Risk of Recall Among Plastic Surgery Devices Cleared Through the FDA 510(k) Pathway.

Area of Science:

• Medical device regulation
• Plastic surgery
• Regulatory science

Background:

• The U.S. Food and Drug Administration (FDA) 510(k) pathway is the primary route for medical device market entry.
• Prior research on FDA recall risk has not specifically focused on plastic surgery devices or their subcategories.

Purpose of the Study:

• To assess FDA recall rates and severity for 510(k)-cleared plastic surgery devices.
• To compare recall risks among plastic surgery subcategories.
• To benchmark plastic surgery device recall risk against all other 510(k) devices.

Main Methods:

• Analysis of FDA premarket notification (510[k]) database from 2008-2023.
• Classification of 234 surgical panel product codes to identify 103 plastic surgery codes (3194 devices) across 8 subcategories.
• Matching devices to the FDA recall database via 510(k) number and comparing with 45,182 other 510(k) devices.
• Statistical comparison using chi-squared tests, risk ratios, and Cox proportional hazards regression with Bonferroni correction.

Main Results:

• A total of 197 (6.2%) plastic surgery devices were recalled, with 11 (0.3%) being Class I recalls.
• The overall recall rate for other 510(k) devices was 11.4% (Risk Ratio [RR] = 0.54).
• Elevated recall hazards were identified in implants and fixation (Hazard Ratio [HR] = 3.64), negative pressure wound therapy (HR = 2.53), surgical mesh/acellular dermal matrices (HR = 2.46), and wound closure (HR = 2.01) subcategories compared to lasers and energy devices.

Conclusions:

• Plastic surgery devices exhibit a lower overall recall rate compared to non-plastic surgery devices.
• Significant variations in recall risk exist across different plastic surgery subcategories.
• This study establishes a crucial specialty-specific benchmark for postmarket surveillance of plastic surgery devices.