NSF/FDA SIR: The Role of Microbial Growth on Breast Implant Complications: Integration of Surface Properties, Extractable By-Product, and Biofilm Modeling

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Both the Food and Drug Administration (FDA) and the World Health Organization have identified a rare type of non-Hodgkin’s lymphoma associated with breast implants. FDA data indicate that textured implants are more likely to develop this type of complication. The link is strong enough that the FDA issued a voluntary recall of some textured breast implants (Class I recall). However, the mechanism between how textured implants may trigger this rare non-Hodgkin’s lymphoma is unknown. Thus, the goal of this NSF/FDA Scholar in Residence project is to better understand how these textured surfaces are distinct from smooth surfaces, which may help medical device makers and regulators prevent complications from cosmetic and other types of implants. The project will support the interdisciplinary training of a post-doctoral researcher at Howard University. Additional activities associated with this research include an event at Howard University with experts from various federal and local regulatory agencies to discuss how interdisciplinary science is needed for regulatory activities, standards development, and opportunities for graduate students to work in government agencies after graduation. The goal of this project is to assess how surface properties and particles that are shed from breast implants impact biofilm formation. Evidence of a link between BIA-ALCL (breast implant-associated anaplastic large cell lymphoma) and textured implants was conclusive enough to have recently triggered a series of regulatory actions worldwide. The work is motived by studies that have shown that these textured breast implants shed particles, which has led to the central hypothesis that the surface physicochemical properties such as extractables and particle shedding on breast implants influence biofilm formation. The investigators will employ experimental systems and computational models to test this hypothesis with two objectives. First, a biofilm reactor system will be used to evaluate biofilm formation rates on surfaces with various physiochemical properties, e.g., porosity, how surface features affect particle distribution, and the level of bacterial adhesion and biofilm formation on surfaces with and without particles. Second, a computational model (COMSOL) will to be used to evaluate the effects of surface properties and extractables. A sensitivity analysis will be conducted to determine which model parameters drive the results, including biofilm detachment parameters, Monod kinetic growth parameters, and particle transport parameters. Following sensitivity analysis, the parameters of interest will be calibrated using experimental results obtained in the first objective. Finally, the model will be evaluated using a different experimental condition (different surface roughness) to assess the predictive capability of the model. Information garnered from this project will advance regulatory science by providing a more mechanistic explanation for biofilm growth that may contribute to BIA-ALCL.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.