Plano, Texas devicemaker Surgisil 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,” but the company was marketing its Permalip implant for lip augmentation.
Lip augmentation “constitutes a major change/modification to its intended use” for which the firm lacked approval, the agency said. It warned that use of the PermaLip Implant in lip augmentation could cause the device to shift out of place or protrude due to the lips’ anatomical and physiological differences from the nose, cheeks and skin, warning that infections, chronic pain and the need for surgical removal could follow.
The agency’s investigators examined the company’s instructional videos and marketing materials on its website, finding that they misled patients into believing the device could be used for the unapproved use. For example, the firm’s three-minute facial implant instructional video covered the use of the facial implant in lip augmentation.
The agency also flagged a 12-item surgical checklist that instructed surgeons on using the facial implant, included a procedure for lip augmentation.
The FDA noted that the firm’s website stated the implant is an “FDA approved device” and requested that it remove the false claim.
“The PermaLip Implant is not cleared or approved by FDA for marketing in the United States,” the agency said. “Our office requests that your firm immediately cease activities that result in the misbranding or adulteration of the Permalip Implant, such as the commercial distribution of the device for the uses discussed above.”
Read the Surgisil warning letter here: www.fdanews.com/05-09-19-Surgisil.pdf. — James Miessler
Personnel Requirements for CAPAs
Companies putting together CAPA teams need to assign the following individuals:
Excerpted from the FDAnews management report: Creating QSR-Compliant CAPA Systems: A Practical Guide for Devicemakers.