Recall of breast implants and tissue expanders

Australian Medical Association/AusMed

Irish pharmaceutical device manufacturer Allergan plc (NYSE: AGN) has recalled certain lines of its breast implant products worldwide.

The Therapeutic Goods Administration (TGA) has been informed of the global voluntary recall of BIOCELL® textured breast implants and tissue expanders. A formal review into textured breast implants is currently underway by the TGA in Australia.

The saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available.

Effective immediately (since late-July), healthcare providers should no longer implant new BIOCELL textured breast implants and tissue expanders and unused products should be returned to Allergan.

Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the US Food and Drug Administration (FDA).

Allergan will provide additional information to customers about how to return unused products. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns.

Regulatory bodies around the world, including the TGA ,have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.

This global recall does not affect Allergan’s NATRELLE® smooth or BRST MICROCELL® breast implant products.

The recalled products in Australia include:

Registration (ARTG) number

Product

175422

Natrelle INSPIRA Truform 1 gel, Textured, Single Lumen

175425

Natrelle INSPIRA Truform 2 gel, Textured Single Lumen

175420

Natrelle Truform 1 gel, Textured, Single Lumen

171512

Natrelle Truform 3 gel, Textured Single Lumen

171475

Natrelle Soft Touch, Truform 2 gel, Textured, Single Lumen

171387

Natrelle Truform Dual gel, Textured Single Lumen

171388

Natrelle Saline-filled, Textured

169956

Natrelle Double Lumen Gel/Saline

175797

Natrelle Tissue Expanders – Skin expander

* Generic file photo only

/AMA/AusMed News. This material comes from the originating organization and may be of a point-in-time nature, edited for clarity, style and length.