Clinical UM Guideline

This document addresses autologous fat grafting (autologous fat transfer) and injectable soft tissue fillers.

Autologous fat grafting and injectable soft tissue fillers correct volume loss from trauma, congenital defects, surgical resection, radiation, the natural process of aging, and other causes. A variety of injectable filling agents are available, including temporary fillers that are composed of biodegradable ingredients, such as hyaluronic acid, collagen, calcium hydroxylapatite, and poly-L-lactic acid, and fillers that persist indefinitely in tissue (for example, those containing polymethylmethacrylate microspheres, silicone, or hydrogel polymers).

Note: This document does not address gender affirming care. Criteria for gender affirming care are found in applicable guidelines used by the plan.

Note: For related documents see:

• ANC.00007 Cosmetic and Reconstructive Services: Skin Related
• ANC.00008 Cosmetic and Reconstructive Services of the Head and Neck
• ANC.00009 Cosmetic and Reconstructive Services of the Trunk, Groin, and Extremities
• MED.00110 Silver-based Products for Wound and Soft Tissue Applications
• MED.00132 Autologous Adipose-derived Regenerative Cell Therapy
• SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting
• SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures
• TRANS.00035 Therapeutic use of Stem Cells, Blood and Bone Marrow Products

Medically Necessary: In this document, procedures are considered medically necessary if there is a significant functional impairment AND the procedure can be reasonably expected to improve the functional impairment.

Reconstructive: In this document, procedures are considered reconstructive when intended to address a significant variation from normal related to accidental injury, disease, trauma, treatment of a disease or a congenital defect.

Note: Not all benefit contracts/certificates include benefits for reconstructive services as defined by this document. Benefit language supersedes this document.

Cosmetic: In this document, procedures are considered cosmetic when intended to change a physical appearance that would be considered within normal human anatomic variation. Cosmetic services are often described as those that are primarily intended to preserve or improve appearance.

I. Autologous Fat Grafting:

Autologous fat grafting is considered medically necessary when both of the following criteria have been met:

1. There is documented evidence of significant functional impairment: and
2. The procedure can be reasonably expected to improve the functional impairment.

Autologous fat grafting is considered reconstructive when there is a significant variation from normal, related to any of the following:

1. Accidental injury; or
2. Disease; or
3. Trauma; or
4. Treatment of a disease or congenital defect (for example, for breast contouring following breast reconstruction procedures).

Autologous fat grafting is considered cosmetic and not medically necessary when the criteria above have not been met, including for:

1. Performed in the absence of a significant functional impairment; or
2. Is not reconstructive; or
3. Is intended to change a physical appearance that would be considered within normal human anatomic variation.

II. Injectable Soft Tissue Fillers (for example: poly-L-lactic acid [PLLA], synthetic calcium hydroxylapatite, hyaluronic acid, or collagen)

Use of injectable soft tissue fillers is considered medically necessary when both of the following criteria have been met:

1. There is documented evidence of significant functional impairment; and
2. The procedure can be reasonably expected to improve the functional impairment.

Use of injectable soft tissue fillers is considered reconstructive when there is a significant variation from normal related to any of the following:

1. Accidental injury; or
2. Disease; or
3. Trauma; or
4. Treatment of a disease or congenital defect.

Use of injectable soft tissue fillers is considered cosmetic and not medically necessary the criteria above have not been met, including when:

1. Performed in the absence of a significant functional impairment; or
2. Not reconstructive; or
3. Intended to change a physical appearance that would be considered within normal human anatomic variation (for example: lip enhancement procedures).

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Autologous Fat Grafting

When Services may be Medically Necessary or Reconstructive when criteria are met:

When services are Cosmetic and Not Medically Necessary:
For the procedure codes listed above when criteria are not met for medically necessary or reconstructive services; or when the code describes a procedure indicated in the Position Statement section as cosmetic and not medically necessary.

Injectable Soft Tissue Fillers

When Services may be Medically Necessary or Reconstructive when criteria are met:

When services are Cosmetic and Not Medically Necessary:
For the procedure codes listed above when medically necessary or reconstructive criteria are not met, or when the code describes a procedure indicated in the Position Statement section as cosmetic and not medically necessary.

Autologous Fat Grafting

Autologous fat grafting is also referred to as autologous fat transfer or autologous adipose-derived tissue grafting. These procedures use liposuction to remove fat tissue from one part of the body and inject it into another part of the body to correct contour defects. Autologous fat grafting in comparison to other soft tissue fillers reduces the risk for hypersensitivity or foreign body reactions. However, it also introduces the risk of infections, contour irregularities, prolonged edema, and necrosis or calcification of the injected fat. An additional possible disadvantage of autologous fat grafting is the variable rate and degree of resorption, which limits the predictability of long-term outcomes. Due to this unpredictable characteristic, repeat injections are often required.

Autologous fat grafting is being explored as a treatment for individuals with tissue volume loss due to various causes including but not limited to, disease, trauma, congenital defects, surgical resection, radiation, or the natural process of aging (Tabit, 2012).

Phulpin, and colleagues (2009) reported on their experience using autologous fat grafting to correct aesthetic defects following radiation therapy for head and neck cancer. A total of 11 individuals underwent autologous fat transfer. Researchers were able to follow 9 of the participants for more than 2 years. Aesthetic and functional improvements were documented. The histological exam carried out in 6 of the participants demonstrated an improvement in the vascular network density, reduced fibrosis and absence of necrotic areas. However, 6 participants required fat reinjection 3 months subsequent to the first treatment, due to fat resorption, which led to a volume loss of 20-40%.

Klinger and colleagues (2013) reported the results of a case control study that investigated the use of autologous fat grafting as a treatment of painful and retractile scars that compromised the normal daily activity/mobility of the joint involved. A total of 694 participants were enrolled in the study and autologous fat grafting was performed on 20 of them. Keloids were excluded and although hypertrophic scars were described, the exact number was not specified. Each scar was divided into two parts: one part was infiltrated with normal saline and one part was treated with autologous fat grafting. Outcomes were evaluated using Patient and Observer Scar Assessment Scale (POSAS) and Durometer measurements. Study participants s were followed-up at 5 and 14 days and 1, 3, 6 and 12 months. A statistically significant improvement was observed in skin hardness (Durometer measurements) and all POSAS parameters except itching.

In another study, Fredman and colleagues (2016) conducted a retrospective case review of 7 individuals who underwent autologous fat grafting as a treatment of chronic, refractory neuropathic pain secondary to burn injury. Each participant had failed conventional therapy, which included medical, pharmacologic and laser treatment of the burn scars. Each participant underwent a total of two fat grafting sessions, spaced 2 months apart. The Patient-Reported Outcomes Measurement Information System (PROMIS) was used to assess the perception of pain perception, with participants answering the questionnaire before and after fat grafting. Six of the 7 participants reported improvement in neuropathic pain following fat grafting, which resulted in a reduction in their neuropharmacologic regimen. At 1-year follow-up, 3 of the 5 participants who completed PROMIS questionnaires had PROMIS scores signifying improvement in pain. One participant had similar preoperative and postoperative PROMIS scores, and another had an increase in pain at follow-up; however, he had experienced an additional burn to the same extremity. Donor-site seroma was reported in 1 participant, however no other complications were reported.

Shuck and colleagues (2013) conducted a systematic review to compare the safety, efficacy, and long-term treatment outcomes of autologous fat grafting and injectable dermal fillers for human immunodeficiency virus (HIV)-associated facial lipodystrophy. Based on U.S. Food and Drug Administration approval in HIV lipoatrophy, studies included in the review were limited to the use of hyaluronic acid and/or poly-L-lactic acid. The researchers documented facial volume, subjective participant satisfaction, standardized outcome scales, reinjection rates, and complication rates. A total of 19 studies were included in the analysis, representing 724 participants; hyaluronic acid/poly-L-lactic acid cohort, n=549 and 175 in the autologous fat transfer cohort. Improvements in facial volume and durability of treatment were comparable between dermal fillers and fat transfer, as measured by both subjective participant outcomes and objective means. However, the poly-L-lactic acid cohort was reinjected at a rate three times that of autologous fat, and was associated with a relatively high rate of subcutaneous papule formation at 22% (range, 3 to 44 %t). The authors concluded that both, dermal fillers and autologous fat transfer are effective treatments for HIV-associated facial lipoatrophy, with high rates of facial volume restoration and participant satisfaction. However, autologous fat transfer may provide superior long-term durability but with less of a financial burden compared with injectable fillers. The authors acknowledged that limitations in data and heterogeneity in reporting modalities negated any statistically significant comparison.

Bourne and colleagues (2021) conducted a prospective cohort study evaluating the outcomes for surgical autologous fat transfer applied for traumatic and postsurgical craniofacial deformities. The study involved 20 participants who underwent autologous fat transfer. Volume retention over time was determined using high-resolution computed tomography. Flow cytometry was used to assess cellular subpopulation and viability in the stromal vascular fraction. After completion of the 9-month follow-up, 5 participants were enrolled for a second treatment. Volume retention average was 63 ± 17% at 9 months. The 3-month retention strongly predicted 9-month retention (r=0.996, p<0.0001). There was no correlation between the total volume injected and retention. Participants that underwent a second procedure had similar volume retention as in their first procedure (p=0.05). There were no serious adverse events. The authors note that a limitation of fat grafting is the unpredictability of volume retention.

Common complications and side effects that may be associated with autologous fat grafting include but are not limited to loss of volume, swelling, redness, tingling, and bruising. Less common complications may include cellulitis, hematoma, fibrosis, oil cysts, and calcification. A disadvantage of autologous fat transfer is the unpredictable degree and rate of resorption, which limits the predictability of long-term outcomes. It is not unusual that repeat injections may be required.

Most of the peer-reviewed published literature on autologous fat grafting has explored its use as a reconstructive or cosmetic procedure in individuals who have undergone reconstructive breast procedures. Researchers continue to explore the use of autologous fat grafting additional indications.

Injectable Soft Tissue Fillers

Injectable soft tissue fillers are volume-producing agents that are injected or implanted into the dermal layers to restore the loss of tissue volume due to factors such as congenital defect, lipoatrophy, injury, trauma, or aging. A number of injectable fillers may be used for medical purposes in non-facial areas such as the chest (to improve chest wall defects following mastectomy) and the breast (nipple contouring and breast reconstruction) post breast surgery or radiation therapy for the treatment of breast cancer.

These types of products may be made from a variety of biologic products, synthetic materials, and from absorbable or nonabsorbable compounds, and are generally divided into the following categories: calcium hydroxylapatite (CaHa), collagen, hyaluronic acid, and calcium hydroxylapatite (PLLA) (U.S. FDA, 2018). Some injectable soft tissue fillers, such as injectable collagen and hyaluronic acids, perform primarily through a volume-filling effect. Others, including poly-L-lactic acid and calcium hydroxylapatite fillers, act as platforms for endogenous collagen formation.

As noted above, soft tissue fillers (dermal fillers) are generally divided into the following categories:

• Calcium Hydroxylapatite: Synthetic calcium hydroxylapatite (CaHA) (for example, Radiesse^®, Merz North America, Inc., Franksville, WI) is formed from calcium and phosphorus ions. The CaHA microspheres used in Radiesse have the same chemical arrangement as the inorganic constituent of human teeth and bone. Because CaHA is native to the body, the product does not create antigenic or inflammatory responses (Jacovella, 2008). For wrinkle filling in the hand or face, calcium hydroxylapatite particles are suspended in a gel-like solution and then injected into the wrinkle in the face or under the skin in the dorsum of the hand. While in the body, CaHA will be visible in x-rays and may conceal underlying features.
• Collagen: Collagen is a type of protein that is a major component of skin and other tissues in the body. Sources of purified collagen used in soft tissue fillers can be from human or bovine cells.
• Hyaluronic acid: Hyaluronic acid is a type of polysaccharide that is present in body tissues, such as in cartilage and skin. It is able to combine with water and swell when in gel form, causing a filling/smoothing effect. The hyaluronic acid used in dermal may be derived from bacteria or rooster combs (avian). In some instances, hyaluronic acid used in soft tissue fillers is crosslinked (chemically modified) to make it last longer in the body.
• Poly-L-lactic acid (PLLA): PLLA is a biocompatible, biodegradable, synthetic polymer. This material has wide uses in bone screws and absorbable stitches. PLLA is a long-lasting filler material that is administered in a series of injections over a period of several months.

Several commercial injectable soft tissue fillers have received approval or clearance from the FDA, including but not limited to Belotero Balance^® (Merz North America, Inc., Franksville, WI), Juvederm (Allergan Aesthetics, Irvine, CA) , Restylane^® Lyft (Galderma Laboratories, L.P, Dallas, Tx), Revanesse^® Versa (Prollenium Medical Technologies Inc., Ontario, Canada ), and Sculptra^® (Galderma Laboratories, L.P, Dallas, Tx). For additional information on FDA approved dermal fillers, see: https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers.

Collagen Injections and Implants

Collagen is a type of dermal (soft tissue) filler that may be used to make the skin appear fuller. Collagen fillers are made from a variety of materials including biologic or synthetic materials, and from absorbable or nonabsorbable compounds. Collagen injections and implants involve either the injection of raw collagen or the surgical implantation of a pre-formed collagen implant under the surface of the skin. This procedure may be used to restore the appearance or function after accidental injury. It may also be used to enhance appearance.

Hyaluronic acid

Hyaluronic acid is a naturally occurring glycosaminoglycan polysaccharide that is present in body tissues, such as in skin and cartilage. When combined with water, hyaluronic acid can expand into a gel form, causing a smoothing/filling effect. The injection of exogenous hyaluronic acid into the skin diminishes visible signs of volume loss. Sources of hyaluronic acid used in dermal fillers can be from bacteria or rooster combs (avian). In some cases, hyaluronic acid used in dermal fillers is chemically modified (crosslinked) to make it last longer in the body. The effects of this material last approximately 6-12 months. Examples of hyaluronic acid fillers that are available in the United States includes, but is not necessarily limited to Juvéderm and Restylane.

Poly-L-Lactic Acid as a Treatment of Human Immunodeficiency Virus (HIV)-associated Lipoatrophy

Some medical conditions may result in a condition called lipoatrophy, characterized by facial wasting of fat under the skin of the face and other parts of the body, resulting in a gaunt or wasted appearance. Reconstructive treatments available to HIV-associated lipoatrophy involve the injection of U.S. Food and Drug Administration (FDA) approved dermal fillers such as poly-L-lactic acid implant (Sculptra) or synthetic calcium hydroxylapatite (Radiesse). Poly-L-lactic acid is a biodegradable synthetic substance used in the manufacture of absorbable stitches and implantable medical devices. Sculptra is an injectable form of this material, and it is injected under the skin of an individual with lipoatrophy to restore a more normal facial or body contour. Radiesse, a semi-solid, cohesive implant whose principal component is a synthetic calcium hydroxylapatite suspended in a gel carrier, is also injected subdermally for restoration, correction, or both for individuals with HIV-associated lipoatrophy.

As mentioned above, Shuck and colleagues (2013) compared the safety, efficacy, and long-term treatment outcomes of dermal fillers in HIV-associated facial lipoatrophy to other treatment modalities, reporting high rates of facial volume restoration and participant satisfaction with the procedure.

Synthetic Calcium Hydroxylapatite (Radiesse) as a Treatment of Glottic Insufficiency

Although Radiesse was originally granted FDA approval as a wrinkle filler, in 2007, the FDA granted additional clearance for the product (Radiesse Laryngeal Implant) to be used as a treatment of vocal cord insufficiency (2007). The Radiesse Laryngeal Implant is a sterile, non-pyrogenic injectable material comprised of calcium hydroxylapatite (CaHA) suspended in an aqueous formulation sterile water, glycerin, and sodium carboxymethylcellulose, stabilized with a phosphate buffer. According to the FDA approval letter (K070090):

BioForm’s Radiesse Laryngeal Implant is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue hulking agent. Radiesse Laryngeal Implant injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.

In February 2010, BioForm Medical Inc. was acquired by Merz Aesthetics Inc. which now manufactures Radiesse Laryngeal Implant under the names Radiesse Voice and Radiesse Voice Injectable Implant. Merz Aesthetics Inc. (Sturtevant, WI) has also been granted an FDA clearance for Prolaryn^® Plus, a CaHA compound intended as an injectable, space-occupying implant for vocal fold medialization and augmentation.

Rees and colleagues (2008) reviewed the clinical results of the thyrohyoid approach for in-office vocal fold augmentation using calcium hydroxylapatite (CaHA/Radiesse). The researchers conducted a chart review of all individuals who underwent in-office thyrohyoid vocal fold augmentation between June 1, 2005 and June 1, 2007. Information with respect to participant demographics, indications, complications, and clinical outcome was summarized. A total of 51 thyrohyoid vocal fold augmentations were performed in 33 participants (26 men; mean age of 66 years). Six (13%) procedures were aborted due to an inability to achieve an appropriate injection angle. Two (6%) self-limited complications reported included a vasovagal episode and a small ulcer identified near the petiole of the epiglottis. Pre- and post-procedure data were available for 62.5% of participants. The mean 10-item Voice Handicap Index (VHI) reflected an improvement from 27.9 (± 8.40) pre-procedure to 13.5 (± 10.52) post-procedure (p<0.001). The authors concluded that in-office vocal fold augmentation with the use of the thyrohyoid approach produces excellent clinical results.

Rosen and colleagues (2009) evaluated the long-term effectiveness of CaHA vocal fold injection for individuals with glottic insufficiency. Each participant served as his/her own control. Voice-related outcome measures were assessed for pre-injection, 1, 3, 6, and 12 months. A total of 63 participants were available for evaluation; 53% of the injection procedures were performed in the office and 57 % of participants were diagnosed with unilateral paralysis and 43% with glottal incompetence with mobile vocal folds. Participant satisfaction 12 months after injection demonstrated 67% reporting a significant improvement in voice and 81 % reporting at least a moderate improvement in voice. Utilizing the VHI-10, visual analog scale (vocal effort), Consensus Assessment Perceptual Evaluation V (judgments of voice severity), and objective voice measures of glottal closure (maximum phonation time and S:Z ratio), paired-t tests demonstrated significant improvements after treatment. A 22% further treatment rate was observed at the 12-month time point. The authors concluded that 1-year results of this group of participants with glottal incompetence treated with CaHA vocal fold injection demonstrate that excellent clinical results were achieved.

Carroll and colleagues (2011) investigated the long-term effectiveness of CaHA/Radiesse as a vocal fold injectable by assessing data from a cohort of participants who underwent injection for glottal insufficiency (also known as vocal fold insufficiency). Participants who underwent CaHA injection for glottal insufficiency due to any cause were considered for inclusion in the study. The change in VHI-10 scores between pre-injection scores and best post-injection scores as well as between the pre-injection and the most recent VHI-10 scores were employed as primary outcome measures to determine the persistence of benefit or the time to loss of benefit. Complications among the participants were ascertained. A total of 90 individuals who underwent 108 vocal fold injections with CaHA were evaluated for inclusion. A total of 20 individuals with 22 injections met the criteria for inclusion. Fourteen of 22 (64%) participants demonstrated loss of benefit of the CaHA material. The average length of benefit was 18.6 months, (ranging from 8 to 36 months). Complications were identified in three of the original cohort of 108 injections. The authors concluded that CaHA is an effective and safe long-term vocal fold injectable with an average length of benefit of 18.6 months.

In a prospective study, Mohammed and colleagues (2016) assessed the voice outcomes in individuals with unilateral vocal cord palsy undergoing vocal fold injection augmentation laryngoplasty with Radiesse in a clinic-based setting. Outcomes were assessed using a 10-item voice handicap index (VHI-10) administered as a postal survey before and after intervention. The study involved 43 participants. However, 15 participants died of malignant disease. Only 21 participants responded to the survey. The results of the survey suggest a sustained improvement at 3 months (p<0.01) and 6 months (p<0.033) post-injection.

Other studies have evaluated the role of injection laryngoplasty using CaHA or alternative agents, such as hyaluronic acid, in individuals with unilateral vocal fold paralysis. In a meta-analysis involving 4 cohort studies, Vila and colleagues (2018) found that individuals who received injection laryngoplasty within 6 months following onset of vocal fold paralysis had a relative risk of 0.25 (95% CI, 0.14 to 0.45) compared to conservative management (late or no injection). In another meta-analysis involving 14 studies, Wang and colleagues (2020) found that hyaluronic acid injection laryngoplasty could improve glottal closure insufficiency, maximal phonation time could be prolonged, and perceptual evaluations of the voice could improve. Although the duration of treatment varied across studies, injection laryngoplasty showed promise as an alternative to permanent medialization thyroplasty in appropriately identified individuals.

Collagen injection or implants: The injection of raw collagen, a naturally occurring substance that gives skin its elasticity, or the implantation of an implant made of collagen, to create a fuller appearance to the skin.

Facial lipodystrophy syndrome (LDS): A condition characterized by the localized loss of fat from the face, resulting in extremely sunken cheeks.

Glottic insufficiency: A condition that occurs when the vocal cords cannot close completely. Also known as vocal cord insufficiency.

Larynx: The tube for the passage of air between the pharynx above and the trachea below. During sound production, the vocal cords close together and vibrate as air forced from the lungs passes between them. The larynx is also known as the glottis or voice box.

Reconstructive: A service or procedure that is intended to address a significant variation from normal related to accidental injury, disease, trauma, treatment of a disease or a congenital defect.

Soft tissue fillers: Biocompatible materials used for soft-tissue augmentation, also referred to as dermal fillers.

Peer Reviewed Publications:

1. Alam M, Dover JS. Management of complications and sequelae with temporary injectable fillers. Plast Reconstr Surg. 2007; 120(6 Suppl):98S-105S.
2. Bourne DA, Bliley J, James I, et al. Changing the paradigm of craniofacial reconstruction: a prospective clinical trial of autologous fat transfer for craniofacial deformities. Ann Surg. 2021; 273(5):1004-1011.
3. Carroll TL, Rosen CA. Long-term results of calcium hydroxylapatite for vocal fold augmentation. Laryngoscope. 2011; 121(2):313-319.
4. Fredman R, Edkins RE, Hultman CS. Fat grafting for neuropathic pain after severe burns. Ann Plast Surg 2016; 76:295-303.
5. Jacovella PF. Use of calcium hydroxylapatite (Radiesse) for facial augmentation. Clin Interv Aging. 2008; 3(1):161-174.
6. Klinger M, Caviggioli F, Linger FM, et al. Autologous fat graft in scar treatment. J Craniofac Surg 2013; 24:1610-1615.
7. Lafaurie M, Dolivo M, Porcher R, et al. Treatment of facial lipoatrophy with intradermal injections of polylactic acid in HIV-infected patients. J Acquir Immune Defic Syndr. 2005; 38(4):393-398.
8. Mohammed H, Masterson L, Gendy S, Nassif R. Outpatient-based injection laryngoplasty for the management of unilateral vocal fold paralysis - clinical outcomes from a UK centre. Clin Otolaryngol. 2016; 41(4):341-346.
9. Phulpin, B, Gangloff P, Tran N, et al. Rehabilitation of irradiated head and neck tissues by autologous fat transplantation. Plast. Reconstr. Surg. 2009, 123(4):1187-1197.
10. Rees CJ, Mouadeb DA, Belafsky PC. Thyrohyoid vocal fold augmentation with calcium hydroxyapatite. Otolaryngol Head Neck Surg. 2008; 138(6):743-746.
11. Rosen CA, Gartner-Schmidt J, Casiano R, et al. Vocal fold augmentation with calcium hydroxylapatite: Twelve-month report. Laryngoscope. 2009; 119(5):1033-1041.
12. Shuck J, Iorio ML, Hung R, Davison SP. Autologous fat grafting and injectable dermal fillers for human immunodeficiency virus-associated facial lipodystrophy: a comparison of safety, efficacy, and long-term treatment outcomes. Plast Reconstr Surg. 2013; 131(3):499-506.
13. Silvers SL, Eviatar JA, Echavez MI, Pappas AL. Prospective, open-label, 18-month trial of calcium hydroxylapatite (Radiesse) for facial soft-tissue augmentation in patients with immunodeficiency virus-associated lipoatrophy: one-year durability. Plast Reconstr Surg. 2006; 118(3 Suppl):34S-45S.
14. Sollie M, Toyserkani NM, Bille C, et al. Autologous fat grafting as treatment of postmastectomy pain syndrome: a randomized controlled trial. Plast Reconstr Surg. 2022; 149(2):295-305.
15. Tabit CJ, Slack GC, Fan K, et al. Fat grafting versus adipose-derived stem cell therapy: distinguishing indications, techniques, and outcomes. Aesthetic Plast Surg. 2012; 36(3):704-713.
16. Vila PM, Bhatt NK, Paniello RC. Early-injection laryngoplasty may lower risk of thyroplasty: A systematic review and meta-analysis. Laryngoscope. 2018; 128(4):935-940.
17. Wang CC, Wu SH, Tu YK, et al. Hyaluronic acid injection laryngoplasty for unilateral vocal fold paralysis-a systematic review and meta-analysis. Cells. 2020; 9(11):2417.
18. Weichman KE, Broer PN, Tanna N, et al. The role of autologous fat grafting in secondary microsurgical breast reconstruction. Ann Plast Surg. 2013; 71(1):24-30.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Society of Plastic Surgeons (ASPS). ASPS Recommended insurance coverage criteria autologous fat grafting to the breast. Approved June 2015. Coding updated in January 2020. Available at: https://www.plasticsurgery.org/Documents/Health-Policy/Reimbursement/insurance-2015-autologous-fat-grafting-breast.pdf. Accessed on November 11, 2024.
2. Centers for Medicare and Medicaid Services (CMS). Available at: https://www.cms.gov/medicare-coverage-database/. Accessed on November 11, 2024.
   • National Coverage Determinations (NCD) #150.12 Collagen Meniscus Implant. Effective May 25, 2010.
   • National Coverage Determinations (NCD) #250.5 Dermal Injections for the Treatment of Facial Lipodystrophy Syndrome (LDS). Effective March 23, 2010.
3. Juvederm [Product Insert], Irvine, CA. Allergan; May 2016. Available at: https://allergan-web-cdn-prod.azureedge.net/actavis/actavis/media/allergan-pdf-documents/labeling/juvederm/162053-juvederm-ultra-xc-dfu-may-2016.pdf. Accessed on November 11, 2024.
4. Radiesse Injectable Implant [Product Insert], Franksville, WI. Merz North America, Inc.; Jan 2015. Available at: https://radiesse.com/app/uploads/EM00543-04.pdf. Accessed on November 11, 2024.
5. Restylane [Product Insert], Fort Worth, TX. Galderma Laboratories. April 2016. Available at: https://www.galderma.com/us/sites/g/files/jcdfhc341/files/2018-11/Restylane_IFU.pdf?_ga=2.268924657.1092630607.1557949958-1942077998.1557949958. Accessed on November 11, 2024.
6. Sculptra [Product Insert], Bridgewater, NJ. Dermik Laboratories Sanofi-aventis U.S., LLC); September 2009. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050S002c.pdf. Accessed on October 1, 2024.
7. The Women’s Health and Cancer Rights Act (WHCRA), §713; November 11, 1998. Available at: http://www.cms.gov/Regulations-and-Guidance/Health-Insurance-Reform/HealthInsReformforConsume/downloads/WHCRA_Statute.pdf. Accessed on November 111, 2024.
8. U.S. Food and Drug Administration. Dermal Fillers (Soft Tissue Fillers). July 06, 2023. Available at: https://www.fda.gov/medical-devices/cosmetic-devices/dermal-fillers-soft-tissue-fillers. Accessed on November 11, 2024.
9. U.S. Food and Drug Administration. FDA approved dermal fillers. November 9, 2020. Available at: https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers. Accessed on November 11, 2024.
10. U. S. Food and Drug Administration. Radiesse laryngeal implant. K070090. March 1, 2007. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf7/K070090.pdf. Accessed on November 11, 2024.
11. U. S. Food and Drug Administration. Summary of Safety and Effectiveness Data. Radiesse Laryngeal Implant. 2007. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf7/K070090.pdf. Accessed on November 11, 2024.

Absorbable Dermal Filler
Autologous Fat Grafting
Autologous Fat Transfer
Bellafill
Belotero Balance
Collagen Implant
Collagen Injection
Hyaluronic Acid
Juvederm
Prevelle Silk
Prolaryn Plus
Radiesse
Restylane Lyft
Revanesse Versa
RHA 2
RHA 3
RHA 4
Sculptra
Scleroderma
Soft Tissue Filler
Temporary Dermal Filler
Volbella
Vollure
Voluma

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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