Boston Scientific Recalls ORISE Gel, Used for Complex Mucosal Resections

Late last year, biomedical/biotechnology engineering firm Boston Scientific Corporation voluntarily initiated a US Food and Drug Administration (FDA) class 2 device recall for its ORISE Gel Submucosal Lifting Agent.

This agent, indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers, or other gastrointestinal mucosal lesions prior to excision with a snare or other suitable endoscopic device, was recalled “due to higher incidence of adverse events of foreign body reactions,” according to the FDA website.

Repeat endoscopies after the use of this product have noted a robust foreign body reaction that has led, in a few cases, to a suspicion of malignancy with biopsies or surgical resection that turned out to be negative. Surgeons should be aware of this recall so that they can ask about the use of this product in patients who may be referred to them for resection.

The FDA website has additional instructions and contact information for Boston Scientific to initiate return of unused products.