Patient Safety: An Injectable Education

doi:10.4236/jcdsa.2013.33A2009

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Journal of Cosmetics, Dermatological Sciences and Applications, 2013, 3, 36-39

Published Online November 2013 (http://www.scirp.org/journal/jcdsa)

http://dx.doi.org/10.4236/jcdsa.2013.33A2009

Open Access JCDSA

Patient Safety: An Injectable Education

Arnold William Klein

Geffen School of Medicine, University of California, Los Angeles, USA.

Email: [email protected]

Received April 7th, 2013; revised May 6th, 2013; accepted May 15th, 2013

which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

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

Artecoll®.

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.

REFERENCES

[1] Doctors Warning Facial Fillers.

http://www.theguardian.com/lifeandstyle/2012/jan/07/doc

tors-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.

http://dx.doi.org/10.1097/01.prs.0000234612.20611.5a

[5] A. W. Klein, “The Whol e Truth Please—Sculptra Review

—RealSelf,” 2009.

http://www.realself.com/review/the-whole-truth-please

[6] A. W. Klein, “Soft Tissue Augmentation 2006: Filler F an-

tasy,” Dermatologic Therapy, Vol. 19, No. 3, 2006, pp.

129-133.

http://dx.doi.org/10.1111/j.1529-8019.2006.00066.x

[7] R. Rundle, “Things Get Ugly over a Beauty Injection-

WSJ.”

http://online.wsj.com/news/articles/SB118834446251311

594

[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.

http://dx.doi.org/10.1159/000243804

[9] A. W. Klein, “Sculptra: An Injectable Disaster.”

www.arnoldwklein.com/?p=978

[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.

http://dx.doi.org/10.1016/j.jaad.2004.08.056

Open Access JCDSA

Patient Safety: An Injectable Education

Open Access JCDSA

[11] A. Klein, “Filler Follies, Huffington Post,” 2010.

http://www.huffingtonpost.com/arnold-william-klein/fille

r-follies_b_410987.html

[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...

www.realself.com/review/the-whole-truth-please

[13] A. W. Klein, “What Do about Sculptra (NewFill) Lumps

and Granulomas.”

http://www.realself.com/question/what-can-do-about-scul

ptra-lumps

[14] A. W. Klein, “Substa nces for Soft Tissue Augmentation,”

In: I. Freedberg, Ed., Fitzpatrick’s 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.