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Animal-Derived Implant Found 'Relatively Effective'


 

VAIL, COLO. — An animal-derived extracellular matrix implant could be a longer-lasting alternative to the short-lived fillers used to augment nasolabial folds, lips, and glabella, Dr. Edmund A. Pribitkin said at a symposium sponsored by the American Academy of Facial Plastic and Reconstructive Surgery.

Dr. Pribitkin has used the Food and Drug Administration-approved Surgisis soft tissue graft, which is made from the small intestinal submucosa of pigs, to augment those locations on patients in his practice.

In his experience with using Surgisis to augment nasolabial folds, "the longest person is a year out, so we can't really say anything beyond that. We do seem to get improvement more in people who are thin, who don't have a lot of extra jowling or extra cheek fat that you're really going to have difficulty filling in," said Dr. Pribitkin, professor in the department of otolaryngology-head and neck surgery at Jefferson Medical College, Philadelphia.

Dr. Pribitkin placed the implant at no charge in the nasolabial folds of 15 consecutive women whom he had seen previously for other procedures. Currently, eight patients have 10–12 months of follow-up, five have 7 months, and two have 6 months. Eleven of the women were satisfied early with the implant and said that they would pay to have it done. Two patients wanted more augmentation, and another two thought that it didn't help at all.

At 6 months, 8 of 15 women were satisfied with the results of the implant, but after almost a year, 3 are asking, "'Did I have something done?'" he said.

In eight patients who have undergone lip augmentation, the implant has "been relatively effective" in treating seven upper lips and eight lower lips, he noted.

"Generally speaking, the problem with the lips is—at least in most cases—it's never enough. They want more and more augmentation of the lips," Dr. Pribitkin said at the symposium, which also was sponsored by the American Society for Dermatologic Surgery and the American Society of Ophthalmic Plastic and Reconstructive Surgery.

Before the procedure, patients use a pHisoHex (hexachlorophene) scrub in the morning and do not apply any makeup, and the treatment area is swabbed with alcohol prior to incision. The implant, with a trocar attached, is soaked for about 5 minutes.

With the patient under local anesthesia with 1% lidocaine and epinephrine, the round-shaped trocar is inserted into a stab incision of the lower portion of nasolabial fold. A second stab incision is made in the upper portion of the fold. The implant is run through the incision at a point just underneath the dermis—not deep in the subcutaneous tissue but at the dermal-subcutaneous interface—while the surgeon tries not to touch the implant with gloves.

The implant rolls up on itself as it is pulled through. It is cut at both ends and pulled tight, and one fast-absorbing gut suture is sewn at each point of incision. The patient is then given a dose of antibiotics.

He disclosed that he is a consultant to Cook Biotech Inc., which manufactures Surgisis. The company did not sponsor the use of the implant in facial augmentation, but did provide materials free of charge for evaluation in this trial.

This patient is shown at baseline (top) and 3 months after receiving the Surgisis implant in her nasolabial folds. Photos courtesy Dr. Edmund A. Pribitkin

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