Australia’s TGA considering, but not yet implementing, textured breast implant ban

Australia’s TGA said yesterday that it is seeking new data from suppliers of textured breast implants, which have been linked to a rare immune-system cancer, before making a decision on whether or not to suspend or cancel those products from its Register of Therapeutic Goods.

The regulatory body gave suppliers of the devices 10 working days to respond to the requests for more information, including dates they began to supply the devices and samples of the implants, according to a TGA release.

The decision comes after the convening of a breast implant expert panel on April 8, following recent decisions made in Canada and France to remove select implants from the market.

The implants have been linked to breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

The TGA said that the panel it convened discussed current data on the implants associated with BIA-ALCL and identified gap in the data that affected estimation of the true rate of the cancer in the country.

The regulatory body said that as of April 8, it has received 76 reports of BIA-ALCL in Australian women. The agency said that there are approximately 13,000 to 17,000 breast implant procedures performed in the country each year.

The panel also discussed the benefits of textured implants, particularly for reconstructive new surgery, and made suggestions including a need to update the TGA’s website with risks and benefits and to better encourage use of the Australian Breast Device Registry.

The TGA said that like the FDA and many other regulatory bodies, it has been monitoring BIA-ALCL cases since 2011, adding that the first adverse event report it received related to the cancer came in in 2009.

The agency said that textured implants of varying roughness are used in 82% of operations in the country.

Last month, a panel of experts convened by the FDA said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer.

from MassDevice http://bit.ly/2Ge0cb8