Cannulas Were Approved by the FDA for Restylane Silk….Finally!
On October 12, 2017, Galderma was notified by the FDA that Restylane Silk was approved to be administered using blunt microcannulas. Galderma deserves a huge “high 5” for stepping out of the box in recognizing the improved patient outcomes and safety benefits of cannulas. No other dermal filler in the US has been approved for use with cannulas, it is a “First for Fillers”. Galderma is researching other areas for cannula use and expect approval in 2018 for another 1 or 2 indications.
What’s the big deal with cannulas?
The traditional method to administer dermal fillers is using a needle. Unfortunately, there are many side effects and risks using needles. These include:
- Bruising – sticking a needle into a highly vascular organ, skin, will lead to bruising a majority of the time. This is corroborated by the FDA studies for all the US approved fillers.
- Pain – needles require multiple entry points to deposit the filler. Pain fibers are most prevalent in the dermis.
- Vascular Occlusion Risk – when a blood vessel is cannulated with a needle and the filler is injected directly into the vessel, occlusion of the vessel occurs. The sequelae of such event can result in skin necrosis, eye injury, or even blindness.
Cannulas have a blunted, rounded tip which is less likely to injure blood vessels than a needle is. When the cannula brushes up against a vessel, it is deflected away, in distinction to a needle which will often pierce the vessel. When a vessel is traumatized, a bruise will occur.
To use cannulas, a small pilot hole using a needle is required. Unfortunately, completely eliminating needles is not possible. However, after that entry is performed, the cannula can be placed through the dermis and into the subcutaneous tissue or deeper fat compartments. The areas below the skin surface are generally less innervated and are more comfortable to place filler.
The most important quality of cannulas is their safety. By design, they are much less likely to result in placement of filler within the lumen of a blood vessel. The rounded tip eludes lumens of blood vessels whereas needles don’t offer that protection. Although vascular occlusion is possible with cannulas, it is much less likely when compared to the risks associated with needles.
Dr. Weiner has been an advocate of injecting dermal fillers with cannulas for the past 6 years, since 2012. He has become one of the most experienced cannula users in the US. He has been chosen by Galderma to use his cannula experience to “Train the Trainers” in the use of cannulas for Restylane Silk in the lips.