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Renowned Urologist for the Plaintiffs Does Not Use Synthetic Mesh

Dr. Jerry Blaivas - Manhattan Urologist This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.

You could call the afternoon witness in the Huskey v. Ethicon trial a rock star among urologists.

Dr. Jerry Blaivas is an internationally renowned doctor who is known as the doctor of  “last resort” for men and women who’ve had unsuccessful urological procedures.

Women from around the globe seek his counsel at his New York City office and have been doing so since the late 70’s.  As well as seeing patients and doing surgery at least once a week, he trains other doctors at Weill Cornell Medical College and is the attending surgeon at New York Presbyterian Hospital  and Lenox Hill Hospital.

Dr. Blaivas was on the stand today in Day Four of a defective product trial that claims Johnson & Johnson’s transvaginal tape (TVT-O) is a defective in its design, its manufacture, and does not adequately inform doctors, therefore patients, on the potential for risks and complications.

U.S. District Court, Charleston, WV

U.S. District Court, Charleston, WV

Blaivas appeared as the plaintiff wrapped up their trial in this Charleston, WV federal courthouse, the courthouse where 66,000 pelvic mesh trials have been consolidated.

Fidelma Fitzpatrick, Motley Rice

Fidelma Fitzpatrick, Motley Rice

 

The doctor was qualified as an expert by Fidelma Fitzpatrick (Motley Rice), one of three attorneys appearing on behalf of Jo Huskey.

According to device instructions, Mrs. Huskey was an appropriate candidate for a TVT-O despite her medical history. But after his exam of the patient, Dr. Blaivas determined  the TVT-O sling had eroded and that fact as well as the attempt to remove the mesh had left a thickened, hard mass of scar tissue on the left side of her vagina, causing her pelvic pain.

Prolene mesh

Prolene mesh

Dr Blaivas is not a fan of the polypropylene synthetic sling. Instead he performs the similar operation but uses a piece of muscle he harvests from the woman’s own body called fascia. The operation takes about an hour and the woman may spend the night in the hospital.

At one time he did try the synthetics but he concluded “I didn’t see a reason to do it and I stopped.” He told the court he’s among a group of doctors who have rejected polypropylene slings.

 

When seeing other patients who have been referred to him, his philosophy is – “First do no harm”  –  and that sometimes means he sacrifices removing all of the mesh because of the potential for further complications.

He told the court the TVT-O is particularly difficult to remove because it can make conditions worse as it passes through the muscles and nerves of the obturator space where the leg connects to the pelvis.  The doctor warned that is not a place that many pelvic surgeons or gynecologists truly understand.

 

MESH CRIPPLES

Scarring from removal and reaction to the mesh causes chronic pain. In an article shown to the jury, Dr. Blaivas and others have characterized injured women as “mesh cripples.”  Under cross examination by Christy Jones, she revealed the article relates to mesh used for pelvic organ prolapse (POP). That mesh usually comes in kits and involves more mesh but Blaivas says the principle is the same and the mesh is the same.

Looking at a document on cure rates five years after a fascial sling, Dr. Blavias said the efficacy was 90 percent with no serious complications.

If Mrs. Huskey got the autologous sling could she be suffering today?  he was asked. “I don’t believe she would.”

He concluded with polypropylene mesh, “The risks do outweigh the benefits,” said Blaivas.

 

PRIOR MEDICAL EVENTS

Fitzpatrick wanted to rule out the potential for pain from any one of Mrs. Huskey’s previous conditions such as an ovarian cyst, diverticulitis or her back pain.  No said the doctor, “They’re not related,” adding that when he looked at her records he did not see that mass of scar tissue in 2010.

 

FAILURE TO INFORM

If a failure to inform is one element of a defective product, Fitzpatrick asked the doctor if there are complications if a doctor follows a manufacturer’s instructions. Yes he said.  He’s even seen patients from some of the world’s most famous surgeons who have been referred to his office for “last resort” treatment, so expertise and experience don’t seem to guarantee a good outcome.

Does the IFU or instruction for use warn adequately warn of the injuries Mrs. Huskey sustained?  “It does not! said Blaivas.

Do you believe the medical consent form is consistent with information in the IFU? Objection!

Did Mrs. Huskey consent with full knowledge  with what could happen to her? Objection!

 

RISKS VERSUS BENEFITS

Dr. Blaivas told the court the TVT-O and its implant and explant were the cause of Mrs. Huskeys abnormal pelvic pain, not the doctors who attended to her. Fitzpatrick continued:

“Is there any surgical intervention that can cure Mrs. Huskey?  No.  

Will she require pain management in the future? Yes she will.

Would you consider her problems transitory? No.

Can it be treated with an over the counter analgesic? No.

Until mesh came along, Dr. Blaivas said he had never seen anything like the mesh-related injuries he sees today.

 

CROSS EXAM

Jones during Linda Gross trial

Jones during Linda Gross trial

Under aggressive cross examination, Jones asked Dr. Blaivas how much he charged to be on the stand here today?  $15,000 he said.  And tomorrow?   No, he thought it would be less.

She asked if he had ever implanted a TVT-O. No, he admitted nor has he ever implanted an mid-urethral sling made by Ethicon.

What about all of the endorsements from the professional medical societies that say TVT and TVT-O slings used to treat stress urinary incontinence are the most common surgery and the  “Gold Standard”?  She went through each organization and repeated the claim that 99% of doctors who belong to the American Urogynecologic  Society (AUGS) use the synthetic slings.

“They do,” said the doctor.

And what about two studies that show great success with TVT slings?

“That’s hardly representative to me of anything. They’re unreliable.  There are millions of these slings done and these are 63 women, I do not support it!”

 

Dr. Blaivis will continue on the stand Friday, the day the plaintiffs are expected to wrap-up their case.  By the middle of next week the defense should also conclude its case and a verdict is expected before the end of the week.

Johnson and Johnson has not yet received a favorable verdict in any of its three jury trials. Last February the judge in this case granted a motion to end the trial in favor of J&J, but the giant healthcare company lost one high profile case in New Jersey last year ($11.1 million Linda Gross) and a case in Dallas earlier this year (Batiste $1.1 million). The Batiste jury also found this SAME mesh, the TVT-O, to be defectively designed!

There are 22,000 similar cases filed in this same court before Judge Goodwin and almost 35,000 filed around the nation naming Johnson & Johnson.

 

6 Comments

  1. stopmeshimplants says:

    This is the information that needs to get out the whole world. Someone needs to share these fact that thousands of women harmed for life by these products. Perhaps this is the doctor and the trial that will do just that. My heart aches every single day that I know more and more women are being implanted and harmed by these products. They will suffer for the rest of their lives and no one is stopping the madness. Write your congressmen and women. Tell them to do something. Honestly, this has gone on long enough. Someone, some people, step up and do something. I am in constant contact my congressman. I am only one. As one constituent it is obvious I cannot do anything. Please make those contacts today.

  2. jade says:

    Of course AUGS endorses the mesh implants – the doctors on their Board of Directors are ALL implanting surgeons WHO under the guise of a “fair” position on mesh implants are actually running scared from the light shed upon mesh. I know my implanting doctor has recently been appointed to the Board and he’s a MARKETER in every sense of the word! Since these mesh trials have gained media attention, he’s been doing EVERYthing he can to circle his wagons – e.g. getting on the Board of AUGS; becoming an Expert Witness for the Defense etc. We all are aware that History repeats itself – remember this, if nothing else…..

    “If you tell a lie big enough and keep repeating it, people will eventually come to believe it. The lie can be maintained only for such time as the State can shield the people from the political, economic and/or military consequences of the lie. It thus becomes vitally important for the State to use all of its powers to repress dissent, for the truth is the mortal enemy of the lie, and thus by extension, the truth is the greatest enemy of the State.”

    The_Craven

    Joseph Goebbels

  3. msm says:

    Photo comparison of “competing” mesh tapes from BARD. Before and after official photo advertisement. Is this evidence or what?

    “Four leading mid-urethral sling meshes were subjected to a 5 lb. tensile stress using an Instron®

    machine. The resulting images depict mesh, fresh out of the box, lying next to each brand’s test sample – relaxed, following the test.”

    http://www.bardmedical.com/media/2962/Align%C2%AE%20Mesh%20Comparison%20Sheet.pdf

  4. Kitty says:

    Jane——- you are so wonderful to me. thank you so much for your rerporting

  5. Dean says:

    What will it take more expert Drs after Drs on the witness stand like the good Dr Razz it’s time they stopped pointing fingers and use common sense where has that gone I’m sure everyone who writes post on here has seen the mesh that has been taken out.My wife’s looked disgusting it looked like a saw blade shrunken and eroded as it was cutting into her urethra it’s posted on Twitter you tell me of something like THAT is not DEFECTIVE it’s wrong very wrong that these cases are still carrying on how much proof do they need until they see the truth thousands upon thousands of these unfortunate Ginny pigs SORY ladies: have been seriously affected by this. On a post the other day I noticed someone stating about people being healthy or thin having this procedure done but not over weight people how did this get brought up in the court room my wife was thin in 2010 because of having this surgery she’s gained as she in no longer able to be active are they trying to saying these people where over weight to begin with unreal.

  6. Dean says:

    Jane could I ask a question as you know I’ve put a few post on this site and like I have said before my wife and myself really really appreciate all of your hard work doing this for everybody to see the updates.My question is how come the media meaning news on TV hasn’t really bothered with this issue two Drs just got flown back to the States nearly dying and it was all over the news don’t get me wrong that was very serious or stories with GM but hardly nothing with thousands of women having there lives turned upside down and there husbands and children too ect it doesn’t seem right you can punch in Mesh on the net and it’s so much on there about the complications and the seriousness of had having this procedure done to those who are suffering.I didn’t even see nothing when Scotland band the mesh that was big news in it’s self it just bugs me that’s all thanks

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