Is Juvederm Safe?

Dermal fillers including brands such as Huntersville Juvederm, Radiesse, and Sculptra are used to smooth lines, wrinkles and help give your face a more youthful appearance.

Dermal fillers have gained popularity in recent years. In the U.S., over 2.4 million filler procedures were completed in 2016 using a hyaluronic acid product such as Juvederm or Restylane. This is more than a 50% increase compared to the previous decade.

Generally speaking, fillers are safe. As with most procedures, there is the possibility of complications. This is especially true when there is a lack of training. While a majority of the issues are not considered life-threatening, fillers have been linked to cases which involved strokes and blindness.

Fortunately, the severe complications are quite rare. Two recent reports analyzed the frequency and severity of complications. One report included 10 years of data and was conducted by Boris Paskhover, MD, a facial plastic and reconstructive surgeon at Rutgers New Jersey Medical School. The second report included three years of data and was conducted by Hani Rayess, MD, an otolaryngology resident at Wayne State University School of Medicine.

10-Year Report

Paskhover evaluated reports from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database which occurred beginning in January, 2007 through July, 2017. Each year, the database receives hundreds of thousands of reports.

According to the 5,000+ reports of problems associated with fillers, the most common issues included the following:

  • Formation of a nodule
  • Infection
  • Inflammation
  • Allergic reaction or complications
  • Vascular issues

The most severe issues included 62 strokes or stroke-like events and 47 cases of blindness associated with the fillers. Strokes can occur if an injection hits a blood vessel and obstructs it. Blindness can occur when there is an injection close to the eye which blocks a blood vessel. Some blindness cases occurred following injections placed in the cheeks and forehead.

The most common fillers associated with reported complications included:

  • Juvederm Voluma XC (hyaluronic acid)
  • Sculptra (poly-1-lactic acid)
  • Radiesse (calcium hydroxylapatite)

3-Year Study

Rayess used the same database, MAUDE, but looked at data from 2014 to 2016. Within this timeframe, there were about 1,750 reported issues. The most common complications were:

  • Blindness (eight cases)
  • Death of tissue
  • Infection
  • Swelling

The report evaluated the most commonly used fillers which included Juvederm, Restylane, Belotero, Sculptra, Radiesse, Artefill, Bellafill and Juvederm Voluma.

The cases of blindness were associated with injections into the nose. While the death of tissue and blindness had a strong connection to the Radiesse injections. Rayess found nine cases of malpractice.

The MAUDE database does have some limitations. While patients, doctors, and other health care professionals are able to file reports, there is no follow up to verify the accuracy of the claim.

The research reflects the reality and raises awareness that, while filler injections are a non-invasive procedure, there can be serious complications.

Most of the issues associated with fillers are minor aesthetic problems. Patients may experience issues such as eyebrows which are too high or lips which are too full. Fortunately, fillers are temporary and over time, these issues will go away. While they are rare, there is a potential for serious complications.

As with any procedure, schedule an appointment with a doctor to discuss your goals, any concerns and the possible complications.

Side Effects of Juvederm