Trial Outcomes & Findings for Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants (NCT NCT02132572)
NCT ID: NCT02132572
Last Updated: 2016-09-13
Results Overview
Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant.
Recruitment status
COMPLETED
Target enrollment
201 participants
Primary outcome timeframe
3 to 10 years
Results posted on
2016-09-13
Participant Flow
Participant milestones
| Measure |
Natrelle BIOCELL™ Textured 410 Implant
Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
|
|---|---|
|
Overall Study
STARTED
|
201
|
|
Overall Study
COMPLETED
|
201
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants
Baseline characteristics by cohort
| Measure |
Natrelle BIOCELL™ Textured 410 Implant
n=201 Participants
Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
|
|---|---|
|
Age, Customized
17 to 30 years
|
67 Participants
n=5 Participants
|
|
Age, Customized
31 to 40 years
|
74 Participants
n=5 Participants
|
|
Age, Customized
41 to 50 years
|
36 Participants
n=5 Participants
|
|
Age, Customized
51 to 60 years
|
18 Participants
n=5 Participants
|
|
Age, Customized
61 to 70 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
Missing age data
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
201 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 to 10 yearsPopulation: Per Protocol: Subjects who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants 3 to 10 years prior to data collection
Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant.
Outcome measures
| Measure |
Natrelle BIOCELL™ Textured 410 Implant
n=175 Participants
Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
|
|---|---|
|
Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant
|
28 Percentage of Subjects
|
Adverse Events
Natrelle BIOCELL™ Textured 410 Implant
Serious events: 30 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Natrelle BIOCELL™ Textured 410 Implant
n=201 participants at risk
Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
|
|---|---|
|
General disorders
Device Breakage
|
3.5%
7/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
General disorders
Device Dislocation
|
4.0%
8/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
General disorders
Capsular Contracture Associated with Breast Implant
|
3.5%
7/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
General disorders
Device Optical Issue
|
3.0%
6/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
General disorders
Device Damage
|
1.00%
2/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
General disorders
Device Deployment Issue
|
0.50%
1/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
General disorders
Device Expulsion
|
0.50%
1/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
General disorders
Impaired Healing
|
0.50%
1/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
General disorders
Implant Site Reaction
|
1.00%
2/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Reproductive system and breast disorders
Nipple Disorder
|
0.50%
1/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Female
|
1.5%
3/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Reproductive system and breast disorders
Breast Pain
|
0.50%
1/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
General disorders
Device Issue
|
0.50%
1/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
2.5%
5/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Surgical and medical procedures
Scar Excision
|
0.50%
1/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Seroma
|
2.0%
4/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Surgical and medical procedures
Surgery
|
0.50%
1/201
The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
|
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