“No amount of money is going to compensate the pain and suffering so many women with transvaginal mesh implants for urinary incontinence or pelvic organ prolapse have endured,” says attorney and doctor Shezad Malik, MD. “If these women were told about transvaginal mesh side effects, they could have made an informed choice after weighing the risks and benefits. I am sure they would have never opted in for the mesh.”
Malik says that placing a dollar value on their pain and suffering is all that can be done at this stage. While some women have successfully had the mesh removed, others have had multiple surgeries with futile results, mainly due to the mesh having eroded into the vaginal wall.
“At the end of the day, transvaginal mesh is a defective device that was approved by the FDA’s controversial 510(k) process,” adds Malik. “TVM manufacturers got a green light from the FDA and their product was fast-tracked; they didn’t need to show patient data to determine whether the mesh was safe so it was rushed to market. And guess what? The pigeons have come home to roost. The whole idea was flawed to begin with.
“Mesh degrades and breaks down over time and the vagina is not a sterile environment, so it is prone to infection once breached and that in turn causes the mesh to erode through the vaginal canal. And then the Pelvic Organ Prolapse ( POP) and Stress Urinary Incontinence that it was meant to treat comes back with a vengeance.”
Shouldn’t the FDA also be held accountable for approving the mesh without patient data or clinical trials? Malik says that even though this happened on the FDA watch, the agency can only do so much. “They are at the mercy of Congress over its funding and they are also overwhelmed by so many products entering the marketplace. But the agency proposed recently a reclassification: transvaginal mesh will be deemed a ‘high risk’ medical device and it will have to go back through the pre-market approval process. This means there will be a lot more stringent hurdles for manufacturers such as AMS.”
The FDA notified manufacturers back in 2008 about reports of potential transvaginal mesh complications. Four years later, AMS and other manufacturers were ordered by the agency to conduct post-market safety studies and monitor the rate at which adverse events were reported.
“These medical device companies failed to warn doctors and consumers and now these companies are settling without admitting liability,” says Malik. “It has come down to economics and how much it will cost to close this litigation down.”
In April 2004, the FDA said it was considering proposals to tighten safety standards for mesh used to treat POP, according to Reuters. If finalized, the manufacturers would be required to submit data proving the devices’ safety and effectiveness before allowing them onto the market.
AMS and Endo Health Solutions settlement
READ MORE AMS TRANSVAGINAL MESH LEGAL NEWS
According to its recent annual filing with the U.S. Securities and Exchange Commission, Endo estimated that out of 500 million women worldwide suffering from urinary or fecal incontinence, about 400,000 surgeries are performed to treat some form of POP.
“The short answer regarding the amount of the AMS settlement is that there is never enough money, but some is better than nothing, and paying money damages is all the TVM maker can do,” says Dr. Malik.