Product News and Recalls

Many transvaginal mesh implants were unnecessary, caused complications

A Consumer Reports article on the hazards of certain medical devices recommends that patients protect themselves by considering what alternatives are available.

In the case of transvaginal mesh implants, for example, patients should ask their doctors what will happen if they don’t get the devices. According to the report, many women who received transvaginal mesh for pelvic organ prolapse – where the pelvic organs move out of alignment because of weakened muscles – never needed the surgery.

The report quotes Daniel S. Elliott, M.D., assistant professor of urology at the Mayo Clinic College of Medicine, as saying: “Pelvic organ prolapse is almost never a life-threatening condition. It’s a quality-of-life issue. The overwhelming majority of women do not need to have surgery. If you’re not bothered by it, then don’t do anything. I think many patients weren’t adequately informed about that.”

Elliot said surgical remedies for prolapse that don’t require mesh are also available.

According to the report, the federal Food and Drug Administration approved the mesh through a loophole allowing medical devices that haven’t been safety tested in humans to go on the market, just because they’re allegedly similar to devices that have been previously approved. Thousands of complaints about malfunction, injury and death from the mesh implants have since surfaced.

If you or someone you love were injured because of transvaginal mesh, contact Lopez McHugh for a free case evaluation.

See the report here: http://www.consumerreports.org/cro/consumer-reports-magazine/May-2012/medical-devices.html