N/A
N=84,329
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Breast Reconstruction
Bottom Line
View on ClinicalTrials.gov: NCT00691327 ↗Enrolled (actual)
84,329
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Local Complications — 15.0; 21.6; 11.1; 10.7 Percentage by Patient
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Natrelle(TM) Silicone-Filled Breast Implants (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Allergan Medical
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Complications |
15.0; 21.6; 11.1; 10.7; 7.1; 11.4 | — |
| SECONDARY Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale |
4.4; 4.3; 4.4; 4.3 | — |
Summary
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
Eligibility Criteria
Inclusion Criteria
- Females of any age for which breast reconstruction is considered appropriate (Patients under 18 years old require parental/legal guardian consent to participate.
- Females seeking revision augmentation or revision reconstruction, where problems exist
- Have any of the following conditions or situations present:
- Post mastectomy surgical removal of the breast for cancer or other disease;
- Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity;
- Severe ptosis requiring reconstruction;
- Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity.
- Adequate tissue available to cover implants.
- Saline-filled implants are not an appropriate choice.
Exclusion Criteria
- Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
- Existing carcinoma of the breast, without mastectomy.
- Abscess of infection in the body at the time of enrollment.
- Pregnant or nursing.
- Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
- Show tissue characteristics which are clinically incompatible with mammaplasty.
- Have, or under treatment for any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk.
- Are not willing to undergo further surgery for revision, if medically required.
- Diagnosis of lupus or scleroderma.
Data sourced from ClinicalTrials.gov (NCT00691327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.