An interventional study of Natrelle(TM) Silicone-Filled Breast Implants in Breast Augmentation, Breast Reconstruction and Revision of Augmentation or Reconstruction, sponsored by Allergan Medical. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-13.
Sponsored by Allergan Medical · Not applicable and Interventional
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
Allergan Medical is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Primary augmentation
Device: Natrelle(TM) Silicone-Filled Breast Implants
Primary reconstruction
Device: Natrelle(TM) Silicone-Filled Breast Implants
Revision-augmentation
Device: Natrelle(TM) Silicone-Filled Breast Implants
Revision-reconstruction
Device: Natrelle(TM) Silicone-Filled Breast Implants
Breast implant surgery
Local Complications
By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts
Time frame: 10 years
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale
Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied
Time frame: 10 years
Enrollment: January 6, 1999-June 30, 2000 at multiple US sites
| Milestone | Primary Augmentation | Primary Reconstruction | Revision-augmentation | Revision-reconstruction |
|---|---|---|---|---|
| Started | 455 | 98 | 147 | 15 |
| Completed | 280 | 46 | 74 | 8 |
| Not completed | 175 | 52 | 73 | 7 |
| Withdrew: Lost to follow-up | 123 | 13 | 37 | 1 |
| Withdrew: Explanted of all study devices | 36 | 25 | 29 | 3 |
| Withdrew: Withdrawal by subject | 13 | 3 | 4 | 1 |
| Withdrew: Death | 1 | 10 | 2 | 2 |
| Withdrew: Physician decision | 2 | 1 | 1 | 0 |
By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts
| percentage by patient | Primary Augmentation | Primary Reconstruction | Revision-augmentation | Revision-reconstruction |
|---|---|---|---|---|
| Capsular Contracture | 18.9 (15.4 to 23.1) | 24.6 (16.2 to 36.2) | 28.7 (21.3 to 37.9) | 6.7 (0.2 to 31.9) |
| Breast Pain | 11.5 (8.7 to 15.0) | 6.8 (2.8 to 16.1) | 11.7 (7.1 to 18.8) | 0 (0 to 0) |
| Swelling | 9.2 (6.8 to 12.4) | 7.1 (3.5 to 14.4) | 8.2 (4.6 to 14.5) | 0 (0 to 0) |
| Implant Malposition | 6.9 (4.8 to 9.7) | 2.3 (0.6 to 8.9) | 6.0 (3.1 to 11.7) | 13.3 (1.7 to 40.5) |
| Nipple Complications | 6.3 (4.3 to 9.1) | 3.3 (1.1 to 9.8) | 1.4 (0.3 to 5.4) | 0 (0 to 0) |
| Hypertrophic/Other Abnormal Scarring | 4.2 (2.6 to 6.5) | 5.5 (2.3 to 12.7) | 6.6 (3.5 to 12.3) | 0 (0 to 0) |
| Asymmetry | 3.3 (2.0 to 5.6) | 23.2 (15.4 to 33.9) | 6.5 (3.2 to 12.8) | 6.7 (0.2 to 31.9) |
| Wrinkling | 1.8 (0.8 to 3.7) | 10.2 (5.2 to 19.6) | 5.4 (2.6 to 11.0) | 0 (0 to 0) |
| Implant Palpability/Visibility | 1.6 (0.8 to 3.4) | 6.4 (2.3 to 12.7) | 6.0 (3.0 to 11.6) | 6.7 (0.2 to 31.9) |
| Seroma/Fluid Accumulation | 1.8 (0.9 to 3.4) | 2.3 (0.3 to 15.4) | 6.0 (3.0 to 11.6) | 6.7 (0.2 to 31.9) |
| Bruising | 0.4 (0.1 to 1.8) | 1.0 (0.1 to 7.1) | 3.0 (1.1 to 7.8) | 6.7 (0.2 to 31.9) |
| Skin Rash | 0.9 (0.3 to 2.3) | 2.0 (0.5 to 7.9) | 0.7 (0.1 to 4.9) | 6.7 (0.2 to 31.9) |
Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied
| units on a scale | Primary Augmentation | Primary Reconstruction | Revision-augmentation | Revision-reconstruction |
|---|---|---|---|---|
| Physician satisfaction | 4.8 ± 0.7 | 4.7 ± 0.6 | 4.4 ± 1.1 | 4.6 ± 1.1 |
| Patient satisfaction | 4.8 ± 0.7 | 4.6 ± 0.7 | 4.4 ± 1.2 | 4.5 ± 1.4 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Primary Augmentation | — | 0/455 (0%) | 0/455 (0%) |
| Primary Reconstruction | — | 0/98 (0%) | 0/98 (0%) |
| Revision-augmentation | — | 0/147 (0%) | 0/147 (0%) |
| Revision-reconstruction | — | 0/15 (0%) | 0/15 (0%) |
| Age, Customized(participants) | Primary Augmentation | Primary Reconstruction | Revision-augmentation | Revision-reconstruction | Total |
|---|---|---|---|---|---|
| <=40 years | 319 | 10 | 61 | 0 | 390 |
| Between 40 and 60 years | 136 | 73 | 84 | 9 | 302 |
| >=60 years | 0 | 15 | 2 | 6 | 23 |
| Sex: Female, Male(Participants) | Primary Augmentation | Primary Reconstruction | Revision-augmentation | Revision-reconstruction | Total |
|---|---|---|---|---|---|
| Female | 455 | 98 | 147 | 15 | 715 |
| Male | 0 | 0 | 0 | 0 | 0 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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