Regulatory Focus™ > News Articles > 2019 > 4 > Texas Firm Draws FDA Warning Over Adulterated Device

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Posted 30 April 2019 | By Ana Mulero 

Texas Firm Draws FDA Warning Over Adulterated Device

2849 In a new US Food and Drug Administration (FDA) warning letter, Plano, TX-based Surgisil was urged to come into compliance with the marketing of its Perma Facial Implant over an unapproved intended use.

FDA conducted an inspection of Surgisil’s operations, including its website, last September and determined the firm had been marketing the Perma Facial Implant for augmentation of the lips. The device obtained 510(k) clearance for “cosmetic augmentation and corrections in the face, including areas such as the nose, chin and cheek.” But the cleared intended uses did not include lip augmentation.

Marketing the Perma Facial Implant for lip augmentation constituted a major change not covered in the clearance and lacked an approved premarket approval application or investigational device exemption.

As examples of the marketing practices that resulted in the device being adulterated, the warning letter pointed to a Perma Facial Implant instructional video and a Surgisil training checklist for surgeons’ use.

“The lips are physiologically and anatomically different from the nose, chin and cheeks, including in vascularity, high mobility and bone support,” said Shari Shambaugh, program division director at FDA’s Office of Medical Device and Radiological Health. “Due to lack of bone structure in the lips, the implanted device can ‘free float’ when compared to implantation in the other organs and thereby leading to migration and protrusion.” The “free-floating nature” of a lip-implanted device “exacerbates risks such as device extrusions,” which could “require surgical removal and extensive dermal repair.”

Several plastic surgeons have touted the use of the Perma Facial Implant for lip augmentation. Yet at least some cautioned about complications resulting from the technique.

The warning letter took issue with Surgisil’s claims about the Perma Facial Implant being FDA approved rather than cleared because clearance merely established substantial equivalence to an existing device. 

Surgisil’s PermaLip Implant was also cited for lacking approval or clearance prior to marketing in the US.

“We recognize and take seriously the significance of the observations in the warning letter and are committed to taking all actions necessary to ensure that our labeling and promotional activities are in compliance with FDA and international requirements,” Surgisil quality assurance manager Ellen Ballon told Focus. The firm has “taken swift action to completely address all violations” in the warning letter.

Warning letter


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