Curing Incontinence May Cause Greater Harm

Brenda Fulmer

Attorney
(866) 735-1102 Ext 703

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The Food & Drug Administration recently issued warnings to patients and physicians regarding the rising tide of complaints related to surgical mesh products. Specifically, the medical devices that are used in surgeries for women suffering from bladder incontinence. Although the reports indicate that this is a new problem, it really is an old story. The complications reported in the latest news releases from the FDA include chronic infections, extrusion of the devices, abscess formation, and vaginal erosion. These are the very same complications reported years ago with Boston Scientific’s troubled ProteGen bladder sling. That sling was removed from the market in 1999. For years after that, the sling manufacturer was involved in lawsuits filed by hundreds of women who had suffered tragically catastrophic injuries due to the defective devices.

There has also been more recent litigation over the use of Mentor ObTape, a similar product utilized in incontinence surgeries. Unfortunately, the withdrawal of Mentor ObTape has not received a great deal of notice by the public and physicians. A number of lawsuits relating to Mentor ObTape are now coordinated by a federal court in Georgia.

The latest update from the FDA notes that it has received more than 1,000 reports of serious complications associated with the use of surgical mesh products in surgeries to repair bladder or vaginal prolapse and to treat stress urinary incontinence. These reports have come from nine different manufacturers, which certainly raises the question whether virtually all of these products are potentially defective or inappropriate for the recommended use in all patients.