A Prospective Study of Autologous Fat Grafting for Breast Augmentation
Condition: Breast Augmentation; Fat Grafting
Study type: Interventional

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.
    

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).
    

Intervention name(s): breast implants; Liposuction, fat grafting
Intervention type(s): Procedure; Procedure
Intervention description(s): patients will have breast augmentation using implants; 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 intervention name(s): Allergan; Mentor; Lipovage; Vectra 3-D
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lipoaugmentation; breast augmentation; fat grafting; liposuction; lipoinfiltration; Spear; breast implants; ASERF; Lipivage; Baker; harvest; autologous; Georgetown