Boston Scientific added new safety warnings to the labels of its most heavily litigated products — surgical mesh devices used to repair pelvic disorders in women.
The Marlborough, Mass.-based device manufacturer has faced more than 35,000 product liability lawsuits from women claiming injury when their devices became infected or eroded surrounding tissue. Lawsuits cite flaws in design and manufacturing, failure to warn of known dangers, breach of warranty, fraud and loss of consortium.
Boston Scientific added "erosion" and "ongoing pain" to the list of warnings on the medical devices this week. The new label will state that meshes and slings are considered permanent implants, warning that removal can be complicated or impossible.
The label changes affect five brands of slings — Advantage, Lynx, Obtryx, Obtryx II and Solyx — and three types of mesh — Uphold LITE, Pinnacle LITE and Upsylon Y.
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