Ann: Notice of Proposal to Suspend AeroForm Devices from TGA, page-7

Whilst I agree this could be overcome but when the company is built using Jango sticks, unfortunately this is the wrong stick to pull out. Distributor in AU will send their stock back which may be significant considering they probably channel stuffed when they transitioned to distributor model.

Not good for safety profile as regulators speak to each other and doctors get spooked for a while. It is a ridiculous decision by TGA to compare it to a permanent implant, but women's breasts are sensitive (politically speaking) so they will shoot first and asks questions later. AXP will need to come up with some good reasons why it needs to be used ahead of saline expanders such as remote locations etc

Looks like they are already working on a 'smooth' version. Now why would they do that if the TGA or some other regulatory authority hadn't warned them of this issue? Another non disclosure to add the the class action.