Summary Safety Review - Barbed (knotless) sutures - Assessing the potential risk of intestine blockage (small bowel obstruction)

January 5, 2018

Product

Barbed (knotless) sutures

Potential Safety Issue

Blockage of the small intestine (small bowel obstruction)

Key Messages

  • Barbed sutures (also known as knotless sutures) are medical devices that are used to close tissues or wounds.
  • Reports were published that a portion of barbed suture used during surgeries appeared to hook onto part of the small intestine, leading to a blockage and another surgery.
  • After reviewing the available information, Health Canada has confirmed the potential for barbed sutures used in surgeries in the stomach area and below (e.g., abdomen or pelvic regions) to hook onto the small intestine and create a blockage.
  • Health Canada will work with manufacturers to update the safety information for all barbed sutures to include details about this potential risk. Health Canada will also publish a Health Product Risk Communication to raise awareness of this potential risk and the updated safety information.

Overview

Health Canada reviewed the potential risk of blockage of the small intestine when barbed sutures are used. Health Canada conducted the review after becoming aware of published reports that a portion of a barbed suture used during surgeries became hooked onto a part of the small intestine, leading to a blockage and another surgery.

Use in Canada

  • Barbed sutures are medical devices authorized for sale in Canada to close tissues or wounds. They have many thorn-like barbs along the length of the thread so the suture can pass through tissue in one direction but not the other, eliminating the need for tying a knot.
  • Barbed sutures have been marketed in Canada since 2009. They are available in various versions (i.e., some are absorbed by the body over time, while others are not) and are currently sold in Canada by four different manufacturers.

Safety Review Findings

  • At the time of the review, Health Canada had not received any Canadian reports of problems regarding barbed sutures and blockage of the intestine.
  • A review of published medical reports found 27 cases of blockage of the small intestine that were specifically linked to the use of barbed sutures. Out of these 27 cases, the blockage was noticed anywhere between 1 day and 4 months after surgery, with most cases between 2 and 4 weeks after surgery. All 27 cases required another surgery to treat the blockage. Most patients were able to leave the hospital during the first week after the surgery, but one patient with more severe intestinal damage had to have part of the small intestine removed, and spent an extra 2 months in the hospital.
  • It seems that the intestine becomes blocked when either the cut end of the thread or a barb sticks into the wall of the small intestine, causing a kink. Some authors of the reported cases suggest that either cutting the end of the suture so that it is even with the surface of the tissue or covering the cut end of the suture with another device, such as a barrier or clip, may reduce the risk of intestinal blockage with barbed sutures. However, some cases of blockage have been reported even when a barrier or clip is used.

Conclusions and Actions

  • Health Canada's review of the available information has confirmed the potential for barbed sutures used in surgeries in the stomach area and below to hook onto the small intestine and result in a blockage.
  • The current safety information for barbed sutures does not describe this risk. Therefore, Health Canada will work with manufacturers to update the safety information for all barbed sutures to include details about this potential risk. Health Canada will also publish a Health Product Risk Communication to raise awareness of this potential risk and the updated safety information.
  • Health Canada will continue to monitor safety information involving barbed sutures, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international safety information and what is known about the use of this device both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

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