2021 FDA Science Forum
The Effects of Topography on Bacterial Attachment for Textured Breast Implant Materials
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Contributing OfficeCenter for Drug Evaluation and Research
Abstract
As of January 5, 2020, 733 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) including 36 deaths had been reported to FDA. After systematic review, it was determined that 496 of these reports (68%) involved textured breast implants. In July 2019, some textured breast implants were recalled.
A number of clinical researchers and standards organizations hypothesized that bacterial colonization of textured breast implants may be linked to BIA-ALCL. To identify the causative factors linking surface texture features with BIA-ALCL, we investigated how the surface properties of textured breast implants affect bacterial adhesion.
First, we created a library of differentially textured surfaces. By varying the dimensions of recessive features and spacing, we were able to elucidate the relationship between surface features and bacterial adhesion. The attachment of Escherichia coli was investigated under both static and dynamic fluid conditions, as well as overnight biofilm growth. The results showed that E. coli did not follow a monotonic, linear relationship with surface roughness and preferred to attach to recessed features around 10 µm in size. Future work will focus on biological responses to better understand why bacteria prefer to attach to the intersection of planes. The results will help inform international standards development for texture implant risk classification and regulatory evaluation of breast implant safety.
