Medical device manufacturer, Ethicon, has issued a medical device safety alert concerning its PHYSIOMESH Flexible Composite Mesh [All product codes].
The manufacturer has initiated a worldwide medical device removal of ETHICON PHYSIOMESH Flexible Composite Mesh (for laparoscopic use). The manufacturer is removing the product following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two large independent hernia registries (Herniamed German Registry and Danish Hernia Database-DHDB). The recurrence/ reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH Flexible Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.
Based on the currently available data, the manufacturer believes that the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but the manufacturer have not been able to fully characterize these factors. Consequently, the manufacturer has not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to remove ETHICON PHYSIOMESH Composite Mesh from the global market.
Health care practitioners that have treated patients using ETHICON PHYSIOMESH Composite Mesh are advised to follow those patients in the usual manner.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 May 2016