J&J Ethicon’s Gynecare TVT off the Australian TGA Register

J&J Ethicon’s Gynecare TVT off the Australian TGA Register

Introduction

A recent report stated that J&J’s Ethicon, Inc. has failed to meet a regulatory deadline set forth by Australian Therapeutics Good Administration (TGA) for updating the products’ “instructions for use” for its Gynecare TVT, a pelvic mesh device, which was set as January 17th. This has resulted in the withdrawing of the product from the Australian market and the product no longer appears on the TGA Register. However, the company clarified that this was not a product recall and required no action by those who had received the product.