New FDA Statement on Renuvion Skin Tightening: What You Need to KnowPosted on April 8, 2022 | by Boston Plastic Surgery
The Food and Drug Administration (FDA) recently released a statement about Renuvion, the device often used in aesthetic procedures to promote skin contraction and/or improve the results of liposuction. This statement discusses serious potential side effects that surgeons and patients should be aware of before performing or receiving treatment with Renuvion.
However, this statement does not constitute cause for panic. As one of the numerous board-certified plastic surgeons who have offered Renuvion to my patients for a number of years, I can personally attest to its safety and efficacy in the right hands. Today’s blog is intended to help you make sense of the FDA statement. First, let’s discuss what Renuvion is and how it works.
- What is Renuvion, and how does it work?
- The 2022 FDA safety communication
- What we know about the safety of Renuvion
- What do I need to know if I already had Renuvion?
- FDA clearance and off-label use of Renuvion
- Choose an experienced, expert Renuvion provider
What is Renuvion, and how does it work?
Renuvion is a device that is FDA-cleared for certain uses during surgery. The Renuvion handpiece contains a handle and a long, thin “wand” that emits radiofrequency energy (RF) and cooling helium plasma.
Renuvion is primarily used as a skin tightening device during cosmetic procedures. When inserted beneath the skin, the RF heats the underlying layers of skin in order to promote contraction and to prompt collagen production. This leads to the appearance of firmer, tighter, and more youthful skin.
The 2022 FDA safety communication
In March of 2022, the FDA released a statement, formally termed a “safety communication,” titled “FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures.” While the device remains FDA-cleared, the statement warns that negative side effects may occur when Renuvion is used for specific aesthetic procedures to promote skin contraction (i.e. skin tightening) or dermal resurfacing (to improve wrinkles).
The FDA statement listed the following reported adverse events as the risks associated with Renuvion for aesthetic improvement: burns, infection, change in skin color, scars, nerve damage, significant bleeding, and air or gas accumulation beneath the skin, in the body, or in blood vessels.
What we know about the safety of Renuvion
After the FDA’s statement, Renuvion’s manufacturer Apyx Medical provided surgeons who use Renuvion with the data about medical device reports (MDRs). This information is the same information that was sent to the FDA. The manufacturer found that the rate (or percentage of procedures) of these reports of adverse events remained steady from 2020 to 2021, at 0.04%.
Apyx Medical states that the FDA released its safety communication as a response to an increase in the number of MDRs from 2020 to 2021; however, this number of reported adverse events simply rose in proportion to the rising number of Renuvion procedures performed. This means that we have no reason to believe that Renuvion is less safe than previously believed.
We have no reason to believe that Renuvion is less safe than previously believed.
Further, compared with other popular cosmetic plastic surgeries, Renuvion’s rate of adverse events is lower than average. Cosmetic liposuction, for example, carries a complication rate of about 0.7%, which is generally considered to be an acceptable risk for patients making an informed decision to undergo the procedure. By comparison, Renuvion’s rate of 0.04% is more than ten times lower.
What do I need to know if I already had Renuvion?
If you had Renuvion in the past, you may wonder what this FDA statement means for you. If you have not yet experienced any of the side effects listed in the statement, it is unlikely that you will experience these side effects from Renuvion; these issues are readily apparent soon after the procedure.
If you have experienced side effects that you believe were associated with Renuvion, I encourage you to talk to your doctor and report your side effects to the FDA.
However, if you have experienced side effects that you believe were associated with Renuvion, I encourage you to talk to your doctor and report your side effects to the FDA. As with all FDA-cleared or -approved products or devices, the FDA urges all physicians and patients who have a concern related to Renuvion to report the problem directly to them in addition to seeking medical advice.
FDA clearance and off-label use of Renuvion
Renuvion is FDA-cleared to be used as a device to manipulate soft tissues during surgery. But it is not cleared as safe or effective for specific aesthetic procedures. When Renuvion is used by cosmetic plastic surgeons in face or body contouring procedures to promote skin tightening (whether alone or to enhance the results of liposuction), this is considered an “off-label” use of Renuvion.
According to the FDA’s explanation of off-label use, “…once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.” This “off-label” prescribing of drugs also applies to devices, which are similarly regulated by the FDA.
It is normal (and indeed common) for doctors to use FDA-regulated drugs or devices off-label. One well-known example is BOTOX®, which is used outside of its specific FDA-approval parameters in areas like the upper lip, the neck, the jawline, and even the hands to treat excessive sweating.
Apyx Medical is currently conducting clinical trials and collecting data about using Renuvion for cosmetic skin tightening and resurfacing, and they report that they are actively working with the FDA to establish the device’s safety in and obtain FDA clearance for Renuvion in aesthetic procedures.
Choose an experienced, expert Renuvion provider
Choosing an experienced, board certified plastic surgeon for your Renuvion procedure is a must for receiving safe treatment. Not only should your plastic surgeon hold board certification and specialize in aesthetic procedures, but they should also be specifically trained in the use of this specialized device. With proper use, I have helped many happy patients safely achieve results with Renuvion.
- Learn more about board certified plastic surgeon Dr. Fouad Samaha »
- Call 617.786.7600 or contact us online to speak with our patient care coordinators or to schedule a consultation »