We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

A Prospective Study of Autologous Fat Grafting for Breast Augmentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00663156
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
This research study is to evaluate the natural history of fat transplanted from a person's body to their breasts. We are seeking a natural, safe, and effective alternative to breast implants. Patients will undergo liposuction of their body followed by infiltration of this harvested fat around their breasts. The study protocol will involve preoperative and postoperative photographs, mammograms, and MRI to look for changes in the breast shape and size, as well as any internal changes in the breast tissue.

Condition or disease Intervention/treatment
Breast Augmentation Fat Grafting Procedure: breast implants Procedure: Liposuction, fat grafting

Detailed Description:

The current standard for breast augmentation involves placement of an implant. Although implants are safe, they are foreign bodies and thus have inherent risks including infection, failure, malposition, etc. In order to avoid the inherent risks of an implanted device, some surgeons and patients have elected to proceed with breast augmentation from autologous tissue. Early reports of autologous fat transplantation to the breasts were successful, but increases in breast volume were modest (Bircoll, 1987). There were also hypothetical concerns about changes in the breast tissue that would interfere with mammographic screening for breast cancer.

Spear et al (2005) performed autologous fat transplantation to reconstructed breasts in 37 patients with 2-dimensional photographic evidence of improved breast shape and volume suggesting that this technique can be effectively performed. However, these patients had all received mastectomies so mammographic screening was not indicated. Coleman and Saboeiro (2007) performed autologous fat transplantation to the breasts in 17 patients. Fifteen of the 17 patients received post-operative mammograms, 7 (47%) of which were abnormal. However, none of these abnormal findings interfered with cancer screening. Furthermore, 2 patients in the study did develop breast cancer which was successfully detected by mammography. Other studies have confirmed the ability to differentiate benign from malignant findings on mammogram after autologous fat transplantation. Pulagam et al (2006) reported long term (10 and 8 year) findings on 2 patients that underwent autologous fat transplantation to the breasts. Mammography and ultrasound were used to differentiate benign from malignant appearing calcifications. Some authors have speculated that autologous fat transplantation to the breast would lead to mammographic changes similar to routine breast procedures such as breast reduction and mastopexy (Coleman and Saboeiro, 2007).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : March 2008
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: subject
10 subjects receiving breast augmentation with fat grafting
Procedure: Liposuction, fat grafting
Autologous fat will be harvested from the body (typically the abdomen or thighs) using syringe aspiration techniques and then infiltrated into the subcutaneous tissue around the breast as well as between the breast and the underlying musculature using blunt cannulas. These procedures will be done in an outpatient surgery setting in the Georgetown University Hospital under general anesthesia and sterile conditions.
Other Names:
  • Lipovage
  • Vectra 3-D
10 control will have breast augmentation using breast implants
Procedure: breast implants
patients will have breast augmentation using implants
Other Names:
  • Allergan
  • Mentor

Outcome Measures

Primary Outcome Measures :
  1. Effectiveness will be evaluated by comparing breast volume pre-operatively and at 1 year post-operatively using 3-dimensional picture imaging to obtain objective volume measurements. [ Time Frame: One year post-op ]

Secondary Outcome Measures :
  1. Patients will be evaluated by mammogram, MRI, and 3-D photography to monitor for breast tissue abnormalities and measure increase in volume [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 20-50 years old
  • willing to have mammogram, MRI, and photographs
  • willing to follow study requirements and sign informed consent
  • no previous breast surgeries
  • must reside within 50 miles of the Washington, D.C. Metropolitan area

Exclusion Criteria:

  • pregnant or nursing
  • existing breast cancer
  • advanced fibrocystic disease
  • protease inhibitors
  • any condition leading to surgical risk
  • any disease known to affect wound healing
  • abscess or infection in the body
  • incompatible psychological factors
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663156

United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Principal Investigator: Scott L Spear, MD Georgetown University hospital
More Information

Responsible Party: Scott L. Spear, M.D., Chief Plastic Surgery, Georgetown University
ClinicalTrials.gov Identifier: NCT00663156     History of Changes
Other Study ID Numbers: 4359-617
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Scott L. Spear, M.D., Georgetown University:
breast augmentation
fat grafting
breast implants