Plastic Surgery Foundation Receives IDE Approval
The FDA has approved an Investigational Device Exemption (IDE) request by the Plastic Surgery Foundation for a study of surgical mesh used in breast reconstruction.
The IDE allows the foundation to sponsor an observational trial studying the impact of surgical mesh, including acellular dermal matrix, in implant-based breast reconstruction.
No surgical mesh devices have received FDA’s approval for any breast reconstruction indication. The organization hopes to develop scientific evidence that would lead to a Premarket Approval Application.
The first patients are expected to be enrolled in the study in early 2023.