A recent study published in Obstetrics and Gynecology (May 4, 2016) by Northwestern University researchers criticizes the FDA for approving a number of high-risk women’s health devices, including transvaginal mesh, based on weak clinical studies.“Although it is impossible to know retrospectively whether more rigorous regulation would have prevented complications associated with [transvaginal mesh], it may have provided earlier warning of patient safety risks,” said lead researcher Dr. Steve Xu.
Transvaginal mesh was approved under a fast-track FDA process that deemed it similar to older mesh products. In fact, about 90 percent of medical devices sold in the United States are cleared under this 501(k) process, which is “a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval,” according to the FDA website. But the new mesh devices were not similar to the older types.
It took the FDA until the beginning of this year to classify the transvaginal mesh as a class III, or high-risk, medical device. Manufacturers will now be required to submit premarket approval applications demonstrating the safety and effectiveness of their products. Devices posing the highest potential risk to patients, such as pacemakers, must submit enough clinical data to the FDA that demonstrates safety and effectiveness. Transvaginal mesh was approved by the fast-track process and did not require so much clinical data. But it now falls into the same category as life-support or life-sustaining devices - e.g., pacemakers and heart valves.
From the FDA’s database, the Northwestern researchers studied 18 high-risk devices that were approved between 2000 and 2015. Of the 18, four devices did not demonstrate effectiveness, six were not required to conduct post-marketing safety studies, and three have been withdrawn from the market by makers because of safety or other problems.
READ MORE TRANSVAGINAL MESH LEGAL NEWS
“Device regulation is just so much weaker than drug regulation, and it doesn’t make any sense,” said Dr. Xu.
“The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?”Xu also voiced concern that the 21st Century Cures Act - legislation that has passed the House and is being considered in the Senate - would make device regulation even weaker. Critics of the Act say that it would speed up medical “innovation” by weakening the FDA and its standards for drug and medical device approval. And it would increase pharmaceutical companies’ profits. They will no doubt need increased profits to cover increased medical device lawsuits.
READER COMMENTS
Dorothy Griggs
on
Brenda K. Williams Clark
on
I have had 2 surgeries from complications of my mesh sling, severe bladder onfection yhat was surgically scrapped off of my bladder . Sling was embedded into my organs and was very difficult to remove. I suffer from severe pain and very bad incontinence. Still no word from my attorney regarding my case. .
Linda Wyatt
on
denise
on
Victoria Baker Clearwater Florida
on
Plus many mesh ppl got lobular kidneys from this an liver damage. Fourteen yrs with This Death Trap Stuck in me.
Damn does it hurt, & robbed my life like use can never imagine. Any Dr can put this in. But where are the trained Surgeons to remove these products, it's so inhumane to let this many ppl suffer worse than dogs. Shame on use.Drs shouldn't take a oath to turn a blind eye, while women die. I never okayed for this to be in me, I woke up an it was just in me. Lord help me please......Thank You Victoria Baker most likely will die much to early of this horrible product. But hey keep installing it, so rich ppl can live gd off of death money. Pathetic
Oh by the way my neighbor had 16 surg an still has mesh in her an can't walk now.Damn if you do an Damned if you dont. It's like medicine they give you something to fix what's wrong but than you come out worse than you already were in the first place.