“PermaLip implants are soft, flexible silicone tubes, tapered at each end, that augment without shaping,” explains Dr. Steve Laverson, a San Diego plastic surgeon.
As the name implies, PermaLip implant results can be permanent, though “they’re easily removed if you don’t like them or if you have a problem such as migration, asymmetry, capsular contracture [a hardened capsule of tissue that can form around an implant] with immobility of lips, or a disappointing result.”
If you're considering PermaLip implants, it's important to be aware that they’re not approved by the U.S. Food & Drug Administration (FDA) for use in the lips.
Surgisil, the company that manufactures PermaLip, has FDA clearance for the Perma Facial Implant, with an indication for it to be implanted in the chin, jaw, and nose.
According to a warning letter the FDA sent to the company in April 2019, “use of the Perma Facial Implant for augmentation of the lips constitutes a major change/modification to its intended use for which you lack approval.”
The specific concern is that the physiological and anatomical differences between the lips and the nose, chin, and cheeks (lack of bone structure, for instance) allow the implant to “free float," which “may cause migration or protrusion of the implant.”
Indeed, some RealSelf members have reported that their lip implants have migrated or protruded.
Another issue, according to the FDA: “Since the lips are very actively used, the free-floating nature of implanted devices exacerbates risks such as device extrusions, which, when they occur, may require surgical removal and extensive dermal repair. Migration and protrusion also increase other risks to the patient, such as infection and chronic pain.”
Because the PermaLip implant is not cleared or approved by the FDA for marketing in the U.S., the FDA requested in its warning letter that Surgisil immediately stop distributing the device for use in the lip.
A disclaimer on the company website says that “the intended use of the PermaLip Product is not approved for distribution within the United States,” but it’s still featured on the company website and sold to plastic surgeons, many of whom mistakenly say on their websites that PermaLip is FDA-approved.
