Update on Mentor Implants / ALCL

Please find below updates announced by the TGA regarding textured implants.

Posted: July 12th, 2019

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BIA-ALCL back in the news

BIA-ALCL is back in the news following the TGA’s announcement yesterday. At the outset, it is important to state that there has been no new information and no changes to established investigation and treatment protocols.

Under section 42 of the Therapeutic Goods Act 1989 the TGA has formally requested textured implant suppliers provide detailed information and samples of the implants for analysis before considering whether to suspend or ban the products.  Suppliers have ten working days to respond.

After receiving information from suppliers, [the] TGA will consider whether to suspend or cancel particular products from the Australian Register of Therapeutic Goods.

Which implants are in question?

In France, macro-textured and polyurethane models of implants made by six manufacturers: Macro-textured Natrelle implants by Allergan; Monobloc textured implants by Arion; Silicone textured implants by SEBBIN; GFX, IMPLEO and COGEL implants by Nagor; MATRIX implants by Eurosilicone; and POLYtxt, Sublime Lime, Microthane and Diagon\Gel® 4Two implants by Polytech.

The ANSM (French regulator) banned these products following hearings in February. Canada Health (the Canadian Department of Health) issued a statement of its intent to ban Biocell implants which are the only macro-textured implant on this list available in Canada http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/69520a-eng.php.

In the Netherlands, the Dutch Plastic Surgery Association has advised members to suspend use of the macro-textured and polyurethane devices while the Dutch authorities complete further research into them. Other European countries have not followed the French.

Key Points on BIA – ALCL

  • To date, although there are hypotheses, no one can claim to know the exact cause of BIA-ALCL.  The hypotheses with most scientific support involve textured implants, the presence of bacteria, host genetic predisposition, chronic T-cell response with eventual monoclonal proliferation and transformation into lymphoma
  • The updated Australian and New Zealand figures due to be published next month:
    • Show that 70% of ANZ cases are diagnosed before any capsular invasion and a further 7.4% with tumour invading but not through the capsule. This is stage 1 disease.
    • In these cases, complete surgical removal is curative with enbloc capsulectomy and implant removal.
    • Shows the risk for Silimed polyurethane implants 1:2832, Allergan Biocell implants 1:3345 and Mentor Siltex 1:86000.

Posted: April 12th, 2019

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