Circumplast is FDA approved, CE certified and TGA approved.

Circumplast has completely eliminated well known risks associated with the use of bell shaped devices such as the Plastibell. In particular, complications arising from proximal migration of the Plastibell device has been completely eliminated by the design of Circumplast.

The surgical procedure required for Circumplast is essentially identical to Plastibell.

Please see company website for further details: 

http://www.novadien.com/for-doctors/