An FDA advisory panel on general and plastic surgery recently shot down Integra LifeSciences’ SurgiMend mesh for the specific indication of breast reconstruction, even though the device has been used in breast reconstruction for more than a decade under a 510(k) clearance.
All hope may not be lost, however. During Integra’s third-quarter earnings call, the company’s management team sounded confident that FDA approval for post-mastectomy breast reconstruction is still within grasp.
Is Integra’s Breast Reconstruction PMA Doomed?
