Updated March 2026
GalaFLEX Breast Mesh Litigation Is Growing
Women nationwide are reporting serious complications after GalaFLEX mesh placement during breast lifts, reductions, reconstructions, and augmentation revisions.
Key Facts
- GalaFLEX is a poly-4-hydroxybutyrate (P4HB) bioresorbable surgical mesh.
- It was FDA 510(k) cleared, not approved through the stricter PMA pathway.
- It is marketed to provide soft-tissue support and then naturally resorb.
- Reported injuries include premature degradation, loss of support, chronic pain, and capsular contracture.
- Women report implant displacement, infection, revision surgery, and disfigurement.
- Litigation remains in a pre-MDL stage with growing adverse event attention.
Defendants Commonly Named
Galatea Surgical (subsidiary of Tepha, Inc.) and, in some cases, surgeons who used the device.
Who May Qualify
- Women who received GalaFLEX mesh during breast reconstruction or cosmetic breast surgery.
- Patients who developed chronic pain, infection, implant failure, capsular contracture, or significant deformity.
- Patients who required corrective or revision surgery after GalaFLEX placement.