October 1, 2011

In October 2010, a federal court agreed to consolidate 21 lawsuits against a medical device manufacturer. A few weeks ago, another 29 plaintiffs asked to join that consolidated action. All the plaintiffs are women who have suffered serious injuries from transvaginal mesh products made by the defendant company.

Last year’s suits concerned just three mesh products. These more recent complaints add six more brands to that list of dangerous products. Patients’ claims for the most part include negligent design and failure to warn.

The mesh products are used to treat pelvic organ prolapse, a condition caused by weakened internal support for lower abdominal organs, including the uterus, bladder and bowels. The mesh is surgically implanted to prevent the organs from bulging into the vagina.

Vaginal mesh products have been on the Food and Drug Administration’s radar for several years. The FDA issued a warning in 2008 that included all manufacturers’ vaginal mesh products. In July, following a dramatic increase in the number of reports of adverse events, the agency followed up with a stronger warning.

The notice, from the FDA’s Center for Devices and Radiological Health, asked surgeons “to carefully consider all other treatment options,” as well as “to make sure their patients are fully informed of potential complications from surgical mesh.” The mesh products expose patients to unnecessary risk for very little benefit. Other treatment options likely have better outcomes and fewer risks.

The complications include vaginal erosion, pain, and erosion or extrusion of the mesh. The mesh has also hardened or shrunk. The mesh is implanted permanently — reversal of any of these side effects is difficult if not impossible.

An FDA panel is currently considering options for vaginal mesh products. Reportedly, the agency is leaning toward a reclassification to Class III. Class III is the rating just before recall.

While the FDA works on its approach, the three major manufacturers of vaginal mesh are pondering their own options. Reportedly they agree that additional safety testing may be in order and that new labels containing specific warning information would be appropriate. For new medical applications of the mesh, the companies recommend clinical testing.

Source: Massachusetts Medical Devices Journal, “Mesh lawsuits pile up for C.R. Bard,” MassDevice staff, Sept. 29, 2011


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