Clinical Trial
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Use of Poly-4-Hydroxybutyrate Mesh to Optimize Soft-Tissue Support in Mastopexy: A Single-Site Study.

BACKGROUND: The ptotic breast is surgically rejuvenated through a mastopexy procedure. Recurrent ptosis or other negative changes to the breast shape are not uncommon following mastopexy, as the tissue laxity and skin quality that contributed to ptosis are not surgically corrected. The purpose of this study was to assess the postsurgical changes in the breasts of patients who underwent a primary mastopexy procedure with soft-tissue reinforcement using a long-term poly-4-hydroxybutyrate resorbable scaffold (i.e., GalaFLEX).

METHODS: From July of 2012 to January of 2014, 11 consecutive patients underwent a central mound mastopexy with soft-tissue reinforcement in the lower pole using a poly-4-hydroxybutyrate resorbable scaffold. Patients returned for postoperative follow-up visits that included three-dimensional scans of their breasts at months 1, 3, 6, and 12.

RESULTS: There were no major complications in the study. Changes in the breast shape defined by distances between predefined landmarks between months 1 and 12 ranged from 1.5 to 9.6 percent. Some postoperative breast settlement occurred between months 1 and 3. The mean change in the nipple-to-inframammary fold distance from months 1 to 12 was 8 mm. Lower pole stretch was 5 percent.

CONCLUSIONS: Initial findings suggest that central mound mastopexy with soft-tissue reinforcement in the lower pole performed on difficult larger breasts yields a relatively stable result for 1 year after surgery. There was no statistically significant change between months 3 and 12 from the sternal notch to lowest point on the breast as determined by established three-dimensional imaging techniques.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

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