Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process

Hernia (2011) 15:603605DOI 10.1007/s10029-011-0872-3

INVITED REVIEW

Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process

B. S. Ashar J. M. Dang D. Krause M. C. Luke

Received: 6 April 2011 / Accepted: 31 July 2011 / Published online: 11 September 2011 Springer-Verlag (outside the USA) 2011

Abstract The FDAs Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and eVectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/ approved any mesh devices intended for certain speciWc uses, such as for infected wounds, hernia prevention, bioWlm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking speciWc hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims.

Keywords Mesh Hernia FDA Regulation IDE preIDE

Introduction

As numerous synthetic and biological hernia mesh device options exist, surgeons are seeking to understand how patient outcomes can be optimized by selecting the most appropriate mesh device to best achieve the operative goal for speciWc clinical scenarios. Although a paucity of data guiding such speciWc use exists, guidelines regarding the process for determining the need for hernia mesh and then choosing a speciWc mesh are being discussed at surgical conferences and within the surgical literature. In an eVort to further inform this productive dialogue, we provide a description of the US Food and Drug Administration (FDA) regulatory process for

hernia mesh device clearance/approval and the information typically submitted by manufacturers to the FDA prior to hernia mesh device marketing clearance for general indications for use. We also describe some of the types of speciWc indications for hernia mesh device use where the Agency has typically requested clinical study data. The scope of this article does not include mesh devices used in pelvic Xoor repair and orthopedic procedures.

FDA regulatory process

The US FDA Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety and eVectiveness of all medical devices marketed within the US and to date has granted 400 mesh device clearances, which

represents new mesh devices together with existing mesh devices modiWed...