Grants Funded
ASPS/PSF leadership is committed to continuing to provide high levels of investigator-initiated research support to ensure that plastic surgeons have the needed research resources to be pioneers and innovators in advancing the practice of medicine.
Research Abstracts
Search The PSF database to have easy access to full-text grant abstracts from past PSF-funded research projects 2003 to present. All abstracts are the work of the Principal Investigators and were retrieved from their PSF grant applications. Several different filters may be applied to locate abstracts specific to a particular focus area or PSF funding mechanism.
Breast Implant Positional Stability without Traditional Texture
Principal Investigator
Jason Spector MD
Jason Spector MD
Year
2025
2025
Institution
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Funding Mechanism
Focus Area
Breast (Cosmetic/Reconstructive), Technology Based
Breast (Cosmetic/Reconstructive), Technology Based
Abstract
Project Summary
Due to the association of Breast Implant Associated-Acute Large Cell Lymphoma (BIA-ALCL) with textured breast implants, the FDA recommended the voluntary recall of textured implants. With the recall came the loss of one of the major benefits conferred by the
textured surface: positional stability for anatomically shaped implants. To date, there have been limited modifications, such as suture tabs, which typically provide only temporary expander/implant stability. Our group has engineered a novel smooth breast
implant surface that promotes tissue ingrowth into positionally stable smooth implants (PSSI), which have millimeter-scale surface well indentations along the implant surface. This novel topography facilitates tissue ingrowth into the outer surface of the implant,
thereby fixing the implant into position as the implant capsule forms. Previously published studies performed by our group in rodent models demonstrated tissue ingrowth into the wells by one-month post-implantation and showed increased rotational stability in all PSSI groups vs smooth implants by three months, comparable to textured implants. This study aims to validate our pilot study findings by investigating several PSSI designs scaled-up by one order of magnitude, which more closely recapitulates the clinical breast environment. To accomplish this, anatomic miniature 25cc implants with shells of variable surface topography will be fabricated using polydimethylsiloxane (PDMS) and filled with silicone gel. The implant surface will include with the following variations in width, W, depth, D, and well number (#): W2D1(56), W2D1(112), and W4D2(56) (widths and depths in millimeters). Control groups will include smooth and textured implants topographically comparable to commercially available implants. Implants will be evaluated in a rabbit subcutaneous model over three months. Implant rotation and movement relative to original implant location will be assessed at 2, 4, and 6 weeks, and 3 months. The implant-capsule unit will be explanted to evaluate tissue ingrowth and histological analysis will assess capsule thickness, myofibroblast presence, collagen formation, and immune cell presence. This project will also quantitatively assess the impact of the increased surface area on bacterial load and on nanoparticle release. Validation of the PSSI design will provide crucial supportive data for future NIH grant submission for porcine studies using clinically sized implants.
Impact Statement
Textured breast implants have fallen out of favor due to their established association with BIA-ALCL; the field of plastic surgery awaits a replacement technology. Textured breast implants shells were developed to hold shaped implants in the correct
orientation. With the discovery that textured implants are implicated in the pathogenesis of BIA-ALCL, few surgeons now use the textured devices. As a result, surgeons are limited to using smooth, round (non-anatomic) implants. We propose a novel smooth
breast implant design that maintains implant position ostensibly without risk that accompanies textured surfaces. By developing and refining this technology, these findings may restore the use of anatomically shaped implants and the benefits they confer in
augmentation and reconstructive cases.
Project Summary
Due to the association of Breast Implant Associated-Acute Large Cell Lymphoma (BIA-ALCL) with textured breast implants, the FDA recommended the voluntary recall of textured implants. With the recall came the loss of one of the major benefits conferred by the
textured surface: positional stability for anatomically shaped implants. To date, there have been limited modifications, such as suture tabs, which typically provide only temporary expander/implant stability. Our group has engineered a novel smooth breast
implant surface that promotes tissue ingrowth into positionally stable smooth implants (PSSI), which have millimeter-scale surface well indentations along the implant surface. This novel topography facilitates tissue ingrowth into the outer surface of the implant,
thereby fixing the implant into position as the implant capsule forms. Previously published studies performed by our group in rodent models demonstrated tissue ingrowth into the wells by one-month post-implantation and showed increased rotational stability in all PSSI groups vs smooth implants by three months, comparable to textured implants. This study aims to validate our pilot study findings by investigating several PSSI designs scaled-up by one order of magnitude, which more closely recapitulates the clinical breast environment. To accomplish this, anatomic miniature 25cc implants with shells of variable surface topography will be fabricated using polydimethylsiloxane (PDMS) and filled with silicone gel. The implant surface will include with the following variations in width, W, depth, D, and well number (#): W2D1(56), W2D1(112), and W4D2(56) (widths and depths in millimeters). Control groups will include smooth and textured implants topographically comparable to commercially available implants. Implants will be evaluated in a rabbit subcutaneous model over three months. Implant rotation and movement relative to original implant location will be assessed at 2, 4, and 6 weeks, and 3 months. The implant-capsule unit will be explanted to evaluate tissue ingrowth and histological analysis will assess capsule thickness, myofibroblast presence, collagen formation, and immune cell presence. This project will also quantitatively assess the impact of the increased surface area on bacterial load and on nanoparticle release. Validation of the PSSI design will provide crucial supportive data for future NIH grant submission for porcine studies using clinically sized implants.
Impact Statement
Textured breast implants have fallen out of favor due to their established association with BIA-ALCL; the field of plastic surgery awaits a replacement technology. Textured breast implants shells were developed to hold shaped implants in the correct
orientation. With the discovery that textured implants are implicated in the pathogenesis of BIA-ALCL, few surgeons now use the textured devices. As a result, surgeons are limited to using smooth, round (non-anatomic) implants. We propose a novel smooth
breast implant design that maintains implant position ostensibly without risk that accompanies textured surfaces. By developing and refining this technology, these findings may restore the use of anatomically shaped implants and the benefits they confer in
augmentation and reconstructive cases.
Biography
Dr. Jason Spector is a nationally recognized clinician, researcher and educator. He holds two patents, and has been an integral part several Cornell University-Weill Cornell Medical College translational research teams. He participates in the NIH and Howard Hughes Medical Institute sponsored Clinical Summer Immersion for Biomedical Engineering Program, mentoring engineering doctoral students. Since 2007, he has been a lecturer at Cornell University's Biomedical Engineering Science and Technology course, "Approaches to Problems in Human Needs." Dr. Spector serves as an Ad-Hoc reviewer for six prestigious medical journals, and has presented at national and international medical meetings. He recently served as Moderator of the Emerging Technologies Section, at the American Surgical Congress in 2011.
Dr. Jason Spector is a nationally recognized clinician, researcher and educator. He holds two patents, and has been an integral part several Cornell University-Weill Cornell Medical College translational research teams. He participates in the NIH and Howard Hughes Medical Institute sponsored Clinical Summer Immersion for Biomedical Engineering Program, mentoring engineering doctoral students. Since 2007, he has been a lecturer at Cornell University's Biomedical Engineering Science and Technology course, "Approaches to Problems in Human Needs." Dr. Spector serves as an Ad-Hoc reviewer for six prestigious medical journals, and has presented at national and international medical meetings. He recently served as Moderator of the Emerging Technologies Section, at the American Surgical Congress in 2011.