Many familiar with transvaginal mesh have been aware of the risks for some time, but until recently, the Food and Drug Administration (FDA) had limited the classification of the devices. On January 4, 2016, that changed when the FDA announced two major updates to its position on transvaginal mesh.
The first was the reclassification of the transvaginal mesh device to a Class III device, which means the agency acknowledges users face potential high risks. Transvaginal mesh (TVM) was previously a Class II device, which indicated only moderate risk for users.
The second change for the FDA is that it will now require all TVM manufacturers to submit a pre-market approval application for their products. All new devices will need this approval before manufacturers can begin marketing their product and existing products require approval within the next 30 months.
This is not the first time the FDA has reassessed its position on TVM devices. Beginning in 2008, the agency issued a warning that using TVM to treat pelvic organ prolapse appeared to increase the risk for adverse events. In 2011, an advisory panel was created to further examine the dangers associated with the device and in 2012, the FDA ordered further studies on TVM devices already on the market. The initial proposal for the recent reclassification was discussed beginning in 2014.
Many affected by and familiar with TVM dangers are happy the changes have finally taken place and hope that fewer women in the future will have to suffer.
Why is Transvaginal Mesh Dangerous?
The mesh used in TVM devices was originally intended to be used for treating hernias. Since it was already approved for that purpose, manufacturers were only required to submit the product through the FDA's 510 (k) Premarket Notification Process for treating pelvic organ prolapse, which meant no additional testing was needed even though the device was being used in a different procedure.
Unfortunately, as many patients soon learned, the mesh used for treating hernias did not function the same when it was used to treat pelvic organ prolapse, and many experienced mesh erosion following their procedures. This erosion creates a number of subsequent problems, including:
• Organ perforation, usually in the bowel, rectum, uterus, or bladder
• Excess scar tissue which can interfere with a woman's ability to have intercourse
• Permanent incontinence
• Need for revision surgery
Because the TVM devices had not been tested in treating pelvic organ prolapse, patients and doctors were unaware of the risks until problems arose. The FDA's reclassification will help to call attention to the problem and alert women and doctors to the fact they should consider TVM high risk and weigh that against any benefit they would gain from using the device.