A Plano, Texas devicemaker is in hot water with the FDA over its Perma Facial Implant, a device that is only cleared for cosmetic facial augmentation and augmentations in areas like the nose, chin and cheeks.
The agency sent a warning letter after a September 2018 inspection, flagging the marketing of the implant for an unapproved use. The agency said the device was "intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear.”
Surgisil marketed the device for lip augmentation, a use the agency said “constitutes a major change/modification to its intended use for which you lack approval.”
