The Federal Commission for the Protection against Health Risks (Cofepris) issued an alert to the population due to the counterfeiting and illegal marketing of Restylane Kyssea medical device used in cosmetic lip filler procedures.
Restylane Kysse is a gel hyaluronic acid which can be injected into the lips to restore or add volume, definition and moisture or smooth the look of rough or wrinkled skin.
The company that owns the health registry notified Cofepris that the counterfeit product There are several anomalies on the box, as it shows the lot number 16787-9 and expiration date 2026-01-10; spelling errors; Furthermore, it boasts fake originality seal and QR code. In addition, the syringe is smaller than the original and the packaging that protects it indicates batch 14482-1 and lacks an expiration date.
With the aim of preventing possible health risks, the agency recommended that beauty clinics and other establishments where this device is sold, before purchasing it Verify that the distributor is authorized and validated by the manufacturer. In addition, the distributor must have a health license and operating notice issued by Cofepris, and demonstrate the legality of the acquisition of the product.
“The marketing of the counterfeit product, through social networks and internet sites, as well as its distribution through national and international parcel services fail to comply with the provisions of the General Health Law, so this authority will impose sanctions that may include fines and temporary or permanent closures,” Cofepris detailed in a statement.
The agency stressed that before using Restylane Kysse (gel with lidocaine) doctors should verify that the lot numbers on the box and packaging of the syringe do not match those mentioned above.
If there is any quality problem or adverse incident related to the use of Restylane Kysse or other medical devices, the agency asked to report it in the Online Medical Device Adverse Incident Reporting System.
