Trial Outcomes & Findings for NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study (NCT NCT01870869)
NCT ID: NCT01870869
Last Updated: 2020-06-22
Results Overview
The investigator rated their satisfaction with the participant's breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1951 participants
Primary outcome timeframe
5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Results posted on
2020-06-22
Participant Flow
Participant milestones
| Measure |
Augmentation
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
288
|
206
|
1222
|
235
|
|
Overall Study
COMPLETED
|
260
|
192
|
1092
|
205
|
|
Overall Study
NOT COMPLETED
|
28
|
14
|
130
|
30
|
Reasons for withdrawal
| Measure |
Augmentation
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Overall Study
Implanted with nonstudy device
|
1
|
3
|
14
|
4
|
|
Overall Study
Death
|
0
|
0
|
7
|
1
|
|
Overall Study
Subject choice
|
6
|
2
|
22
|
8
|
|
Overall Study
Lost to Follow-up
|
10
|
2
|
25
|
3
|
|
Overall Study
Reason not Specified
|
1
|
2
|
20
|
4
|
|
Overall Study
Not evaluable
|
10
|
5
|
42
|
10
|
Baseline Characteristics
Number analyzed is the number of participants with available age data.
Baseline characteristics by cohort
| Measure |
Augmentation
n=278 Participants
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=201 Participants
Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=1180 Participants
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=225 Participants
Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
|
Total
n=1884 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.5 years
n=277 Participants • Number analyzed is the number of participants with available age data.
|
47.3 years
n=201 Participants • Number analyzed is the number of participants with available age data.
|
50.3 years
n=1176 Participants • Number analyzed is the number of participants with available age data.
|
54.4 years
n=223 Participants • Number analyzed is the number of participants with available age data.
|
48.1 years
n=1877 Participants • Number analyzed is the number of participants with available age data.
|
|
Sex: Female, Male
Female
|
278 Participants
n=278 Participants
|
201 Participants
n=201 Participants
|
1180 Participants
n=1180 Participants
|
225 Participants
n=225 Participants
|
1884 Participants
n=1884 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=278 Participants
|
0 Participants
n=201 Participants
|
0 Participants
n=1180 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=1884 Participants
|
PRIMARY outcome
Timeframe: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)Population: Participants from the Evaluable population, all participants enrolled under this study protocol who received a NATRELLE® 410 X- or L-style device, with data available for analysis.
The investigator rated their satisfaction with the participant's breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Outcome measures
| Measure |
Augmentation
n=77 Participants
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=34 Participants
Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=247 Participants
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=52 Participants
Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Percentage of Participants According to Investigator Satisfaction With Implants
Definitely satisfied
|
94.8 percentage of participants
|
85.3 percentage of participants
|
74.1 percentage of participants
|
73.1 percentage of participants
|
|
Percentage of Participants According to Investigator Satisfaction With Implants
Somewhat satisfied
|
3.9 percentage of participants
|
8.8 percentage of participants
|
21.5 percentage of participants
|
23.1 percentage of participants
|
PRIMARY outcome
Timeframe: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)Population: Participants from the Evaluable population, all participants enrolled under this study protocol who received a NATRELLE® 410 X- or L-style device, with data available for analysis.
The participant rated their satisfaction with the breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants who responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Outcome measures
| Measure |
Augmentation
n=77 Participants
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=34 Participants
Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=247 Participants
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=52 Participants
Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Percentage of Participants According to Participant Satisfaction With Implants
Definitely satisfied
|
88.3 percentage of participants
|
76.5 percentage of participants
|
68.0 percentage of participants
|
65.4 percentage of participants
|
|
Percentage of Participants According to Participant Satisfaction With Implants
Somewhat satisfied
|
5.2 percentage of participants
|
17.6 percentage of participants
|
24.7 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)Population: Evaluable population was defined as all participants enrolled under this study protocol who received a NATRELLE® 410 X- or L-style device.
Kaplan-Meier risk rates (estimation of the percentage of participants) of developing local complications is presented. Local complications collected in the study were: Asymmetry, Breast pain, Capsular contracture, Delayed wound healing, Fluid accumulation/seroma, Hematoma, Hypertrophic scarring/other abnormal scarring, Implant extrusion, Implant malposition, Implant palpability/visibility, Implant rupture, Infection, Redness, Skin rash, Swelling, Tissue/skin necrosis, Upper pole fullness, Wrinkling/rippling and Other complications .
Outcome measures
| Measure |
Augmentation
n=278 Participants
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=201 Participants
Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=1180 Participants
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=225 Participants
Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Percentage of Participants With Local Complications
Any complication
|
6.62 percentage of participants
Interval 3.78 to 11.45
|
9.09 percentage of participants
Interval 5.65 to 14.46
|
14.50 percentage of participants
Interval 11.78 to 17.78
|
10.19 percentage of participants
Interval 6.81 to 15.11
|
|
Percentage of Participants With Local Complications
Asymmetry
|
1.11 percentage of participants
Interval 0.26 to 4.73
|
1.99 percentage of participants
Interval 0.75 to 5.21
|
2.34 percentage of participants
Interval 1.59 to 3.44
|
2.67 percentage of participants
Interval 1.21 to 5.84
|
|
Percentage of Participants With Local Complications
Breast pain
|
1.93 percentage of participants
Interval 0.51 to 7.15
|
1.08 percentage of participants
Interval 0.15 to 7.39
|
0.51 percentage of participants
Interval 0.23 to 1.13
|
1.07 percentage of participants
Interval 0.26 to 4.3
|
|
Percentage of Participants With Local Complications
Capsular contracture
|
1.85 percentage of participants
Interval 0.68 to 4.98
|
7.90 percentage of participants
Interval 3.57 to 17.01
|
20.14 percentage of participants
Interval 8.9 to 41.85
|
27.03 percentage of participants
Interval 9.04 to 64.93
|
|
Percentage of Participants With Local Complications
Delayed wound healing
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.50 percentage of participants
Interval 0.07 to 3.48
|
0.34 percentage of participants
Interval 0.13 to 0.9
|
1.78 percentage of participants
Interval 0.67 to 4.67
|
|
Percentage of Participants With Local Complications
Fluid accumulation/seroma
|
0.37 percentage of participants
Interval 0.05 to 2.57
|
0.50 percentage of participants
Interval 0.07 to 3.48
|
0.57 percentage of participants
Interval 0.26 to 1.28
|
1.78 percentage of participants
Interval 0.67 to 4.67
|
|
Percentage of Participants With Local Complications
Hematoma
|
0.00 percentage of participants
Interval 0.0 to 0.43
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.43 percentage of participants
Interval 0.18 to 1.04
|
0.44 percentage of participants
Interval 0.06 to 3.11
|
|
Percentage of Participants With Local Complications
Hypertrophic scarring/other abnormal scarring
|
0.72 percentage of participants
Interval 0.18 to 2.85
|
1.29 percentage of participants
Interval 0.32 to 5.12
|
0.75 percentage of participants
Interval 0.24 to 2.3
|
0.44 percentage of participants
Interval 0.06 to 3.11
|
|
Percentage of Participants With Local Complications
Implant extrusion
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.98 percentage of participants
Interval 0.4 to 2.38
|
0.60 percentage of participants
Interval 0.08 to 4.17
|
|
Percentage of Participants With Local Complications
Implant malposition
|
2.21 percentage of participants
Interval 0.8 to 6.07
|
1.00 percentage of participants
Interval 0.25 to 3.92
|
1.22 percentage of participants
Interval 0.52 to 2.84
|
1.33 percentage of participants
Interval 0.43 to 4.08
|
|
Percentage of Participants With Local Complications
Implant palpability/visibility
|
0.48 percentage of participants
Interval 0.07 to 3.33
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.25 percentage of participants
Interval 0.08 to 0.79
|
0.44 percentage of participants
Interval 0.06 to 3.11
|
|
Percentage of Participants With Local Complications
Implant rupture
|
2.14 percentage of participants
Interval 0.67 to 6.75
|
6.15 percentage of participants
Interval 1.77 to 20.22
|
2.03 percentage of participants
Interval 0.91 to 4.5
|
3.84 percentage of participants
Interval 1.39 to 10.38
|
|
Percentage of Participants With Local Complications
Infection
|
0.36 percentage of participants
Interval 0.05 to 2.53
|
1.49 percentage of participants
Interval 0.48 to 4.56
|
1.21 percentage of participants
Interval 0.72 to 2.04
|
3.18 percentage of participants
Interval 1.53 to 6.56
|
|
Percentage of Participants With Local Complications
Redness
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.50 percentage of participants
Interval 0.07 to 3.48
|
0.83 percentage of participants
Interval 0.29 to 2.38
|
3.31 percentage of participants
Interval 1.01 to 10.59
|
|
Percentage of Participants With Local Complications
Skin rash
|
0.36 percentage of participants
Interval 0.05 to 2.53
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.08 percentage of participants
Interval 0.01 to 0.6
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Local Complications
Swelling
|
0.72 percentage of participants
Interval 0.18 to 2.85
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.17 percentage of participants
Interval 0.04 to 0.68
|
0.44 percentage of participants
Interval 0.06 to 3.11
|
|
Percentage of Participants With Local Complications
Tissue/skin necrosis
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.17 percentage of participants
Interval 0.04 to 0.68
|
0.50 percentage of participants
Interval 0.07 to 3.51
|
|
Percentage of Participants With Local Complications
Upper pole fullness
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.44 percentage of participants
Interval 0.06 to 3.11
|
|
Percentage of Participants With Local Complications
Wrinkling/rippling
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.50 percentage of participants
Interval 0.07 to 3.48
|
1.61 percentage of participants
Interval 0.78 to 3.33
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Local Complications
Other complications
|
1.46 percentage of participants
Interval 0.45 to 4.7
|
2.99 percentage of participants
Interval 1.35 to 6.52
|
4.37 percentage of participants
Interval 2.94 to 6.46
|
1.43 percentage of participants
Interval 0.46 to 4.38
|
SECONDARY outcome
Timeframe: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)Population: Evaluable population was defined as all participants enrolled under this study protocol who received a NATRELLE® 410 X- or L-style device.
Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.
Outcome measures
| Measure |
Augmentation
n=278 Participants
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=201 Participants
Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=1180 Participants
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=225 Participants
Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Percentage of Participants With Reoperations
|
13.02 percentage of participants
Interval 8.42 to 19.84
|
25.08 percentage of participants
Interval 16.99 to 36.09
|
39.70 percentage of participants
Interval 35.35 to 44.38
|
35.75 percentage of participants
Interval 27.42 to 45.72
|
SECONDARY outcome
Timeframe: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)Population: Evaluable population was defined as all participants enrolled under this study protocol who received a NATRELLE® 410 X- or L-style device.
Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement is reported.
Outcome measures
| Measure |
Augmentation
n=278 Participants
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=201 Participants
Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=1180 Participants
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=225 Participants
Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Percentage of Participants With Implant Removal With or Without Replacement
|
7.17 percentage of participants
Interval 3.8 to 13.31
|
19.09 percentage of participants
Interval 11.12 to 31.66
|
19.54 percentage of participants
Interval 15.79 to 24.03
|
20.59 percentage of participants
Interval 13.59 to 30.5
|
Adverse Events
Augmentation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Revision-Augmentation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reconstruction
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Revision-Reconstruction
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Augmentation
n=278 participants at risk
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=201 participants at risk
Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=1180 participants at risk
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=225 participants at risk
Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/278 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.00%
0/201 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.17%
2/1180 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.00%
0/225 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/278 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.00%
0/201 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.08%
1/1180 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.00%
0/225 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma to liver
|
0.00%
0/278 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.00%
0/201 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.08%
1/1180 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.00%
0/225 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrence of breast cancer
|
0.00%
0/278 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.00%
0/201 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.08%
1/1180 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.00%
0/225 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver cancer
|
0.00%
0/278 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.00%
0/201 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.00%
0/1180 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.44%
1/225 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic breast cancer
|
0.00%
0/278 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.00%
0/201 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.17%
2/1180 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
0.00%
0/225 • 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER