AE type

All participants (N = 1552)

Total

n (%)

8 (0.5)

95% CI

(0.2, 1.0)

Nodules

n (%)

2 (0.1)

95% CI

(0.0, 0.5)

Local pain

n (%)

2 (0.1)

95% CI

(0.0, 0.5)

Local allergic reaction

n (%)

2 (0.1)

95% CI

(0.0, 0.5)

Pruritis

n (%)

1 (0.1)

95% CI

(0.0, 0.4)

Implant displacement or bulge

n (%)

1 (0.1)

95% CI

(0.0, 0.4)