Devices › Implant, dermal, for aesthetic use
Device brand name · Implant dermal for aesthetic use
Radiesse: medical device reports filed with FDA
181 reports name it, 2004–2026. Manufacturer given most often on reports: Merz North America Franksville. Product code LMH.
- 181
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 67
- reports, 12 months to August 2026
- 36 in the 12 months before
- 1.1%
- 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 181 reports that name the brand "Radiesse" (implant dermal for aesthetic use), received between October 2004 and August 2026; the manufacturer given most often on reports is Merz North America Franksville. Spellings of one product vary from report to report.
67 reports arrived in the 12 months to August 2026, up 86% from 36 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 (80.7%), other (16.6%) and malfunction (1.1%); 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 off-label use (32.6%), improper or incorrect procedure or method (18.8%) and device remains implanted (7.7%). The patient problems coded most often are obstruction/occlusion, nodule and skin inflammation/ irritation. 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 |
|---|---|---|---|
| Off-label use | 59 | 32.6% | 4.2% |
| Improper or incorrect procedure or method | 34 | 18.8% | 7.5% |
| Device remains implanted | 14 | 7.7% | 2.3% |
| Migrationthe device moved from where it was placed | 6 | 3.3% | 0.4% |
| Explanted | 2 | 1.1% | 0.1% |
| Migration or expulsion of device | 2 | 1.1% | 0.7% |
| Device appears to trigger rejection | 1 | 0.6% | 0.2% |
| Implant extrusion | 1 | 0.6% | 0% |
| Material disintegration | 1 | 0.6% | 0% |
| Method, improper/incorrect | 1 | 0.6% | 0% |
| Nonstandard device | 1 | 0.6% | 0% |
| Patient device interaction problem | 1 | 0.6% | 0.1% |
| Reactiona reaction, type not specified | 1 | 0.6% | 3.6% |
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 |
|---|---|---|
| Obstruction/occlusion | 30 | 16.6% |
| Nodule | 23 | 12.7% |
| Skin inflammation/ irritation | 14 | 7.7% |
| Subcutaneous nodule | 13 | 7.2% |
| Swelling/ edema | 13 | 7.2% |
| Deposits | 11 | 6.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 10 | 5.5% |
| Necrosisdeath of tissue | 9 | 5% |
| Skin infection | 9 | 5% |
| Granuloma | 6 | 3.3% |
| Implant pain | 6 | 3.3% |
| Allergic reactionan allergic reaction | 5 | 2.8% |
| Cellulitisa skin infection | 5 | 2.8% |
| Local reaction | 5 | 2.8% |
| Other (for use when an appropriate patient code cannot be identified) | 5 | 2.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Radiesse | Product code LMH | All MAUDE reports |
|---|---|---|---|
| Reports | 181 | 22,802 | 26,136,888 |
| Share of that pool | — | 0.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 80.7% | 83.7% | 36.2% |
| Classified as malfunction | 1.1% | 7.2% | 62.3% |
| Filed by the manufacturer | 83.4% | 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 |
|---|---|---|---|
| Sculptra | 1,593 | 91 | 0% |
| 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% |
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 Radiesse reports
How many FDA reports name Radiesse?
181 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 67 in the latest 12 months.
What kinds of events are reported?
injury (80.7%), other (16.6%) and malfunction (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
off-label use (32.6%), improper or incorrect procedure or method (18.8%), device remains implanted (7.7%), migration (3.3%) and explanted (1.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (83.4%) and voluntary reports (16%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Radiesse 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.