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# FDA Says Surgisil Selling Device without Approved PMA
- URL: https://www.fdaweb.com/fda-says-surgisil-selling-device-without-approved-pma/
- Published: 2019-04-30T12:00:00.000Z
- Updated: 2026-09-15T01:23:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143985

A 9/20-9/25/18 FDA inspection at Surgisil, Plano, TX, found that the firm is manufacturing the Perma Facial Implant without an approved PMA or IDE in effect. A 4/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/surgisil-llp-567886-04152019?ref=fdaweb.com) says the company has a cleared 510(k) for the device “intended for use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections in the face, including areas such as the nose, chin, and cheeks.”

FDA says its inspection and review of the firm’s instructional videos and training materials indicates that it is marketing the Perma Facial Implant for augmentation of the lips, which constitutes a major change/modification to its intended use, for which Surgisil lacks approval.

The letter also says the firm’s Web site showed that the device labeling in terms of its promotional materials contains statements that are misleading in that they create an impression of official approval of a device due to clearance of a premarket notification submission. The agency says it did not “approve” the device, as stated on the Web site, but rather found it to be substantially equivalent within the meaning of the law.

Finally, FDA says its Web site review found that Surgisil is marketing an unapproved device, the PermaLip Implant.

“We have not received any written response to our inspection as of the date of this letter,” the agency says. “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.”

Surgisil was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each step, and a timetable for completion.