FDA ORDERS MORE TRIALS FOR VAGINAL MESH PRODUCTS

Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are not easy subjects for women to talk about. SUI and POP are often the outcomes of weakening muscle tension caused by age or child birth. Stress urinary incontinence is triggered by the weakening of the pelvic muscles, and it can lead an involuntary loss of urine that results from physical activity. Pelvic Organ Prolapse is a condition where a pelvic organ drops and the bulges against the walls of the vagina often protruding outside the vagina.

Many women seek help for these conditions in the form of vaginal mesh implants. These implants help to strengthen and support the pelvic muscles and organs. It sounds like a simple and easy solution, but many women are now experiencing more pain and infection associated with these devices. Many women who have been implanted with this mesh are experiencing edges of mesh fibers constricting or cutting into internal organs.

Last July, a study found a significant increase in deaths, injuries and malfunctions associated with these products, and an advisory panel recommendation sought to reclassify this mesh as high-risk.

Now, the FDA has ordered 35 manufacturers of mesh devices to conduct three years of trials to determine their safeness and effectiveness. Because vaginal mesh is a permanent implant and the complete removal of mesh might not always be feasible, the FDA released a statement asking surgeons to “carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh.”

Vaginal Mesh complications are not rare, and there is a lack of evidence showing mesh is more beneficial than non-mesh procedures. These are alarming side effects that should have been tested years ago, but were not because of the FDA’s 510k process or accelerated review program. Devices approved under this expedited review process are permitted to skip the clinical trial testing phase because these devices are similar to those already on the market (which had been tested).

Unfortunately, it is too little, too late for women everywhere, who are suffering and undergoing multiple surgeries to try and repair this problem.

If you or someone you know has suffered serious complications and additional surgery as a result of a transvaginal mesh or sling medical device, please contact Pogust Braslow & Millrood. Just fill out this form, click here to send us an email or call us at (610) 941-4204.