Status:
COMPLETED
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Lead Sponsor:
Allergan Medical
Conditions:
Breast Reconstruction
Eligibility:
FEMALE
Phase:
NA
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
December 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
84329 Patients enrolled
Trial Details
Trial ID
NCT00691327
Start Date
December 1 1997
End Date
December 1 2012
Last Update
October 13 2014
Active Locations (1)
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1
Indianapolis, Indiana, United States