Cosmetic Facial Fillers Linked to Permanent Blindness

Yael Waknine

October 03, 2012

October 3, 2012 ( UPDATED October 10, 2012 ) — Improper use of dermal fillers to treat frown and laugh lines can cause retinal artery occlusion (RAO) and permanent blindness, according to a South Korean study published online July 26 in the American Journal of Ophthalmology and in the October print issue.

The findings may be eye-opening for the rising number of young, healthy women who undergo soft-tissue augmentation in the glabella or nasolabial folds, viewing this procedure as a safe method of achieving cosmetic goals.

In reviewing the medical records of 12 patients with sudden vision loss after filler injections, researchers led by Se Joon Woo, MD, from Seoul National University's Bundang Hospital in Seongnam, Korea, found that ophthalmic RAO with choroidal ischemia was most prevalent and led to permanent blindness with no light perception (mean final best-corrected visual acuity [BVCA] ± standard deviation, 6.00 ± 0.00 logMAR units).

In 4 of the 7 patients with ophthalmic artery occlusion, blindness followed autologous fat injections in the glabellar region; 2 patients received autologous fat in the nasolabial fold, and 1 was injected with hyaluronic acid in both regions.

Nonischemic central RAO occurred in 2 patients who had been injected with autologous fat and collagen in the glabellar region (final BVCA, 2.76 ± 3.17 logMAR units); branch RAO occurred in patients who had received hyaluronic acid injections in the glabella (n = 1) and nasolabial fold (n = 2; final BVCA, 2.23 ± 3.28 logMAR units).

Use of autologous fat yielded significantly worse outcomes than hyaluronic acid and collagen injections (final BVCA, 5.86 ± 0.38 logMAR units vs 1.47 ± 2.56 logMAR units; P = .010), potentially because of the variable particle size, which can lead to blockage of different-sized arteries.

Two patients who had received fat injections in the glabella sustained a cerebral fat embolism leading to brain infarction, potentially by way of the anastomosis between the angular and ophthalmic arteries.

"Patients should be aware of the possibility of development of retinal/ophthalmic artery occlusion and if RAO develops, the visual prognosis is poor," Dr. Woo told Medscape Medical News in an online interview.

"Brain infarction, sensory strabismus, and even phthisis can develop in those cases," Dr. Woo added, noting that use of autologous fat is more dangerous than smaller-sized materials such as collagen and hyaluronic acid.

An "Extremely Rare" Complication?

The article is silent on the study population, the question of who performed the injections, and other clinical details of the cosmetic procedures.

"We cannot estimate the incidence of these devastating complications among recipients to filler injections. It must be extremely rare, but it does happen," Dr. Woo told Medscape Medical News.

"When I asked doctors who injected fillers, they said they could not remember whether they had checked for [arterial puncture]. To our thought, doctors should check before infusion whether the needle punctured arteries by withdrawing the plunger.

"If physicians performed the injections, what was their specialty training and experience with injections?" questioned C. William Hanke, MD, from the Laser and Skin Surgery Center of Indiana in Carmel, in an interview with Medscape Medical News. "I have never seen this complication personally, and it is rare or nonexistent in the specialty of dermatology."

Tom E. Rohrer, MD, from SkinCare Physicians in Chestnut Hill, Massachusetts, agrees, calling the study results "surprising" and the complication "extremely rare." Dr. Roher is also clinical associate professor of dermatology at Brown University in Providence, Rhode Island.

"While we inform our patients about this and all potential complications, we have never seen this in our large aesthetic dermatology practice and have not seen it presented in any of the national meetings," Dr. Rohrer told Medscape Medical News, noting that one of the most appealing aspects of appropriately injected fillers is their "excellent safety profile" and "outstanding and very natural effects."

"Most dermatologists perform the injections personally, which I believe results in good outcomes and rare complications," Dr. Hanke said, noting that vascular anatomy usually precludes use of deep injections in the glabellar region. "In dermatology, we hardly ever inject deeply in this area. Many of the complications occurred in patients who had fat injections, [which are usually] performed more deeply and in larger volumes than hyaluronic acid."

Dr. Hanke advises that patients seek out physicians with experience in performing injections and think twice before agreeing to fat injections in the glabella or nasolabial fold.

The 12 patients who met inclusion criteria for the study had been treated between January 2003 and January 2012 and then referred to National University Bundang Hospital, the only facility in South Korea where intraarterial thrombolysis can be performed. All were women (mean age, 30.8 ± 12.8 years) who had a history of sudden visual loss within a day of receiving a dermal filler and had been followed for a mean of 17.1 ± 25.0 weeks. Injection sites included the glabellar region (7 cases [58.3%]), the nasolabial fold (4 cases [33%]), or both regions (1 case [8.3%]).

All patients with iatrogenic ophthalmic RAO, defined as occlusion with concomitant choroidal ischemia, experienced painful blindness; 6 of 7 had received autologous fat, and 1 experienced brain infarction after receiving an injection in the glabella.

None of the patients demonstrated improvement in visual acuity during a mean follow-up period of 14.0 ± 22.1 weeks (BCVA, 6.00 ± 0.00 logMAR units; P = 1.000, Wilcoxon signed-rank test); light perception was nil both on initial and final exam.

Lack of choroidal perfusion, as revealed by angiography, led to profoundly attenuated choroidal vascularity and significantly decreased choroidal thickness compared with the normal eye (P = .014). Over time, choroidal perfusion improved but retinal arterial perfusion did not.

"This is the first visualization of the choroidal vasculature in iatrogenic ophthalmic artery occlusion both quantitatively and qualitatively by SD OCT [spectral-domain optical coherence tomography]. Such choroidal images may help in the diagnosis and prediction of visual outcomes," the authors write.

One patient experienced combined brain infarction after autologous fat injection. Other adverse events included 6 cases of ophthalmoplegia, 6 cases of horizontal strabismus (5 exotropia and 1 esotropia), 4 cases of ptosis, and 1 case each of iris atrophy and corneal edema. All ocular events, with the exception of exotropia and iris atrophy, had resolved by final follow-up.

Central and Branch RAO

Central RAO occurred in 2 patients who experienced vision loss in the absence of ocular pain after glabellar injections of collagen and autologous fat, respectively. Brain infarction occurred in the patient who had received autologous fat.

Fundus fluorescein angiography showed no retinal perfusion, but intact choroidal perfusion, in both patients. No associated initial ocular problems were detected except for a relative afferent pupillary defect.

The initial and final BCVAs of these patients were 3.50 ± 2.12 and 2.76 ± 3.17 logMAR units, respectively.

In 3 patients who had received hyaluronic acid injections (2 nasiolabial and 1 glabellar), occlusion of the superior branch arteries resulted in a painless, inferior visual field defect in the affected eye that was linked to filling defects on angiography.

Initial and final BCVAs were 2.05 ± 3.42 logMAR units and 2.23 ± 3.28 logMAR units, respectively.

Publication of this article was supported in part by the Korea Health Technology R&D Project, Ministry of Health and Welfare, Seoul, Republic of Korea. The authors have disclosed no relevant financial relationships. Dr. Hanke reports having performed clinical trials in the past for Medicis, Allegan, and Galderma, all of whom make hyaluronic acid fillers. Dr. Rohrer reports receiving research grants from Medicis, Merz, and Allergan and serving on the Board of Directors of the American Society for Dermatologic Surgery.

Am J Ophthalmol. 2012;154:653-662. Abstract