Dermal filler adverse events: what 22,242 FDA MAUDE reports reveal

Hyaluronic acid fillers are the single most-performed minimally invasive aesthetic procedure in the United States, with several million injections administered each year. Brands like Juvéderm, Restylane, and Radiesse are used to restore volume, contour the jawline, smooth lines, and reshape the nose and chin. Unlike botulinum toxins, which are regulated as drugs and tracked in the FDA's FAERS database, dermal fillers are regulated as medical devices — Class III implants that enter the market through Premarket Approval (PMA) applications.

That device classification matters for where their safety data lives. Filler adverse events flow into the FDA's MAUDE database (Manufacturer and User Facility Device Experience), the same passive-surveillance system that captures reports on surgical lasers, ultrasound devices, and breast implants. MAUDE aggregates mandatory manufacturer reports, mandatory facility reports, and voluntary reports from patients and providers. It is well known to underreport, so the cases that surface are a fraction of real-world events — but they are the closest thing to a postmarket safety ledger that exists for fillers.

An analysis of 22,242 adverse event reports under FDA product code LMH ("Implant, Dermal, for Aesthetic Use") — received between 1996 and May 2026 — shows which products, which manufacturers, and which injury patterns dominate the device safety record behind the most common injectable in aesthetic medicine.

The dataset at a glance

The overwhelming majority of reports (83%) describe a patient injury rather than a device malfunction. Malfunction reports — defective syringes, leakage, packaging or sterility issues — account for about 7%. The 16 death reports are discussed below; MAUDE records that a death occurred in association with a device, which is not the same as proving the filler caused it.

Which fillers show up most

Grouping the 22,242 reports by product family reveals how thoroughly hyaluronic acid dominates the safety record, and how the legacy collagen era still echoes in the data.

Combined, hyaluronic acid fillers — Juvéderm, Restylane, Belotero, and the unspecified HA bucket — account for roughly 72% of all dermal-filler reports. Biostimulators (Sculptra, Radiesse, and the permanent Bellafill) make up about 17%, and the remaining 9% are legacy bovine-collagen products that have not been widely used for two decades.

These shares are not direct risk rates. They reflect market exposure: Juvéderm is the highest-volume filler family in the United States, so it generates the largest absolute number of reports even at a low per-injection rate. A product that appears near the top of this table is not necessarily more dangerous per treatment — it is more used.

The serious events: vascular occlusion, blindness, and 16 deaths

Filler reports are classified as injuries for a reason. The most serious injuries in the dataset cluster around a single mechanism that the FDA has flagged repeatedly: accidental injection into a blood vessel.

When filler is inadvertently injected into an artery, it can occlude the vessel and starve downstream tissue of blood. The consequences depend on where the occlusion occurs:

• Skin necrosis — tissue death in the injected area (commonly the nose, nasolabial fold, or glabella), which can leave permanent scarring.
• Blindness and visual compromise — filler that enters vessels connected to the ophthalmic artery can travel retrograde and occlude the central retinal artery. The FDA's 2025 General Issues Panel executive summary on dermal fillers identifies injection-related visual compromise (IRVC) as one of the most serious risks, noting it can cause permanent blindness and, in rare cases, stroke or death.
• Stroke and neurologic injury — intravascular filler reaching the internal carotid circulation has produced hemiplegia, dysarthria, and altered mental status.
• Late nodules and granulomas — inflammatory lumps that appear weeks to months later, especially with biostimulators and permanent fillers.

The 16 death reports in the LMH data are a small fraction of the total, and MAUDE's association-only standard means not all are clearly filler-caused. But filler-related vascular events can be fatal: published case reports and the 2024 RANZCO filler-blindness guideline note that death has followed ophthalmic artery occlusion with subsequent intracranial involvement. The data point is best read as "deaths have occurred in temporal association with dermal fillers," not as a precise mortality count.

What the serious injuries actually are

The "Injury" label is blunt. The FDA's 2025 executive summary review of the dermal-filler MDR database (product codes LMH and PKY, figures current as of November 2024) recorded 17,768 serious-injury reports all-time and broke the serious events down by type. The top categories were:

FDA noted that vascular-system impairment "continues to be a common serious adverse event," and that reporting climbed steadily — 786 reports in 2014 and 887 in 2015 prompted an FDA Safety Communication on the risks of intravascular injection, with annual counts continuing to rise through 2023 (1,478 reports). Because MAUDE underreports, FDA states plainly that "the actual number of adverse events is expected to be substantially higher than what is reported."

The other signature filler complaint is subtler and far more common: nodules, swelling, asymmetry, and infection. A peer-reviewed cross-sectional analysis of the MAUDE database (JAMA Facial Plastic Surgery, 2014–2016 data) found that across 1,748 adverse events, the most common sites were the cheek (43%) and the lip (30%), and the most common event types were swelling (43%) and infection (42%). The same study confirmed that blindness was significantly associated with dorsal nasal injection, and that vascular compromise with necrosis or blindness was significantly associated with Radiesse (calcium hydroxylapatite) — a reminder that the non-HA, non-reversible fillers carry a sharper edge when something goes wrong. An ASDS Task Force review separately identified 2,537 nodule and inflammatory events tied to HA fillers in MAUDE over 2007–2017. These rarely threaten vision or life but drive much of the patient dissatisfaction captured in the database.

Why HA reversibility shapes the risk picture

A central asymmetry runs through this dataset. Hyaluronic acid fillers — which make up the bulk of reports — have a specific antidote: hyaluronidase, an enzyme that dissolves HA filler, can reverse vascular occlusion and remove misplaced product. The 2025 EYE-CODE protocol and ASDS guidance call for immediate hyaluronidase injection when HA-related vascular compromise or vision loss is suspected. Every HA injector should have hyaluronidase on site.

Biostimulators and permanent fillers do not have this safety net. Sculptra (poly-L-lactic acid), Radiesse (calcium hydroxylapatite), and especially Bellafill (polymethylmethacrylate) cannot be dissolved. If they cause a nodule, granuloma, or vascular event, management is far harder — typically steroids, antibiotics, surgery, or simply waiting. This is why biostimulators are disproportionately represented in serious late-complication case series even though their raw MAUDE counts are lower than HA's. The lower count reflects lower use, not lower consequence.

Patients weighing a permanent or semi-permanent filler should understand that reversibility is itself a safety feature. A product that cannot be dissolved is not automatically riskier per injection, but when something goes wrong, the toolbox is smaller.

Two eras in the data: collagen, then hyaluronic acid

The reporting timeline maps neatly onto the history of the filler market.

The early years (1996–2005) are the bovine-collagen era, when Zyplast and Zyderm — the original injectable implants from Collagen Corp — were the standard. Those products required allergy skin testing and have since been displaced, but they still account for roughly 9% of the cumulative report count because they were the only option for a decade.

Hyaluronic acid fillers overtook collagen in the 2000s. The 2009 reporting surge (1,221 reports) coincided with a period of heightened regulatory attention to filler safety, including FDA labeling reviews; MAUDE receipt dates can also cluster because manufacturers submit mandatory reports in batches. The steady climb through 2017–2018 reflects the proliferation of the modern HA families — Juvéderm's Vycross line (Voluma, Volbella, Vollure) and Restylane's NASHA and XpresHA products — which dramatically expanded the treatable areas.

The 2025 total of 1,825 is the highest annual count in the hyaluronic acid era and reverts the slight decline seen in 2023–2024. The first five months of 2026 already show 729 reports, on a pace that would match or exceed 2025. Whether this reflects a real rise in events, expanded manufacturer reporting, or both cannot be disentangled from MAUDE alone — but the trend merits monitoring.

What patients should understand

"FDA-approved" fillers are still implants

Each dermal filler entered the market through a PMA application, which is more rigorous than the 510(k) clearance used for lasers and devices. PMA approval means clinical data supported safety and effectiveness for a specific indication. It does not mean the product is risk-free — it means the benefit/risk balance was acceptable for the studied population and indication. Many common injection sites and uses are off-label.

The anatomic area drives vascular risk

The highest-risk zones for blindness and necrosis are the glabella (between the brows), nose, nasolabial fold, and forehead — areas supplied by branches of the ophthalmic artery. The FDA has repeatedly flagged these regions. A provider's knowledge of facial vascular anatomy, use of low injection volumes, consideration of aspiration or blunt cannulas, and willingness to stop at the first sign of blanching matter more than which specific HA brand is in the syringe.

Reversibility should be confirmed, not assumed

If you are receiving an HA filler, confirm the clinic stocks hyaluronidase and has a written vascular-occlusion protocol. If you are receiving a biostimulator or permanent filler, understand that early dissolution is not an option. These are different risk profiles dressed up in similar marketing.

MAUDE underreports — the real number is higher

MAUDE is a passive system, and adverse-event reporting is incomplete by design. The 22,242 reports here represent a fraction of actual events. Several analyses of passive device surveillance suggest captured reports may represent only a small share of real-world incidents. The dataset is most useful for patterns — which injuries, which products, which trends — not for precise incidence rates.

What to ask before a filler treatment

• Which specific product will be used, and is the treatment area within its FDA-approved indication or off-label?
• Is this an HA filler (reversible with hyaluronidase) or a biostimulator/permanent filler (not reversible)?
• Does the clinic stock hyaluronidase on site and have a written protocol for vascular occlusion?
• How does the provider reduce vascular risk in high-risk areas (cannula vs. needle, aspiration, volume limits, knowledge of the relevant arteries)?
• What is the plan if a nodule, asymmetry, or vascular event appears days or weeks later?

Patients who experience severe pain, skin discoloration or blanching, vision changes, or neurologic symptoms during or after a filler injection should be evaluated immediately — vision changes are an emergency. Non-urgent adverse events can be reported to the FDA through the MedWatch system.

Sources

• FDA MAUDE database — search by product code LMH: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
• FDA Executive Summary, General and Plastic Surgery Devices Panel Meeting on Dermal Fillers (Aug 2025; MDR data current as of Nov 2024): https://www.fda.gov/media/188185/download
• FDA — Dermal Fillers and Other Aesthetic Cosmetic Devices: https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices
• FDA Safety Communication — Risk of intravascular injection (2015): https://www.fda.gov/medical-devices/safety-communications/injectable-soft-tissue-fillers-fda-safety-communication-awareness-risks
• Rayess HM, Svider PF, et al. A Cross-sectional Analysis of Adverse Events and Litigation for Injectable Fillers (MAUDE 2014–2016). JAMA Facial Plast Surg. 2018;20(3):207–214 (PubMed 29270603). https://spafacialplastics.com/wp-content/uploads/2021/09/cross-sectional-analysis-adverse-events-fillers.pdf
• ASDS Task Force — Preventing and Treating Adverse Events of Injectable Fillers: https://www.asds.net/Portals/0/PDF/asdsa/Preventing%20and%20Treating%20Adverse%20Events%20of%20Injectable%20Fillers%20Evidence-Based%20Recs%20From%20ASDS%20Task%20Force%20Article.pdf
• EYE-CODE Protocol for the Nonophthalmologist for Treatment of Retinal Artery Occlusion After Intra-Arterial Injection of Soft-Tissue Fillers: 2025 Update. PMC12239549. https://pmc.ncbi.nlm.nih.gov/articles/PMC12239549
• RANZCO Guideline for Filler Blindness (2024): https://ranzco.edu/wp-content/uploads/2024/06/RANZCO-Filler-Blindness-Guidelines_2024.pdf
• Madala S, et al. Management of vision loss associated with complications of cosmetic filler injections. Front Ophthalmol. 2025;5:1568370. https://www.frontiersin.org/journals/ophthalmology/articles/10.3389/fopht.2025.1568370/full

Analysis sample: FDA MAUDE database extract dated 2026-06-10, 22,242 adverse event reports under product code LMH (Implant, Dermal, for Aesthetic Use), received 1996 through May 2026. Product families assigned from the brand_name field. Analysis by AestheticMedGuide.