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Fighting Capsular Contracture with a Breast Implant Wrapping

Course or Client

Design of Medical Devices and Implants

Adviser: Prof. Myron Spector

Status

Started February 2025

Completed May 2025

Contributions

Research

Final Presentation and Report Writing

Final Presentation

Final Report

FDA Report

Project Overview: Capsular contracture (defined as "a tight or constricting scar tissue capsule forming around a [breast] implant... resulting in chronic pain") is the most common complication of breast reconstruction and augmentation surgery with levels of severity from I to IV. Popular theory for the formation of the fibrous scar tissue around the implant states that epithelial cells that have transitioned to myofibroblasts produce 𝛼-smooth muscle actin (𝛼-SMA) and collagen fibers in an attempt to both isolate the foreign object from the rest of the body and heal the surgical site. While both non-surgical and surgical options exist to treat symptoms of capsular contracture, there are currently few available options for preventing the condition, and fewer still for prevention in high risk patients. Thus, a novel breast implant wrapping composed of a sheet of acellular dermal matrix soaked in a pirfenidone seeded poly(ethylene glycol) hydrogel was proposed. Targeting the critical first few days after surgery, the loaded pirfenidone would help to locally down regulate growth factors such as TGF-β which drives epithelial to mesenchymal transition. The use of acellular dermal matrix in the implant would increase overall physical robustness and has additionally been shown to decrease rates of capsular contracture in patients with breast implants.

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