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Transvaginal Mesh and FDA Failure

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Washington, DCToo many women who have suffered transvaginal mesh complications wonder how it was ever approved by the FDA and why it took the agency so long to classify the mesh as a high-risk medical device. And when TVM victims find out, they are furious at both the FDA and the mesh makers.

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did not demonstrate effectiveness, six were not required to conduct post-marketing safety studies, and three have been withdrawn from the market by makers because of safety or other problems.

“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.

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READER COMMENTS

Posted by

on
I am having great difficulty in understanding why a Tier system was set up to begin with. Those who had,mesh put in early on most didn't even know they were getting mesh never agreed to it. No one told them . I am one of these patients I have been to many doctors with pain feeling like I have knives stabbing me where I suppose anchors are tied down or screwed in.i have pain near my grown area, many bladder infections, a shortened vagina not even able to be examined with a pediatric speculum therefore go figure no sex life, I have developed many complications, fibromyalgia, anenia, thyroid , vulular squamous cell carcinoma grade 2 , grade 3 would effect my kidneys, I have developed S.E. Lupus ,Phillips Petroleum MSDS sheet on polypropylene says it is not to be used in the body and can cause lupus, among other illnesses, so why are settlements being based in Tiers, when some women are just as bad off after removal or have to have 15-20 surgeries. We spend years looking for a doctor that can help us, get lied to about and humiliated and on top of all this the Mesh Manufactures knew from the BEGINING it was going to cause problems just how soon they did not know ? And WHY are the patients the Victims being required to reimburse Insurance companies when the F.D.A. approved these defective devices grandfathered them in on 510K on a product they had recalled. The patients the victims should not be reimbursing insurance companies the Mesh Manufactures, Doctors,Hospitals the ones that profited by this not suffered by this product should be the ones reimbursing . If it was even Legal to bill. I HAVE READ IT WAS A FELONEY 1998-2006 TO bill it would have been classified as a Expiremental procedure , since follow up data was not submitted to F.D.A. at the required time periods and additionally that if the billing was submitted through the U.S. Mail system you have a second felony of nail fraud. What about criminal act of mutilation to us women. And where are we suppose to magically have the funds to chase doctors all over the place for every related pain and urinary infection, and the Mesh cutting into our intestines, waking up in kidney pain. Swollen lymph glands barely being able to walk or take care of yourself and your home , and then their is a TIER system to try to push you over the edge strongly suggesting you take it that nothing else can be done for you. No we won't do that most of us won't anyway no matter how much we may need the money, it doesn't begin to come close to anything acceptable, we should not be reimbursing insurance companies or are we really since it is the Mesh Manufacturer Attorneys writing out the checks dispensing the monies ? Who knows if it is our bill or the Mesh Manufactures bill. This has been the biggest medical scandal , the highest corruption. Where people now fear for their safety fear their attorneys are going to drop them when they don't except LOW BALL OFFERS. I want to understand how this has happened ? I want our President of The U.S. yo stand with the Mesh Injured just as he is taking a stand on the opioid crisis and pharmaceutical companies there. There should not be so many defective medical devices on the market . I believe I have read 250,000 deaths due to failed medical devices . I don't want to be one of those numbers my biological sister was.

Posted by

on
My attorney doesnt seem to be doing ANYTHING yo help me get my case resolved! I would like to know how to get another attorney to take over my case.

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. .

Posted by

on
What are the Judges and Attorneys thinking, I had surgery April 19, 2010. By the 11 month all came loose, my incontience started again, pain and infection I have chills on and off at different times, I have not had Sex since my surgery, I cannot go to public places without wearing heavy pads, This is A Joke to our Physicians.. They say just use a lot of Gel for sex? Not amusing At All. Sent me to a urologist to check my bladder, try to examine me But He couldn't, So get this He had to put me to Sleep just to Examine me, beCAUSE THE PAIN WAS UNBEARABLE. Dr said he would take mesh out if he could at this time that he put me to sleep. When I came to and we talked he said the Bladder was fine (no cancer) but no way could he remove my mesh Because it was In bedded in my muscles and tissues ! my life is a living Hell, But Who really cares it's all about money, Boston Scientific doesn't care about My Life, my marriage broke up. Sorry would never Be enough ! I feel like taking 6 years from my life and what do I have left. This is just part of what's happen since my Great Surgery! But Again who really cares, I'm just a name and Number to them?

Posted by

on
1998 I had my first over 14 removable fixing it using a hammer a chisel to get the anchors out .I live with pain all day everyday sex haven't had that since then hurts to much. that was the worst thing I let someone to me. I will never be the same and haven't gotten a dime.

Posted by

on
In 2002 I went for a sling held by 2 pins. After Surg my Dr Todd J. Fusia says his gun jammed so I got mesh on right side. My neighbor went a yr later to this Dr. & his gun jammed again & she got mesh on r side as well. I went to this Dr for my surg papers he ripped bk pg saying I didn't need bar codes. Fourteen yrs later I could have gotten funded for surg but since I dont have sticker page. I can't qualify? Reg Drs in town won't touch ya , they say you need a Specialist.After my surg my Dr says to me ya know in ten yrs you have to change sling. Than why put a product that's not intended to be removed or has to be Filleted from your skin?
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.

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