In the field of aesthetics, there is a prevailing notion that American providers are consistently late to embrace the latest treatments, often trailing behind others, mainly due to the notoriously complex approval processes established by the U.S. Food and Drug Administration (FDA). Our doctors are aware of the numerous dermal fillers available across Europe, the hyaluronic acid (HA) “skin boosters” favored by neighbors in the North, and the injectable antioxidants and array of threads commonly used to enhance and shape the faces of South Korea's meticulous beauty seekers.
Some of these innovations are currently undergoing clinical trials in the U.S. and might arrive soon – sooner or later. Others, we might never have access to. Aesthetic approvals are so scarce here that we tend to enthusiastically celebrate the authorization of every new filler, toxin, or device even before fully grasping its worth – what it could potentially contribute to our existing FDA-approved collection, which includes dozens of devices, approximately 35 fillers from a few brands, and four neuromodulators.
Dr. Paul Friedman, a board-certified dermatologist in Houston, explains that the FDA, responsible for ensuring the safety and efficacy of drugs and medical devices in the U.S., classifies botulinum toxins like Botox and Dysport as drugs and fillers – both HA varieties and non-HA biostimulatory types – as implantable medical devices. Since fillers are regarded as Class III devices, they are subject to the strictest supervision. Meanwhile, other types of devices, such as mechanical and energy-based tools, might fall into a lower-risk category that requires less evidence for approval, especially if they are considered substantially similar to an already approved “predicate” device. Dr. Friedman adds that non-filler device trials, in general, “tend to be smaller than drug trials and are more challenging to blind, randomize, and control.”
Interestingly, lasers and other resurfacing, toning, or sculpting devices frequently originate in the U.S. – Fraxel, CoolSculpting, and Ellacor micro-coring, for instance, were all invented in Boston – allowing us to commonly gain access to top-notch devices before the rest of the world.
For neuromodulators and fillers to obtain FDA approval, they must undergo a rigorous process involving at least three phases of clinical trials to assess safety and efficacy, each taking approximately one to four years to complete. Once these standard trials conclude, the FDA must review the data, which can also consume months to years. Additionally, “Phase IV post-approval clinical trials may be mandated by the FDA for ongoing monitoring of safety and other effects – and these can last for years, even up to 10 years,” explains Dr. Hema Sundaram, a board-certified dermatologist in Fairfax, Virginia, and Rockville, Maryland, and a regulatory advisor in North America, Europe, and Asia.
As part of the FDA review, “manufacturing facilities and the entire manufacturing process must also undergo inspection,” notes Dr. Sundaram – and this is not always straightforward.
Revance, the manufacturer of a neuromodulator called DAXI (DaxibotulinumtoxinA for Injection) – shown in trials to freeze frown lines for a considerable six months – was dealt a significant surprise in the fall of 2024 when the FDA rejected the drug due to certain “manufacturing deficiencies.” This could delay its approval for at least several more months. While DAXI is not yet approved for use anywhere in the world, the American aesthetics community had quietly anticipated a late 2024 launch.
All in all, the FDA approval process is “truly a laborious undertaking,” Dr. Sundaram adds. “As an FDA principal investigator myself, I have direct knowledge of the countless hours my study team and I devote to conducting clinical trials and the associated responsibilities, including monitoring visits by the research organizations that independently oversee the trials as well as interacting with the Institutional Review Boards that ensure ethical study conduct and treatment of study subjects.”
Meanwhile, elsewhere in the world…
Other countries have their own regulatory entities and protocols. In Europe, the approval process for drugs, such as neuromodulators, is reportedly as meticulous as ours. (Despite what you might have heard about the FDA's slow pace, studies have actually shown that drugs are frequently approved and brought to market faster in the U.S. than in the European Union or Canada.) Devices, including fillers, are typically handled differently abroad. To start, “in the U.S., a device must demonstrate both safety and efficacy for FDA approval,” Dr. Friedman tells us. Whereas in Europe, “a device must demonstrate safety and performance – that is, it functions as designed – but it is not required to show clinical efficacy.”
Approval guidelines in Europe are currently being revised – more on that shortly – but historically, for a filler to be sold in Europe, it had to have what is known as a CE (conformité européenne) mark. Instead of a central authority analyzing trial data and granting approvals, device applications have long been reviewed by a “notified body” (NB), or a private company that provides certifications for a fee, explains Dr. Friedman.
In a 2016 paper comparing European and American approval processes, Dr. Gail A. Van Norman, a professor in the department of anesthesiology and pain medicine at the University of Washington in Seattle, states that “although the CE mark is often wrongly equated to being a quality seal, in reality, obtaining a CE mark merely indicates that the device in question complies fully with European legislation.” The author further elaborates on how standards vary among NBs, with some being much less rigorous than others.
“The CE mark does not signify scientific quality,” laments Dr. Jonquille Chantrey, an aesthetic physician in London. “CE-mark approval may take 4 to 16 weeks – the process is much faster than approval for a drug in the U.K., as there are fewer medical restrictions and requirements.” While botulinum toxins are treated as prescription drugs in the U.K. and are appropriately examined, she says, “the majority of cosmetic injectables available here are medical devices and do not need to undergo clinical trials and scientific safety licensing.”
Dr. Sundaram highlights another crucial difference between FDA approval and CE marks. In the U.S., a filler or neurotoxin can reach injectors only after “several phases of comprehensive clinical trials [have been] conducted on the actual product, with rigorous data analysis, to determine safety and efficacy for a specific product indication.” In Europe, on the other hand, CE marks have traditionally been awarded “through the submission of published data for already existing equivalent products plus post-marketing clinical follow-up after obtaining the CE marking,” Dr. Sundaram explains. What this means, she adds, is that a product’s “side effects might only become apparent after approval, after a large number of patients have already been treated.”
Back in the U.S., Canadian physicians also have access to certain injectables before American doctors. In many cases, this is because “the clinical trials were initiated earlier in Canada and thus the data was submitted sooner,” Dr. Sundaram points out. Moreover, unlike the FDA, which requires evidence from U.S.-specific clinical trials, Canada’s regulatory agency (Health Canada) is willing to accept data from other countries, notes Dr. Katie Beleznay, a board-certified dermatologist in Vancouver, British Columbia.
Similarly, “some non-European countries, like Hong Kong, will automatically approve a product for use if it has a CE marking,” says Dr. Sundaram. In Mexico, devices that are cleared in the U.S. or Canada are likewise expedited and only need to have technical documents translated into Spanish and notarized, according to a 2017 study on global device-approval practices.
The global game changers doctors are excited about
“Skin Boosters,” also known as injectable hydrators
When a product is approved abroad years before meeting the FDA's standards, American providers benefit from the trial-and-error experiences of their international counterparts. Among all the injectables circulating worldwide, a group of HAs labeled “skin boosters” – ultra-fine gels like Juvéderm Volite and Restylane Vital, which are injected superficially into the dermis over wide areas to smooth and hydrate the skin – are likely most sought-after by American injectors because they can produce effects that traditional volumizing fillers cannot. Profhilo is another standout: this HA, uniquely free of the crosslinking chemical BDDE, stimulates collagen and elastin growth while blurring fine lines and remaining undetectable even under thin skin, such as that of the neck.
“Skin boosters have truly gained popularity since the introduction of Profhilo,” says Dr. Ashwin Soni, a plastic and reconstructive surgeon in Surrey and Berkshire, England. “Now there are several filler companies developing these hydrating and skin remodeling injections – Teoxane Redensity 1 and Belotero Revive are becoming popular here – to improve skin health and create the beautiful glow that patients desire.”
An innovative breast implant
In the surgical domain, new approvals can generate novel concepts – and sometimes even transform a doctor's surgical approach. According to Dr. Jamil Ahmad, a board-certified plastic surgeon in Mississauga, Ontario, Allergan's Inspira breast implants – which he describes as “optimally filled cohesive gel implants” – were launched in Canada several years before receiving FDA approval in the U.S. During that time, he discovered that the shell of these smooth, round implants was less prone to collapse and rippling compared to other devices he had previously used. This enabled him to perform “many subfascial breast augmentations, even in very thin patients with minimal breast tissue,” he says – thereby avoiding “some of the aesthetic drawbacks of going under the muscle,” like animation deformity (the implant flattening or moving down and out when the pectoral muscle flexes) and “double bubble,” which appears as a crease above the breast fold, says Dr. Ahmad, and develops due to “a discordance between the ligaments within the breast and the muscle window-shading up” when it is cut during surgery.
“These may not be the newest things approved here compared to the U.S.,” says Dr. Ahmad, “but they are the things we should be discussing in terms of providing more options to patients, many of whom undergo dual-plane [under-the-muscle breast augmentations] without any discussion.”
Skin tightening devices
While Dr. Ahmad shares his global experiences through lectures and studies, he admits to being equally informed and influenced by the first-hand accounts of his foreign colleagues. Only in the past year or so has he adopted Morpheus8 and BodyTite, two radiofrequency-based skin tightening technologies from InMode, both highly popular in the U.S. “They have been around much longer in the U.S. but are only now starting to gain interest in Canada,” he says – largely thanks to U.S. doctors posting about the devices on social media. Dr. Ahmad uses Morpheus8 for both facial resurfacing and to tighten crepey skin on the abdomen, thighs, and calves. BodyTite, he pairs with liposuction, especially when contouring the flanks and neck, to help the defatted skin contract a little more than it would with lipo alone.
Sculptra
The world also looks to the U.S. for insights on Sculptra, the poly-L-lactic acid suspension that gradually rejuvenates the skin by stimulating collagen production. While the injectable has been FDA approved for cosmetic use since 2009 – and for facial wasting associated with HIV since 2004 – plastic surgeon Dr. Rosalia Luketina says it is only now launching in her Zurich clinic. In Munich, board-certified dermatologist Dr. Timm Golueke has been using Sculptra on the face for years but has recently witnessed an increased demand for buttocks and abdomen injections. “Clearance for body treatments is still pending, but many colleagues are using it off-label,” he says. The situation is similar in the U.S., where Sculptra is currently in clinical trials for the treatment of cellulite of the buttocks and thighs.
Regulatory changes in progress
After years of rapid clearances based on minimal testing, European regulators are now aiming to align their approval processes with those of the FDA.
The impetus for change actually dates back decades, to when the systemic shortcomings of the European Union were exposed by the PIP breast implant scandal. To simplify, the French implants were denied FDA approval but obtained a CE mark in the mid-1990s and were widely used throughout Europe, the U.K., Brazil, and Latin America. “In 2001, PIP began manufacturing and selling implants that contained unapproved, cheaper, industrial-grade silicone instead of the medical-grade silicone for which they were authorized,” says Dr. Sundaram – a fraudulent act that led to an exceptionally high rate of rupture. The implants were removed from the market in 2010 and have been linked to several cases of breast cancer and toxicity-related deaths.
This incident initiated a significant, multi-year overhaul of European device regulations, the implications of which are only now starting to take effect. Moving forward, “manufacturers of fillers and other implants as well as lasers and IPL will face more rigorous requirements for safety, product performance, and quality control,” Dr. Sundaram tells us. As a result, “we can expect new fillers to take considerably longer to obtain the CE marking.”
American investigators are also observing the evolution of approval paradigms within the U.S. While dark skin types have traditionally been underrepresented in aesthetics clinical trials, more recent “FDA studies of neuromodulators and fillers tend to require a diverse subject population, with a certain percentage of patients of color, [to ensure] data reflects the real-world patient population in which the product will ultimately be used,” Dr. Sundaram says. This long-overdue change, combined with updates abroad, should make our proverbial beauty party a safer and more inclusive event.
