CM – Study examines how the surfaces of breast implants affect the immune response


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June 21, 2021

from Rice University

Bioengineers from Rice University collaborated on a six-year study that systematically analyzed how the surface architecture of breast implants affects the development of side effects, including an unusual type of lymphoma.

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Each year in the United States, approximately 400,000 people receive silicone breast implants. According to FDA data, most of these implants must be replaced within 10 years due to the formation of scar tissue and other complications.

A team of researchers from the Massachusetts Institute of Technology (MIT), Rice, of the University’s MD Anderson Cancer Center of Texas and Baylor College of Medicine published their results online today in Nature Biomedical Engineering.

« The surface topography of an implant can dramatically affect the perception of the immune response, and this has important implications for [implant] design » said Omid Veiseh, assistant professor of bioengineering in Rice, who did the research six years ago while on a postdoctoral fellowship at MIT. « We hope this paper provides a foundation for plastic surgeons to evaluate and better understand how implant choice can affect the patient experience. »

The results were co-authored by two dozen researchers, including the co- Lead authors Veiseh and Joshua Doloff from Johns Hopkins University, Robert Langer from MIT, and two of Veiseh’s associates from Texas Medical Center, Baylors Courtney Hodges and MD Anderson’s Mark Clemens.

Veiseh, whose laboratory focuses on developing and studying biocompatible materials focused, is particularly excited to discover that the surface architecture can be tuned to reduce the host’s immune response and reduce fibrosis to breast implants.

« We still don’t know how the immune system orchestrates its response to implants, and it’s really important to understand this in the context of biomaterials, « said Veiseh.

Veiseh continued the research ng continued after joining Rice’s faculty in 2017 as a CPRIT fellow at the Cancer Prevention and Research Institute of Texas. He and two Ph.D. Students of his laboratory, Amanda Nash and Samira Aghlara-Fotovat, worked on the project with the research groups of MD Anderson’s Clemens and Baylor’s Hodges to correlate findings from MIT animal studies with clinical data from human patients.

“Clinically we observed that patients exposed to textured surface breast implants may develop breast implant-associated large cell lymphoma (BIA-ALCL), but this has not occurred with smooth surface implants, ”said Clemens, Associate Professor of Plastics Surgery at MD Anderson, who leads a multidisciplinary treatment team for the disease. « This paper provides important new insights into cancer pathogenesis with clear implications for preventing disease before it develops. »

« That’s the most exciting part of it: it could lead to safer, more compatible biomaterials and implant designs, » said Veiseh.

Silicone breast implants have been used since the 1960s. The earliest versions had smooth surfaces, but patients with these implants often had a complication called capsular contracture, in which scar tissue formed around the implant and pressed it, causing pain or discomfort as well as visible deformities. Implants can also flip over after implantation and require surgical adjustment or removal.

In the late 1980s, some companies introduced rougher surfaces to reduce capsular contracture rates and keep the implants in place. The structured surfaces have tips of different heights. The peaks of a few average hundreds of microns.

In 2019, the FDA urged breast implant maker Allergan to recall highly textured breast implants with an average surface roughness of about 80 microns due to the risk of BIA-ALCL, a cancer of the immune system .

In 2015 Veiseh and Doloff, then postdocs in Langer’s laboratory at MIT, began testing five commercially available implants with different surface designs to see how they interact with the surrounding tissue and the immune system. These included the heavily textured one that was remembered earlier, one that was completely smooth, and three that lay somewhere in between.

In a study on rabbits, the researchers found that tissue that was exposed to the more textured implant surfaces , Showed signs of increased activity of macrophages – immune cells that usually remove foreign cells and debris.

However, all implants stimulated immune cells called T cells in different ways. The study found that implants with rougher surfaces stimulated more pro-inflammatory T-cell responses. Among the non-smooth implants, those with the least degree of roughness (4 microns) stimulated T cells, which appeared to inhibit tissue inflammation.

The results suggest that rougher implants rub against surrounding tissue and cause more irritation. This could explain why the rougher implants can lead to lymphoma: the hypothesis is that some of the texture will peel off and become trapped in nearby tissue, where it causes chronic inflammation that can eventually lead to cancer.

The Researchers also tested miniaturized versions of implants on mice. They made these implants using the same techniques used to make human-sized versions, showing that more textured implants produced more macrophage activity, more scar tissue formation, and higher levels of inflammatory T cells. The researchers worked with Hodges’ laboratory in Baylor to perform single-cell RNA sequencing of immune cells from these tissues to reveal the specific signals that made the immune cells more anti-inflammatory.

« The surface properties of the implants are fundamentally different Effects on key signals between immune cells that help recognize and respond to foreign materials, « said Hodges, assistant professor of molecular and cell biology at Baylor. « The results show that the slightly structured surface avoids the strong negative cytokine immune response that is induced by the rough surface. »

After their animal experiments, the researchers examined how human patients react to different types of silicone breast implants by working with MD Anderson to analyze tissue samples from BIA-ALCL patients.

They found evidence of the same types of immune responses seen in the animal studies. For example, they observed that tissue samples from patients who had received highly textured implants for many years showed signs of a chronic, long-term immune response. They also found that the scar tissue was thicker in patients with more textured implants.

« General comparisons in mice, rabbits, and then human [tissue samples] really provide much more robust and substantial evidence of how these compare « Said Veiseh.

The authors hope their data sets will help other researchers optimize the design of silicone breast implants and other types of medical silicone implants for greater safety.

 » We are delighted that we were able to introduce new material science approaches to better understand questions of biocompatibility in the area of ​​breast implants, « said Langer, lead author of the study and professor at the David H. Koch Institute at MIT. « We also hope that the studies we have conducted will generally be useful in understanding how safer and more effective implants of all types can be developed. »

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