Skeptical panel picks at, then backs, Adcon-L

BETHESDA, Md. - An FDA advisory committee on Friday grudgingly recommended that the agency approve Gliatech Inc.'s Adcon-L anti-adhesion gel for the prevention of scarring following lumbar disc surgery on the condition that there is no mention on the label of effects on pain.

Several members of the Orthopedics and Rehabilitation Devices Advisory Panel qualified their recommendation for approval by stating that GLIA demonstrated only marginal efficacy. They also debated the basic mechanism for the product's efficacy: that reducing the extent of scarring resulting from lumbar surgery is a significant benefit to patients...