Devices › Implant, dermal, for aesthetic use
Device brand name · Injectable
Sculptra: medical device reports filed with FDA
1,593 reports name it, 2005–2026. Manufacturer given most often on reports: Global Pharmacovigilance And Epidemiology/Sanofi-Aventis. Product code LMH.
- 1,593
- device reports naming the brand
- 0% of all MAUDE reports · about 76 a year
- 91
- reports, 12 months to August 2026
- 29 in the 12 months before
- 0.6%
- classified as malfunction
- 7.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,593 reports that name the brand "Sculptra" (injectable), received between September 2005 and August 2026; the manufacturer given most often on reports is Global Pharmacovigilance And Epidemiology/Sanofi-Aventis. Spellings of one product vary from report to report.
91 reports arrived in the 12 months to August 2026, up 214% from 29 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (41.7%), other (4.4%) and malfunction (0.6%); across all implant, dermal, for aesthetic use reports (product code LMH) death is recorded in 0.1% and malfunction in 7.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (53.6%), patient-device incompatibility (4.1%) and improper or incorrect procedure or method (2%). The patient problems coded most often are swelling, granuloma and pain. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 22,802 reports carrying product code LMH. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Insufficient device problem information | 854 | 53.6% | 10.2% |
| Patient-device incompatibilitythe device did not suit the patient | 65 | 4.1% | 2.4% |
| Improper or incorrect procedure or method | 32 | 2% | 7.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 18 | 1.1% | 0.5% |
| Device remains implanted | 6 | 0.4% | 2.3% |
| Migration or expulsion of device | 5 | 0.3% | 0.7% |
| Occlusion within devicethe device blocked | 4 | 0.3% | 0% |
| Malposition of device | 3 | 0.2% | 0.1% |
| Complete blockage | 2 | 0.1% | 0% |
| Human-device interface problem | 2 | 0.1% | 0% |
| Labelling, instructions for use or training problem | 2 | 0.1% | 0% |
| Nonstandard device | 2 | 0.1% | 0% |
| Other (for use when an appropriate device code cannot be identified) | 2 | 0.1% | 0.1% |
| Patient device interaction problem | 2 | 0.1% | 0.1% |
| Product quality problem | 2 | 0.1% | 0.1% |
| Application program problem: medication error | 1 | 0.1% | 0% |
| Bent | 1 | 0.1% | 0% |
| Breakthe device broke | 1 | 0.1% | 0.9% |
| Device issuea problem with the device | 1 | 0.1% | 0% |
| Device or device fragments location unknown | 1 | 0.1% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Swellingswelling | 931 | 58.4% |
| Granuloma | 181 | 11.4% |
| Painpain, site not specified | 136 | 8.5% |
| Erythemaskin redness | 94 | 5.9% |
| Subcutaneous nodule | 87 | 5.5% |
| Skin discoloration | 81 | 5.1% |
| Bruise/contusion | 67 | 4.2% |
| Inflammationinflammation | 64 | 4% |
| Deformity/ disfigurement | 55 | 3.5% |
| Hypersensitivity/allergic reaction | 55 | 3.5% |
| Reactiona reaction, type not specified | 53 | 3.3% |
| Skin inflammation | 52 | 3.3% |
| Edemaswelling from fluid | 47 | 3% |
| Swelling/ edema | 38 | 2.4% |
| Foreign body reaction | 31 | 1.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sculptra | Product code LMH | All MAUDE reports |
|---|---|---|---|
| Reports | 1,593 | 22,802 | 26,136,888 |
| Share of that pool | — | 7% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 41.7% | 83.7% | 36.2% |
| Classified as malfunction | 0.6% | 7.2% | 62.3% |
| Filed by the manufacturer | 93.2% | 95.3% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code LMH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Juvederm Voluma Xc/Lido Volume Unknown | 1,047 | 194 | 0.1% |
| Juvederm Voluma XC 27G 2 x 1mL | 901 | 78 | 0% |
| Juvederm Ultra Xc Tsk Us | 681 | 1 | 0% |
| Unk Volbella | 663 | 70 | 0% |
| VOLBELLA with LIDOCAINE | 641 | 5 | 0.2% |
| Juvederm VOLUMA WITH LIDOCAINE 1mL | 622 | 23 | 0% |
| Radiesse Dermal Filler | 596 | 0 | 0% |
| Juvederm Volume/Concentration/Additive Unknown | 502 | 24 | 0.6% |
| Juvederm Ultra Plus Xc Tsk Us | 495 | 5 | 0% |
| Zyplast Collagen Implant | 466 | 0 | 0% |
| VOLIFT with LIDOCAINE | 458 | 10 | 0% |
| Unk Juvederm Volux | 445 | 133 | 0% |
| Radiesse Injectable Implant | 441 | 0 | 0% |
| JUVEDERM VOLLURE XC 2x1 mL | 427 | 24 | 0.5% |
| Juvederm Voluma Volume/Additive Unknown | 426 | 13 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Sculptra reports
How many FDA reports name Sculptra?
1,593 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 91 in the latest 12 months.
What kinds of events are reported?
injury (41.7%), other (4.4%) and malfunction (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (53.6%), patient-device incompatibility (4.1%), improper or incorrect procedure or method (2%), device operates differently than expected (1.1%) and device remains implanted (0.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (93.2%), voluntary reports (3.5%) and distributor reports (3.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Sculptra was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.