Autologous Fat Grafting

Autologous Fat Grafting to the Breast

 

Description of Procedure or Service

Recent advances and innovations in surgical techniques and radiology and the discovery that multipotent adult stem cells are present in human adipose tissue have contributed to renewed interest in performing autologous fat grafting to the breast for aesthetic and reconstructive purposes.

 

Autologous fat grafting to the breast

Transplantation of autologous fat has been performed for over 100 years, primarily in cosmetic facial surgery. Since the 1980s, there has been an increased interest in autologous fat transfer for breast augmentation; however, variability in long-term results and oncologic concerns have limited its application in the breast. In 1987, the American Society of Plastic and Reconstructive Surgeons (ASPRS) Ad-Hoc Committee on New Procedures determined that fat grafting to the breast region could impede breast cancer detection because of possible complications including fat necrosis, cyst formation and calcifications, and that fat grafting to this area should be avoided. This position was supported by several subsequent studies that reported severe complications due to fat grafting for breast augmentation. Until 2005, most physicians refrained from performing fat grafting to the breast.

Technical advances in fat grafting such as the development of devices like liposuction cannulae and more sophisticated methods to detect breast cancer, which can provide a relatively precise distinction between microcalcifications associated with fat grafting and those associated with cancer, led physicians to develop improved fat grafting techniques. However, in 2007, the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) announced that fat grafting for breast augmentation was still not recommended based on a lack of available clinical data on the safety and efficacy of the procedure and the possibility that the procedure might interfere with cancer detection.

In 2009, the ASPS issued a new position on fat transfer, grafting, and injection to the body, which was based on a review of the literature of patients who had undergone fat grafting (238 of whom underwent fat grafting to the breast). The ASPS task force concluded that fat grafting could be considered for breast augmentation and to correct defects associated with medical conditions and previous breast operations, although it cautioned that the results are largely dependent on technique and surgeon expertise and that because the lifetime of fat grafts is unknown, additional treatments may be necessary. Although no scientific evidence was found that specifically addressed patient selection, physicians were advised to exercise caution when considering patients at high risk for developing breast cancer (e.g. BRCA-1, BRCA-2, and/or a personal or family history of breast cancer) when determining whether a patient is an appropriate candidate for autologous fat grafting to the breast.

 

Autologous Fat Grafting to the Breast

 

Adipose tissue physiology in fat grafting

Harvesting of adipose tissue by liposuction is technically easy, minimally invasive, and associated with little patient discomfort and morbidity, and small amounts (100-200 mL) can be obtained under local anesthesia.

Adipose tissue is a highly vascularized tissue, and adipocytes are in direct contact with adjacent capillary vessels. In free fat grafting, direct diffusion of nutrients from plasma in the surrounding bed and subsequent revascularization usually occurs within 48 hours and are essential for graft survival. If the local environment does not undergo revascularization, the grafted fat tissue eventually undergoes necrosis, one complication after fat grafting. There is general unpredictability and a low rate of graft survival due to partial necrosis. Other complications include oil cyst formation, indurations in either the subcutis or breast parenchyma, calcification, and severe breast deformity.

 

Adipose-derived stem cells

Stem cell biology, and the related field of regenerative medicine, involves multipotent stem cells that exist within a variety of tissues, including bone marrow and adipose tissue. Studies have shown that 1 gram of adipose tissue yields approximately 5 x 10³ stem cells, which is up to 500 times greater than the number of mesenchymal stem cells in 1 gram of bone marrow. Stem cells, because of their pluripotentiality and unlimited capacity for self-renewal, offer promise for tissue engineering and advances in reconstructive procedures. Adipose tissue in particular represents an abundant and easily accessible source of adipose-derived stem cells (ADSCs), which can differentiate along multiple mesodermal lineages. ADSCs may allow for improved graft survival and generation of new fat tissue after transfer from another site.

This identification of several potentially beneficial therapeutic properties of ADSC has led to proposed novel techniques of fat grafting in conjunction with ADSC therapy for breast fat grafting, including the differentiation of ADSC into adipocytes as a reservoir for adipose tissue turnover, the differentiation of ADSC into endothelial cells and the subsequent increase in blood supply to the grafted fat tissue, thereby decreasing the rate of graft resorption, the release of angiogenic growth factors by ADSC and the induction of angiogenesis, protection of the graft from ischemic reperfusion injury by ADSC and acceleration of wound healing at the recipient site.

Current methods for isolating ADSCs can involve a variety of processes which may include centrifugation and enzymatic techniques that rely on collagenase digestion followed by centrifugal separation to isolate the stem cells from primary adipocytes,. Isolated ADSCs can be expanded in monolayer on standard tissue culture plastic with a basal medium containing 10% fetal bovine serum, and newly developed culture conditions provide an environment within which the study of ADSCs can be done without the interference of animal serum. They also allow rapid expansion of autologous ADSCs in culture for use in human clinical trials. A standard expansion method has not yet been established.

Yoshimura and colleagues, in an effort to address the problems of unpredictability and low rates of fat graft survival, developed a technique known as cell-assisted lipotransfer (CAL), which produces

autogenous fat rich in ADSCs. In CAL, half of the lipoaspirate is centrifuged to obtain a fraction of

concentrated ADSCs while the other half is washed, enzymatically digested, filtered and spun down to an ADSC-rich pellet. The latter is then mixed with the former, converting a relatively ADSC-poor aspirated fat to ADSC-rich fat.

A point-of care system is available for concentrating ADSC from mature fat. The Celution™ system

(Cytori Therapeutics, Inc.) is designed to transfer a patient’s own adipose tissue from one part of the body to another in the same surgical procedure.

 

Autologous Fat Grafting to the Breast

 

Regulatory Status

Cytori Therapeutics, Inc. was awarded 510(k) marketing clearance in September 2006 from the U.S.

Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) for the Celution™ Cell Concentration System as a cell saver device. The system is cleared for the collection, concentration, washing and re-infusion of a patient’s own cells for applications that may include, but are not limited to, cardiovascular, plastic and reconstructive, orthopedic, vascular, and urological surgeries and procedures.

Please note, this policy only addresses graft tissue harvested by liposuction technique.

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician.

 

Policy

Autologous fat grafting to the breast is considered investigational. BCBSNC does not provide coverage for investigational services or procedures.

 

Benefits Application

This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy.

 

When Autologous Fat Grafting to the Breast is covered

Not applicable.

 

When Autologous Fat Grafting to the Breast is not covered

The use of autologous fat grafting and adipose-derived stem cells for augmentation or reconstruction of the breast is considered investigational.

 

Policy Guidelines

Fat grafting to the breast for reconstructive and aesthetic purposes has been gaining popularity over the past several years, and the use of adipose-derived stem cells in conjunction with fat grafting to the breast represents a potential new advance in the field of regenerative medicine. Although there is a possible role that these stem cells could play in graft survival through both adipogenesis and angiogenesis, a complete understanding of the mechanisms of interactions among adipose stem cells and growth factors is lacking, as is the understanding of any possible role they may have in tumorigenesis.

The mechanism of injected fat survival, the way to control adipose-derived stem cell differentiation and the fate of the stem cells also remains unknown. Controlled, prospective trials are needed to further investigate the many unanswered questions relating to the application of autologous fat grafting to the breast and the use of adipose-derived stem cells in conjunction with this procedure.

 

Autologous Fat Grafting to the Breast

The impact of fat grafting and the use of adipose-derived stem cells on net health outcome in augmentation or reconstruction of the breast is unknown and therefore, is considered to be investigational.

The American Society of Plastic Surgeons announced in 2009 that fat grafting to the breast is not a

strongly recommended procedure, as there are limited scientific data on the safety and efficacy of this particular type of fat transfer. The use of adipose-derived stem cells is not addressed.

 

Billing/Coding/Physician Documentation Information

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

Applicable service codes: There is no specific code for this service. CPT code 19499 or 19366 might be used.

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

 

Scientific Background and Reference Sources

BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.129, 7/12/12

Rigotti G, Marchi A, Galie M et al. Clinical treatment of radiotherapy tissue damage by lipoaspirate

transplant: a healing process mediated by adipose-derived adult stem cells. Plast Reconstr Surg

2007; 119(5):1409-22; discussion 23-4.

Yoshimura K, Sato K, Aoi N et al. Cell-assisted lipotransfer for cosmetic breast augmentation:

supportive use of adipose-derived stem/stromal cells. Aesthet Plast Surg 2008; 32(1):48-55;

discussion 56-7.

Food and Drug Association (FDA). 510(k) Summary #K060482 for Cytori Celution Cell Concentration Device. September 2006. Retrieved from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060482.pdf

American Society for Aesthetic Plastic Surgery (ASAPS)/ American Society of Plastic Surgeons (ASPS). Position Statement on Stem Cells and Fat Grafting. Aesthetic Surgery Journal August 2011 vol. 31 no. 6 716-717. Retrieved from http://aes.sagepub.com/content/31/6/716.full

American Society for Aesthetic Plastic Surgery (ASAPS), Fat Transfer/Fat Graft and Fat Injection

ASPS Guiding Principles. January 2009. Retrieved from http://www.plasticsurgery.org/Documents/medical-professionals/health-policy/guiding-principles/ASPS-Fat-Transfer-Graft-Guiding-Principles.pdf

Specialty Matched Consultant Advisory Panel review 9/2013

Medical Director review 9/2013

 

Autologous Fat Grafting to the Breast

 

Policy Implementation/Update Information

10/16/12 New policy developed. The use of autologous fat grafting and adipose-derived stem cells for augmentation or reconstruction of the breast is considered investigational. Ninety day notice given 10/16/2012 for effective date of 01/15/2013. (mco)

10/15/13 Specialty Matched Consultant Advisory Panel review 9/2013. Medical Director review 9/2013. (mco)

Medical policy is not an authorization, certification, explanation of benefits or a contract. Benefits and eligibility are determined before medical guidelines and payment guidelines are applied. Benefits are determined by the group contract and subscriber certificate that is in effect at the time services are rendered. This document is solely provided for informational purposes only and is based on research of current medical literature and review of common medical practices in the treatment and diagnosis of disease. Medical practices and knowledge are constantly changing and BCBSNC reserves the right to review and revise its medical policies periodically.

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