Women suffering from severe pelvic organ prolapse (POP) and stress urinary incontinence(SUI) often undergo a surgical operation for vaginal or bladder mesh implantation, medical experts say. POP occurs when their reproductive or pelvic organs fall into or go through the vaginal opening; SUI is a medical condition marked by the involuntary leakage of urine from a woman’s urethra during moments of physical stress. However, the use of these medical devices have been reported to result to a rising number of inadvertent effects which have been reportedly behind the safety warnings released by the United States Food and Drug Administration in 2008 and 2011.
Manufacturers who wish to legally produce and market a certain medical device usually go through a process that may allow the United States Food and Drug Administration to determine whether or not an equipment may be “substantially equivalent” in safety and effectiveness to that of another already in the consumer market, medical experts say. Known as the FDA 510 (k) premarket approval process, it is exactly the same process presented and explored in both its advantageous and seemingly less favorable aspects in a popular PBS TV program “Need to Know” last month.
And in the center of it all was a medical device infamously known to women as vaginal mesh, alternately known as surgical or bladder mesh. On national TV, medical experts who represent both sides of the coin shared notions on how the process may both pave way to a pipeline of promising medical devices designed to sustain and improve quality of life in patients, or rather compromise the health and safety of a consumer.
Read More: PBS Shows Two Sides of Medical Device Approval Process Issue