GalaFLEX Breast Mesh Lawsuit FAQ
What are GalaFLEX lawsuits about? +
These claims allege GalaFLEX mesh degraded prematurely, losing structural support before tissue healing was complete and leading to avoidable complications.
Who are the defendants? +
Galatea Surgical (a subsidiary of Tepha, Inc.) is commonly named. Depending on the facts, some cases also involve claims against surgeons who used the product.
What complications are being reported? +
Women report chronic pain, capsular contracture, implant displacement or failure, infection, disfigurement, and the need for revision surgery.
Was GalaFLEX fully FDA approved? +
GalaFLEX was cleared through the FDA 510(k) pathway, which is different from the stricter PMA approval process used for some higher-risk devices.
Is there an MDL yet? +
As of March 2026, this litigation is generally considered pre-MDL, with filings and investigation activity continuing to grow.