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[63]
whereas light microscopy sections at 6 months post-injection with the aim of inducing l fibroplasia and volumization.
showed tight aggregates of microspherules surrounded Moreover, it is characterized as a clear, colorless fluid
by thick collagen and histiocytes. Multinucleated giant with general physiological inertness and resistance to
[63]
cells surrounding each microspherule were also observed. decomposition under extreme temperatures. If the
All treated subjects reported high satisfaction levels at 6 product is inadvertently injected into the blood stream, it
months, and there were no reports of adverse reactions. behaves very much like injections of air; small doses of the
material are distributed throughout the body, while large
Another pivotal study testing the efficacy of Radiesse® for doses can cause various severe complications including
the treatment of nasolabial folds involved 117 subjects with emboli and cellulitis. This product is overall very
[63]
a random split-face design. Radiesse® was injected on one advantageous in the correction of facial defects, and other
side and collagen was injected on the other. Radiesse® intradermal treatments that previously required excessive
[61]
was found to be superior to collagen in 79% of the folds surgical intervention. [63]
after 6 months, and required almost half of the volume that
was used with collagen. The long-term safety and efficacy Injectable silicone oils for augmentation of the facial tissues
[61]
of Radiesse® was also tested in the treatment of nasolabial were approved by the FDA in the early 1960s. In spite
[64]
folds by extending the previous study and offering re- of the tremendous criticism that silicone has received
treatment between 6 and 12 months. Out of a total of due to its adverse complications, it has been shown to be
[60]
117 subjects, 102 patients enrolled and were evaluated at very effective in facial augmentation. A clinical study
[64]
39 months after the last injection. At 30 months following conducted by Hevia demonstrated the efficacy of silicone
[65]
[60]
the last treatment with Radiesse®, improvement was still oil in soft tissue augmentation. In total 916 patients were
observed in 40% of the folds, and no adverse events were treated with PDMS-1000 (purified polydimethylsiloxane),
reported. Safety and efficacy has also been tested for an FDA approved silicone oil, over a six year period during
[60]
an injectable implant in which where researchers at two which only 1% showed adverse granulomatous reactions.
[65]
different treatment centers injected CaHA into 113 subjects. [5] All treatments were performed with a serial puncture
75 patients received single injections and 38 had multiple technique, which is well-suited for the injection of silicone
sessions, with most patients receiving 1 mL per session. oil. Narins and Beer note that the oil must be injected
[5]
[64]
[65]
The results suggested a very favorable safety profile with a into the immediate subdermal plane or deeper to avoid
very high patient satisfaction rating (over 90% indicated that dermal erythema and ridging. The volume should be
their results were “good” or “very good”) and only 7 minor limited to no more than 0.5 mL for small areas including the
adverse events which resolved within one month. [5] nasolabial fold, and 2.0 mL for larger areas as seen in facial
lipoatrophy. [64]
Although the majority of studies did not show any adverse
effects, side effects of Radiesse® may include edema, Another study by Jones et al. evaluated the injection of
[66]
erythema and transient lumpiness. Radiesse® is not liquid silicone into HIV patients with facial lipoatrophy. In
[63]
recommended for lip injection because of the frequent this study, 77 patients received either Silikon® 1000 (Alcon
occurrence of mucosal nodules. [58] Radiesse® may not Inc., Fort Worth, TX, USA) or VitreSil® 1000 (Richard James
be suitable for the treatments of periorbital and glabellar Inc., Peabody, MA, USA). Less than 2 mL of silicone oil was
rhytids secondary to safety concerns regarding embolism repeatedly injected at intervals of at least a month until
and necrosis. A case was reported in which a 35-year-old a state of “prelipoatrophy” was achieved. Most patients
women experienced nausea, vomiting, headache, ptosis developed erythema and edema following injection which
and periorbital pain ten minutes following CaHA injection resolved within 3 days. Patient satisfaction in this study
into the nasal tip and dorsum. The symptoms worsened and was reported to be high although specific details were not
resulted in sudden monocular vision loss. Although many provided.
[62]
of the fillers discussed may be associated with very mild
temporary reactions, the injector must remain alert to the Although many studies have shown the efficacy of silicone
risk of more serious adverse reactions. oil, an equal number of studies have highlighted adverse
reactions secondary to misuse. The improper use of silicone
[9]
Permanent fillers oils including incorrect dosage, improper technique, and
Silicone impurity of materials has resulted in serious repercussions
A primary consideration in the choice of filler is the degree including cellulitis, product migration, and death. A report
[9]
of maintenance that is required. Some advantages associated by Requena et al. presents 4 cases in which patients
[67]
with permanent fillers include low maintenance as a regular experienced moderate to severe complications following
schedule for re-treatmentis not required, and a lower overall silicone injections.
cost because the procedure is performed only once.
All 4 patients were diagnosed with orofacial granulomatosis
[56]
Liquid injectable silicone, commonly available as Silikon after 8-12 months of treatment. It was suggested that
1000 and AdatoSil 5000, is classified as a permanent filler the histological appearance of the odemas be studied as
for soft tissue augmentation. The chemical composition of they give direct information regarding the form and purity
the material is predominantly dimethyl polysiloxane, which of silicone used, including solid elastomer silicone and oil/
is available as fluid with variable levels of viscosity. It is gel silicone. The proper use of liquid silicone, i.e. small
[56]
injected into either the deep dermis or subcutaneous fat volumes, high purity, and the microdroplet technique, is
80 Plast Aesthet Res || Vol 3 || Mar 23, 2016