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 code
Sponsor
Product name
Description
Size
Benefit
ARTG
AW004
Allergan Australia Pty Limited
Natrelle 510 TruForm Dual Gel Breast Prosthesis
Anatomical 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
$1,170
171387
AW005
Allergan Australia Pty Limited
Natrelle INSPIRA TruForm Textured Mammary Implant
Round implants with textured surface. Available in 4 projections: low, moderate, full and extra-full; and 2 cohesive gel types: TruForm 1 Responsive Gel and TruForm Soft-Touch Gel.
110–800 grams
$741
175422
175425
AW007
Allergan Australia Pty Limited
Natrelle 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
$1,170
171475
171512
AW012
Allergan Australia Pty Limited
Natrelle 150, 1-Stage BioDimensional Tissue Expander
Full height, Short Height, textured
9.6–16cm width x 8–17cm height x 4.2–7.1cm projection
$1,989
169956
AW013
Allergan Australia Pty Limited
Natrelle 133, 2-Stage BioDimensional⢠Tissue Expander
Silicone Elastomer. Saline filled.
150–950 cm3
$1,024
175797
The Amending Rules commences the day after registration.