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TGA statement on Allergan breast implant withdrawal in Europe
Allergan has withdrawn textured breast implants in Europe
The TGA is aware that Allergan textured implants and tissue expanders are no longer being supplied in the EU as of 17 December 2018. Allergan has released a statement on its website.
The TGA will determine, following further discussion with Allergan Australia, what is an appropriate course of action here.
The TGA has been advised that the European conformity assessment certificate (referred to CE approval or EC Certificate) for Allergan's range of textured breast implants and tissue expanders expired on 17 December 2018. The European Notified Body (GMED) which is an organisation that undertakes medical device technical evaluations, notified the French regulator (ANSM) it had requested Allegan to provide (by 31 March 2019) an updated technical file so that further clinical evaluation could be undertaken.
It is important to note that the French regulator (ANSM) has confirmed there has been no additional safety related information and therefore, pending the advice of its expert committee, maintains its general recommendation (from 21 November 2018) to preferably use smooth implants. ANSM has advised in its own publication (not available in English as yet) that it has not identified an immediate risk for the health of women carrying the implants but women with breast implants should be monitored annually. The TGA notes the ANSM has scheduled public hearings on 8-9 February 2019 at which the ANSM expert committee will further discuss breast implants.
The UK regulator (MHRA) confirms in its web statement that there is currently no evidence of an increased risk to patients. Whilst the TGA is aware of the French action regarding the lapse in certification and withdrawal of the product, we are in further discussions with both Allergan and European regulators about the circumstances for the voluntary withdrawal.
The TGA will continue to collaborate with an expert panel (established by the TGA in 2016) and has sent information about the recent actions in France, including advice from GMED and ANSM, to discuss at a meeting in January 2019.
The advice provided on the TGA website (Breast implants and anaplastic large cell lymphoma) is still current at this time. The TGA will continue to update this information as required.
At this time the TGA does not recommend removal of breast implants.
The TGA will closely monitor developments and ensure any change is promptly communicated.