Tag Archive for: filler

Dr Lalloo has been using Radiesse in the hands for over ten years now, at last the FDA have caught up!

Cost, €450 – 800 for both hands. No down time as such.

The US Food and Drug Administration (FDA) has approved the injectable dermal filler Radiesse (Merz North America, Inc) for hand augmentation to correct volume loss in the dorsum of the hands, the company announced June 4.

Earlier this year, as reported by Medscape Medical News, the FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted 9 to 4 that the benefits of Radiesse outweigh its risks. A majority of panelists also voted that it is safe and effective.

“Radiesse provides an immediate volumizing effect and can help to reduce the prominence of tendons and veins in the hands, delivering smooth, natural-looking results that can last up to 1 year,” the company said.

Radiesse is an opaque dermal filler composed of synthetic calcium hydroxylapatite microspheres suspended in a water-based gel carrier. It was first approved in the United States in 2001, and has since had subsequent approvals, including for correction of nasolabial folds in 2006. It has been used off-label for hand augmentation — and is approved in 52 countries for that indication.

Data to support FDA approval for hand augmentation came from a multicenter, randomized controlled study of 114 patients. Most were white women with an average age of 53 years. Eighty-five patients were randomly assigned to immediate treatment, and 29 to delayed treatment and were considered controls. The control group crossed over to treatment at 12 weeks.

The effectiveness of Radiesse was measured by the Merz Hand Grading Scale (MHGS) — validated by the company in another study — and the Global Aesthetic Improvement Scale (GAIS), which the patients used to self-assess results.

According to the MHGS, 75% of Radiesse patients experienced at least a one-point improvement at 3 months compared with 3% of those in the control group. The mean change in the MHGS from baseline was 1.1 point for those given Radiesse compared with 0.1 in the control group.

In addition, 98% of treated patients reported improvement in the appearance of their hands at 3 months. Improved aesthetic outcomes as measured on the GAIS after initial and repeat treatments correlating with clinical improvement were demonstrated in this study, with all primary and secondary endpoints being met, the company said.

Most adverse events were injection site reactions such as swelling, redness, pain, and bruising, which were usually mild to moderate, short in duration (lasting about 1 week), and required no treatment. No severe device-related adverse events were reported that required treatment, according to the company.

Radiesse is contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies; patients with known hypersensitivity to any of the components; and patients with bleeding disorders.

Botox Injections May Affect Skin Structure

NEW YORK (Reuters Health) – Injections of onabotulinum toxin A increase skin pliability and elastic recoil, new findings show.
“Apart from just seeing the paralysis in the muscles that are treated, we are also seeing changes in the skin that are indicative of possible changes in fibroblasts,” Dr. James Bonaparte of the University of Ottawa in Ontario, Canada, one of the new study’s authors, told Reuters Health.
The findings raise the possibility that botulinum toxin A has direct anti-aging effects on the skin, and also suggest that it may be useful for scar treatment, Dr. Bonaparte added in a telephone interview.
Previous investigations have shown that wrinkles fade after repeated botox injections, but the reason why is not clear, Dr. Bonaparte and Dr. David Ellis of the University of Toronto noted in their report, published online May 21 in JAMA Facial and Plastic Surgery.
In a 2014 study, Dr. Bonaparte and Dr. Ellis reported biomechanical changes in the skin after botox injections, but their study only followed patients for up to two months (http://bit.ly/1J1Om02). Critics had questioned whether these changes were due to inflammation from the injections.
In the current study, to address this issue, the researchers followed patients for four months. They enrolled 48 women with no previous botox injections and with mild wrinkles at the glabella and lateral orbit. Forty-three women completed the study. The researchers used a Cutometer MPA 580 skin elasticity meter (Courage & Khazaka Electronic, Cologne, German), which measures deformation and relaxation of the skin when suction is applied and removed.
All patients received injections to the glabella, supraorbit, and lateral orbit, and all showed increases in skin pliability and elastic recoil at all sites.
Study participants also had reductions in the ratio of the viscoelastic component of resistance to elastic resistance, indicating that the changes were not related to swelling and inflammation. All measurements had returned to baseline levels by four months.
It’s possible, Dr. Bonaparte said, that fibroblasts may have receptors that interact with botox, causing the cells to produce more collagen, elastin and other substances that tighten the skin. He pointed to a 2014 laboratory study that found onabotulinum toxin A blocked the expression of aging-related proteins in fibroblasts exposed to UV B radiation, while increasing collagen production (http://bit.ly/1FDrNuA).
If this hypothesis is true, he added, it may be possible to reduce wrinkles by injecting onabotulinum toxin A directly into the skin, rather than using it to paralyze facial muscles. And if the injections do produce these changes in fibroblasts, he added, they could prove useful for scar treatment.
In an editorial, Dr. Catherine Winslow of Indiana University School of Medicine in Bloomington notes that onabotulinum toxin A could also directly affect skin by preventing the release of free radicals that occurs with muscular contraction.
“Piecing together this research with continued studies on elasticity and collagen content of injected skin will further the ability of facial plastic surgeons to refine their strategy for long-term planning of antiaging strategies with patients and educate them as to the importance of nonsurgical therapies for maintenance, in addition to opening new fields of potential treatment options for difficult scars and skin conditions,” she concludes.
Dr. Ellis and Dr. Bonaparte have received funding from Allergan, which markets onabotulinum toxin A as Botox.
SOURCE: http://bit.ly/1FDupZw
JAMA Facial Plastic Surg 2015.