The Government of Australia, Department of Health Therapeutic Goods Administration - Alert for breast implants and anaplastic large cell lymphoma
Update - TGA's review of textured breast implants and preliminary outcomes
11 July 2019
The Government of Australia, Department of Health Therapeutic Goods Administration released an updated alert breast implants and ALCL. "The update reflects the TGA's initial views following recent laboratory testing and statistical analysis. Breast implant sponsors have until 24 July to provide additional information which will be assessed before reaching a final decision".
The original review was announced on 3 May 2019 and involved both laboratory testing and statistical analysis of supply information and the known cases of BIA-ALCL to estimate the risks associated for each type of implant.
Information for consumers about BIA-ALCL, its symptoms and treatments is available on the TGA's breast implant hub.
The proposed regulatory actions for particular products and the affected brand(s) and for quick reference we have included the list of implants below:
Proposed Cancellation
"If the entries of the above products are cancelled, the products would no longer be able to be imported, manufactured or exported from Australia by the sponsor. The TGA is also proposing to require the sponsor to recall the products to remove all remaining products from the market. The recall would only apply to product that is waiting to be implanted. There is not a recommendation to surgeons to remove implants in the absence of a BIA-ALCL diagnosis."
Proposed Suspension (on the basis that it is likely that there are grounds for cancelling the entries of the products)
Imposition of conditions – patient information leaflet
"To support informed patient choices, the TGA has imposed a condition on the ARTG entries of the products in the table below that the sponsors are to make available to patients a patient information leaflet that includes information about the therapeutic good including warnings and risks associated with the product."
To read the full article visit: https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma
All posts are intended strictly for educational purposes. It is not intended to make any representations or warranties about the outcome of any procedure. It is not a substitute for a thorough in-person consultation with a medical professional. If you have questions about your personal medical situation, please call your healthcare provider.
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