In the European Union (EU), a simple approval process for hyaluronic acid (HA) products has yielded a broader array of offerings than what’s available in the United States, an expert says. Easier EU approvals also have given HA a virtual lock on the European filler market, he adds.
Las Vegas - In the European Union (EU), a simple approval process for hyaluronic acid (HA) products has yielded a broader array of offerings than what’s available in the United States, an expert says. Easier EU approvals also have given HA a virtual lock on the European filler market, he adds.
“The European Commission considers fillers to be medical devices, and it is easier to obtain a CE mark than FDA (Food and Drug Administration) approval,” says Patrick Trevidic, M.D., a Paris-based plastic, reconstructive and cosmetic surgeon in private practice. “That’s why HA has 95 percent of the filler market in Europe.”
These conditions also explain why the European filler market includes a broader spectrum of HA cohesivity.
“We have high-cohesivity HAs, as well as very low-cohesivity HAs, that are not available in the United States,” he says.
Indications for the former include body and buttocks remodeling, versus facial and fine line filling for the low-cohesivity fillers, which generally use non-cross-linked HA.
In 2012, after conferring with European authorities, Galderma subsidiary Q-Med stopped marketing the highly cohesive Macrolane (HA) for breast augmentation because radiologists say it can make reading mammograms difficult, and because HA degradation stimulates neovascularization, Dr. Trevidic says. Presently, he adds, “We are waiting for more clinical and radiological studies to be completed.” Recent research includes a two-year follow-up study that he and several colleagues recently completed (submitted for publication).
Regulators are looking for longer-term data, Dr. Trevidic says, but he expresses confidence that in time, research will show that Macrolane is safe for breast augmentation. All forms of breast augmentation can make reading mammograms more challenging, says a Q-Med press release. Macrolane is still available for body contouring in the EU, Dr. Trevidic says.
As for injection tools, “In Europe, we were first to launch the cannula, starting more than five years ago with the Pix’L Micro Cannula (Q-Med). We began using it for some specific areas such as the periorbital area and the perioral/lip area. And now we use the cannula for virtually all injection areas” because cannulas cause less pain and bruising and fewer hematomas.
“Also, because the cannula has a blunt tip, we have fewer adverse events like embolisms. Cannulas are a little more expensive, but they are a step forward for our patients,” he says.
For superficial injections using low-cohesivity HA, Dr. Trevidic recommends using 30- to 27-gauge flexible cannulas, versus 25-, 23- or 21-gauge rigid cannulas for deeper injections designed to replace volume and lift skin, such as in the periorbital area. Additionally, Expert2 Expert (E2e), a Paris-based organization offering education in aesthetic medicine and dermatology, provides the following consensus recommendations:
Regarding injection-site pain, he says, Allergan was the first HA filler manufacturer to incorporate lidocaine into its products in Europe. Conversely, European law prohibits physicians from mixing other filler materials such as calcium hydroxylapatite with lidocaine. Accordingly, “CHA is not used often in Europe. We prefer HA, which is now mixed with lidocaine in all manufacturers’ prepackaged syringes.”
In 2010, Dr. Trevidic was a co-investigator with Paris-based plastic surgeon Flavio Facchini, M.D., on a double-blinded, randomized, controlled trial involving 32 patients. It showed that lidocaine decreases pain for 97 percent of patients (data on file with manufacturer). Other studies assessing pain during injections of HA combined with lidocaine revealed similar results: greater comfort for patients, he says.
In contrast, Dr. Trevidic says that much of the EU excludes silicone and other permanent fillers. In France’s experience, he says, such fillers may not pose dangers immediately, but they may at two to four years after implantation, when granulomas may form.
For similar reasons, the EU suspended its approval of DermaLive (acrylic hydrogel, HA; Dermatech) in 2003. People may have called this product a semi-permanent filler, he says, “But that means nothing.” Because it included silicone, Dr. Trevidic says, any problems the material created were likely to last a lifetime.
Disclosures: Dr. Trevidic is a consultant for Merz, Teoxane, Galderma, Ipsen/Galderma and TSK Laboratory but owns no stock in these companies. He is also a member of E2e.