh products and the impact of safety studies the FDA mandated in 2012 because of emerging harms.

Methods

We used FDA databases to determine the evidence for approval of transvaginal mesh. To create a 'family tree' of device equivalence, we used the 510(k) regulatory approval of the 1985 Mersilene Mesh (Ethicon) and the 1996 ProteGen Sling (Boston Scientific), searched for all subsequently related device approvals, and for the first published randomised trial e

SUBMITTER: Heneghan CJ 

PROVIDER: S-EPMC5728256 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature