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Postmarket Modifications of High-risk Plastic Surgery Devices
Oluwatobi R Olaiya1, Doyinsola Oyesile2, Nicholas Stone3
1Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
Plastic and Reconstructive Surgery. Global Open
|April 21, 2020
Summary
High-risk plastic surgery devices undergo frequent modifications via supplemental review. Manufacturers increasingly use this pathway, potentially altering devices without new safety and efficacy data.
Area of Science:
- Medical Device Regulation
- Plastic Surgery Devices
- Regulatory Science
Background:
- High-risk medical devices require premarket approval (PMA) with safety and efficacy evidence.
- The PMA supplemental review allows modifications without new clinical studies.
- This study examines changes in high-risk plastic surgery devices post-clearance.
Purpose of the Study:
- To characterize modifications made to high-risk plastic surgery devices after initial FDA clearance.
- To analyze trends in the use of the PMA supplemental review pathway for these devices.
Main Methods:
- Retrospective analysis of the FDA PMA database (1980-2018).
- Extracted data included device type, supplement details, and withdrawal dates.
- Calculated median modifications and device lifetime in years.
Main Results:
- 39 original plastic surgery devices were approved.
- PMA supplement usage significantly increased over time.
- Devices underwent a median of 11 modifications; breast implants had the most (median 28).
Conclusions:
- Plastic surgery device manufacturers increasingly use the supplemental review track.
- High-risk devices may undergo frequent changes without new clinical evidence.
- The safety and efficacy of modified devices warrant further investigation.
