Summary Safety Review - Esophageal Stents - Assessing the Potential Risk of Bilateral Vocal Cord Paralysis
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Potential Safety Issue
Bilateral vocal cord paralysis, a rare, but serious, medical condition which occurs when the nerve impulses to the vocal cords are disrupted resulting in issues with speaking, breathing and swallowing.
Use in Canada
- Esophageal stents are medical devices authorized for sale in Canada that help allow for the proper passage of food and drink from the mouth to the stomach, through the esophagus. They are metal or plastic hollow tubes placed inside the esophagus to widen areas that have become narrow due to cancer or scarring, or to seal off leaks in the esophagus. Esophageal stents may only be implanted by a physician.
- Esophageal stents have been marketed in Canada since 1998 under various brand names.
Safety Review Findings
- Health Canada reviewed information from the Canadian incident reporting database, and medical and scientific literature.
- At the time of the review, Health Canada had not received any Canadian reports of bilateral vocal cord paralysis related to esophageal stent placement.
- Health Canada reviewed 7 articles from the published scientific literature. The literature reviewed could not conclude whether esophageal stents was associated with bilateral vocal cord paralysis, since this rare condition can also occur as a result of disease progression or as a consequence of other medical conditions that require stent placement.
Conclusions and actions
- Health Canada's review of the available information did not establish a link between the use of esophageal stents and the risk of bilateral vocal cord paralysis.
- Health Canada encourages healthcare professionals to report any side effects related to the use of esophageal stents.
- Health Canada will continue to monitor safety information involving esophageal stents, 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 should any new health risks be identified.
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 esophageal stents both in Canada and internationally.
For additional information, contact the Medical Devices Directorate.