FDA warns Surgisil for unapproved facial implant marketing

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So how do you know which implant. In July 2008, FDA officials warned that Infuse, approved only for oral, facial, and lower spine procedures, can cause severe breathing problems when used off-label.

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DEVICE | Surgisil, LLP. Surgisil, LLP (Plano, TX) received a warning letter on April 15, 2019 based on the outcome of an inspection ending September 25, 2018. The firm manufactures the Perma Facial Implant. The device is adulterated because the firm did not have an approved premarket approval (PMA) or an approved IDE.

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Warning Letters; Surgisil, LLP – 567886 – 04/15/2019. states that the "Perma Facial Implant is a patented, FDA approved device designed for tissue augmentation of the face and has undergone.

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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.

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