Benefits and risks

Information for the public

When NICE looked at the evidence, it decided that there is not much good evidence about how well this procedure works or how safe it is. The 5 studies that NICE looked at involved a total of 19 patients.

The studies showed that the procedure closed the fistula at the first attempt in 12 out of 16 patients. The risks of insertion of a collagen plug included:

the fistula not closing after the first attempt, or closing but then coming back several months later, needing further surgery. One person had the procedure 3 times in total, but the fistula did not close
the silicone footplate moving out of the fistula, inside the body, and causing fluid to collect or an abscess. One person died from complications after surgery to remove a footplate that had moved into the body
1 person died 1 month after the procedure, from an infection and multiple abscesses.

NICE was also told about the risk of severe pain during the procedure, leading to the patient needing general anaesthesia.

If you want to know more about the studies, see the guidance. Ask your health professional to explain anything you don't understand.