Request Legal Help Now - Free
LAWSUITS NEWS & LEGAL INFORMATION

New Transvaginal Mesh Product Approved While Mesh Lawsuits Ongoing

. By
Washington, DCDespite the fact that several transvaginal mesh manufacturers, such as American Medical Systems, have settled mesh lawsuits for millions of dollars and thousands more lawsuits are outstanding, the FDA has approved another type of vaginal mesh for pelvic organ prolapse. Approved, despite the fact that the FDA is currently considering reclassifying pelvic mesh from a moderate risk to a high-risk device.

This decision doesn’t sit too well with AMS transvaginal mesh victims like Valerie. “There is nothing good about this mesh and I can’t understand why some makes are still on the market,” she said. Valerie has suffered with painful intercourse for nine years, ever since she had the AMS transvaginal mesh implanted for incontinence. She was simply prescribed a vaginal cream for the discomfort.
“Of course that did nothing to relieve the pain, and to make matters worse, my incontinence came back.”


Patti had an AMS mesh product implanted to treat pelvic organ prolapse (POP) in January 2009. “Since that time I have pain urinating, leakage and I can’t completely empty my bladder,” she said in an e-mail. “I have constant lower back pain and fatigue. When I called my doctor three months after the surgery, he said it was ‘all in my head’ and these symptoms would go away. He never took my calls again. I wish doctors like him could live with these mesh side effects just for one day - that would change their thinking.”

Patti would no doubt like to see FDA officials live with transvaginal mesh complications. If they did so, perhaps start-up Caldera Medical wouldn’t have been cleared to treat POP. TVM lawsuits have already been filed against Caldera, claiming its T-Sling is defective. So how did its new mesh get fast-tracked and approved?

A Georgia federal judge in October 2012 refused to dismiss claims against Caldera Medical Inc. in a suit in multidistrict litigation accusing the J&J unit and others of making defective pelvic mesh implants, rejecting the contention the allegations are too vague, according to Law360.

Since 2011, the FDA has said that transvaginal complications are not rare. Further, the jury is still out regarding the use of mesh in POP; there is surgical repair that does not include the use of mesh that may be more effective.

And how is this for timing: in April 2015, the FDA proposed to raise transvaginal mesh risk from moderate to high. Just a few months later, the agency allows Caldera’s “new” mesh on the market.

But Caldera doesn’t cite any specific safety advantages for Vertessa Lite, which the agency first signed off on in 2013, according to FierceMedicalDevices. The medical news site said it tried to contact Caldera for comment, but hadn’t received a response at press time. Caldera’s Vertessa Lite has been fast-tracked by the FDA through its 510(k) approval process. AMS took its Apogee and Perigee pelvic organ transvaginal mesh (TVM) off the market, before having to follow up with the FDA order of post-market monitoring.

Caldera pointed out that about 40 percent of women have some form of pelvic prolapse, with as many as 250,000 surgeries to treat it annually. Let’s hope Caldera saves some of its profits for TVM lawsuits.

READ ABOUT AMS TRANSVAGINAL MESH LAWSUITS

AMS Transvaginal Mesh Legal Help

If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your AMS Transvaginal Mesh claim at no cost or obligation.

READER COMMENTS

Posted by

on
OMG DAKEY I adore you this is the smartest thing I have seen on these posts !!! I agree one hundred percent !100% this is a joke and then they go do this, WHERE MESH ISN'T SUPPOSE TO BE IN THE VAGINIA !!! It is too moist and grows bacteria and harbors infection and can fall out the vaginal wall or erode away from the blood vessels looking for openings to intertwine with the mesh holes and engulf your bladder and start to cut into your bladder that will eventually grow into an pinch your plutus nerve and bend your urethra so you don't void right.. These corps are not educated and they are not Dr's to make these devices to manufacturer and profit from human experiments and then have these lawsuits and give all the fat cats the money and tell us that are suffering to basically take the ridiculous amount of the lowest offer that the best they can do!! I'm really right along side of ya on this one man these people need to be held accountable wake up people its time to take the bull by the horns and wise up, women being misinformed and it's not all our fault, you listen to the Dr as you feel they know best and they listen to the corps and they don't know anything !!!!

Posted by

on
Have the FDA LOST THEIR MINDS!!!!!!!!! THE FDA should STOP TAKING MONEY FROM THE CORPORATIONS. THIS IS MONEY LAUNDERING. WOMEN PLEASE DON'T LET DOCTOR BUTCHER US ANY MORE. THIS VAGINAL MESH REPAIR CAN ONLY BE DONE WITH YOUR VERY OWN TISSUES. THERE WILL NEVER BE A PRODUCT THAT A CORPORATION CAN INVENT TO GO INSIDE HUMANS ALONG SIDE OUR NERVOUS SYSTEM AND OUR LEGIMENTS ,MUCLE , NOTHING BUT OUR VERY OWN BODY. THESE CORPORATIONS CAN ONLY BE STOP IF WE REFUSE THE PRODUCTS. THIS IS THE WAY THE CORPORATIONS KEEP WOMEN DOWN. THESE SAME CORPORATIONS WANT WOMEN TO STAY HURTING AND KEEP THE MEDICAL INDUSTRY USING US AS GUINEA PIGS. WE ARE HUMANS!!!!!!!! HOSPITALS AND DOCTORS ARE AFRAID OF THESE CORPORATIONS. THE DOCTORS WILL HAVE TO SAY NO . STAND YOUR GROUND DOCTORS YOUR BEING BULLIED. VAGINAL MESH IS A CONCRETE THAT PERMITTELY CAN NOT BE REMOVE UNLESS A DOCTOR CUT OUT OUT HALF YOUR BODILY TISSUES. WE NEED TO REMOVE THE FDA AND THE FRAUD THAT GOES ON IN OUR COUNTRY AND AROUND THE WORLD.

ADD YOUR COMMENT ON THIS STORY

Fields marked * are mandatory. Please read our comment guidelines before posting.

*Name:

Note: Your name will be published with your comment.

*Email Address:

Your email will only be used if a response is needed.
*Your Comment:

Are you the defendant or a subject matter expert on this topic with an opposing viewpoint? We'd love to hear your comments here as well, or if you'd like to contact us for an interview please submit your details here.


Click to learn more about LawyersandSettlements.com
Request Legal Help Now! - Free