TGA Proposes to Reclassify Synthetic Meshes as ‘High Risk’
Transvaginal mesh devices and mesh used for hernia repair may soon be classed as "high risk" by the Australian government.
The Therapeutic Goods Administration is proposing that all synthetic meshes be bumped from Class IIb (medium to high risk) up to Class III (high risk), requiring manufacturers to seek additional regulatory approval.
Surgical mesh is used to provide temporary or permanent support for weakened structures and/or muscles in surgery. Other common uses include repair of hernias, pelvic organ prolapse, and stress urinary incontinence.
The move by the TGA comes on the heels of controversy regarding the mesh devices. A class action suit involving 700 women against Johnson and Johnson alleges the company didn’t perform proper clinical trials to determine the product’s safety.
Implants for pelvic organ prolapse have been linked with chronic pain, nerve damage, bleeding and infection, with mesh erosion cutting through the vaginal wall.
Currently, synthetic surgical meshes are classified as Class IIb. While some surgical meshes such as those including medicines or materials of animal, microbial or recombinant origin, are already classified as Class III.
As it seeks this regulatory change, the TGA is hoping to introduce formal requirements for medical device makers to provide patient implant cards and product information for all active and implantable medical devices.
The moves are part of TGA’s effort to align itself with the European Commission as that organization updates regulatory processes. The proposed changes follow a decision by the European Commission to implement a number of medical device reforms, including to up-classify all surgical mesh medical devices to Class III and to provide patient implant cards and consumer product information for all implantable medical devices.