PIP breast implants: Update to testing results of PIP breast implants

2 March 2012

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.

Table 1: Median shell thickness and tensile properties of PIP implants
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.

URL: 
https://www.tga.gov.au/node/193
Category: 
Alert/Advisory, Medical devices safety
Tags: 
Poly Implant Prothese (PIP) breast implants