GalaFLEX is a trio of surgical scaffolds placed in the body for support during a procedure. They provide internal reinforcement to tissues that need strengthening or repair, encouraging regeneration and growth of your own natural tissue. Along with breast implant surgeries and revision procedures, GalaFLEX products were typically used in various surgeries related to weak or compromised tissue, as well as in non-implant surgeries such as breast lifts, breast reduction, and mastectomies.
Described as “knitted monofilament surgical scaffolds,” they’re made from P4HB, a porous polymer (naturally found in your body) that has been cleared for sale in the United States and Europe since 2007. P4BH is created via a biological fermentation process, a common method of pharmaceutical production that’s considered safe. So far, more than three million patients worldwide have had P4HB devices implanted during a surgical procedure.Â
Surgical scaffolds provide immediate soft-tissue support, so you’ll see instant fullness or lift where tissues or fibers were once lax or sagging. The scaffold temporarily bears the load while new tissue grows into its porous material, replacing the polymer that’s slowly “bioresorbed” into your body over the next 18 to 24 months.
According to the manufacturer's studies, the surgical area becomes three to four times stronger after the scaffold is absorbed.
GalaFLEX offers three types of surgical scaffolds.Â
GalaFLEXÂ scaffolds are indicated and FDA-approved for use where there may be weaknesses or voids in soft tissue that need extra support.Â
“I have used GalaFLEX over the past two years, and my main indication is women with weaker tissues, such as in massive-weight-loss patients,” says Dr. Michael Edwards, a plastic surgeon in Las Vegas, in a RealSelf Q&A.Â
“The goal is to provide additional support [in order] to try to prevent [a breast] implant from sitting too low and to try to maintain good position. In terms of safety, I have personally not had any issues, and it is absorbed over time by your body.”
GalaFLEXÂ scaffolds do have some potential risks, including infection, seroma (a buildup of fluid), pain, scaffold migration, hemorrhage, hematoma (when blood pools outside a vessel), and inflammation.
Updated June 13, 2023