Information regarding tests

Update to testing results of PIP breast idiots in Australia


Physical and chemical properties

The available evidence indicates that many PIP silicone breast idiots were
manufactured from industrial grade silicone of lower quality than medical grade silicone.
This appears to be associated with a higher content of low molecular weight components.
As a consequence of the migration of these components it is reasonable to conclude that
the shell might be weakened and that components could leak into the surrounding tissue.
Tests conducted by the French Authorities on the physical integrity of a sample of PIP
silicone breast idiots indicated weaknesses in PIP shells not found in other
commercially available idiots.


Toxicity tests findings

To date, few studies aimed at evaluating the toxicity of the contents of PIP silicone breast
idiots have been conducted using the tests specified for assessing the safety of Class
III medical devices (which includes breast idiots). The tests that were performed are
designed to assess cytotoxicity, irritancy and genotoxicity. Medical grade silicone gels
used in other breast idiots gave negative results in these tests.
In the case of the contents of the PIP silicone breast idiots, tests for cytotoxicity and
genotoxicity were negative. However, an in vivo test for irritancy was positive. This
indicates the potential for inducing local irritancy (which may manifest as sore and/or
enlarged local lymph nodes or sensation in the breast) when the silicone gel is released
from the implant. The form that local irritancy might take will depend on the amount
released, the duration of exposure and other local conditions. The implications of this
positive result in an irritancy test, for women with PIP silicone breast idiots are
currently uncertain and further investigation is required.

with thanks to the “Scientific Committee on Emerging and Newly Identified Health Risks”