TGA decision to grant Special Access Scheme B approval for suspended breast implants

Breast implants

I recently submitted a complaint to the TGA about the promotion by JT Medical of ARTG suspended POLYTECH Breast implants (AC-G8RWXAES/2019). I was concerned that these implants were being promoted to the public with no mention of the risks of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).

The TGA’s decision to suspend certain breast implants was in response to the increasing incidence of BIA-ALCL and new evidence correlating BIA-ALCL to textured implant devices.

Despite this evidence, following application from six surgeons, the TGA has allowed 36 patients access to suspended breast implants via Special Access Scheme (SAS) B. Such applications must be reviewed and approved by TGA before a suspended product may be supplied to a patient. In granting approval, the TGA must consider the risks and benefits of the device proposed, and why a device currently included in the ARTG cannot be used for the treatment of the individual patient.

Given the reasons for the ARTG suspension, including that the claimed benefits of the highly textured surface of the device was not supported by the manufacturer’s evidence, it is hard to understand why SAS B approval was given, especially when the applications were for cosmetic breast augmentation, not breast reconstruction. In my opinion, these decisions undermine the credibility of the TGA.

The TGA has published, “Information for consumers: What you need to know about unapproved breast implants”. I am concerned that this document hands responsibility for what should be a regulatory decision to an ill-informed consumer in a power imbalance with her surgeon (who may have undisclosed conflicts of interest with the device sponsor).

There is a discrepancy between disclosure of remuneration by prescription medicine companies to Australian doctors compared with medical device companies. The former, stimulated by the ACCC who authorise Medicines Australia Code of Conduct, transparently publish such remuneration; the latter do not! In the USA transparency of payments to doctors by all therapeutic goods companies is mandated by law, in Australia it is not.

I have written to Health Minister Hunt requesting he initiates a Ministerial review of the decision by the TGA to give SAS B approval to use suspended breast implants for 36 patients following applications from six surgeons.

I have also requested he makes disclosure of remuneration to medical practitioners uniform for all manufacturers of therapeutic goods by including this provision as a condition of product listing / registration / inclusion on the ARTG.

Update: 29 October 2020. Suspended breast implant devices now cancelled

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Advertising, Medical Devices and tagged , , . Bookmark the permalink.

1 Response to TGA decision to grant Special Access Scheme B approval for suspended breast implants

  1. Very informative article about breast implants

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