Is Sculptra FDA-Approved for the Buttocks? Three Face Indications, Zero Gluteal PMA

When patients research non-surgical body contouring, medical spa websites and social media feeds frequently promote the "Sculptra butt lift" or "Sculptra BBL" as a low-downtime, collagen-stimulating alternative to surgery. Prominent consumer health portals add to the confusion: Cleveland Clinic's nonsurgical butt-lift explainer asserts that "many types of butt-lift injections, like Sculptra, are FDA-approved." Meanwhile, search engine results for queries regarding gluteal approval often display an official U.S. Food and Drug Administration (FDA) page announcing an approval for Sculptra, leading prospective patients to believe a formal federal approval covers buttocks enhancement.

The regulatory reality is unambiguous: Sculptra is not FDA-approved for the buttocks, the hips, or any other body site.

In the United States, Sculptra (injectable poly-L-lactic acid, or PLLA-SCA) is regulated as a Class III medical device under a single Premarket Approval, PMA P030050, held by applicant Q-Med AB (a Galderma company) under Product Code LMH. The FDA PMA database and historical dataset records reflect 54 total regulatory actions for P030050 (1 original approval and 53 supplements through mid-2026), ending on the live FDA database at supplement S055. Across this entire regulatory history, the FDA has approved exactly three indication-bearing decisions—and all three are strictly confined to the human face:

1. Original PMA P030050 (approved August 3, 2004): Restoration and/or correction of the signs of facial fat loss (lipoatrophy) in patients with human immunodeficiency virus (HIV).
2. Supplement S002 (approved July 28, 2009, panel-track): Sculptra Aesthetic for use in immune-competent patients as a single regimen for correction of shallow to deep nasolabial fold (NLF) contour deficiencies and other facial wrinkles in which deep dermal grid-pattern (cross-hatch) injection technique is appropriate.
3. Supplement S039 (approved April 25, 2023, panel-track): Correction of fine lines and wrinkles in the cheek region in immune-competent subjects.

When Google ranks the FDA's page for Sculptra P030050/S039 in response to queries about gluteal injections, it is serving a wrong-intent search result: that 2023 approval evaluated midface fine lines and cheek wrinkles, not gluteal volume. Cleveland Clinic's statement that butt-lift injections like Sculptra are FDA-approved is factually false. While Healthline correctly identifies that buttock use is off-label, its editorial copy presents an outdated 2018 pricing estimate of $915 per vial and frames a 4-vial regimen ($4,000 to $7,000) as a "minor lift." Four vials is a clinic quote, not a labeled gluteal dose, and there is no FDA last-visit table for buttock projection.

Under the Precautions section of the current FDA-approved physician labeling (P030050/S039C), the manufacturer states:

"The safety and effectiveness of injecting Sculptra in larger amounts, at different frequencies, at anatomic sites different than specified for the intended use, or at sites that have had other dermal fillers, have not been evaluated."

Administering Sculptra into the gluteal subcutaneous tissue is entirely off-label. While licensed physicians may legally exercise clinical judgment to use an approved medical device off-label, patients must understand that off-label use lacks FDA review of safety, effectiveness, dosing standardization, or long-term complication rates in the buttocks. Furthermore, poly-L-lactic acid stimulates gradual host neocollagenesis over months and cannot be dissolved with hyaluronidase if complications arise or if the aesthetic result is unsatisfactory.

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Is Sculptra FDA-approved for the buttocks, or only for named facial indications?

Sculptra has never received FDA Premarket Approval for gluteal augmentation, hip-dip correction, or body contouring. The product code assigned to Sculptra by the FDA's Center for Devices and Radiological Health (CDRH) is LMH (Implant, dermal, for aesthetic use). Sculptra is a Class III PMA device, not a 510(k) energy platform.

To date, no injectable dermal filler holds an FDA Premarket Approval for gluteal augmentation. The FDA's dermal fillers (soft tissue fillers) page states that fillers are not approved for body contouring or enhancement of the buttocks or breasts, and separately warns against injectable silicone marketed for those same uses.

Every valid U.S. FDA approval order for Sculptra is anchored in clinical trials that treated facial anatomy exclusively:

Commercial marketing that blurs these distinctions exploits the common consumer assumption that "FDA approval" is a general blanket endorsement of a drug or device. In reality, FDA approval is granted only for specific labeled indications, specific anatomic target planes, and specific dosing protocols established in prospective, controlled clinical trials.

When a clinic markets a "Sculptra Butt Lift," it is using a facial PMA product in an anatomic zone the IFU lists as unevaluated, usually at clinic vial counts far above a labeled cheek course.

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Which P030050 decisions actually added an indication, and is S039 a cheek PMA or a hidden body PMA?

A rigorous audit of the CDRH PMA database clarifies how Sculptra evolved from an expedited-review reconstructive implant to a cosmetic aesthetic product, and confirms that no hidden body supplement exists.

Within the FDA PMA dataset, P030050 contains 54 total records held by applicant Q-Med AB:

• 1 Original PMA order;
• 53 supplements tracking manufacturing changes, shelf-life extensions, packaging updates, trade-name unifications, and clinical indication expansions.

The live FDA supplement sequence extends to Supplement S055 (issued June 22, 2026). Across these 54 records, only three panel-track supplements or original orders ever expanded clinical indications:

1. Original PMA P030050 (August 3, 2004)

The initial approval of Sculptra addressed severe facial lipodystrophy associated with antiretroviral therapy in HIV patients. According to the original Summary of Safety and Effectiveness Data (SSED P030050B), the application evaluated four open-label clinical studies (VEGA, Chelsea & Westminster, APEX 002, and Blue Pacific) encompassing 277 patients. The primary endpoint measured cutaneous thickness of the hollowed cheek via serial ultrasound. It established that microparticulate PLLA induces a subclinical foreign-body inflammatory cascade, recruiting macrophages and fibroblasts to deposit endogenous Type I and Type III collagen. This was a purely facial reconstructive trial; gluteal soft tissue was neither evaluated nor mentioned.

2. Supplement S002 (July 28, 2009)

Galderma expanded Sculptra into the general cosmetic market under the brand name Sculptra Aesthetic via Supplement S002 (with formal FDA notice published August 4, 2009). The pivotal clinical trial documented in SSED P030050S002B randomized 233 immune-competent subjects across 10 U.S. centers, comparing Sculptra Aesthetic (n = 116) against an active CosmoPlast collagen control (n = 117). The approved indication was restricted to shallow to deep nasolabial folds and other facial wrinkles using a deep dermal cross-hatch injection technique.

Some secondary summaries, including our Galderma aesthetics portfolio overview, still list this 2009 fold indication as supplement 12. The live PMA record is S002; there is no S012 row.

3. Supplement S039 (April 25, 2023)

The most recent clinical supplement, S039, was approved on April 25, 2023 (while the approval order header displays April 18, 2023, the official FDA decision date in the CDRH database is April 25, 2023). Based on a randomized, evaluator-blinded, multicenter U.S. study (NCT04124692) detailed in SSED P030050S039B, this supplement added the indication for correction of fine lines and wrinkles in the cheek region.

The trial enrolled 149 subjects (97 randomized to Sculptra and 52 to a no-treatment control). The primary efficacy endpoint was the proportion of subjects demonstrating at least a 1-grade improvement on the Galderma Cheek Wrinkle Scale (GCWS) At Rest in both cheeks at Month 12, as evaluated by blinded live raters. In the primary intention-to-treat (ITT) multiple imputation analysis, 70.7% of Sculptra subjects met the responder criteria compared to 25.9% in the control arm (p < 0.0001). Among observed cases at Month 12, 71.6% (63/88) of Sculptra-treated patients responded versus 26.1% (12/46) of controls. In the 24-month safety and durability extension, 76.9% (50/65) of evaluated subjects maintained cheek wrinkle improvement.

Because S039 is indexed on the FDA's "Recently-Approved Devices" portal, automated search engines surfacing results for "is Sculptra FDA-approved for buttocks" frequently display the S039 cheek approval page. Patients reading snippet cards see "Sculptra Approved by FDA" without realizing that the SSED evaluated cheek wrinkles, not gluteal volume: a maximum of 9 mL of reconstituted product per cheek per session (one vial per side), up to four sessions, with a mean of 3.6 treatments. In 334 of 345 treatment sessions (96.8%), investigators used one vial.

Process and Non-Indication Supplements (S034, S054, S055)

None of the remaining 51 supplements touch clinical indications:

• Supplement S034 (approved November 23, 2021) combined the physician labeling for Sculptra and Sculptra Aesthetic, marketed both under the single trade name Sculptra, changed reconstitution and injection procedure, and updated secondary packaging (PMA P030050/S034). It did not add a body indication. Current labeling still describes both a 5 mL SWFI reconstitution (with a standing hydration step) and an 8 mL SWFI reconstitution for immediate use; this page does not reprint that protocol.
• Supplement S054 (approved April 15, 2026) was a real-time manufacturing chemistry supplement terminating routine elemental-impurity testing for vial stoppers based on historical compliance data.
• Supplement S055 (approved June 22, 2026) was a 30-day notice approving a secondary compounding and filling autoclave.

Neither the 2026 manufacturing updates nor any prior supplements contain clinical protocols, safety endpoints, or approval orders for the human buttocks.

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Does Cleveland Clinic 'FDA-approved' for butt-lift injections match the IFU, or is Healthline closer?

A direct comparison of online authority sources reveals how medical misinformation enters consumer research:

Cleveland Clinic's article on non-surgical buttock lifts conflates the existence of an FDA Premarket Approval for a product line with approval for a specific anatomic procedure. By publishing that "butt-lift injections, like Sculptra, are FDA-approved," the Cleveland Clinic article creates a false impression of federal safety validation.

In contrast, Healthline's review correctly informs readers that Sculptra is approved solely for facial wrinkles and that gluteal injections are off-label. However, Healthline's commercial estimates introduce significant clinical distortion:

1. Dosing Fallacy: Healthline quotes a four-vial regimen ($4,000 to $7,000 based on a 2018 benchmark of $915 per vial) as sufficient for a "minor lift." That is a clinic price envelope, not a labeled gluteal dose. Four U.S. vials contain 1,470 mg of total dry formulation (367.5 mg per vial of lyophilized PLLA, sodium carboxymethylcellulose, and mannitol—not 1,470 mg of PLLA microparticles alone). The S039 cheek trial used up to four sessions, typically one vial per session, to treat facial cheek wrinkles. Spreading a similar vial count across two adult gluteal hemispheres is not a labeled regimen and has no FDA last-visit projection table.
2. Nodule Incidence Misattribution: Healthline quotes a historical 7% to 9% nodule rate from 2015 literature. While informative as a generic safety caution, that figure is not a gluteal PMA table. The labeled nasolabial-fold rate is 17.2% (20/116) in S002. Neither number answers buttocks risk. Off-label body papers describe higher reconstitution volumes than the labeled facial 5 mL or 8 mL SWFI regimens; those papers are not an IFU.

The manufacturer's official U.S. patient portal (sculptrausa.com) stays inside facial claims: its Important Safety Information lists nasolabial folds, cheek fine lines and wrinkles, and other facial wrinkles. It does not list buttocks. HIV facial lipoatrophy remains on the physician IFU.

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Do facial 24-month cheek tables or NLF nodule rates answer how long a Sculptra butt lift lasts?

Med spas frequently cite Sculptra's "up to 2 years" or "24-month duration" when pitching buttock enhancement. These longevity claims are directly borrowed from facial clinical trials and cannot be scientifically transferred to the buttocks.

The Mechanism of Action: PLLA vs. Traditional Fillers

Unlike hyaluronic acid gels that provide immediate, space-occupying hydrostatic volume, Sculptra is a biostimulatory implant composed of crystalline poly-L-lactic acid microparticles (40 to 63 microns in diameter) formulated with sodium carboxymethylcellulose (USP) and non-pyrogenic mannitol. As detailed in our comprehensive guide to Sculptra's mechanism vs. dermal fillers, the carrier fluid is absorbed within 24 to 48 hours post-injection, returning the tissue temporarily to its baseline appearance. Over the subsequent 8 to 24 weeks, the PLLA microparticles stimulate a controlled subclinical foreign-body response, recruiting macrophages, giant cells, and fibroblasts to deposit new endogenous Type I and Type III collagen fibers before the polymer hydrolyzes into lactic acid, carbon dioxide, and water.

For facial indications, this collagen synthesis produces measurable clinical durability:

• In the S039 cheek trial, blinded evaluators confirmed that 76.9% (50/65) of subjects in the long-term extension maintained aesthetic cheek wrinkle improvement at Month 24.
• In our analysis of how long Sculptra takes to work, facial collagen neocollagenesis peaks between 6 and 9 months and can persist for 24 to 36 months in dermal and subdermal planes.

Why Facial Duration Data Does Not Predict Gluteal Outcomes

Translating facial 24-month data to the buttocks fails on several physiological grounds:

1. Dynamic Mechanical Shear: The gluteus maximus and overlying soft tissue sustain substantial compressive and shear loads during sitting, athletic movement, and ambulation. Mechanical loading alters the architectural deposition of newly formed extracellular matrix.
2. Subcutaneous Dispersion in Adipose Tissue: Facial PLLA is placed in the deep dermis or immediate subdermal plane against rigid facial bony scaffolding (zygoma, maxilla). In the buttocks, PLLA must be placed within the deep subcutaneous adipose layer above the gluteal fascia. Adipose tissue has lower fibroblast density compared to facial reticular dermis, resulting in variable and less predictable collagen synthesis per milligram of PLLA injected.
3. Endpoint Disparity (Wrinkle Smoothing vs. Volumetric Projection): A 1-grade improvement on a facial wrinkle scale requires microscopic dermal thickening (less than 1 mm). Creating visible gluteal projection requires a different, unlabeled volumetric goal. If collagen yield is modest or vial count is low, any perceived result may fade sooner than the cheek 24-month ceiling. There is no US PMA table that answers that question for the buttocks.

Complication Data: Nodules and Granulomas

Adverse event rates also cannot be inferred from facial trials. In the pivotal nasolabial fold trial (P030050/S002), non-adverse papules and nodules occurred in 17.2% (20/116) of Sculptra subjects. In our dedicated investigation into Sculptra delayed-onset nodules and lumps, we detail how unhydrated microparticle aggregation or superficial placement leads to palpable, non-inflammatory collagen nodules months after injection.

In the buttocks, published off-label technique papers describe deep subcutaneous cannula placement and higher reconstitution volumes than the labeled facial IFU. That literature does not create a PMA indication and does not supply a US last-visit volume table. Different anatomy also means different failure modes:

• Foreign-Body Granulomas: Late-onset, immune-mediated granulomas can develop months after injection, presenting as large, indurated, tender masses.
• Irreversibility: Because PLLA is not a glycosaminoglycan like hyaluronic acid, hyaluronidase has no enzymatic effect on Sculptra. As outlined in our clinical guide to dissolving filler with hyaluronidase, reversing PLLA complications is not a hyaluronidase problem. Facial labeling and published reports describe corticosteroid injections and, in refractory cases, excision—not an office "dissolve" visit.

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Is a hip-dip quote the same decision as gluteal augmentation, and is PLLA a surgical BBL substitute?

Prospective patients frequently evaluate a "Sculptra BBL" against two completely different clinical procedures: lateral hip-dip correction and surgical autologous fat grafting (the traditional Brazilian Butt Lift). Conflating these three procedures leads to severe financial and aesthetic misalignment.

Hip-Dip Correction vs. Posterior Gluteal Augmentation

The lateral trochanteric depression (commonly called the "hip dip") is an anatomic contour gap between the iliac crest and the greater trochanter of the femur. As analyzed in our definitive clinical guide to hip-dip filler anatomy, safety, and longevity, treating hip dips is primarily an exercise in smoothing a localized focal depression, not building global gluteal projection.

Because the trochanteric hollow is bounded by rigid fascial planes (the tensor fasciae latae and gluteal aponeurosis), a targeted volume of biostimulator (such as 4 to 8 vials of Sculptra or hyperdilute Radiesse) can soften the inward curve. In contrast, posterior gluteal augmentation requires expanding a massive muscular and adipose hemisphere to lift and project the buttocks against gravity. Patients seeking projection who are quoted a small hip-dip package will inevitably experience profound aesthetic disappointment.

Why Sculptra is Not a "Non-Surgical BBL"

Marketing Sculptra as a "non-surgical BBL" misrepresents both the capacity of biostimulators and the nature of surgery:

1. Volumetric Reality: A surgical Brazilian Butt Lift typically harvests autologous adipose tissue via liposuction from the abdomen, flanks, and back, purifying and grafting 300 mL to 800 mL of living fat per buttock. A U.S. Sculptra vial is a 367.5 mg dose vial of lyophilized powder. Even a large multi-vial clinic protocol is collagen thickening in subcutaneous fat, not a labeled substitute for surgical-scale fat transfer, and there is no PMA cubic-centimeter table for gluteal PLLA.
2. Safety Profile Differences: The surgical BBL carries serious surgical risks, historically documented in our report on Brazilian Butt Lift safety and mortality. When fat is inadvertently injected intramuscularly beneath the gluteal fascia, damage to the deep inferior or superior gluteal veins can cause fatal pulmonary fat embolism (PFE). While subcutaneous PLLA injection does not carry the risk of macroscopic fat embolization, it introduces risks of large-volume foreign-body reactions, deep infection, biofilm formation, asymmetry, and severe financial depletion without permanent volumetric guarantees.

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What does Sculptra for the buttocks actually cost?

Because Sculptra has no labeled dosing for body contouring, medical spas package treatments arbitrarily, typically charging per vial or through multi-vial tiered packages.

In the facial aesthetic market, as detailed in our analysis of Sculptra cost per vial and treatment planning, a single vial of Sculptra is commonly quoted between $800 and $1,200. Consumer cost copy sometimes describes a 150 mg PLLA vial; U.S. physician labeling lists a 367.5 mg dose vial of lyophilized PLLA, sodium carboxymethylcellulose, and mannitol. Peer-reviewed formulation summaries often split that mass as about 150 mg PLLA plus the two excipients. Either way, milligrams on the vial are not a labeled gluteal dose.

The table below is a clinic-quote envelope, not an IFU. Healthline's 2018 four-vial $4,000 to $7,000 "minor lift" sits at the low end. Hip-dip plans on this site are often described in the 10-vial range. None of these numbers is a labeled buttocks regimen.

A 20-vial off-label plan can cost as much as, or more than, a surgical BBL without being a labeled alternative. Four-vial "trial" packages should be read as a quote, not as a minor labeled lift.

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Who should skip a Sculptra-butt quote?

Any patient presented with a treatment plan for gluteal Sculptra should critically evaluate the provider's claims against regulatory and clinical contraindications. You should immediately decline or walk away from a consultation under the following circumstances:

1. The Provider Asserts the Injections Are "FDA-Approved"

If an injector, med spa coordinator, or marketing brochure states that Sculptra is FDA-approved for buttock enhancement, they are either misinformed or deliberately misleading you. Ethical medical practices operating under formal off-label aesthetic injection guidelines explicitly disclose in written informed consent that the product is being used off-label, explain the absence of FDA premarket review for gluteal safety, and detail the alternative approaches.

2. The Provider Promises Volumetric Transformation from 2 to 4 Vials

A provider who quotes a single syringe or 2 to 4 vials of Sculptra for a "butt lift" is selling a labeled-dose story that does not exist. Four vials equal 1,470 mg of total dry formulation, in the same vial-count neighborhood as a full cheek course, spread over a much larger area. Off-label body injectors who publish technique papers typically describe multi-session, double-digit vial plans. Those plans are still not a PMA.

3. You Expect Surgical-Scale Projection

If your aesthetic goal is substantial projection, significant lateral hip widening, or dramatic silhouette alteration, a biostimulator quote is the wrong decision class. Redirect toward a consultation with a board-certified plastic surgeon regarding surgical BBL techniques and candidacy or gluteal implants.

4. You Have a History of Keloids or Hypertrophic Scars

S039C contraindications state that Sculptra should not be used in patients with known history of or susceptibility to keloid formation or hypertrophic scarring. Because the product works by a local fibroblastic response, that labeled exclusion applies on the face and is not waived for an off-label body site.

5. Pregnancy, Lactation, or Age Under 18

S039C states that safety and effectiveness have not been evaluated in patients who are pregnant, lactating, breastfeeding, or under 18 years of age. That is a labeled precaution, not the keloid contraindication. It is still a reason to skip a gluteal quote.

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Frequently Asked Questions

Is Sculptra FDA-approved for the buttocks or for a Sculptra BBL?

No. Sculptra has never received FDA approval for gluteal augmentation, buttocks lifting, or any body contouring procedure. Under Premarket Approval P030050 (Product Code LMH), Sculptra is FDA-approved solely for facial indications: HIV-associated facial lipoatrophy (2004), nasolabial folds and facial wrinkles (2009, S002), and cheek fine lines and wrinkles (2023, S039). Any injection of Sculptra into the buttocks is an off-label medical procedure.

What is Sculptra actually FDA-approved for in the United States?

In the U.S., Sculptra is FDA-approved for three specific facial uses:

1. Restoration or correction of facial fat loss (lipoatrophy) in people with HIV.
2. Correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in immune-competent adults.
3. Correction of fine lines and wrinkles in the cheek region in immune-competent adults. All other applications—including the buttocks, hips, breasts, biceps, thighs, and neck—are off-label.

Is a Sculptra butt lift the same as a surgical Brazilian butt lift?

No. A surgical Brazilian Butt Lift (BBL) is an operative surgical procedure where large volumes (typically 300 mL to 800 mL per side) of living autologous adipose tissue are harvested via liposuction and grafted into the buttocks. A Sculptra butt lift is an off-label office procedure that injects microparticulate poly-L-lactic acid to stimulate modest collagen thickening in the skin and subcutaneous fat. It cannot replicate the volumetric enlargement or projection of a surgical BBL.

How much does Sculptra for the buttocks cost, and is there a labeled vial count?

There is no FDA-labeled vial count or dosage for the buttocks. Clinic quotes often run 10 to 20+ vials across multiple sessions at about $800 to $1,200 per vial, so an $8,000 to $24,000 envelope is a market quote, not an IFU. Healthline's 2018 four-vial $4,000 to $7,000 figure is the same kind of quote. None of those numbers is a labeled gluteal dose.

Can Sculptra in the buttocks be dissolved if I do not like it?

No. Sculptra is poly-L-lactic acid microparticles that stimulate host collagen. It is not hyaluronic acid, and hyaluronidase cannot dissolve it. Particles hydrolyze over time; the collagen they induce is not reversed in an office visit. Nodules and asymmetry are managed without hyaluronidase; published facial reports include corticosteroids and, rarely, excision.

Is Sculptra for hip dips FDA-approved?

No. Injections of Sculptra into the lateral trochanteric depressions (hip dips) are also off-label. While hip dips represent a smaller, more localized anatomic depression than the entire gluteal hemisphere, the procedure carries the same off-label regulatory status, requires non-standardized multi-vial dosing, and cannot be enzymatically dissolved.

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Sources

• U.S. Food and Drug Administration. Premarket Approval (PMA) Database: P030050 (Sculptra). Applicant: Q-Med AB; Product Code: LMH. Approved August 3, 2004. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030050
• U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Sculptra, PMA P030050. August 3, 2004. https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050B.pdf
• U.S. Food and Drug Administration. Premarket Approval (PMA) Database: P030050/S002 (Sculptra Aesthetic). Approved July 28, 2009. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030050S002
• U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Sculptra Aesthetic, PMA P030050/S002. July 28, 2009. https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050S002B.pdf
• U.S. Food and Drug Administration. Premarket Approval (PMA) Database: P030050/S039 (Sculptra Cheek Wrinkles). Approved April 25, 2023. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030050S039
• U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Sculptra, PMA P030050/S039. April 25, 2023. https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050S039B.pdf
• U.S. Food and Drug Administration. Physician Labeling: Sculptra (Injectable Poly-L-Lactic Acid), PMA P030050/S039C. April 2023. https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050S039C.pdf
• U.S. Food and Drug Administration. Recently-Approved Devices: Sculptra — P030050/S039. April 25, 2023. https://www.fda.gov/medical-devices/recently-approved-devices/sculptra-p030050s039
• U.S. Food and Drug Administration. Premarket Approval (PMA) Database: P030050/S034. Approved November 23, 2021. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030050S034
• U.S. Food and Drug Administration. Premarket Approval (PMA) Database: P030050/S054. Approved April 15, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030050S054
• U.S. Food and Drug Administration. Premarket Approval (PMA) Database: P030050/S055. Approved June 22, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030050S055
• U.S. Food and Drug Administration. Dermal Fillers (Soft Tissue Fillers). Unapproved uses; body contouring and enhancement. Retrieved September 5, 2026. https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/dermal-fillers-soft-tissue-fillers
• Galderma Laboratories, L.P. Sculptra Aesthetic Important Safety Information. Retrieved September 5, 2026. https://www.sculptrausa.com
• Cleveland Clinic. Nonsurgical Butt Lift (Buttock Augmentation). Health Library: Procedures. Retrieved September 5, 2026. https://my.clevelandclinic.org/health/procedures/non-surgical-butt-lift
• Healthline. Sculptra Butt Lift: Procedure, Benefits, Side Effects, and Cost. Retrieved September 5, 2026. https://www.healthline.com/health/beauty-skin-care/sculptra-butt-lift
• Vleggaar D, Fitzgerald R. Dermatological applications of poly-L-lactic acid (PLLA). Journal of Drugs in Dermatology. 2014;13(4 Suppl):s29-s31. https://pubmed.ncbi.nlm.nih.gov/24719077/
• Kates RE, Fitzgerald R. Poly-L-Lactic Acid for Body Contouring: Clinical Evidence and Practice Considerations. Aesthetic Surgery Journal Open Forum. 2023;5:ojad042. https://pmc.ncbi.nlm.nih.gov/articles/PMC10286883/