The researchers evaluated the safety and persistence of the PEG-HA implants with a 12-week experiment in three volunteers already undergoing abdominoplasty, or "tummy tucks." Technicians injected about five drops of PEG-HA or HA alone under the belly skin. None of the participants experienced hospitalization, disability or death directly related to the implant, which was about 8 mm longor about as wide as a pinky fingernail. However, the participants said they sensed heat and pain during the gel setting process. Twelve-weeks after implantation, MRI revealed no loss of implant size in patients. Removal of the implants and inspection of the surrounding tissue revealed mild to moderate inflammation due to the presence of certain types of white blood cells. The researchers said the same inflammatory response was seen in rats, although the types of white blood cells responding to implant differed between the rodents and humans, a difference the researchers attribute to the back muscles the target tissue in the ratsbeing different than human belly fat.
"We still have to evaluate the persistence and safety of our material in other types of human tissues, like muscle or less fatty regions under the skin of the face, so we can optimize it for specific procedures," says Elisseeff.
Elisseeff said the team has especially high hopes for the composite's use in people w
|Contact: Vanessa McMains|
Johns Hopkins Medical Institutions