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.
Product types