• 07
  • February
    2012

The Food and Drug Administration (FDA) is reconsidering its stance on mesh implants after receiving more than 1,500 complaints between 2008 and 2010. The FDA may reclassify transvaginal mesh implants into a higher-risk category.

Since the 1990s mesh has been used in pelvic organ prolapsed (POP) surgeries, to treat a condition in which a woman's abdominal organs bulge into the vaginal area after a weakening of the tissue that holds the organs in place. Reuters reports that in 2010 approximately 75,000 women underwent POP surgeries in which mesh was used.

Initial Accelerated Application Process

Much of the mesh used in these surgeries was cleared for use by the FDA under the 501(k) accelerated application process. This process allows manufacturers to avoid conducting clinical trials involving people, if the product they are seeking clearance for is substantially similar to a product that the FDA has already cleared for use. During POP surgery, mesh is surgically inserted to reinforce the weakening tissue.

However, many women experience adverse side-effects from the mesh, including:

  • mesh erosion,
  • bleeding and
  • infection

Due to the number of complaints about the side effects of the mesh, Reuters notes that mesh complications were "not rare" and, in fact, surgeries involving mesh may put patients at "greater risk than other surgeries and treatments."

Additionally, the FDA is calling on manufacturers to conduct studies of the risks and benefits of using the mesh for POP and urinary incontinence surgeries. The FDA is asking these companies to look into the side effects and the overall quality of life for women who have undergone surgeries involving their mesh.

Source: Reuters, FDA wants new studies on surgical mesh implants," Anna Yukhananov, Jan. 5, 2012