Patient Safety: An Injectable Educa ti on
38
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
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