FDA WARNING_LETTER - Surgisil, LLP - September 25, 2018

On April 15, 2019, the FDA issued a Warning Letter to Surgisil, LLP, following an inspection from September 20-25, 2018, at their Plano, TX facility. The inspection revealed that Surgisil's Perma Facial Implant is adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) for its current marketing.

While the Perma Facial Implant has 510(k) clearance (K071823) for use in the nose, chin, and cheeks, the FDA found that Surgisil is marketing the device for lip augmentation. This constitutes a major change in intended use, as evidenced by instructional videos and training materials specifically detailing lip implantation. The FDA highlighted anatomical differences in the lips (vascularity, high mobility, lack of bone support) that increase risks like migration, protrusion, extrusion, infection, and chronic pain when the device is used for lip augmentation.

Additionally, the FDA cited misleading promotional materials on Surgisil's website (www.surgisil.com/us/), which falsely state the Perma Facial Implant is "FDA approved," when it was only found substantially equivalent. The firm was also found to be marketing the unapproved PermaLip Implant, as indicated by its promotion on the "