Ethicon is voluntarily withdrawing its surgical mesh product, Physiomesh due to higher than average revision rates after use.
The J&J subsidiary decided to withdraw the flexible composite mesh following analysis of data from two large independent hernia registries that showed higher than average rates of recurrence after laparoscopic ventral hernia repair compared to other meshes.
Patients already implanted with the product should be followed as usual, the company said. The withdrawal does not involve any other Ethicon meshes.
The field safety notice with the affected product codes can be found here: www.fdanews.com/06-23-16-EthiconMeshWarning.pdf. — Joya Patel