Washington, DCTransvaginal mesh implants that have been linked to injuries in women with pelvic organ prolapse, are being removed from the market by their manufacturer, Johnson & Johnson (J&J) over the next three to six months. Transvaginal Mesh and Transvaginal Slings are medical devices that are surgically implanted to treat Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI).
Hundreds of personal injury lawsuits have been brought against J&J by women who have suffered injuries resulting from the mesh products. According to a report by the Associated Press, J&J sent a letter Monday to judges in New Jersey and West Virginia who are overseeing patient lawsuits the company is facing.
Since 2005 more than 1,000 TVT sling complaints from nine different manufacturers have been reported to the FDA, which culminated in a FDA safety alert in 2008 about serious complications associated with the use of mesh products--also known as pelvic or vaginal mesh and bladder slings-- in treatment of SUI and POP. A number of women have undergone surgeries to have the mesh removed. In 2009 the FDA issued another FDA safety alert. According to the FDA, about 1,500 reports were filed between 2008 and 2010.
In January 2012, the FDA ordered the makers of transvaginal surgical mesh products to study the risks associated with the products. The order came following the recommendation of an FDA advisory panel in September 2011. According to the FDA, between 2008 and 2010 the number of adverse events reports to the FDA about transvaginal meshes increased five times. Not all surgical mesh products are affected by the FDA's order; those that are implanted through the abdomen are not included.
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