Summary Safety Review - SurgiWrap Adhesion Barrier Film - Assessing the potential risk of foreign body reactions that mimic local re-appearance of cancer

March 9, 2018

Product

SurgiWrap adhesion barrier film

Potential Safety Issue

Foreign body reactions (FBRs, reactions to foreign materials in the body) that may mimic the local re-appearance of cancer

Key Messages

  • SurgiWrap is a medical device authorized for sale in Canada to be placed inside the body during surgery to prevent internal scar tissues (adhesions) from forming.
  • Health Canada reviewed the potential risk of the development of foreign body reactions (FBRs) to SurgiWrap which could produce a mass that mimics a local re-appearance of cancer. This safety review was triggered after Health Canada became aware of published articles that suggested this risk which could lead to additional and unnecessary medical procedures and increase stress for patients.
  • Health Canada’s review of the available information did not find enough evidence to link SurgiWrap to the development of FBRs mimicking the re-appearance of cancer. Since the Instruction for Use manual for SurgiWrap contains a warning for FBRs, Health Canada concluded that no additional safety measures are needed at this time. Health Canada will continue to monitor the safety of SurgiWrap.

Overview

Health Canada reviewed the potential risk of FBRs to SurgiWrap, which could produce a mass that may look like a re-appearance of cancer. Some scientific publications have described this risk after surgery for women’s reproductive system cancers (i.e., gynaecological cancers).

SurgiWrap adhesion barrier film is a physical barrier placed inside the body during surgery to prevent adhesions, which are types of internal scar tissue that can form around the surgical area. It is also used to help with healing by acting as a temporary support for soft tissue.

Use in Canada

  • SurgiWrap is a medical device authorized for sale in Canada to be placed inside the body during surgery to help with the procedure and to prevent adhesions from forming. It is also used to help with healing by acting as a temporary support for soft tissue.
  • SurgiWrap has been marketed in Canada since 2003.

Safety Review Findings

  • During the review, Health Canada identified one Canadian report of the development of a FBR to SurgiWrap. However, the report did not suggest mimicking re-appearance of cancer.
  • Health Canada reviewed six international reports of FBRs to SurgiWrap. These reports also did not suggest mimicking of cancer re-appearance.
  • Health Canada reviewed four publications suggesting that FBRs mimicking cancer re-appearance are linked to SurgiWrap. However, it was not possible to conclude such a link due to a lack of patient information and medical history in these publications.

Conclusions and Actions

  • Health Canada’s review concluded that there is currently not enough evidence to link the use of SurgiWrap to the development of FBRs mimicking the local re-appearance of cancer. No Canadian reports of FBRs were found that describe this side effect. The safety information for this product is suitable at this time as the Instructions for Use manual already contains a warning that FBRs may occur.
  • Healthcare professionals are encouraged to consider this potential risk for the management of patients with cancer when SurgiWrap is used.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of this and other health products.
  • Health Canada will continue to monitor safety information involving SurgiWrap, 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 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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