Synthetic Reabsorbable Mesh (GalaFLEX) as Soft Tissue Adjunct in Breast Augmentation Revision Surgery

Abstract

Background A significant number of patients with a previous submuscular breast augmentation require a revision surgical procedure during their long-term follow-up period that involves implant pocket change from submuscular to subglandular. Reduced soft tissues thickness represent a major concern that would discourage surgeon to undertake this approach. Objectives The authors sought to determine whether a synthetic resorbable mesh use as supplemental covering device was safe and yielded improved soft tissues thickness and protection against capsular contracture in patients that undergo implant plane shift to subglandular. Methods A retrospective review of 34 patients who underwent revision of a previous breast augmentation involving implant change in a subglandular pocket and upper pole GalaFLEX (Galatea Surgical, Lexington, MA, USA) mesh coverage was conducted. Minor and major complications onset were recorded during short and medium-term follow-up. Patient satisfaction was assessed via an anonymous questionnaire administered 6 months postoperatively. Results During our follow-up period that ranged from a minimum of 6 months to a maximum of 28 months we did not report minor or major complications. In particular we did not observe wrinkling/rippling or significant capsular contracture onset. High levels of patients’ satisfaction were determined, according to self-reporting questionnaires. Conclusions Initial results of this preliminary report from our case series demonstrate the safety of GalaFLEX as supplemental device in terms of improved soft tissue coverage of the implant for complex revisional cases in breast augmentation.

Innovative Application of GalaFLEX Poly-4-Hydroxybutyrate Scaffold in Breast Reduction/Mastopexy with Inferiorly Based Dermo-adipose Flap

“…Infection, seroma, and delayed healing are reported in the literature as rare complications in larger number case studies. 4,6 Takeaways Question: Recurrence of breast ptosis after reduction mammaplasty surgery is a real concern for every surgeon. How we can enhance the outcome's longevity?…”

“…Infection, seroma, and delayed healing are reported in the literature as rare complications in larger number case studies. 4 , 6 …”

“…Even if the P4HB scaffold is still not FDA approved for breast surgery in the United States, promising data from multicenter clinical studies in other countries (CE approval) have already been reported for its use in augmentation mastopexy, breast reduction, and breast revision surgery, demonstrating its ability to deliver enduring aesthetic results. 3–6…”

“…2 Even if the P4HB scaffold is still not FDA approved for breast surgery in the United States, promising data from multicenter clinical studies in other countries (CE approval) have already been reported for its use in augmentation mastopexy, breast reduction, and breast revision surgery, demonstrating its ability to deliver enduring aesthetic results. [3][4][5][6] To ensure optimal results, the authors recommend a single, large rectangular sheet of P4HB scaffold (15 × 20 cm) for both breasts. Even if the monofilament design of this scaffold is intended to minimize the risk of infection, with a low infection rate compared with other…”