Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
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 | |||||
| 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 |
| Smooth Shell | |||||
| 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.