Table 4.

Characteristics of Included Approved High-risk Plastic Surgery Devices

Devices (n = 39)
Initial clearance date	n (%)
1980–1989	4 (10.0%)
1990–1999	5 (13.0%)
2000–2009	20 (51.0%)
2010–present	10 (26.0%)
Implantable
Yes	26 (67.0%)
No	13 (33.0%)
Device type
Wound device	6 (15.0%)
Breast implant	8 (20.5%)
Dermal implant	17 (43.6%)
Laser	4 (10.0%)
Hemostasis adjunct	1 (2.50%)
Vascular reconstruction adhesive	1 (2.5%)
Electrical impedance spectrometer	1 (2.5%)
Suture	1 (2.5%)
Total	39
No. supplements
Breast implant	206 (23.0%)
Dermal implant	522 (58.2%)
Electrical impedance spectrometer	2 (0.2%)
Laser	9 (1.0%)
Suture	0 (0.0%)
Vascular reconstruction adhesive	3 (0.3%)
Wound device	155 (17.4%)
Total	897