Palo Alto Plastic Surgeon Participates in Trials for Innovative Breast Reconstruction Technique

PALO ALTO, CA--(Marketwired - Jul 24, 2013) - Dr. Lauren Greenberg, a board-certified Palo Alto plastic surgeon, is excited about the recent developments in breast reconstruction that utilize a skin graft and fat transfer process to produce more natural-looking results than traditional techniques. For her patients who have undergone a mastectomy, breast reconstruction surgery with fat transfer can recreate a breast that mimics the form and appearance of the patients' natural breast and boost self-confidence.

BRAVA® is an innovative "breast enhancement and shaping system" which originally was touted to grow the patient's natural breast tissue. Its better use is to help stretch the breast skin to accommodate fat during fat transfer, according to Dr. Greenberg. Thrilled with this new technology, Dr. Greenberg was dismayed when she received a letter informing her that new patients were no longer permitted to enroll in BRAVA® studies.

In a blog post titled "BRAVA On Hold For Now," she outlines how the tissue and skin expansion encouraged by BRAVA® assists in the success of fat transfer procedures. BRAVA® is used for preoperative breast skin expansion to enable fat transfers. Without the assistance of BRAVA®, fat transfer breast reconstruction surgeries would pose more of a challenge.

Dr. Greenberg was particularly affected by the hold on BRAVA® trials as she participated in the Institutional Review Board (IRB) trial for the product and had witnessed firsthand the successful results that could be achieved. Since the use of BRAVA® facilitated the more modern fat transfer techniques, she believed that the chances for an effective, natural-looking breast reconstruction significantly diminished in its absence. The decision to place the study on hold was especially confusing as the BRAVA® trials had been going on for quite some time -- over 600 patients were already using the product and very few complications had been reported.

Dr. Greenberg's wait for BRAVA® studies was brief -- not only did the FDA determine that there were no concerns to inhibit BRAVA®'s continued use, insurance companies announced that they may be covering BRAVA® treatments in the near future. In her blog post titled "BRAVA Back! FDA Completed the Review and it May Now be Covered by Insurance," Dr. Greenberg relayed a statement from BRAVA® stating: "The FDA has determined there are no subject protection concerns that preclude initiation of the investigation and has approved BRAVA LLC's application subject to minor modifications of the informed consent ... We have been given permission to resume the referenced study."

In addition, since the FDA categorized the BRAVA® device as CMS Reimbursement Category B1 type, the device is eligible for insurance reimbursement via the Centers for Medicare and Medicaid Services. At the present moment, BRAVA® is in its final stages of study to validate the product's efficacy. Dr. Greenberg looks forward to being able to offer this state-of-the-art breast reconstruction technique to all of her Bay Area plastic surgery patients in the near future.

About Lauren Greenberg, MD

Dr. Lauren Greenberg is a board-certified plastic surgeon. She is a graduate of Dartmouth College and earned her medical degree at Northwestern University Medical School. In addition to publishing chapters in surgical textbooks, Dr. Greenberg has delivered numerous national medical presentations. She is available for interview upon request.

For more information about Dr. Greenberg's practice, please visit laurengreenbergmd.com or facebook.com/laurengreenbergmd.