Implants in Australia
Back in July, health officials in Australia recommended the ban of textured implants. Our previous July 2019 article, “Textured Breast Implants Ban: Onto Australia“, discussed the type of implants up for suspension by Australia’s Therapeutic Goods Administration (TGA).
Now in Australia, textured breast implants being sold there are under regulation due to the risk of BIA-ALCL. This recall and ban includes eight types of “macro” and “micro” textured implants. The Medtechdive article, “Australia enforces new regs on all breast implant makers, suspends some devices“, discusses what led to the regulations:
The regulator’s review took into account input from manufacturers, patients and the Breast Implant Working Group, a cohort of experts TGA convened in April after regulators in France and Canada took action against textured implants. The review involved lab testing of implant samples as well as a “full statistical review” of all BIA-ALCL cases reported through the end of May.
The TGA said all implants and tissue expanders will be banned for the next 6 weeks until concerns are addressed and fixed.
Regulations and Statistics
Here are the regulations being placed on breast implant manufacturers and sponsors:
Implant sponsors must report all cases of BIA-ALCL to the TGA within 10 working days and provide six-monthly reports of Australian and worldwide supply, complaints and adverse events data.
Manufacturers must also provide doctors and patients with clear, written information about the risk of BIA-ALCL, which is very rare.
According to the Sydney Morning Herald article,” ‘Significant jump’ in cancer linked to breast implants as ban decision looms“, 73.9 percent of the 700 confirmed cases of BIA-ALCL were in connection with the highest textured implants, grade 4 and grade 3. Getting ALCL was 1 in 2800 for grade 4 implants and 1 in 3300 for grade 3 implants. Grade 2 implants were the least concerning, only being 19.6 percent of the 700 cases and with a risk of 1 in 84,000.
Australia’s TGA and United States’ FDA
Our July 2019 article referenced another article by the Sydney Morning Herald, “Breast Implant Ban, Recall Proposed by TGA“, which provided a chart of the sixteen implants under proposed suspension. Of those sixteen, seven manufacturers also appear in the United States. The eight textured implants that are being recalled and banned in Australia right now are not ones that are also in the U.S.
From the Medtechdive article, we can also learn that the FDA may be placing more regulations on products manufactured in the United States, “At a two-day advisory committee meeting on the subject in March, stakeholders discussed the possibility of adding a black box warning and a more thorough informed consent checklist to the devices”.
We are glad to see the positive step that the TGA is making as regards breast implants and emphasizing the seriousness of the risks. We will continue to provide updates as we learn more information about any decisions to recall or ban implants.
Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.