Following an extensive review that included laboratory testing and analysis of the available statistical data, the Australian Therapeutic Goods Administration (TGA) have announced a suspension and recall of specific breast implants for a period of six months, during which time the implant company will be able to submit additional information proving the implants’ ‘safety and performance’. The implants in question are those that have been linked to a higher rate of BIA-ALCL and other patient safety issues, otherwise known as Grades 3 and 4 of “macrotextured” implants and all “microtextured” implants.
In addition, there are new conditions on all breast implants and tissue expanders in that their manufacturers are required to provide more detailed information to surgeons and patients on possible side effects of implants including BIA-ALCL. Some implant manufacturers have made the decision to completely remove one or more of their implants from the market permanently. This follows implant manufacturer Allergan’s announcement earlier this year.
Implant manufacturers must also disclose any case of BIA-ALCL to the TGA within 10 days and submit twice-yearly reports containing information on their Australian and international supply of implants and including complaints received and “adverse events” including capsular contracture and rupturing.
BIA-ALCL – The Facts
It is important to note that BIA-ALCL is still considered extremely rare despite growing international concern. Keeping in mind that millions of women worldwide and around 40,000 women in Australia each year have breast augmentation with implants; there have been 23 deaths with 700 confirmed cases reported worldwide, 107 of these in Australia. Australian researchers identified 73.9 percent of these were linked to Grade 3 and Grade 4 implants, with 19.6 percent linked to Grade 2 implants. The TGA says, “The suspensions and cancellations [affect] 13 percent of the supply of breast implant devices on the Australian market by volume.” The Sydney Morning Herald reported, “All Australian cases have involved textured implants, the greater the texture, the higher the risk. The chance of developing ALCL from grade 4 implants was one in 2800 breast augmentations and one in 3300 for grade 3. The risk drops off markedly for the lesser textured grade 2 (one in about 84,000).”
To see the full list of recalled and suspended implants and to learn more about the content in this article, head to the TGA website.