Table 1.
Assessment and Comparisons of Heavy Metal Levels for Each Cohort
| Metal | Detection limit (µg/g)a |
Odds ratio BII vs non-BII (Cohort A vs Cohort B) |
P value BII vs non-BII (Cohort A vs Cohort B) | Acceptable internal exposureb (µg/day) |
Mean (median) BII (Cohort A) (µg/g) |
Mean amount in a 40-g capsulec BII (Cohort A) (µg) |
Mean (median) non-BII (Cohort B) (µg/g) |
Mean amount in a 40-g capsule non-BII (Cohort B) (µg) |
Mean (median) mastopexy (Cohort C) (µg/g) |
Mean amount in a 40-g breast tissue mastopexy (Cohort C) (µg) |
|---|---|---|---|---|---|---|---|---|---|---|
| Aluminum | 0.05 | 0.892 | 0.308 | 50 | 0.33 (<0.05) |
13 | 0.83 (<0.05) |
33.2 | <0.05 (<0.05) |
<2 |
| Antimony | 0.001 | 0.067 | 0.177 | 94 | 0.11 (0.089) |
4.3 | 0.14 (0.087) |
5.6 | 0.094 (0.091) |
3.8 |
| Arsenicd | 0.01 | >999 | 0.0001 | 15 | 0.20 (0.20) |
7.8 | 0.12 (0.090) |
4.8 | 0.36 (0.39) |
14.0 |
| Barium | 0.002 | 2.751 | 0.419 | 730 | 0.15 (0.085) |
5.9 | 0.12 (0.073) |
4.7 | 0.042 (0.050) |
1.7 |
| Beryllium | 0.003 | NA | NA | 0.14 | <0.003 (<0.003) |
<0.12 | <0.003 (<0.003) |
<0.12 | <0.003 (<0.003) |
<0.12 |
| Cadmium | 0.0003 | 0.600 | 0.978 | 1.7 | 0.016 (0.014) |
0.65 | 0.016 (0.013) |
0.7 | 0.011 (0.01) |
0.4 |
| Chromium | 0.03 | 0.913 | 0.621 | 1070 | 1.08 (0.97) |
43 | 1.19 (0.90) |
48 | 0.11 (<0.03) |
4.4 |
| Cobalte | 0.0006 | <0.001 | 0.0011 | 5 | 0.0020 (<0.0006) |
0.08 | 0.024 (<0.0006) |
0.9 | <0.0006 (<0.0006) |
<0.024 |
| Copper | 0.002 | 1.364 | 0.462 | 340 | 0.79 (0.70) |
32 | 0.72 (0.64) |
29 | 0.17 (<0.002) |
6.7 |
| Iron | 0.3 | 0.999 | 0.893 | 6300 | 49 (47) |
1977 | 50 (45) |
2015 | 13 (<0.3) |
525.0 |
| Lead | 0.0008 | 16.915 | 0.625 | 5 | 0.016 (<0.0008) |
0.63 | 0.013 (<0.0008) |
0.5 | 0.0024 (<0.0008) |
0.1 |
| Lithium | 0.01 | 3.913 | 0.287 | 280 | 0.077 (<0.01) |
3.1 | 0.040 (<0.01) |
1.6 | 0.20 (<0.01) |
7.8 |
| Manganesee | 0.0008 | 0.011 | 0.0009 | 18 | 0.13 (0.14) |
5.2 | 0.32 (0.21) |
13.0 | 0.092 (<0.0008) |
3.7 |
| Mercury | 0.0005 | 1.029 | 0.669 | 3 | 0.0015 (<0.005) |
0.062 | 0.0013 (<0.005) |
0.1 | <0.005 (<0.005) |
<0.02 |
| Molybdenum | 0.001 | 1.195 | 0.947 | 1700 | 0.01 (<0.001) |
0.58 | 0.013 (<0.001) |
0.5 | 0.36 (<0.001) |
14 |
| Nickel | 0.0009 | 1.604 | 0.439 | 22 | 0.41 (0.33) |
17 | 0.36 (0.29) |
14.5 | <0.0009 (<0.0009) |
<0.036 |
| Platinum | 0.25 | 0.289 | 0.502 | 10 | 0.0069 (<0.25) |
0.28 | 0.031 (<0.25) |
1.2 | <0.25 (<0.25) |
<10 |
| Selenium | 0.01 | 5.629 | 0.264 | 85 | 0.64 (0.62) |
25 | 0.60 (0.59) |
24 | 0.71 (0.69) |
28 |
| Silvere | 0.0004 | <0.001 | <0.0001 | 14 | 0.0024 (<0.0004) |
0.095 | 0.030 (<0.0004) |
1.2 | 0.001 (<0.0004) |
0.04 |
| Thallium | 0.0001 | NA | NA | 8 | <0.0001 (<0.0001) |
<0.004 | <0.0001 (<0.0001) |
<0.004 | 0.003 (<0.0001) |
0.1 |
| Tine | 0.005 | 0.006 | 0.0105 | 640 | 0.026 (<0.005) |
1.05 | 0.096 (<0.005) |
3.8 | <0.005 (<0.005) |
<0.2 |
| Titanium | 0.02 | 21.706 | 0.574 | 1200 | 0.016 (<0.02) |
0.64 | 0.012 (<0.02) |
0.5 | <0.02 (<0.02) |
<0.8 |
| Uranium | 0.001 | NA | NA | 0.6 | <0.001 (<0.001) |
<0.04 | <0.001 (<0.001) |
<0.04 | <0.001 (<0.001) |
<0.04 |
| Vanadium | 0.004 | <0.001 | 0.212 | 12 | 0.0006 (<0.004) |
0.022 | 0.0022 (<0.004) |
0.1 | 0.031 (<0.004) |
1.2 |
| Zincd | 0.01 | 1.118 | 0.0007 | 6400 | 21 (16) |
826 | 11 (8.4) |
424 | 2.3 (2.3) |
93 |
BII indicates those patients seeking explantation because they believe their implants are responsible for their symptoms. Cohort A: patients with self-reported BII requesting explantation; Cohort B: patients requesting implant exchange or explantation without self-reported BII; Cohort C: patients with mastopexy (without soft-tissue support or implants). BII, breast implant illness; NA, not available.
aµg/g = micrograms per gram, equivalent to milligrams per kilogram, equivalent to parts per million (ppm).
bAcceptable internal exposure (µg/g) sourced or derived primarily from International Conference on Harmonization Q3C guidance and National Institutes of Health Office of Dietary Supplements Fact Sheets for Health Professionals (Bethesda, MD).
cMean amount in a 40-g capsule = mean concentration × 40 g capsular tissue (approximate average weight of 2 capsules).
dSignificantly (P < 0.05) elevated level in Cohort A relative to Cohort B.
eSignificantly (P < 0.05) decreased level in Cohort A relative to Cohort B.