I just became aware of all of the complications surrounding Johnson and Johnson’s vaginal mesh so I did some more reading. Transvaginal mesh products are sometimes used during hernia surgery or to repair pelvic organ prolapse or stress urinary incontinence. From what I havw read, the mesh has been risky from the start. The very first mesh in 1999 was recalled but the FDA continued to approve other products based on this design. The FDA has changed the device from Class II to Class III, some product have been recalled such as Boston Scientific’s ProteGen and some companies have discontinued certain product lines without taking the full responsibility of a recall. The FDA also issued numerous safety notices about the products, but the FDA says it hasn’t received enough data to warrant a full recall.
In this case, I believe the FDA is to blame. The issue seems systematic, with a propagating fundamental issue, and it doesn’t isolated to one manufacturers. This just leads me to wonder, where does the FDA draw the line?