FDA Panel Recommends Approval of Genzyme’s Seprafilm
WASHINGTON (AP) _ A special membrane that helps reduce a dangerous type of scar tissue in surgery patients should be approved for sale, scientists told the Food and Drug Administration on Monday.
A panel of scientific advisers voted 5-1 to approve Genzyme Corp.’s Seprafilm, a thin membrane made with an acid that naturally lubricates human tissues.
The FDA isn’t bound by but usually follows advisory committee decisions.
Seprafilm is intended for use in abdominal and gynecological surgery to reduce adhesions. This type of internal scar tissue joins tissues and organs that normally are separate, leading to such complications as chronic pain or intestinal obstruction.
Seprafilm is to be placed over a surgical wound just before the surgeon sews up the patient. The temporary barrier is supposed to lubricate the wound and prevent scar tissue from forming so readily.
The film dissolves in a few days, and the body naturally excretes it.
In a study of abdominal surgery, 51 percent of Seprafilm patients formed no adhesions vs. 6 percent of patients treated without the membrane.
Genzyme estimates that Seprafilm could be used in 3 million surgeries a year.