Late last year, the TGA followed the European Regulators lead and removed the approval of any textured implants with a European stamp of approval, prior to December 17.
It is thought to be linked to a bacteria that grows in a grooves of textured implants which enter during the initial surgeryAny women with concerns should consult their surgeon A number of Australian women who received Allergan implants after mastectomies are now considering a class action. "The Australian Society of Plastic Surgeons would support the TGA should it decide to ban Allergan textured implants," she said.
A spokesman for the Food and Drug Administration said in most cases, BIA ALCL was found in the scar tissue and fluid near the implant, but in some cases it could spread throughout the body. As of September 30, 2018, the FDA had received a total of 660 medical device reports of BIA ALCL worldwide, including the death of nine patients.Manufacturers say they are safe
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