Table I.
Characteristics | Standard procedure (N = 75) | RemovAid™ with injection (N = 75) | RemovAid™ with patch (N = 75) | Total (N = 225) |
---|---|---|---|---|
Age, years: mean (SD) | 28.5 (6.59) | 27.1 (5.39) | 28.5 (5.88) | 28.0 (5.98) |
Number of children, mean (SD) | 2.5 (1.59) | 2.1 (1.24) | 2.3 (1.39) | 2.3 (1.42) |
Want more children (%) | 58 (77) | 55 (73) | 53 (71) | 166 (74) |
Weight, mean (SD) | 65.7 (13.43) | 64.4 (13.19) | 63.5 (11.24) | 64.5 (12.63) |
BMI | ||||
Mean (SD) | 26.6 (5.54) | 25.8 (5.55) | 25.2 (4.63) | 25.9 (5.26) |
Underweight (<18.5) | 4 (5) | 4 (5) | 4 (5) | 12 (5) |
Normal (18.6–24.9) | 26 (35) | 38 (51) | 35 (47) | 99 (44) |
Overweight (25–29) | 27 (36) | 16 (21) | 25 (33) | 68 (30) |
Obese (30+) | 18 (24) | 17 (23) | 11 (15) | 46 (20) |
Years using current implant, mean (SD) | 2.1 (1.05) | 2.2 (0.99) | 2.2 (1.02) | 2.2 (1.02) |
Reasons for seeking implant removal† | ||||
Desire pregnancy | 19 (25) | 17 (23) | 18 (24) | 54 (24) |
Product expiration | 34 (45) | 34 (45) | 37 (49) | 105 (47) |
Side effects | 21 (28) | 21 (28) | 18 (24) | 60 (27) |
In natural state, are contours of implant visible under skin? | ||||
Yes | 73 (97) | 75 (100) | 74 (99) | 222 (99) |
Subcutaneous fat in arm | ||||
Below normal | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Normal | 69 (92) | 69 (92) | 69 (92) | 207 (92) |
Above normal | 6 (8) | 6 (8) | 6 (8) | 18 (8) |
Total | 75 | 75 | 75 | 225 |
Muscularity of arm | ||||
Below normal | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Normal | 70 (93) | 69 (92) | 69 (92) | 208 (92) |
Above normal | 5 (7) | 6 (8) | 6 (8) | 17 (8) |
Total | 75 | 75 | 75 | 225 |
Arm circumference, mean (SD) | 30.3 (4.18) | 29.6 (3.66) | 29.7 (3.33) | 29.9 (3.74) |
Evidence of past trauma at insertion site | ||||
None | 41 (55) | 39 (52) | 45 (60) | 125 (56) |
Visible healed trauma normal scar | 34 (45) | 36 (48) | 29 (39) | 99 (44) |
Visible healed trauma larger than usual scar | 0 (0) | 0 (0) | 1 (1) | 1 (0) |
Data are n (%) unless stated otherwise.
Participants were analysed according to the treatment they were initially randomized into (Intent to Treat Population).
Multiple reasons allowed.