The reality of J-Plasma

FDA warns about the risks in the use of the Renuvion/J-Plasma device (Apyx Medical) for certain aesthetic procedures.

On March 14 of this year, the FDA issued a warning both for consumers (potential patients) and, for those in charge (providers and specialists) in medical care about the use of the Renuvion/J-Plasma device (Apyx Medical) for dermal skin rejuvenation or skin contraction.

The FDA (Food and Drug Administration) is the agency of the United States Government responsible for the regulation of food, drugs, cosmetics, medical devices, biological products, and blood derivatives. It aims to protect public health by guaranteeing the safety, efficacy, quality, of drugs, vaccines, and other biological products both for human and veterinary use. The FDA regulates as well medical devices such as Renuvion/J-Plasma.

In its statement, the FDA clarified, "the use of this device (Renuvion/J-Plasma) has not been determined to be safe or effective for any specific procedure intended to improve the appearance of the skin."

According to the release, the FDA has received reports describing serious adverse events when using the device directly on the skin, including life-threatening adverse events when used under the skin.

Reported adverse events are understood as second and third-degree burns, infection, skin color variation, scars, nerve damage, significant bleeding, accumulation of air or gas under the skin, in body cavities, and blood vessels. Cases have even been reported where patients have had to be referred to the Intensive Care Unit.

The FDA created the following list of recommendations for patients, providers, and healthcare specialists:

1. The FDA has not approved the use of Renuvion/J-Plasma for any cosmetic procedure intended to improve the appearance of the skin.
2. If you are planning to carry out any type of plastic surgery or aesthetic procedure, you should ask the specialist if he is going to use the Renuvion/J-Plasma device during the intervention.
3. If you have problems or feel concerned after a procedure with Renuvion/J-Plasma, seek care from a specialist member of the Society of Plastic Surgery in the country where he practices.
4. Report to the FDA any type of complication you may experience after a procedure performed with Renuvion / J-Plasma.

In the case of health care providers and specialists, it is recommended to keep in mind:

1. The use of Renuvion/J-Plasma is not approved by the FDA for any cosmetic skin procedure.
2. Using Renuvion/J-Plasma in an aesthetic skin intervention or its use in combination in any plastic surgery procedure can lead to serious and life-threatening adverse events.
3. Inform in a clear way what plastic surgeries are available, the benefits and risks of these procedures. Also inform which devices will be used during the procedures.
4. Immediately report to the FDA any inconvenience or complication experienced by patients after a procedure where Renuvion/J-Plasma is used.

At Dr. Alfonso Riascos's office, we consider it essential that the general public, and especially those interested in having an aesthetic procedure or plastic surgery be completely informed. They should receive information on both, the type of machines and the technology to be used. Patients should be aware of the experience, trajectory, and training of the plastic surgeon in charge of performing the intervention. Additionally the patients must be informed of the quality and credentials of the medical institution where the operation will be carried out.

For the FDA Communication on Renuvion/J-Plasma (Apyx Medical) published on March 14, 2022: More information.