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%
* The number of patients evaluated at the 10 year follow-up were: 269 (primary augmentation), 74 (revision augmentation), 44 (primary reconstruction), and 8 (revision reconstruction).
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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)
* The number of patients evaluated at the 10 year follow-up were: 291 (primary augmentation), 77 (revision augmentation), 151 (primary reconstruction), and 36 (revision reconstruction).

** Rupture rates were estimated in MRI cohort at 8 years post-implantation.
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