Published on:

FDA Again Strengthens Requirements For Mesh

001

Mesh warnings from the U.S. Food and Drug Administration (FDA) are nothing new, but last week the FDA announced that surgical mesh to treat pelvic organ prolapse (POP) will be reclassified as a Class III (or high risk) medical device. Part of the FDA press release also indicated that manufacturers will need to receive premarket approval (PMA) for their safety and effectiveness in order to keep selling their product.

Back in 2002, surgical mesh was cleared by the FDA as a Class II (or moderate risk) treatment for reinforcing pelvic floor muscles and permanently repairing pelvic organ prolapse. In the 10 years which followed, the agency received thousands of reports about adverse events connected to mesh products.

The FDA first cautioned patients about mesh in 2008. That year, the federal agency reported more than 1,000 mesh adverse reports for (among others) pelvic pain, infection, bleeding, organ perforation, urinary problems (to put it lightly), and vaginal scarring. In 2011, the FDA issued a second warning. They had received nearly 2,000 more adverse reports, and only went do far as to say the events were ‘not rare’. Providers and patients were warned to ‘be aware of the risks’ before pursuring mesh-related treatments.

After those relatively light warnings, it’s no wonder POP-related surgeries using mesh went up between 2008 and 2011. One study found a nearly 45% increase in New York from 2008 to 2011. POP-related surgeries are big business. In the United States alone, there are over 300,000 such surgeries annually.

Only now that there are tens of thousands pending mesh-related lawsuits, and even more advserse events stacking up, the FDA is finally getting serious regarding mesh usage. Unless the five manufacturers currently making transvaginal mesh can document its safety, it’s entirely likely the product will will be gone by the end of this decade.

Data indicates POP repair with surgical mesh is no more effective than POP repair with sutures alone. It’s doubtful anyone will miss mesh at that point. Except for the manufactures who made billions of dollars from mesh.

Sources:

FDA News Release

The Daily Beast – Transvaginal Mesh Is the Stuff of Nightmares

Contact Information