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Procedure

Implant Failure for Sagging Breasts

N/A
Waitlist Available
Led By Kamran Khoobehi, MD
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women with the following conditions micromastia, breast ptosis, post mastectomy breast reconstruction, asymmetric breasts, congenital malformations of breast development and for treatment of complications associated with implant augmentation mammoplasty.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months and annually
Awards & highlights

Study Summary

Structural fat grafting is a form of tissue transfer where the autologous fat is harvested and subsequently transferred to a different region of the body at the same setting. It is an excellent technique for filling soft tissue and contour defects. Fat has the benefit of being abundantly available and easy to harvest. Further more, it is cheap and autogenous and thus lacks the side effects of synthetic fillers or implants. Autogenous fat transfer is a relatively common procedure performed by plastic and reconstructive surgeons. The goal of fat grafting is to provide the patient with a predictable, long lasting autogenous soft tissue augmentation. Autogenous fat transfer has been used extensively as an adjunct to facial rejuvenation. As well it has been applied to body contouring and augmentation of the hips, trochanteric areas, thighs and buttocks, back, torso and breast. The transfer of autologous fat dates back to 1890s and more specifically as injectable grafts since the 1920s. However, over the past 20 years the popularity of structural fat grafting has increased as a contouring modality. Fat transfer to the breast, popularized by Coleman, has been performed internationally since the 1990s. Despite the duration, the literature lacks accurate outcomes data on fat transfer to the breast and questions regarding the viability of adipocytes after the transfer exist. Sources from various publications show cell viability of up to 100% however studies of long term clinical outcomes quote rates of 10% to 80%.

Eligible Conditions
  • Breast Hypoplasia or Breast Asymmetry
  • Sagging Breasts
  • Implant Failure
  • Breast Reconstruction
  • Congenital Birth Defects

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months and annually
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months and annually for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
3 Dimensional volumetric analysis of results and photographic analysis by board certified plastic surgeons.
Secondary outcome measures
Patient satisfaction with cosmetic and reconstructive results

Trial Design

6Treatment groups
Experimental Treatment
Group I: Post mastectomy breast reconstructionExperimental Treatment1 Intervention
Group II: MicromastiaExperimental Treatment1 Intervention
Group III: Implant FailureExperimental Treatment1 Intervention
Group IV: Congenital malformationsExperimental Treatment1 Intervention
Group V: Breast PtosisExperimental Treatment1 Intervention
Group VI: Asymmetric BreastsExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansLead Sponsor
114 Previous Clinical Trials
43,953 Total Patients Enrolled
Alireza Sadeghi, MDStudy DirectorLSUHSC
Kamran Khoobehi, MDPrincipal InvestigatorLSUHSC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby May 2025