Will Transvaginal Mesh Become an FDA High Risk Medical Device?

On April 29, 2014, the FDA proposed a significant change in how pelvic mesh should be classified in the United States. If the proposal goes into effect, plastic transvaginal pelvic mesh that is used to treat pelvic organ prolapse would be reclassified as a high risk medical device.

What Does This Mean?

If you have already had transvaginal mesh surgery at Norton Hospital or you are considering surgery at a Louisville hospital then you may have questions about the FDA proposal.

Here is what we know so far:

  • Transvaginal mesh is currently classified as a moderate-risk medical device. This classification requires less rigorous testing than high risk medical devices require.
  • The FDA is proposing the change in classification because of the reports of pain, bleeding, and infection received over the last few years. The proposal comes approximately three years after the FDA first found that women who have transvaginal mesh to treat their pelvic organ prolapse have higher complication rates than women who have other kinds of surgeries to treat these conditions.
  • If the proposal is finalized, the makers of transvaginal mesh products would need to establish that their products are safe and effective before they could be sold.

A chief scientist for the FDA’s medical device center has reportedly explained the proposal this way, “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….”

What Now?

Comments on the FDA’s proposal will remain open for 90 days. Sometime after that a decision will be made by the federal agency that will affect women in Louisville, Kentucky, and throughout the United States.

Please like us on Facebook and check our blog often for updates to this important story.


Mark K. Gray
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Louisville attorney serving the seriously injured in Kentucky
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