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April 21

The Risk Associated With Using Uncertified Dermal Fillers

The Risks Associated with Using Uncertified Dermal Fillers Dermal fillers have come to play an essential role in the management of aging skin, becoming part of the grooming regime for women and men. The exponential growth of dermal fillers’ market is the result of increasing demand for non-surgical treatments, as well as improvements in the manufacturing of new types which allow to not only correct the wrinkles and folds but also contour and replace the lost volume. Safety Considerations Injectables are generally considered safe, however, as in any other medical procedures, there are some risks related with using them, especially if relevant precautions and contraindications are not adopted from both doctor and patient. The probability of side effects taking place can significantly increase when, firstly, products used in the treatment are of non-confirmed origin and with unapproved ingredients and, secondly, non-certified or non-trained practitioner conducts the injections using an inappropriate technique. First Step: Licensed Medical Professional Those looking to get dermal fillers should look for the licensed and board-certified healthcare professional, with a speciality in dermatology or plastic surgery, and trained to perform this kind of procedure. Dermal fillers are now being promoted as “lunch-time” treatments that can be done in under 30 minutes and maybe that’s why they sometimes look so easy to conduct. The truth is these procedures require extensive knowledge of the facial anatomy and various injection techniques, which can be possessed only by a qualified surgeon or dermatologist. A dermal injection conducted in the wrong way can have severe consequences, starting with undesired patient’s appearance (facial or body asymmetry, skin stretching, lumps) and finishing with serious skin damage (such as wounds, infections and scarring) or even blindness. Online Businesses and Fake Dermal Fillers An immense threat comes also from a growing interest in purchasing dermal fillers online, which only contributes to the rise in sales of counterfeit products from illegal businesses run by unlicensed distributors. Dermal fillers are officially qualified as medical devices and no lawful company would ever sell them directly to the consumer. When purchasing products online, patients can never be sure what’s inside the packaging, because even if it's mentioned it’s hyaluronic acid, it can be literally everything. Non-sterile Environments This all is accompanied by not enough awareness about the risks of undergoing the treatments in non-medical settings, for example in the privacy of someone’s home, with consumers going as far as injecting themselves after watching YouTube tutorials. According to the Consumer Complaints Audit Report 2017-2018 published by Save Face , 33% of complaints were results of treatments conducted in domestic setting, 26% in a beauty salon, 17% using services of a mobile practitioner, 11% during a treatment party, 9% in a hair salon and 4% on training venues and conferences. According to the same source, 84% of patients didn’t know what products were used during the procedure and 31% weren’t aware of what qualifications or training their practitioner had undertaken. As scary as it sounds, the results of such activities can be irreversible. Enhanced Regulations On a positive side, we are witnessing the introduction of the tightened control mechanisms for medical devices throughout Europe which are meant to ensure better protection of public health and increase patients’ safety by improving the quality of the medical devices and harmonizing the legislation within the EU. The EU Medical Devices Regulation (MDR), published on 5th May 2017, replaced the EU’s Medical Devices Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC) with a 3-year transitional period. That means that all dermal fillers are now being classified as medical devices and must be CE-certified by a notified body to be allowed to be sold after 26th May 2020, with current certificates in accordance with the old directive (93/42/EEC) remaining valid until the expiry. The new directive classifies injectable dermal fillers with hyaluronic acid as the highest risk class – III, which refers to medical devices with absorbed ingredients. Safety and Quality Commitment At BioScience, we truly believe that the growth in the aesthetics and injectables market should be primarily about the quality, not quantity. We’re proudly holding a CE mark 2409 for all of the ranges of dermal fillers for not only face but also body and we have confidence that only demanding legislation and tight regulations can boost confidence in the medical devices industry. We want to draw the attention to the risks that may arise after the misuse of dermal fillers and at the same time stand for the rules that should be paramount for everyone operating in this field to promote only certified and verified products. Source: https://biosciencegmbh.com/