FDA Hands Warning Letters to Three Surgical Mesh Makers
Three medical devicemakers received FDA warning letters for marketing surgical mesh for off-label use in breast surgery.
In a June 1 letter to Allergan, the agency cites the company for promoting its SERI Surgical Scaffold for use in breast revision surgeries, breast lift procedures with or without augmentation, and breast reductions. The FDA cleared the scaffold for use as general soft tissue reinforcement, the letter notes.
A same day letter to Bridgewater, N.J.-based LifeCell letter accuses the company of promoting its Strattice Tissue Matrix for use in breast reconstructive surgery and breast augmentation, although it was cleared only for use as a soft tissue patch to reinforce weak soft tissue or repair damaged or ruptured soft tissue membranes. This is a major alteration to its intended use, the FDA says.
Similarly, TEI Biosciences’ SurgiMend was cleared for plastic and reconstructive surgery, muscle flap reinforcement or hernia repair, but the firm marketed it as the superior biologic matrix for breast surgery patients, the May 29 warning letter says.
The agency wants all three companies to stop distributing the devices for use in breast surgery and submit remediation plans within 15 business days.