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Home » Plastic Surgery Foundation Receives IDE Approval
Plastic Surgery Foundation Receives IDE Approval
October 18, 2022
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.
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