Journal of Cosmetics, Dermatological Sciences and Applications, 2013, 3, 36-39
Published Online November 2013 (
Open Access JCDSA
Patient Safety: An Injectable Education
Arnold William Klein
Geffen School of Medicine, University of California, Los Angeles, USA.
Received April 7th, 2013; revised May 6th, 2013; accepted May 15th, 2013
Copyright © 2013 Arnold William Klein. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Until recently, the effects of all injectable filling agents were temporary and very rarely associated with permanent
problems. In the past, the permanent injectable silicone had b een used but had been so problematic that the Ju stice De-
partment filed injunctions against certain physicians on behalf of the FDA. After 2000 a dangerous pattern grew in the
corridors of Washington DC, where politics and money changed the face of America and the field of aesthetics to the
detriment of the faces of the consumers. Industry has accomplished the approval of synthetic agents that should have
never reached the market. Once injected under skin, the body cannot digest these agents and the immune system walls
them off with resultant formation of nodules, which at times require surgical removal.
Keywords: Fillers; Sculptra; Artefill; Artecoll; Safety; Injectables
1. Introduction
In 2011, next to Botox, injectable fillers beca me the most
popular cosmetic procedure in the United States [1].
Having been the physician responsible for the Black Box
warning on Botox both the public and physicians are
frequently unaware of the safety profile of certain in-
jectables [2]. Neither the FDA and the medical literature,
nor the beauty magazines provide adequate information
concerning th e problematic nature of certain fillers.
The cosmetic literature in the United States is largely
written by physicians who are supported by Big Pharma
and there is little written about adverse reactions to in-
jectable agents for soft tissue. This is not the case in the
United Kingdom [1]. Plastic surgeons in Britain in No-
vember of 2012 reported a dramatic rise in botched skin
filler procedures leaving women with lifelong disfigure-
ment. Some 70 percent of Britain’s plastic surgeons have
seen patients with problems resulting from temporary
skin fillers. In addition, half of surgeons reported seeing
patients with more serious complications from permanent
fillers or semi-permanent fillers. Of these, 84 percent
required corrective surgery or were deemed untreatable
due to permanent damage [1].
2. Reactions to Fillers
While injection technique is important what happens un-
der the skin once injected is far more critical. What you
seek to avoid at all costs is an immunologic or allergic
reaction to the implanted substance. Such reactions can
cause large lumps that at times can be so severe they can
result in facial deformity [3-5]. The popularity of fillers
for facial restoration has seen the approval of various
injectable agents by the FDA which should have never
seen the light of day [2,3]. In the past, the permanent
injectable silicone had been used but had been so prob-
lematic that the Justice Department filed injunctions
against certain physicians on behalf of the FDA [2]. Af-
ter 2000 a dangerous pattern grew in the corridors of
Washington DC, where politics and money changed the
face of America and the field of aesthetics to the detri-
ment of the faces of the consumers.
3. Maintaining Integrity vs. Big Pharma
Industry and greed has accomplished the approval of
synthetic agents which should have never reached the
market. Once injected under skin the body cannot digest
these agents and the immune system walls them off with
resultant formation of nodules, which at times require
surgical removal [3,5,6]. One such product that was ap-
proved was Artefill® also known as Artecoll®. This
product is polymethylmethacrylate which is a form of
injectable Plexiglas beads. This product has long been
associated in the worldwide dermatologic literature with
scarring, and disfigurement only amenable to correction
Patient Safety: An Injectable Education 37
by surgery or at times steroid/5 fu injections sometimes.
At present, Artecoll®, the predecessor of Artefill®, is no
longer available in Canada. Furthermore both Germany
and Switzerland have already advised physicians not to
use this product [2,3].
4. The System of Trust Is Broken
We know from the experience of Artecoll® in Canada
that pharmaceutical companies cannot be relied upon to
report adverse events to authorities, yet the FDA claims
that it can evaluate adverse reactions by relying on doc-
tors and “Big Pharma” to report these directly to the
FDA. Furthermore, merely changing the name of the
product (e.g. Artecoll® to Artefill®) doesn’t change the
history or adverse experiences of the past. In the litera-
ture, consultants have used the names interchangeably
[2,3]. Furthermore, if Artefill® is new and improved, how
can one gain FDA approval of Artefill® by studying
5. Artecoll/Artefill®
The purpose of the FDA is to protect the public interest
in safety and efficacy of all medical products. Prior to the
release of Artefill® in the USA, a senior member of the
FDA was contacted with articles regarding the foreign
experience with Artecoll. This did not prevent release of
this product. Subsequently an article in the “Wall Street
Journal” revealing the seriousness of adverse reactions to
Artefill® helped cause the parent company to go into
bankruptcy [7]. Recently Suneva Medicial Inc. San
Diego, CA has brought this product back to market and
as expected numerous adverse reactions have been seen.
What follows are just a few of the cases I have recently
seen [8].
5.1. Case 1: Vision Loss
D.S. is a 33 y.o. female actress on a well known televi-
sion show. On 1/29/13 she had a minor cosmetic proce-
dure on her lip. While under anesthesia, her plastic sur-
geon injected Artefill in the depressions under her eyes.
As soon as she awoke she could not see. She told the
nurse who brushed her aside. She went home and spoke
to her surgeon the next day. She was highly anxious and
she had almost totally lost vision in her left eye. Subse-
quently she has seen three retinal specialists who have
concluded that the Artefill occluded the blood supply to
her left retina. Presently she has lost total vision in her
left eye.
5.2. Case 2: Partial Recovery
LL is a 49 y.o. homemaker who had injections of Ar tefill
6 months before she was seen by my office. In the month
prior to being seen she developed intermittent swelling
around every site where the Artefill was implanted. She
has refused to leave her house. After a series of precise
injections of cortisone and an anticancer drug 5fu into the
sites she is currently 80% better.
6. Sculptra
Initially Sculptra received FDA approval for treatment of
HIV associated fat loss in the face. This was a critical
indication in that this condition had essentially become
the Scarlet Letter of the 90’s and was in need of a
method of cosmetic management. It has now been ap-
proved for individuals without HIV who are seeking
cosmetic enhancement. Daily calls and emails to my of-
fice are received from men and women who have had
severe problematic reactions to Sculptra [4,7].
6.1. Case 1: Nasiolabial Folds
DP is a 45 y.o. female who 11 months prior to being seen
had undergone a series of three monthly injections of
Sculptra to the cheeks, nasolabial folds, and periorbital
areas. By the third visit she developed severe swelling in
the periorbital area and refused further treatment. She
had seen multiple physicians for this swelling and dis-
coloration and received intralesional steroid injections
which provided little improvement [9-11].
Most recently she saw a physician who suggested ex-
cision. When seen she had 3 - 4 nodules (>10 mm) in the
inferior periorbital area and 2 on her right nasolabial fold
(Figure 1) It was decided to use intralesional injectable 5
fu (5 parts) mixed with one part Kenalog 10 mg/cc with
an excellent response. However, in long standing cases it
may not work.
Figure 1. Suborbital Sculptra reaction.
Open Access JCDSA
Patient Safety: An Injectable Educa ti on
6.2. Case 2: Internet Posting
MK is a 38 y.o. female: in a letter she wrote, “I don’t
really need to see Dr. Klein but I want to r e ally thank you
to him for his stance on Sculptra in Real Self. I was just
released from the hospital 3 weeks ago and nearly lost
my life [5,10-13] it, until now [5]. I had a deep neck in-
fection or abscess that was linked back to Sculptra. I had
a touch up 3 weeks prior to getting sick. I had a surgery
to put a drain in my neck and was given antibiotics, 24
hours later my airway was closing again and the infection
was spreading. The doctors couldn’t understand why it
was still spreading. I had a 2nd surgery to place more
neck drains, intubated and put in ICU. My daughter was
looking into all the case studies for Sculptra and found
out that the staph and strep biofilm infections are methi-
cillin resistant. I ended with a total o f six drain s. I spent a
total of 16 days in the hospital, 8 in the ICU and came
home on 4 IV antibiotics and all the drains in place. It
has been a few weeks with all the drains removed and off
all meds. I am grateful to be alive and I respect what you
are telling people because it is true. You Dr. Klein saved
my Life. I don’t want to see anyone have to go through
what I just endured and what my husband and daughters
went through. I feel that the makers of Sculptra are hid-
ing facts and it has everything to do with money. Again, I
just wanted to express my thanks to you for being honest
and taking a stand. You are a lifesaver [5,10].”
7. Some Common Mistakes
Sculptra is an injectable agent that supposedly induces
the formation of new collagen. However the FDA has
never evaluated the fate of this injectable once im-
planted. Should not a biopsy be required for an agent’s
approval? Contrary to what the company suggests from
biopsies of reactions it is an “immunologic foreign body
reaction” that is noted after implantation. At times this
reaction will fill volume but at others many lumps are
seen. In the initial studies for HIV facial fat loss in the
USA nodules were visual and palpable in many indi-
viduals in these trials. 52 percent were seen in the VEGA
study, and 31 percent in the C & W study. The average
on-set was up to 218 days, with a range from 9 to 748.
Scuptra has been now been approved for immunocope-
tent individuals. For this study every single investigator
was a paid consultant for the manufacturer of Sculptra
and no biopsies were performed. This indicates how se-
riously inadequately cosmetic devices are evaluated by
the FDA prior to their release. Large nodules have been
seen above the lips, in the cheeks, under the eye and
elsewhere in countless patients [4-7,1 2-15].
Prior to its approval in the USA a European literature
did exist on the problems with Sculptra. In a series of
100 patients treated, 5 cases of infection, 12 cases of
granuloma and 3 cases of long term allergic reactions
were noted (Aesth Surgery). These reactions must be
reported by affected individuals directly to the FDA.
In 2013, the manufacturers of fillers underwrite the
costs of large conventions, travel, exotic vacations, and
CME courses to the tune of a billion dollars annually.
This behavior is ram-pant in the world of facial aesthetics.
So please be cautious of what you put in your face or as
an injector in your patient’s faces. Please read as much as
you possibly can before you let anyone put a needle in
your face [2 ,6,7,10].
8. Acknowledgements
P.S.C Tha nk you.
[1] Doctors Warning Facial Fillers.
[2] A. W. Klein, “Avoi ding Adverse Events with Fillers: Fat,
Collagen, Radiance, Silicone, Restylane, Artecoll: Letter
to the Editor,” Cosmetic Surgery Times, Vol. 6, No. 6,
2003, p. 3.
[3] A. W. Klein, “Reluctant to Use Artecoll: Letter to the
Editor,” Skin & Allergy News, Rockville, 2002, p. 16.
[4] B. Azizzadeh and M. Graivier, “Injectable Poly-L-Lactic
Acid (Sculptra): Technical Considerations in Soft-Tissue
Contouring,” Plastic and Reconstructive Surgery, Vol.
118, Suppl. 3, 2006, pp. 55S-63S.
[5] A. W. Klein, “The Whol e Truth Please—Sculptra Review
—RealSelf,” 2009.
[6] A. W. Klein, “Soft Tissue Augmentation 2006: Filler F an-
tasy,” Dermatologic Therapy, Vol. 19, No. 3, 2006, pp.
[7] R. Rundle, “Things Get Ugly over a Beauty Injection-
[8] J. Alijotas-Reig, V. Garcia-Gimenez and M. Vilardell-
Tarres, “Late-Onset Immune-Mediated Adverse Effects
after Poly-L-Lactic Acid Injection in Non-HIV Patients:
Clinical Findings and Long-Term Follow-Up,” Derma-
tology, Vol. 219, No. 4, 2009, pp. 303-308.
[9] A. W. Klein, “Sculptra: An Injectable Disaster.”
[10] C. M. Burgess and R. M. Quiroga, “Assessment of the
Safety and Efficacy of Poly-L-Lactic Acid for the Treat-
ment of HIV-Associated Facial Lipoatrophy,” Journal of
the American Academy of Dermatology, Vol. 52, No. 2,
2005, pp. 233-239.
Open Access JCDSA
Patient Safety: An Injectable Education
Open Access JCDSA
[11] A. Klein, “Filler Follies, Huffington Post,” 2010.
[12] Apr 23, 2012—Dear Dr. Klein Disaster: I Was Injected
Sculptra First Time in May 2009 (3 Series) in Cheek Hol-
lows, Temples and Neck. I Had Excelent Subtle Re-
sults, ...What Do About Sculptra (NewFill) Lumps and
Granulomas Doctor...
[13] A. W. Klein, “What Do about Sculptra (NewFill) Lumps
and Granulomas.”
[14] A. W. Klein, “Substa nces for Soft Tissue Augmentation,”
In: I. Freedberg, Ed., Fitzpatricks Dermatology in Gen-
eral Medicine, 6th Edition, McGraw Hill, New York, 2003.
[15] A. W. Klein and B. W. Ayers, “Lip Augmentation,” In: S.
J. Aston, Ed., Aesthetic Plastic Surgery, Elsevier BV, Am-
sterdam, 2009, pp. 855-860.