The QMN Weekly Bulletin
Medical Devices / Postmarket Safety

Boston Scientific Updates Warnings on Pelvic Mesh Products

Aug. 5, 2016

Boston Scientific has issued updated warnings for 16 of its pelvic mesh products, labeling meshes as permanent implants and warning of complications associated with removal.

The device giant added new directions for use and precautions, warning that regardless of the route of delivery, meshes have been linked to erosion, and treatment of adverse events would require surgical intervention if possible.

“Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications,” the new precautions section warns, adding that “the response to these events may persist as a permanent condition after the intervention.”

The list of possible adverse events was updated to include: perforation or laceration of vessels, nerves, bladder urethra or bowl may occur during placement, scarring and ongoing pain.

Last year, Boston Scientific was fined $100 million in a pelvic mesh lawsuit. A jury found the company guilty of negligence, failing to warn patients and doctors about possible risks. However, in October, a Delaware judge reduced the fine to $10 million.

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