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Biomaterials and Engineering Laboratory Report: Non-active mammary implants
Breast implant associated cancer, also known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), is a rare cancer of the immune system.
On 3 May 2019, the Therapeutic Goods Administration (TGA) began a review involving laboratory testing, statistical analysis of product supply information and known cases of BIA-ALCL. The purpose of the review was to estimate the risks associated with different products on the Australian market. There is evidence that BIA-ALCL is more likely to occur in implants with a rough surface.
As part of the review, TGA's Laboratories investigated the surface of 52 different models of breast implants and tissue expanders. The study found that the sponsors correctly classified surface roughness in almost all cases, in accordance with the relevant international standard (ISO 14607:2018). The standard classifies implants as smooth, micro- or macro-textured based on surface roughness. It is important to note that the standard does not claim these groupings have any clinical relevance.
This study found that surface roughness measurements do not provide a complete picture of surface texture. As a result, other classification systems were also considered. Overall, this study found that it may be appropriate to consider surface texturing methods in the classification standard as similar methods have similar characteristics. Further investigation is needed to develop a comprehensive classification system with practical and clinical applications.
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- Biomaterials & Engineering Laboratory Report: Non-active mammary implants (pdf,6.03Mb)
- Biomaterials & Engineering Laboratory Report: Non-active mammary implants (docx,12.2Mb)
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- Executive summary
- Sponsor submission evaluation
- Test methods
- Results and discussion