Cosmetic Filler–Induced Vascular Occlusion: A Rising Threat Presenting to Emergency Departments

By Danny J. Soares MD , Stephanie D. Hynes NP-C , Christina H. Yi MD, Sabrina Shah-Desai MS, FRCS, Steven C. Irving MD

Vascular emergencies from cosmetic filler–induced vascular occlusion represent an iatrogenic etiology that poses a threat to patients, with sequelae that range from disfiguring skin necrosis to blindness and stroke. As cosmetic fillers continue to grow in popularity, the importance of early identification, triaging, and management of these rare but potentially disabling injuries has motivated efforts to educate the public and professional audiences. In this practice review article, we outline components of acute care pertaining to these injuries based on evolving practice guidelines and best evidence recommendations.

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Reversing Dermal Filler Blindness

Dr. Patrick Treacy summarises his key findings around reversing blindness caused by dermal filler

In 2016, I read an article by Greg J Goodman and Mike D. Clague on treating a potential occlusive eye injury by using the supraorbital route.10They stated: “A female patient was being injected deeply in her temples and brow with HA when she noted a flashing sensation in her right eye and partial loss of vision. The practitioner then injected approximately 0.8 mL (300 units) of hyaluronidase twice in short succession into the area of the supratrochlear and supraorbital notches with the second injection bringing instant relief of visual symptoms and return of eyesight.

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Gabrielle Rios
Cosmetic patient sues doctor, nurse after Restylane® injection left her blind in one eye

By: Darcy Spears

LAS VEGAS (KTNV) — What was supposed to be a minor cosmetic injection procedure turned into a medical nightmare for a patient whose life is forever changed.

Medical expert Dr. Philip Robb says fillers like Restylane®, "Especially when performed in the nasal area... Present serious risks that are not generally known by patients."

Veins running through the nose supply blood and oxygen to the eyes, as explained in Saban Y, Andretto Amodeo. As the scientific paper further explains, "If you occlude it, which is what a filler can do, it's like a stroke. You're having a stroke to the eye," said Attorney Dan Carvalho, who's representing Crystal in her lawsuit against VIP Plastic Surgery, which is owned and operated by Dr. Christopher Khorsandi.

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Gabrielle Rios
FDA Approves Juvéderm Volbella® XC for Undereye Hollows

By Linda Stocum, Associate Editor

Allergan® Aesthetics, an AbbVie® company, announced that the FDA has approved Juvéderm Volbella® XC for infraorbital hollow improvement for patients over the age of 21. The clinical trial (NCT03418545) found that 90% of patients reported satisfaction through 1 year after receiving treatment. The FDA requires that Allergan® Aesthetics provide a product training program for all interested providers, which will include facial anatomy and considerations for safe injections in this area, as well as how to identify and manage potential complications of treatment. This training must be completed successfully before use of Juvéderm Volbella® XC in this new indication.

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Gabrielle Rios
Lilly Ghalichi’s Filler Mishap Shows the Dangers of Vascular Occlusion

By Tatiana Bido, Aesthetic Content Manager

There is always a risk whenever you undergo any cosmetic treatment, but with something as noninvasive and common as injectables, it’s hard to consider the possibility that something could go wrong. For former Shahs of Sunset star Lilly Ghalichi, something did go wrong, and she took to her Instagram account to share it with her followers. 

After receiving a bit of under-eye filler, Ghalichi started to notice that her skin appeared to be red and turning darker, as if it were bruised. Before she knew it, her skin began to get worse. What happened during her treatment is called Vacular Occlusion, which is caused by an accidental injection of filler into an artery.

The single most important thing in trying to minimize the risk of vascular occlusion is to find an expert injector who is very familiar with facial anatomy. “I did an extra year of advanced cosmetic training after medical school and dermatology residency,” says Dr. Hausauer. “One of the first things I had to do as a fellow was draw all the major blood vessels of the face on a patient from memory. Knowing the anatomy—location, depth, variation of blood vessels—allows for the safest techniques.”

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Gabrielle Rios
Can You Become Permanently Blind After Using Dermal Fillers?

By Millicent Odunze, MD

Medically reviewed by William Truswell, MD

Facial injections can be done with dermal fillers or fat to fill laugh lines that run from the outer nostril to the corner of the mouth, or to fill the vertical frown lines in between the eyes. Cosmetic injections with dermal fillers, such as Juvéderm®, Restylane®, Perlane®, Radiesse®, Collagen, etc., and fat injections to the face are becoming more and more popular. While mostly safe, there is one devastating, but extremely rare complication to consider.

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Gabrielle Rios
Vision Loss and Blindness Following Fillers

By Ann Q. Tran, MD, Wendy W. Lee, MD, MS, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, Manhattan Eye Ear Throat Hospital, Northwell Health, New York, NY

No proven treatment has been shown to reverse vision loss; thus, understanding facial anatomy and proper injection technique is key. If vision loss were to occur, prompt recognition and referral to ophthalmology should be performed. Immediately, the injection of filler should be discontinued. A quick visual acuity test and pupil examination should be performed. Typically after 90 minutes, intravascular occlusion from filler will lead to irreversible ischemia and necrosis of the retina.

In-office treatments typically involve attempts to lower the intraocular pressure and dislodge the embolus. The patient should be placed supine, ocular massage can be performed, and intraocular lowering pressure agents can be given, such as topical aqueous suppression drops, acetazolamide or mannitol. An anterior chamber paracentesis can manual removed aqueous to lower the intraocular pressure. The use of hyperbaric oxygen has not improved vision outcomes. Treatment of corticosteroids may improve associated orbital inflammation but again does not restore vision.

Hyaluronic acid filler can be depolymerized by an endogenous enzyme hyaluronidase. In any office where injectables are to be performed, hyaluronidase should be readily available to allow for immediate reversible of soft tissue filler application. Case reports and animal models of hyaluronidase to restore vision loss have not demonstrated the ability to reverse vision loss.

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Gabrielle Rios
Popular cosmetic procedures can cause serious injuries including blindness

By Kris Pickel

According to the FDA, fillers are a medical device and warn the procedure should only be done by a licensed healthcare practitioner. However, there is no national standard of training or required training before a health care professional can perform the procedure.

A search online reveals courses offering dermal filler training that last as little as one day or are completely online. In May of 2021, the FDA held a virtual meeting to discuss the risks vs. benefits of fillers. A point repeated throughout the meeting by experts was the need for extensive training.

Being an expert on the anatomy of the face is crucial when doing Dermal fillers, according to plastic surgeon Brian Gawley who runs MD Skin Lounge, where fillers are a popular procedure. “Our face has the most prolific network of blood vessels in the entire body,” explains Dr. Gawley.

“If you wonder why patients say they were not informed of the risks, just go to Google or another search engine and type in the name of one of these products with the term “risks.” You will be bombarded with ads and other promotional information, and you will see how difficult it is to find any meaningful risk information,” wrote Dr. Zuckerman.

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Gabrielle Rios
FDA Highlights Importance of Physician Training in Dermal Filler Injections

The importance of adequate clinical training in preventing adverse events.

It was highlighted in the meeting that making it more difficult for undertrained providers to fly "under a patient's radar" is one concrete step the agency can take toward addressing the issue. Specific actions proposed toward this end included standardized patient labeling with consistent presentation of benefits and risks, a boxed warning regarding the risk of intravascular injection, and a Patient Decision Checklist that includes specific mention of the risks of soft tissue necrosis, blindness and stroke, and allows for patients and providers to affirmatively acknowledge that each item was read and discussed.

The agency's panel of experts clearly stated that a provider's direct, quality training in facial anatomy is critical to preventing adverse events that carry devastating patient effects. Physicians and scientists on the panel discussed the FDA's ability to require that treatment with an investigational device in a clinical study be performed only by qualified individuals by "reason of their scientific training and/or experience."

The FDA's panel of experts also emphasized that the knowledge, training and skillset of plastic surgeons in particular make them uniquely qualified to administer dermal filler injections. In his presentation, the FDA's Dr. Henry Lee stated that "premarket clinical studies typically utilize highly qualified physicians, such as plastic surgeons or dermatologists, with extensive experience with dermal filler injection...In postmarket clinical use, the injector may not have adequate training to safely inject the device for a particular indication." Dr. Lee further emphasized that "well-trained and experienced providers may mitigate risk of complications."

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Gabrielle Rios
FDA Executive Summary General Issues Panel Meeting on Dermal Filler

As required by section 513(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Food and Drug Administration (FDA) is convening the General and Plastic Surgery Devices Advisory Panel (the Panel) for the purposes of discussing and making recommendations regarding the benefits and risks of dermal fillers concerning the following topics: (1) risks associated with intravascular injection of dermal fillers and (2) patient preference and informed decision-making.

An all-time search of the MDR database for the dermal filler product codes LMH and PKY resulted in a total of 10,325 Serious Injury2 reports as presented in Figure 2. The results show that the number of reports has steadily increased. The increases in 2014 and 2015 led to a Safety Communication from the Agency regarding the risks associated with intravascular injection (2). Since that time, the reports received by the Agency have continued to increase.

Dermal filler injections have become one of the most commonly performed aesthetic procedures in the United States and abroad(1). Increased use has been accompanied by a concomitant increase in medical device reports (MDR) of adverse events, for both approved and unapproved fillers, techniques, and indications. Specifically, there are increasing reports of serious visual impairment, resulting from unintentional intravascular injection. Nearly every filler type has been associated with a severe complication leading to visual impairment, blindness, or stroke. FDA has responded with a multi-faceted set of premarket and postmarket actions. Premarket, the Agency has adopted a revised paradigm for clinical study design which includes safety assessments to characterize the risk of intravascular injection.

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Gabrielle Rios
Safety Update: Periocular Dermal Fillers

By Lori Baker-Schena, MBA, EdD, interviewing Robert A. Goldberg, MD, Femida Kherani, MD, and Rachna Murthy, MBBS, FRCOphth

While dermal fillers have come a long way since the days of paraffin wax and fat injections to improve facial function and aesthetics, the periocular hyaluronic acid (HA) dermal fillers of today are not without their complications.

Fortunately, most adverse reactions are transient and mild, noted Robert A. Goldberg, MD, at the UCLA Stein Eye Institute in Los Angeles. Yet the rarer complications—such as skin necrosis, blindness, and stroke—can be cata­strophic, “which is why we encourage clinicians to become familiar with managing the range of complications.”

The need for education is particularly pressing given the popularity of HA fillers, which were first FDA-approved in 1996 and today represent a multibil­lion-dollar industry.

Many nonophthalmologists inject these fillers, including dermatologists, plastic surgeons, and dentists. (See “In Whose Hands?”) But if there is a vision-related complication, ophthal­mologists may be called upon in the management, said Femida Kherani, MD, at the University of British Columbia in Vancouver, British Columbia, Canada.

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Gabrielle Rios
200 people report blindness after botched dermal filler procedures

By Imogen Reid

They’re becoming as commonplace as getting a facial, but doctors have issued a stern warning to those looking to get cosmetic injectables.

“The public needs protection from untrained, inexperienced, ‘occasional’ practitioners offering cosmetic procedures who do not understand the high-risk areas of the face,” Dr Kushelew said.

“Many practitioners undergo a one or two-day training course only for cosmetic injectables — this is simple not adequate.”

The figures have increased by 94 per cent globally — an alarming rate as the cosmetic trend continues to rapidly grow in popularity.

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Gabrielle Rios
Soft-tissue Filler–associated Blindness: A Systematic Review of Case Reports and Case Series

By Vandana Chatrath, MSc,*† Pooja S. Banerjee, MPharm,‡ Greg J. Goodman, MD, FACD,§ and Eqram Rahman, MBBS, MS, PhD¶

With the increase in the use of soft-tissue fillers worldwide, there has been a rise in the serious adverse events such as vascular compromise and blindness. This article aims to review the role of fillers in causing blindness and the association between hyaluronic acid (HA) filler and blindness.

A total of 190 cases of filler-induced blindness were identified in the present study. The maximum cases of filler-induced blindness or other ocular disturbances were attributed to autologous fat injections (90 cases; 47%). The second most prominent cause of filler-induced blindness was due to HA (53 cases; 28%), whereas rest of the cases were attributed to collagen, calcium hydroxylapatite, and other fillers.

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Gabrielle Rios
Wrinkle Filler Lawsuit – $750,000 Verdict Won

The Dawson Law Firm received a verdict in the amount of $750,000 following a trial for damages arising out of a wrinkle filler lawsuit for negligence arising out of the administration of a popular wrinkle filler, Restylane® injection from a local South Florida Med Spa.

The Plaintiff has sustained a disfigurement under her left eye. Also, she suffered from twitching, and some loss of vision.  The  injection was not properly supervised and was injected in a negligent fashion. The Plaintiff testified of loss of enjoyment of life arising out of her embarrassment because of the disfigurement and tearing from her eye.

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Gabrielle Rios
Nearly 100 blinded after facial filler injections

Nearly 100 people have been left blind by cosmetic treatments that went wrong, according to a doctor who pioneered the use of Botox.

Dr. Jean Carruthers said 98 patients worldwide had lost vision in one or both eyes after being injected with dermal fillers in the face.

These fillers are used to smooth away frown lines and plump up sallow skin below the eyes.

But there can be 'catastrophic' results if they are mistakenly injected into a blood vessel, leading to blockage of crucial arteries supplying blood to the eyes, she said.

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Gabrielle Rios
FDA warns of risk from cosmetic facial fillers

By Robert Preidt

Soft tissue fillers used in cosmetic procedures can accidentally be injected into blood vessels in the face and cause serious harm, the U.S. Food and Drug Administration warns.

The fillers are approved to treat wrinkles or to enhance cheeks or lips.

Injection of facial fillers into blood vessels can cause blockages that restrict blood supply to tissues. Filler material injected into blood vessels can also travel to other areas and cause stroke, vision problems, blindness and damage and/or death of the skin and underlying facial structures, the agency said in a news release.

Doctors should inject soft tissue fillers only if they have appropriate training and experience, and should be familiar with each patient's blood vessel anatomy, which can vary between people, the FDA said.

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Gabrielle Rios