FDA Takes Steps to Diminish the Risks Associated with Transvaginal Mesh

After years of lawsuits and complaints about transvaginal mesh, the U.S. Food and Drug Administration (FDA) has issued proposals to address the risks associated with transvaginal repair of pelvic organ prolapse (POP).

If the orders are finalized, the following would occur:

  • Surgical mesh used for transvaginal repair of POP would be reclassified from a moderate-risk device (class II) to a high-risk device (class III)
  • Manufacturers would have to submit a premarket approval application to the FDA so that their devices would be evaluated for their safety and effectiveness

In the words of the deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health, "The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products."

Who Would Benefit from the Finalized Orders

If the orders are finalized, it seems likely that fewer women would endure the painful side effects associated with transvaginal repair of POP and fewer lawsuits would be filed as a result. It would be a notable victory for women who have suffered from transvaginal mesh and who have tried to get the word out about its dangers.

Big name manufacturers, however, are sure to not like these developments. Examples of some of the more popular manufacturers of surgical mesh include the following:

  • American Medical Systems (AMS)
  • Boston Scientific
  • C.R. Bard
  • Ethicon
  • Tyco Healthcare (now Covidien)

What is POP?

POP is when the internal structures that support the pelvic organs (such as the bladder, uterus and bowel) become so weak that the organs drop from their normal position and prolapse into the vagina. Women with POP tend to suffer from pelvic discomfort, as well as the disruption of sexual, aurinary, and defecatory functions.

Past FDA Warnings About the Risks of TVM

Surgical mesh can provide support to weakened tissue, but not without risk.

Past warnings issued by the FDA concerning surgical mesh have included:

  • January 2012: Manufacturers were ordered to conduct postmarket surveillance studies to address safety and effectiveness related to transvaginal mesh
  • September 2011: The FDA's Obstetrics and Gynecology Devices Panel recommended that surgical mesh be reclassified from a class II to a class III device
  • July 2011: The FDA released an updated safety communication about the complications associated with transvaginal mesh as well as a review of the serious safety and effectiveness concerns

FDA warnings about the use of transvaginal mesh to repair pelvic organ prolapse can be traced all the way back to October 2008. Complications associated with transvaginal mesh include pain, bloating, abdominal inflammation, recurrence of POP and stress urinary incontinence, infection, mesh erosion, pain during sexual intercourse, bladder perforation, and depression.

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