Study of Blossom Smart Expander Device Compared to Standard Tissue Expansion for Breast Reconstruction or Augmentation in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the Blossom Smart Expander Technology for two-stage tissue expander and implant-based breast reconstruction or augmentation. This study compares the new device, designed to slowly and continuously inject saline to expand breast tissue without frequent needle injections, against standard tissue expansion methods. The goal is to assess the clinical effectiveness of this technology in patients undergoing breast reconstruction or augmentation who prefer a less uncomfortable expansion process. Participants are randomly assigned to one of two groups the intervention group receives the Mentor Spectrum tissue expander combined with the Blossom Syringe Assist device, while the control group receives the standard Mentor Spectrum tissue expander without the Blossom device. Both devices are placed above the pectoralis major muscle in a surgery similar to conventional methods. Postoperative care includes follow-ups within one week of surgery and weekly visits to monitor expansion progress until completion, scar stabilization, and removal of drains. Monthly visits follow as part of routine care before the second stage of implant exchange. During the study, participants will have clinical data recorded regularly, including patient satisfaction surveys and pain assessments at standard postoperative times up to the second surgery, which usually occurs 3 to 6 months after the first. Researchers will monitor the time to complete tissue expansion and track complications until the expander is removed. The total participation duration can last up to approximately six months, including follow-ups and the second-stage implant surgery.

Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction