The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
The TGA has increased the number of samples of PIP breast implants tested for shell integrity by measuring the tensile elongation of a further 7 samples to the original 8 samples that were tested in 2010. All tensile elongation results for the 15 samples now tested meet the requirements of the standard (ISO 14607:2007 Annex B Section 1.2) - the elongation at break of the shell specimen must exceed 450% compared to the original length of the specimen.
Model | Lot No. | Expiry | Thickness (mm) | Force (N) | Elongation (%) |
---|---|---|---|---|---|
Textured Shell | |||||
Smooth Shell | |||||
IMGHC-TX-S-205 | 25109 | 2014-05 | 0.81 | 19 | 581 * |
IMGHC-TX-S-265 | 35008 | 2013-06 | 0.94 | 21 | 569 * |
IMGHC-TX-H-430 | 16609 | 2014-03 | 0.98 | 20 | 578 * |
IMGHC-TX-H-290 | 25009 | 2014-05 | 0.85 | 14 | 569 |
IMGHC-TX-H-430 | 15809 | 2014-03 | 0.87 | 14 | 546 |
IMGHC-TX-S-365 | 09709 | 2014-03 | 0.81 | 15 | 568 |
IMGHC-TX-H-470 | 01809 | 2014-01 | 0.90 | 16.0 | 592 |
IMGHC-TX-H-430 | 18809 | 2014-04 | 0.83 | 14 | 619 |
IMGHC-LS-S-205 | 56206 | 2011-10 | 0.50 | 13 | 513 * |
IMGHC-LS-S-305 | 54206 | 2011-10 | 0.47 | 15 | 567 * |
IMGHC-LS-H-350 | 27909 | 2014-07 | 0.50 | 15 | 633 * |
IMGHC-LS-H-350 | 36709 | 2014-09 | 0.63 | 20 | 666 * |
IMGHC-LS-H-430 | 36709 | 2014-09 | 0.70 | 21 | 663 * |
IMGHC-LS-H-430 | 36709 | 2014-09 | 0.89 | 17 | 661 |
IMGHC-LS-H-350 | 35909 | 2014-09 | 0.68 | 17 | 661 |
* These values were reported in Table 3 on 12 January 2012. They have been adjusted to account for a testing instrument zeroing function, which was not included in the original calculation, and/or reporting as median values rather than average values.