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AMS Transvaginal Mesh Settlement “Never Enough,” Says Attorney

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Dallas, TXAt first glance, American Medical Systems’ $830 million agreement to settle about 22,000 AMS transvaginal mesh complaints seems generous. But that only averages about $40,000 per case, before legal fees. The lawsuits allege the AMS polypropylene mesh is defective and that doctors and consumers were not properly warned about transvaginal mesh complications.

“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

Endo Health Solutions took over AMS in 2011 for $2.9 billion. The settlement stipulates that women who sign will typically be expected to sign a confidentiality agreement and the company does not admit to liability. Generally, plaintiffs must have a majority willing to agree to any amounts for the settlement to go forward. Last year Endo agreed to settle an undisclosed number of mesh cases for $54 million.

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.

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READER COMMENTS

Posted by

on
I had 3 pieces of mesh placed in 2007. I now have myelofibrosis caused by polypropylene. My original attorney claimed there wasn't proof of this being used in mesh. I proved it to him several times. I was told by Mayo Clinnic I had. Maximum time of 24 months with this bone marrow cancer caused by mesh. Is there anything I can do to switch attorneys. Original attorney handed it over to different attorneys. They are being very vague on my settlement amount and payout. This was before the cancer has eaten away my body

Posted by

on
I'm 41yrs old. I've had so many surgeries in the past. The removal of my sigmoid colon and now my urologies want the slings/meshes/ and tapes removed. I can not afford to do this. I'm in pain everyday cant have intercourse with my spouse. But i have to work to keep my insurance because my spouse has dementia. In the past i have gone to so many specialists and i keep hearing "it is part of the healing process". Excuse me, but urination on yourself sould not br part of a healing process. I am on the verge of losing everything i have worked for due to missed work and medical bills. My attornies just tells we we are in litigation. What exactly does that mean? I have to lose everything before anything gets done or that the settlement will be so small tjat i will lose everthing anyways

Posted by

on
I wonder if we start committing suicide will get someone's attention. At least then my husband would get compensated for a defective wife!

Posted by

on
Hi Ed,
We are not privy to what each claimant for the AMS agreement will receive. If you have been represented by a particular law firm regarding your case, you really have to work through their office/your attorney to find out any more information. It's frustrating for sure, but they are the only ones who can really answer your question.
-Admin

Posted by

on
I've posted on here a couple of times now, and I have yet to receive an answer to my questions. I'm begining to wonder if this forum is cappable of posting an answer to any question ?
All I'm reading is questions and no answers to our questions ?

I would really like an answer to any question that has been posted on this forum.
I'm tired of waiting. I want my money. No more talk about this letter or that letter. BULL POOP ! I would like my questions answered. Lord knows the Law Firm won't answer my questions. Big mistake hirring them.

Posted by

on
I posted on 12/29/2014, you can still see my post. no one has yet to send me an answer to my question. how ever i did read where AWKO did receive 328 Million Dollars for seteling with American Medical Systems. What's going on here? The firm gets a pay day and we get crumbs. This is not right. Hey, they had me get my medical records. I do all of the work and the attorney's get paid for it. Can any one please tell me what to expect, money wise. And YES to me it is all about the money.

Posted by

on
YOU HAVE THAT RIGHT I WONT SIT DOWN FOR 40 I HAD ALLTOGETHER 3 SURGERY HAVENT BEEN WITH A MAN IN 4 YEARS BEEB TOGHTER FOR 30 BUT WAS NEVER MARRIE AND BEEN LEFT AND WAS TOLD THAT HE COULDNT RECIVED NOTHING BECAUSE WE WASNT MARRIE BUT I DO BELIVE MO HAS COM LAW AFATER SO MANY YEARS SO NO I DAM SURE WONT TAKE IT

Posted by

on
$40,000? REALLY? SERIOUSLY? I THINK THATS A DAMN SHAME. THATS NOT NEAR ENOUGH TO COVER THE PAIN AND SUFFERING I'VE ENDURED SINCE 2009. MUCH LESS ENOUGH TO COVER LOST WAGES AND MEDICAL EXPENSES. I CANT ENJOY SEX AT ALL ANYMORE, IM STILL YOUNG AND HAVE NEEDS THAT CAN'T BE FULFILLED BECAUSE IT HURTS TO BAD. I CONSTANTLY HAVE TO PEE AND AM Always IN FEAR I WON'T MAKE IT TO THE BATHROOM. LIKE I SAID IT'S A DAMN SHAME!

Posted by

on
I WOULD LIKE TO KNOW HOW MUCH MONEY AMERICAN MEDICAL SYSTEMS SETTLED FOR WITH THE LAW FIRM OF AWKO ? I AM A CLIENT AND AWKO WILL NOT TELL ME ANYTHING OTHER THEM I'LL BE RECEIVING A SETTLEMENT LETTER EXPLAINING EVERY THING. AWKO HAS BEEN TELLING ME ABOUT THIS SETTLEMENT LETTER FOR WELL OVER A YEAR NOW. AND WILL NOT TELL ME ANYTHING ELSE. WHO EVER YOU ARE, DO YOU KNOW ANY THING ABOUT A SETTLEMENT LETTER? OR HOW MUCH MONEY AWKO SETTLED FOR WITH AMS IN OCTOBER OF 2014? THANK YOU FOR ANY THING YOU CAN TELL ME.

Posted by

on
I notice alot of questions asked here I am part of this fiasco too my question is where are some of the snswers to the questions?One . In particular what happens if you decline this measly amount?

Posted by

on
REALLY???? I am with the other commenters on here. Y r our lawyers going to agree to this? Do we hav a final say about this? The judge over seeing this shud on our behalf laugh at the company & fine them for even offering this low settlement....wat is their child, sister, wife or mothers life worth...that wont even buy me a special vehicle to go see my dr.'s in. Fix my house to where I can get around in it without falling. That doesnt rven cover yhe cost of the meds ive had to purchase in the last few years...I prsy that this judge has a hesrt & doesnt accept. Maybe they shud appoint a woman judge to oversee this...send out letters to sll plaintiffs & ask them if this is wat they r willing to settle for...I know I wud decline. It wont make my pain n e better or take n e of my stress awsy from no longer b n able to b the wife, mother, grandmother & friend that I once was...let alone make new memories with my family b 4 this mesh takes me outta this world..b 4 u agree judge ask urself wat ur family's life is worth to u....then make a decision..or at least call us & talk to us & love n our shoes thru our stories...

Posted by

on
$40,000 really that is so shameful can't say how much I feel for these poor women this is an insult to every one of these 22,000 women how in the world do you expect them to live the rest of there lives on $40,000 they can no longer work let alone the cost of there medications Drs fees loss of there dignity where is the humanity disc gusting it really is greed corporate greed

Posted by

on
i agree my husband is going to leave me he thinks iam cheating on him because we cant have sex it hurts to bad and i bleed ive been with him 30 yrs every thing was good tell i got implant in 2008 y should lawyers get more then me its not right and i think the companys getting of easy what about all the other suites were there getting in the millions for same thing

Posted by

on
Unbelievable.... are we able to negotiate this settlement? The attorneys get a bigger portion of something that I suffer thru....my whole life has changed...I no longer walk in to a home filled with a special someone. I live alone as a result of all my medical stuff. It is humiliating to accidently urinate or be unable to get close to someone due to pain. I have had four surgeries, one of them a revision....which truth be told, they can't totally remove this mesh so I am constantly in pain or infection mode...no amount of money can fix this but certainly would help with moving forward.....but 20,000??? That puts me in the hole still.....I am both sad and angry...does anyone know if we can reject settlement amount and demand more?

Posted by

on
I just read about this and am frankly shocked. I don't know what is worse, the settlement amount or the fact that they won't admit to being guilty!! Personally I will never be the same both physically and mentally. After legal fees and repayment to insurance providers I may have to end up paying. Also no amount of money will ever be enough for loss of consortium. What happens if we don't agree to the amount? Do we even HAVE a choice? Are we then left with nothing?

Posted by

on
$40,000 for a lifetime of pain, infections and additional surgery? And what about how it affects family members? I know if I was told the whole truth I never would have opted for the mesh sling.

Posted by

on
The FDA SOULD BE SUITED!!!!!!!!!! FDA KNOW OF THESE PROBLEMS YEARS AGO, TOOK THE MONEY FROM JOHNSON AND JOHNSON UNDER THE TABLE. WHY??????????????????????????????????????????????????????

Posted by

on
I am involved in that AMS settlement fiasco and I am so glad that I am not the only one to do the math. It averages out to $40,000 per case but after 40% paid to attorney fees the victims of the get about $22,000. That doesn't even come close to covering my financial losses due to my mesh injuries and I know it doesn't come close to compensating the three years of crippling pain I endured. Personally I think their offer is an insult.

Posted by

on
$40,000.00 should be considered a down payment to the women harmed by mesh, with the real compensation to be paid within one year to cover all their medical expenses, cost of surgery to be repaid to their health insurance providers, the loss of wages, their legal fees , the loss of consortium and the cost of remodeling homes to adapt to new normals that include chronic pain, and the need for future and ongoing treatemnts for pain, equip . or treatemts for managing pain and treatment for secondary to mesh injury subsequent inflammation precipitated autoimmune diseases....

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