PHI 51/19 Prostheses List – Removal of Macro Textured Breast Implants and Tissue Expanders

Page last updated: 06 August 2019

PHI 51/19 Prostheses List – Removal of Macro Textured Breast Implants and Tissue Expanders (PDF 446 KB)

The delegate for the Minister for Health has made the Private Health Insurance (Prostheses) Amendment Rules (No. 5) 2019 to remove the listings of five macro textured breast implants and tissue expanders from the Prostheses List.

This follows action taken by the sponsor, Allergan Australia Pty Limited, to voluntarily recall these devices commencing from 30 July 2019.

The listings removed from the Prostheses List are:

Billing CodeSponsorProduct NameDescriptionSizeBenefitARTG
AW004Allergan Australia Pty LimitedNatrelleŽ 510 TruForm™ Dual Gel Breast ProsthesisAnatomical textured implant with dual gel for projection of nipple/areola complex, concave base and tapered edges for minimisation of edge/thoracic wall palpability.LX sizes from 130-575 grams, MX sizes from 145-600 grams, FX sizes from 165-630 grams
AW005Allergan Australia Pty LimitedNatrelleŽ INSPIRAŽ TruForm Textured Mammary ImplantRound implants with textured surface. Available in four projections: low, moderate, full and extra-full; and two cohesive gel types: TruForm™ 1 Responsive Gel and TruForm™ 2 Soft-Touch™ Gel.110 - 800 grams
AW007Allergan Australia Pty LimitedNatrelleŽ 410 BioDIMENSIONAL™TruForm™ 2 Soft-Touch™ Gel and TruForm™ 3 Cohesive Gel Textured Mammary Implants.
Full, moderate or low height;
Extra full,full, moderate or low projection
125 - 775 grams
AW012Allergan Australia Pty LimitedNatrelleŽ 150, 1-Stage BioDimensional™ Tissue ExpanderFull height, Short Height, textured9.6 -16cm width x 8 - 17cm height x 4.2 - 7.1cm projection
AW013Allergan Australia Pty LimitedNatrelleŽ 133, 2-Stage BioDimensional™ Tissue ExpanderSilicone Elastomer. Saline filled.150-950 cm3

The Amending Rules commences the day after registration.