Polymeric injectable fillers for cosmetology: Current status, future trends, and regulatory perspectives

Abstract

Injectable fillers have become a vital part of cosmetology. A wide variety of injectable fillers are developed for either correction of facial wrinkles and folds or facial contouring. As the most popular filler products, polymeric injectable fillers represent a class of the most common implantable medical devices. This review is intended to not only present current filler products, but also share perspectives of future trends, development processes, and regulatory considerations for the next generation of fillers. First, currently approved polymeric injectable fillers are described in detail. Second, future trends of polymeric injectable fillers are discussed. Fillers based on the emerging technologies in tissue engineering and regenerative medicine with stimuli‐responsive or tunable properties, as well as device/drug combination products, are promising candidates. Third, fillers for cosmetology are different from traditionally recognized medical devices. As a result, the target population of such fillers is different from that of other implantable devices, leading to different user needs that impact their development processes. Last, product applications, regulatory requirements, device evaluation, characteristics, and difficulties for regulating filler products for minimally invasive cosmetology are reviewed. Both regulatory science and scientific supervision are needed for polymeric injectable fillers which are facing great opportunities as well as challenges. © 2019 Wiley Periodicals, Inc. J. Appl. Polym. Sci. 2020, 137, 48515.

Tailoring Gelation Mechanisms for Advanced Hydrogel Applications

“…This is particularly important for the clinical translation of hydrogel‐based carriers, implants, and devices, where the selection of the hydrogel base material, hydrogelation mechanism, and trigger are all highly dependent on the envisaged application and route of administration. Many hydrogel products have reached the market, [ 279 ] as part of surgical sealants (e.g., COSEAL, EVICEL fibrin sealant, or ReSURE ocular sealant), [ 280 ] wound dressings (e.g., Granugel), [ 281 ] antibacterial coatings (e.g., DAC), [ 282 ] dermal fillers (e.g., Restylane), [ 283 ] and cartilage repair matrices (e.g., CaReS). [ 284 ] Meanwhile, ongoing and future clinical trials are testing injectable hydrogel formulations for the treatment of knee osteoarthritis [ 285,286 ] and cartilage defects, [ 287 ] antibiotic‐loaded hydrogel coatings for hip implants, [ 288 ] and tissue‐marking hydrogels for radiotherapy.…”

Recurrent Periorbital Edema Associated With Retained Foreign Body After Filler Injection

“…Silicone was also banned by the FDA for use as a dermal filler due to similar ensuing complications. 5 Despite this, use of these materials may occur especially by unlicensed providers due to lack of familiarity or experience, minimal regulation, or decreased cost, which may result in increased risk of severe patient complications that may be further exacerbated by poor knowledge of anatomy and injection technique, lack of sterile environments, and lack of patient follow-up after injection. Seok et al reported 3 cases of delayed inflammatory reactions following filler injection of an unknown material by unlicensed practitioners, with patients presenting with localized erythema and edema that waxed and waned despite oral immunosuppressants and antihistamines.…”

Recent advances in regenerative biomaterials

“…Biomaterials have been applied in the medical cosmetology for many years, such as filler materials and cosmetics. Filler materials can be injected in facial tissue to achieve facial rejuvenation, which requires safe and easy-to-operate biomaterials [ 324 ]. A few polymer materials have been developed for facial injection, such as polyacrylamide, hyaluronic acid, PLA and PLGA.…”