Let’s be clear: the FDA should not be approving any new pelvic mesh products until manufacturers can prove they don’t put women at high risk for severe and permanent injury.
As logical as this sounds, the FDA has not gotten the message. It has signed off on a new pelvic mesh product – Vertessa™ Lite – manufactured by Caldera Medical, a company currently being sued by thousands of women injured by its earlier mesh product, Desara™. Caldera claims this one is safer. But it has offered no proof in the form of clinical trials on actual patients.
The FDA has known since at least 2011 that mesh products – originally approved for use in abdominal hernia surgeries – don’t work the same in vaginal tissue in surgeries to correct pelvic prolapse or stress incontinence. The mesh doesn’t stay put, it slices through surrounding tissue and organs causing pain, bleeding, infection and scarring, and it often can’t be removed without causing even more damage.
FDA Considering Reclassifying Mesh Products as High Risk
Even more illogical, the FDA signed off on Vertessa™ even though the agency announced a year ago it was considering re-classifying all pelvic mesh products from Class II (moderate risk) to Class III (high risk) medical devices because of tens of thousands of reports of adverse outcomes.
A reclassification to Class III would mean that manufacturers would have to obtain pre-market approval of their mesh products, including results of clinical trials on patients showing that the benefits of their use outweigh their risks.
Lawsuits Have Caused Companies to Remove Products
Pelvic mesh products have been involved in scandals for years, generating some 70,000 lawsuits and costing big companies hundreds of millions of dollars in settlements and jury verdicts. As a result, some manufacturers have removed products from the market. The FDA also has ordered many companies to conduct post-market reviews, that is, collect data on actual outcomes.
Meanwhile, lawsuits have revealed that some manufacturers knew their products were dangerous to women but kept that information to themselves. Worse, no studies have shown that these products work better than older, proven surgical approaches.
It’s a travesty that it takes lawsuits to force manufacturers to take products off the market that are causing such misery. I’ve told the stories of a couple of my clients in previous blog posts:
- Verena has undergone six surgeries since her implant in 2010 to repair damage inflicted by the mesh, which cannot be removed because it has become permanently embedded.
- Jennifer suffers chronic pain, painful intercourse and recurrent incontinence. Her intimate relationship with her husband has been permanently affected. And the surgeries aren’t over.
In light of the many stories like these and the FDA’s obvious concerns, why on earth would the FDA approve Vertessa™ Lite? It makes no sense and it puts more women at unnecessary risk. The FDA should reclassify mesh products immediately and pull the plug on Vertessa™ until Caldera Medical can prove that Vertessa™ works better and is safer than any of the other mesh products causing catastrophic harm to women.
I hope I’m being clear.