Journal Article10.1046/J.1524-4725.2002.01251.X
Safety data of injectable nonanimal stabilized hyaluronic acid gel for soft tissue augmentation.
TL;DR: According to the reported worldwide adverse events data, hypersensitivity to nonanimal hyaluronic acid gel is the major adverse event and is most likely secondary to impurities of bacterial fermentation.
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Abstract: background. Nonanimal hyaluronic acid gel was recently developed for soft tissue augmentation and volume expansion and has been shown to offer several advantages in comparison to other augmentation materials. There are rare reports of adverse events believed to be secondary to trace amounts of proteins in the hyaluronic acid raw material. objective. To determine the safety profile of nonanimal stabilized hyaluronic acid gel (Restylane, Perlane, Restylane Fine Lines, Q-Med AB, Uppsala, Sweden) for soft tissue augmentation using a retrospective review of all adverse events data from Europe, Canada, Australia, South American, and Asia from 1999 and 2000. results. Data from an estimated 144,000 patients treated in 1999 indicated the major reaction to injectable hyaluronic acid was localized hypersensitivity reactions, occurring in approximately 1 of every 1400 patients treated. In 1999 there was an adverse event reported for 1 of every 650 patients (0.15%) treated. These were temporary events that included redness, swelling, localized granulomatous reactions, bacterial infection, as well as acneiform and cystic lesions. For 2000 there was an estimated 262,000 patients treated with hyaluronic acid gel. The total number of adverse events was 144, corresponding to one adverse event for every 1800 patients (0.06%) treated. The major adverse event was again hypersensitivity, occurring in 1 of every 5000 patients treated. conclusion. According to the reported worldwide adverse events data, hypersensitivity to nonanimal hyaluronic acid gel is the major adverse event and is most likely secondary to impurities of bacterial fermentation. According to data from 2000, the incidence of hypersensitivity appears to be declining after the
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Citations
A Randomized, Double-Blind, Multicenter Comparison of the Efficacy and Tolerability of Restylane Versus Zyplast for the Correction of Nasolabial Folds
Rhoda S. Narins,Fredric S Brandt,James J. Leyden,Z. Paul Lorenc,Mark A. Rubin,Stacy R. Smith +5 more
TL;DR: Patients and investigators judged hyaluronic acid gel to be more effective in maintaining cosmetic correction and nonanimal stabilized hyaluonic acid provides a more durable aesthetic improvement than bovine collagen and is well tolerated.
709
Human Histology and Persistence of Various Injectable Filler Substances for Soft Tissue Augmentation
TL;DR: Host defense mechanisms react differently to the various filler materials, but all substances appeared to be clinically and histologically safe, although all exhibit undesirable side effects.
Filling the periorbital hollows with hyaluronic acid gel: initial experience with 244 injections.
TL;DR: Most patients considered themselves improved cosmetically, despite occasional side effects including contour irregularity or lumps, bruising, color change, and fluid accumulation, and it is possible to achieve acceptable improvement after hyaluronic acid gel injections.
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Hyaluronic acid: a unique topical vehicle for the localized delivery of drugs to the skin
Marc B. Brown,Stuart A. Jones +1 more
TL;DR: A regulatory approval was granted recently for 3% diclofenac in 2.5% HA gel, Solaraze®, for the topical treatment of actinic keratoses, which is the third most common skin complaint in the USA.
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Hyaluronic acid, a promising skin rejuvenating biomedicine: A review of recent updates and pre-clinical and clinical investigations on cosmetic and nutricosmetic effects.
Syed Nasir Abbas Bukhari,Nur Liyana Roswandi,Muhammad Waqas,Haroon Habib,Fahad Hussain,Shahzeb Khan,Muhammad Sohail,Nor Amlizan Ramli,Hnin Ei Thu,Zahid Hussain +9 more
TL;DR: Critical analysis evidenced that application/administration of HA exhibits outstanding nutricosmetic efficacy and thus is warranted to be used as a prime component of cosmetic products.
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Comparative chemical evaluation of two commercially available derivatives of hyaluronic acid (hylaform from rooster combs and restylane from streptococcus) used for soft tissue augmentation.
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TL;DR: The experience of 400 consecutive patients evaluated for soft tissue augmentation for a variety of contour defects is reviewed here.
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TL;DR: The incidence of adverse reactions is low, and the severity of the reactions does not appear to be serious, but the long-term benefit of ICI has not been established.
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Long-term complications of facial injections with Restylane (injectable hyaluronic acid).
TL;DR: Restylane is a cross-linked, stabilized nonanimal hyaluronic acid gel that was developed by Q-Med in Sweden for soft-tissue augmentation and was described in the American Society of Plastic Surgeons Web site.
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