A Prospective Study of Autologous Fat Grafting for Breast Augmentation

Georgetown University

Status: Completed

Conditions: Breast Augmentation; Fat Grafting

Treatments: Procedure: Liposuction, fat grafting; Procedure: breast implants

Study type: Interventional

Funder types: Other

Identifiers

NCT00663156

4359-617

Details and patient eligibility

About

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.

Full 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).

Enrollment: 13 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

subject

Experimental group

Description:

10 subjects receiving breast augmentation with fat grafting

Treatment:

Procedure: Liposuction, fat grafting

control

Other group

Description:

10 control will have breast augmentation using breast implants

Treatment:

Procedure: breast implants