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Urogynecology: FDA Reclassifies Transvaginal Mesh Implants

Terri Ackerman

Last updated: November 9, 2016 9:13 pm

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On January 4, 2016,  the U.S. Food and Drug Administration (FDA) reclassified transvaginal mesh implants as class III, or high-risk, medical devices. Class III medical devices require FDA premarket approval application (PMA). 1

Transvaginal mesh has been used to surgically repair pelvic organ prolapse (POP). The FDA approved transvaginal mesh as a class II, or moderate-risk, device, in 2002. 2

Dangers of Transvaginal Mesh Implants

Since the FDA approved transvaginal mesh implants for pelvic organ prolapse in 2002, the FDA has received thousands of reports regarding the dangers of transvaginal mesh. Complications and side effects of transvaginal mesh have included “pain during intercourse, infection, and erosion into surrounding tissues.” 3

In 2008, the FDA began issuing safety warnings regarding transvaginal mesh implants. Then, in May 2014, the FDA “proposed orders for the reclassification and PMA requirement” for these urogynecology medical devices. 4

Urogynecology Device Reclassification Applies Only to POP Treatment

The reclassification of transvaginal mesh implants “applies only to surgical mesh marketed for transvaginal treatment” of pelvic organ prolapse, known as POP. The change does not apply “to the device’s use for indications such as stress urinary incontinence or abdominal repair of POP.” 5

Urogynecological Devices Requiring PMA

Based on the FDA’s requirements, “Manufacturers of surgical mesh already on the market for the transvaginal indication will have 30 months to submit a PMA.” In addition, all manufacturers will have to submit a new PMA “for any new mesh proposed for use for transvaginal repair of POP.” 6

Prior to January 4, 2016, while designated as a class II medical device, transvaginal mesh implants for POP did not have to undergo stricter class III medical device premarket approval. Instead, “transvaginal mesh devices were approved by the FDA through the relatively simple 510(k) process…” 7

The 510(k) process requires “only that a prior similar device had been approved” and does not require rigorous research studies. Because “transvaginal mesh implants for POP were originally approved using full-length midurethral slings as the prior approved device,” they were approved quickly and didn’t require extensive clinical trials. 8

Many problems with these devices, however, have been demonstrated, promptly the new FDA requirements for transvaginal mesh implants, which include:

  1. New transvaginal mesh POP devices must be reclassified from class II to class III devices and must go through the more rigorous PMA process.
  2. Existing transvaginal mesh POP devices must comply with Section 522 studies, which allow the FDA to require postmarket surveillance and gather additional safety data for a device that has been cleared. 9

Transvaginal Mesh for POP Deemed High Risk

The FDA has determined that transvaginal mesh implants are high-risk devices when used to surgically repair pelvic organ prolapse. In December 2015 and January 2016, separate juries concluded that Johnson & Johnson’s pelvic mesh implants led to serious injury and awarded millions of dollars to the injured parties. 10

Other lawsuits are currently pending. 11  While past lawsuits are no prediction or guarantee of future results, women who experienced complications after receiving a transvaginal pelvic mesh implant may want to seek legal advice as to whether they should bring a lawsuit to be compensated for their  pain and suffering.

  1. http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/urogynecologists-speak-fda-reclassification-welcome; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm 

  2. http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/urogynecologists-speak-fda-reclassification-welcome; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm 

  3. http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/urogynecologists-speak-fda-reclassification-welcome; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm 

  4. http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/urogynecologists-speak-fda-reclassification-welcome; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm 

  5. http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/urogynecologists-speak-fda-reclassification-welcome; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm 

  6. http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/urogynecologists-speak-fda-reclassification-welcome; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm 

  7. http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/urogynecologists-speak-fda-reclassification-welcome; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm 

  8. http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/urogynecologists-speak-fda-reclassification-welcome; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm 

  9. http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/urogynecologists-speak-fda-reclassification-welcome; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm;
    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostmarketSurveillance/ucm134497.htm 

  10. https://www.law360.com/articles/758125/philly-pelvic-mesh-verdicts-spell-trouble-for-j-j; https://www.law360.com/articles/757629/j-j-hit-with-13-5m-verdict-in-2nd-philly-pelvic-mesh-trial 

  11. https://www.law360.com/articles/758125/philly-pelvic-mesh-verdicts-spell-trouble-for-j-j; https://www.law360.com/articles/757629/j-j-hit-with-13-5m-verdict-in-2nd-philly-pelvic-mesh-trial