Poly Implant Prothèse (PIP) Breast Implants: Report of the Chief Medical Officer
Appendix B
Core Study complications and adverse outcomes as reported in the FDA Update on the Safety of Silicone Gel-Filled Breast Implants, p.45-48 (15).
Table 3. Core Study complications and adverse outcomes over 10 years post-implantation for Allergan Natrelle silicone gel-filled breast implants. Table shows cumulative incidence rates over time and 95% confidence intervals calculated using Kaplan-Meier analysis*.
Complication or Outcome | Primary Augmentation (N=455) | Revision Augmentation (N=147) | Primary Reconstruction (N=98) | Revision Reconstruction (N=15) |
|---|---|---|---|---|
| Asymmetry | 3.3% (2.0-5.1) | 6.5% (3.2-12.8) | 23.2% (15.4-33.9) | 6.7% (0.2-31.9) |
| Breast pain | 10.9% (8.2-14.3) | 11.7% (7.1-18.9) | 6.8% (2.8-16.1) | 0% |
| Breast/skin sensation changes | 1.6% (0.8-3.3) | 2.2% (0.7-6.6) | 0% | 0% |
| Bruising | 0.4% (0.1-1.8) | 3.0% (1.1-7.8) | 1.0% (0.1-7.1) | 6.7% (0.2-31.9) |
| Capsular contracture (Baker III/IV) | 19.1% (15.6-23.3) | 27.5% (20.3-36.6) | 24.6% (16.2-36.2) | 6.7% (0.2-31.9) |
| Delayed wound healing | 1.1% (0.5-2.7) | 0.7% (0.1-4.8) | 1.0% (0.1-7.2) | 0% |
| Hematoma | 1.6% (0.7-3.2) | 2.1% (0.7-6.3) | 1.5% (0.2-10.4) | 0% |
| Implant malposition | 6.3% (3.9-8.4) | 6.0% (3.1-11.7) | 2.3% (0.6-8.9) | 13.3% (1.7-40.5) |
| Implant palpability/visibility | 1.9% (1.0-3.8) | 6.0% (3.0-11.6) | 6.5% (0.4-17.0) | 6.7% (0.2-31.9) |
| Implant removal with or without replacement | 20.8% (17.2-25.2-) | 32.4% (25.0-41.3) | 53.8% (43.65.3) | 20% (4.3-48.1) |
| Implant rupture | 10.1% (7.4-13.7) | 6.3% (2.8-13.7) | 27.2% (17.3-41.3) | 6.7% (.2-31.9) |
| Infection | 0.5% (0.1-2.1) | 1.4% (0.3-5.4) | 3.2% (1.0-9.5) | 0% |
| Irritation | 0% | 0.7% (0.1-5.0) | 0% | 0% |
| Necrosis | 0.2% (0-1.6%) | 0% | 2.3% (0.6-8.8) | 0% |
| Nipple complications | 6.3% (4.3-9.1) | 1.4% (0.3-5.4) | 3.3% (1.1-9.8) | 0% |
| Ptosis | 2.0% (1.0-3.9) | 4.9% (2.2-10.5) | 0% | 0% |
| Redness | 0.7% (0.2-2.0) | 0.8% (0.1-5.2) | 2.1% (0.5-8.3) | 0% |
| Reoperation | 36.1% (31.6-40.9) | 46.0% (38.0-54.9) | 71.9% (61.5-81.4) | 46.7% (21.3-73.4) |
| Scarring/hypertrophic scarring | 4.2% (2.6-6.5) | 6.6% (3.5-12.4) | 5.5% (2.3-12.7) | 0% |
| Seroma/fluid accumulation | 1.8% (0.9-3.5) | 6.0% (3.0-11.7) | 2.4% (0.3-15.7) | 6.7% (0.2-31.9) |
| Skin rash | 0.9% (0.3-2.3) | 0.7% (0.1-4.9) | 2.1% (0.5-7.9) | 6.7% (0.2-31.9) |
| Swelling | 9.2% (6.8-15.0) | 8.3% (4.6-14.5) | 7.1% (3.5-14.4) | 0% |
| Wrinkling | 1.8% (0.8-3.7) | 5.4% (2.6-11.0) | 10.2% (5.2-19.6) | 0% |
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Table 4. Core Study complications and adverse outcomes over 8 years post-implantation for Mentor MemoryGel silicone gel-filled breats implant patients. Table shows cumulative incidence rates over time and 95% confidence intervals calculated using Kaplan-Meier analysis*.
Complication or Outcome | Primary Augmentation (N=552) | Revision Augmentation (N=145) | Primary Reconstruction (N=251) | Revision Reconstruction (N=60) |
|---|---|---|---|---|
| Breast mass | 5.4% (3.7-7.8) | 6.5% (3.4-12.0) | 5.2% (2.9-9.3) | 7.2% (2.8-18.2) |
| Breast pain | 2.5% (1.5-4.3) | 3.4% (1.3-8.8) | 2.8% (1.2-6.2) | 5.2% (1.7-15.3) |
| Breast/skin sensation changes | 2.8% (1.7-4.5) | 1.4% (0.4-5.4) | 0% | 1.8% (0.3-12.0) |
| Capsular contracture (Baker II) | 2.0% (1.1-3.7) | 6.2% (3.1-12.1) | 4.4% (2.3-8.3) | 4.0% (1.0-15.2) |
| Capsular contracture (Baker III/IV) | 10.9% (8.5-13.9) | 24.1% (17.7-32.3) | 15.3% (11.1-20.9) | 23.1% (14.1-36.6) |
| Delayed wound healing | 0% | 2.1% (0.7-6.3) | 0% | 1.7% (0.2-11.3) |
| Dog ear scars from mastectomy | 0% | 0% | 1.6% (0.6-4.3) | 3.4% (0.9-12.8) |
| Granuloma | 0% | 2.4% (0.8-7.4) | 0% | 5.0% (1.6-14.7) |
| Hematoma | 2.9% (1.8-4.8) | 2.8% (1.1-7.2) | 1.3% (0.4-3.9) | 3.4% (0.9-13.0) |
| Implant extrusion | 0% | 1.4% (0.4-5.5) | 1.2% (0.4-3.7) | 1.7% (0.2-11.3) |
| Implant malposition | 0% | 2.5% (0.8-7.9) | 2.6% (1.2-5.8) | 6.7% (2.6-16.9) |
| Implant removal with or without replacement | 7.3% (5.3-9.9) | 21.1% (15.0-29.2) | 23.3% (18.2-29.4) | 29.0% (19.1-42.5) |
| Implant rupture ** | 13.6% (7.6-23.6) | 15.5% (6.5-34.6) | 14.0% (7.6-25.0) | 21.3% (7.3-53.3) |
| Infection | 1.6% (0.9-3.1) | 1.4% (0.4-5.5) | 6.2% (3.8-10.2) | 0% |
| Inflammation of breast | 0% | 1.4% (0.4-5.5) | 0% | 1.7% (0.2-11.4) |
| Lactation difficulties | 2.0% (1.1-3.8) | 1.6% (0.4-6.1) | 0% | 0% |
| Metastatic disease | 0% | 0% | 5.7% (3.3-9.6) | 4.0% (1.0-15.2) |
| Miscarriage | 2.9% (1.8-4.8) | 2.5% (0.8-7.6) | 2.3% (1.0-5.6) | 0% |
| New diagnosis of breast cancer | 0% | 1.8% (0.5-7.2) | 1.9% (0.7-5.1) | 1.7% (0.2-11.4) |
| New diagnosis of rheumatic disease | 1.8% (1.0-3.5) | 1.7% (0.4-6.5) | 2.6% (1.1-6.2) | 3.4% (0.9-12.9) |
| Nipple complications | 0% | 0% | 1.3% (0.4-4.1) | 0% |
| Nipple sensation changes | 11.8% (9.3-14.8) | 14.6% (9.7-21.8) | 2.1% (0.9-5.0) | 1.7% (0.2-11.3) |
| Pre-eclampsia at 36 weeks pregnant | 0% | 1.1% (0.2-7.4) | 0% | 0% |
| Reoperation | 20.1% (17.0-23.8) | 37.8% (30.2-46.6) | 38.8% (32.9-45.5) | 40.8% (29.5-54.5) |
| Seroma | 1.1% (0.5-2.5) | 2.1% (0.7-6.3) | 4.8% (2.8-8.4) | 1.7% (0.2-11.3) |
** Rupture rates were estimated in MRI cohort at 8 years post-implantation.
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