FDA bans surgical mesh for transvaginal repair of pelvic organ prolapse

The FDA’s announcement of the ban is at https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm:

The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016.  Since the FDA has not received sufficient evidence to assure that the probable benefits of these devices outweigh their probable risks, the agency has concluded that these products do not have reasonable assurance of safety and effectiveness.  The companies will have 10 days to submit their plans to withdraw these products from the market.

The announcement includes the following explanation of its previous regulatory action leading up to the ban:

On January 5, 2016, the FDA reclassified surgical mesh for transvaginal repair of pelvic organ prolapse into class III and required submission of premarket approval (PMA) applications, the agency's most stringent device review pathway.  The FDA mandated that premarket approval applications be filed by July 5, 2018 for any surgical mesh marketed for transvaginal pelvic organ prolapse repair.  As a result of the FDA's actions, all manufacturers stopped marketing surgical mesh intended for transvaginal repair of posterior compartment prolapse (rectocele).  On April 16, 2019, the FDA ordered manufacturers of surgical mesh products intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately.  Therefore, there are no FDA-approved surgical mesh products for transvaginal repair of prolapse marketed for use in the U.S.

All I can say is, it’s about time.  Since 2002, when the FDA approved surgical mesh for transvaginal repair of pelvic organ prolapse, “Tens of thousands of lawsuits have been filed against mesh manufacturers by women who have reported pain, bleeding and infection tied to the devices.  In some cases, the mesh can shift out of place, puncturing internal organs or the abdomen wall.  Those problems sometimes require multiple surgeries to remove or reposition the mesh.”  https://www.foxnews.com/health/fda-halts-pelvic-mesh-sales-after-injury-reports  Yet it took 10 years for the agency to issue “postmarket surveillance orders…to manufacturers of surgical mesh for transvaginal POP [pelvic organ prolapse] repair starting on January 3, 2012. The postmarket surveillance orders allow FDA to continue to evaluate the benefit-risk profile of the device.” https://www.federalregister.gov/documents/2016/01/05/2015-33165/obstetrical-and-gynecological-devices-reclassification-of-surgical-mesh-for-transvaginal-pelvic  After that, it took 4 years of “continu[ing] to evaluate the benefit-risk profile” before the FDA reclassified the device into class III in January 2016, as noted above.  The reclassification order gave the manufacturers until July 2018 to produce sufficient evidence that the benefits of transvaginal mesh repair of POP outweigh the risks.  That’s two and half years, which strikes me as a long grace period:  as of January 2016, the manufacturers had been selling this device for over a decade, so if the benefits actually outweighed the risks, they should have had such evidence readily at hand.  And finally, after receiving the premarket approval applications, it has taken the FDA almost a year to conclude that the manufacturers have failed to justify the continued use of surgical mesh for transvaginal POP repair. 


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