Free Case Evaluation
Connect
With Us

Wall Street Journal: Transvaginal Mesh and $800,000 Conflicts of Interest

Dr. Vincent Lucente

Dr. Vincent Lucente

Mesh News Desk, March 14, 2014 ~ Some of the names in this story may sound familiar, primary among them  Dr. Vincente Lucente. He was one of the doctors mentioned during the Linda Gross transvaginal mesh trial naming manufacturer Ethicon (Johnson & Johnson).

Lucente was one of the young doctors brought under the wing of Ethicon to be a preceptor, or trainer of other doctors on the new transvaginal mesh procedures involving mesh “kits.”  In doing so, he trained many doctors that this could be an exciting new source of revenue for a practice for a “minimally-invasive” procedure that can be performed in about 20 minutes.d9 ethicon a j & j company 200

Lucente’s name is central to this Wall Street Journal (WSJ) article from March 13th and his influence reportedly extended beyond training and bringing new doctors into the Ethicon fold.

For his efforts he received a reported $800,000 over 10 years. There are no restrictions on company compensation to consultants, though the Physician Payment Sunshine Act of 2010 is supposed to make that transparent.

“Emails and other documents related to the Ethicon suits, provided by the company during the discovery process, suggest that a physician paid by J&J as a consultant sought to influence the language in treatment guidelines for prolapse put forth by a medical society in 2007. The company also sought to change the language of a high-profile research paper on the mesh procedure published in the New England Journal of Medicine in 2011, the documents show.

The editors of the New England Journal of Medicine are reportedly fighting a subpoena to testify, according to the article.

Back in 2007, the American College of Obstetricians and Gynecologists (ACOG) was prepared to publish a practice guideline for doctors on mesh kits (Prolift for example).

It called them “experimental.” Lucente, a doctor from Allentown, PA told J&J that word had to go, according to emails gathered in preparation for Ethicon lawsuits filed by attorney Adam Slater in New Jersey state court.

Adam Slater during Linda Gross v. Ethicon

Adam Slater during Linda Gross v. Ethicon

Using the word “experimental” would scare off patients and besides, the kits had cleared the FDA.

[Sidebar here- remember Ethicon put Prolift on the market with no notification. It was only noted by the FDA when Ethicon wanted to clear the Prolift +M and put Prolift as a predicate. The FDA noticed the oversight and went ahead and cleared Prolift in 2008 with no sanctions against J&J.]

Prolift as sold on eBay

Prolift as sold on eBay

Yes the word “experimental” in an ACOG bulletin would be a problem agreed David Robinson, the medical director for Ethicon in 2007.  But Ethicon had to be careful not to be seen as too involved in lobbying ACOG to change the wording of any bulletin.

 

An email from Robinson says “Our work remains in the background.”

dr david robinson

 

 

“ACOG’s initial bulletin was published in February 2007 and stated: “Given the limited data and frequent changes in the marketed products…the procedures should be considered experimental and patients should consent to surgery with that understanding.” 

ACOG soon began receiving emails and phone calls from its members who did not like the word “experimental” either.

  “In late August, Dr. Lucente alerted Price St. Hilaire, Ethicon’s U.S. group marketing director, that ACOG was changing its practice bulletin, according to emails. “Note, no further use of the word experimental!” wrote Dr. Lucente. “Well, this is one I’m taking credit for. I led the charge on this and never thought we would get a complete replacement of the earlier bulletin.”  

Seven months after the first bulletin, the word “experimental” was removed.  According to Dr. L. Lewis Wall, a urogynecologist from Washington University, the speed of the change was unprecedented.

Meanwhile consultant dollars went to Dr. Daniel Altman who authored a favorable article on Ethicon for the New England Journal of Medicine. That story was published by Mesh Medical Device News Desk on the Linda Gross trial, February 9, 2013 here.

Wall Street Journal March 13, 2014, Doctors, Device Makers Close Ties here

 

 

4 Comments

  1. HE says:

    Finally! I’ve been thinking about this change in the word “experimental” in the ACOG journal and have wondered why it wasn’t brought out. We knew about this a few years ago. I couldn’t read the wall street journal article, but I’m happy that the news is showing this part in the process that we know as “the NIGHTMARE OF MESH!” If I remember correctly there were many Dr.’s who wrote to ACOG to complain that the insurance companies wouldn’t cover the transvaginal mesh procedures because of the word “experimental”. Dr. Lucente is arrogant and loved taking credit for the profits that we’re going all around, especially into his pocket. I hope the NEJM does have to testify. I remember the letters from a Dr. warning that the mesh should NOT had the word “experimental” taken out of the language, because it wasn’t tested properly and had severe risks. He wrote 3 times to ACOG to put it back in (I cannot remember his name). It was pretty much explained away (with an outrageous argument) and ignored. I remember reading his letters and wished I would have had the foresight to save them. Thank you Jane for watching all these details for us!! You are a giant blessing.

  2. nichole says:

    I am just trying to figure out if and why the case scheduled against Boston Scientific was canceled it was supposed to be on March 10th… and if it was, why it feels like we women who have suffered from this pure evil device are on the losing end of this battle. I feel like every time a case comes up to finely have its day in court something stops it.

  3. she says:

    yeah, he’s arrogant alright so was hitler and some more also that thought the same way. i was reading that the FDA was going to have women speak out in mesh cases too. As someone said is this a joke? They know we are gagged and told we cannot speak out about what we have suffered, I DO NOT LIKE IT AT ALL. NEITHER DO i TRUST THE FDA , FOR TELLING THE TRUTH TO AMERICANS.

    i HATE THE WORDS, of some news media, that use the words , we report , you decide???? decide what if they are lying to american people? That sure sounds like cons to me and the way they think. I thought propaganda lies were from countries with dictatorships that stop truth where people cannot tell the truth of what is happening in their country. LOOKS like america has the same problem, I do not understand why any judge would want to cover up the truth and corrupt his court room . The offers of settlement after so many got rich and favors from the mesh and offer a small price of all the billions that they got, they had so much money to give to each other, and invest. politicians and more. no wonder , people were told they were crazy and pain was all in their head. GUESS THESE DOCTORS LIKE THE ONE THAT TOLD THE WOMAN SHE WAS UNEDUCATED , never was taught, right from wrong, as I HAVE FOUND AS THEY PUT IN PLACE PEOPLE TO COVER IT UP AND LAWS TO STOP TRUTH IN COURTS.

    HUMAN BEINGS ARE NOT ANIMALS, but some people in power just want to do everyone’s thinking for them.. AS the doctor told the woman at walgreens store.

    I personally do not like someone doing my thinking, speaking, or even telling me how I feel, and I don’t like to guess if someone is lying or not, we report you decide and more. YOU GET A REPUTATION OF BEING A HABITUAL LIAR THAT WAY. covering up truth. SOME PEOPLE CAN GET BY WITH MURDER, Laws put in by state reps for them to cover the truth up. I don’t see those in professions so smart and educated that stoop to using dirty tactics especially in courts and represent this country , for favors,

    What women and people are suffering and will suffer for life , is true and real. THEY HAVE IN PLAIN SIGHT THAT CAN BE SEEN OF THEIR DAMAGE, THAT NO MACHINE AND METAL CAN SEE AND TOUCH, BUT THE COMMON SENSE AND HUMAN EYE CAN! tHE DOCTOR CAN SHOVE HIS EDUCATED BUTT, BACK TO SOME WHERE SO HE CAN LEARN COMMON SENSE OF RIGHT AND WRONG, GOOD AND BAD, and how to treat people like he would like to be treated.I am not against medical at all, except when they use humans as animals,

    The women should get the billions they made off of mesh, not millions. FOR OUR SUFFERING,

    i cannot be nice to anyone that are like this doctor and more like him. women too, THEY THINK LIKE THOSE COMPANIES and the FDA THAT KEPT IT COVERED UP.

  4. Richard M Howden(AMU) says:

    I do not know why this ‘revelation’ is so surprising to anyone. The symbiotic relationship between the FDA and the Manufacturers of mesh products is well known and well documented. The fact that the manufacturers can put a product out on the market, bypassing any scrutiny by the FDA, then come back with a ‘new and improved’ model, using the 501K process should have Senate’s scrutiny! What I am seeing is the “D.C. Shuffle”. The Manufacturers can destroy documentation, by pass the law, lie to the consumer and apparently the FDA and we as Mesh victims still cannot convince a Judge that Mesh is a dangerous product. As I have stated many times, until the FDA is forced, kicking and screaming, to admit that all Mesh products are potentially deadly and at the least, dangerous to human implantation, we will see no changes. The wool has been pulled over their eyes and the money in their pocket shuts their mouth. Pure and simple, the FDA has been and continues to be paid off by the Manufacturers. Not only for Mesh but for many prescription drugs and medical devices as well. What other explanation can there be?

Post a Comment

Your email is never published nor shared. Required fields are marked *

*
*

© 2016 - 2017 Mesh Newsdesk. All rights reserved.
This is a Sundown Legal Marketing law firm website.