Dive Brief:
- FDA has sent a warning letter to plastic and cosmetic surgery device maker Surgisil instructing the company to cease marketing two lip implant devices not indicated for that purpose, the agency disclosed Tuesday.
- Surgisil's Perma Facial implant is cleared for use in plastic and reconstructive surgery of the chin, jaw, nose and bones or tissue near the eye or ear. However, the company has been illicitly marketing the device for lip augmentation, the warning letter stated.
- Additionally, regulators warned the Plano, Texas-based company to cease distribution of a second, unapproved device called the Perma Lip implant.
Dive Insight:
FDA granted 510(k) clearance to Surgisil in 2007 to market its Perma Facial implants in plastic and reconstructive surgery for cosmetic augmentation and corrections in the face, specifically the nose, chin and cheeks. The pre-formed silicone implants come in various sizes with tapered ends to reduce visibility after implantation.
In the warning letter posted Tuesday, the agency said it learned during a September 2018 inspection of the company's Plano operations that Surgisil was marketing the Perma Facial device for lip augmentation, a use for which it is not indicated, making the device adulterated.
FDA noted that the lips differ physiologically and anatomically from the nose, chin and cheeks in vascularity, mobility and bone support. Use of the Perma Facial implant in the lips may cause the device to migrate or protrude due to lack of bone structure in the lips.
Additionally, FDA warned the "free-floating nature" of an implanted device increases risks for device extrusion, which could require surgical removal and extensive dermal repair. Migration and protrusion also increases the risk of infection and chronic pain, the agency said.
The agency said Surgisil marketed the implant for lip augmentation in a three-minute instructional video covering materials and procedures for the device. The video shows the device being implanted in the upper and lower lips of a patient. The company also created a 12-item training checklist for medical directors and surgeons to implant the Perma Facial implant in the lips.
FDA said the company also indicated on its website that it would be exhibiting both the Perma Facial and unapproved Perma Lip devices at two cosmetic surgery conferences in 2019.
Regulators asked the company to cease commercial distribution of the Perma Lip device and to stop marketing the Perma Facial device as a lip implant. The agency also instructed Surgisil to remove from its website a statement saying that the agency has approved the Perma Facial device, and warned that failure to correct the violations could result in seizure, injunction and monetary penalties.
