Long-Term Efficacy and Safety of Poly-4-Hydroxybutyrate (P4HB) Scaffold (GalaFLEX) in Mastopexy for Breast Ptosis: A Prospective Study

Abstract

Background

Breast mastopexy poses unique challenges in achieving long-term results, particularly regarding the recurrence of ptosis. For this reason, different surgical techniques have been proposed, including those involving the use of additional devices at the lower pole to provide better support for the mammary gland. To address this issue, we conducted a prospective analysis aimed to evaluate the efficacy of incorporating the bioabsorbable scaffold GalaFLEX with mastopexy procedure in preventing recurrent ptosis during a 12-month follow-up period.

Methods

The study enrolled 60 patients undergoing primary mastopexy for correcting grade III breast ptosis. The cohort was divided into two groups (A and B). Group A underwent mastopexy with the addition of the bioabsorbable mesh sling to the lower pole of the breast, serving as an internal, subcutaneous supportive “bra”. Group B received a standard mastopexy without the mesh support. Patients were followed up for 12 months to assess the outcomes.

Results

The nipple-to-inframammary fold distance was measured before the surgery and during the 1-month and 12-month follow-up checks between the study group (Group A) and the control group (Group B) as indicator of post-operative breast ptosis recurrence. From the 12th post-operative month onward, measurements in Group A showed a statistically significant difference (P < 0.05) compared to Group B, indicating a better maintenance of the long-term results in patients treated with GalaFLEX.

Conclusion

The incorporation of GalaFLEX matrix in mastopexy procedures provided an additional layer of support and demonstrated efficacy in delaying the reoccurrence of ptosis following surgery. This study confirmed the potential benefits of using a bioabsorbable mesh in mastopexy procedures to enhance long-term breast shape stability, offering to the plastic surgeons a valuable adjunct in the management of breast ptosis.

Level of Evidence III

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