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WFAA – Texas AG and 10 Others Investigate Transvaginal Mesh!

WFAA's Janet. St. James

WFAA’s Janet. St. James

WFAA-TV’s reporter Janet St. James has been on the mesh story for years and broke a story today that the Texas Attorney General Greg Abbott is leading a nationwide investigation into Johnson & Johnson and its deceptive trade operations.

St. James says there are ten other states that have joined a nationwide investigation concerning its hernia mesh and polypropylene mesh used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). 

She reports the investigation has been ongoing for two years.

Two weeks ago, Corporate Action Network and a number of mesh-injured women sent a letter to AG Abbott to lend their support to an aggressive investigation. See the letter here.  Readers of Mesh News Desk have been asked to lend their name and city to the letter so the AG understands they are taxpayers of that state who are essentially covering the costs of the alleged deception.can

Corporate Action Network is a consumer group which has urged an investigation into whether the company shredded documents related to how it brought pelvic mesh to market and to its safety and efficacy, all part of a J&JHurtsWomen  campaign.

In addition to Texas, the 9 other states include Illinois, Colorado, Maryland, Washington State, California, South Carolina, Ohio, Pennsylvania and Florida. Additionally CAN has sent letters to AG’s urging the investigation into J&J to Mississippi, New York and Arkansas.

St. James reports the “possible violations” include the false marketing, advertising, promotion, sale and distribution of surgical mesh products.

Aaron Leigh Horton, The Mesh Warrior Foundation

Aaron Leigh Horton, The Mesh Warrior Foundation

AG Abbott has demanded J&J and its subsidiary, Ethicon, provide documents that show how the company justified the safety of polypropylene mesh, including all research, as well as the financial conflict-of-interest payments made to consultant/doctors who promote mesh products and train others to use them.

J&J has been warned not to destroy any documents related to this investigation. Unfortunately the company has already been found to have destroyed hundreds of thousands of pages of documents relating to the marketing of mesh by a Magistrate Judge in West Virginia. See the background story here.

Aaron Leigh Horton, founder of The Mesh Warrior Foundation, (here) was featured in the story and urged the investigation uncover how pelvic mesh products made it to market. “Where was the breakdown?” she asks.

J&J did not respond to WFAA-Television to comment on the story by the time it was produced. Mesh News Desk editor, Jane Akre, is currently working as a spokesperson for Corporate Action Network. #

Learn More:

WFAA-TV story, reporter Janet St. James

http://www.wfaa.com/news/health/Texas-Attorney-General-Investigating-Pelvic-Mesh-266293941.html

The Mesh Warrior Foundation

http://themeshwarrior.com/

PTO # 100 Magistrate Cheryl Eifert on Document Destruction

Carolyn Lewis Doc PTO#100 Doc #1069 Eifert Ruling, Feb 4 2014

Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327

In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation

Joseph R. Goodwin, presiding

What was Lost in J&J Purge of Ethicon Transvaginal Mesh Documents?

http://meshmedicaldevicenewsdesk.com/featured-articles/lost-jj-purge-ethicon-documents/

Plaintiffs’ Motion for a Finding of Spoliation and for Sanctions

in the Ethicon multidistrict litigation, MDL  12-MD-02327,

Doc #952 Pl Motion for a finding of Spoilation and for Sanctions

Plaintiffs’ Memorandum in Support of Their Motion for a Finding of Spoilage and for Sanctions

Doc #953 Pl Motion in Support of Motion for Spoilation and for Sanctions 30 pages

10 Comments

  1. Mary Pat says:

    Wow! Awesome! The truth will come to light.

  2. msm says:

    Big step in the right direction!! Best development in government so far. Thanks, Jane.

  3. Sandy says:

    How can I get AMS investigated as to why their mesh products were put on the market without proper trials. Obviously because of all of the problems with meshes the 501k process was used. I believe me t to J&J AMS has the next largest law suits against them. At least this is what I was told by an attorney from Texas

    • My advocacy began because a former AMS CEO 1995-2006 (Douglas Kohrs) – a serial medical device purveyor/entrepreneur – became CEO of Tornier which produced the elbow replacement that failed in my brother after just 4 months. Kohrs retired abruptly 11/12/2012 at age 56. He had given himself a 56% pay raise (from $500k) a few months earlier. Follow the money!

      • pam says:

        true joleen, We will find the deeper , investigators dig, the uglier it gets , those payed off and more with all bladder mesh companies not just johnson & johnson. EVERY WOMAN DAMAGED BY MESH SHOULD ALSO BE AN INVESTIGATOR, we cannot be with those that are digging, but the truth needs to come out of all involved in cover up of mesh and what they do to women, hopefully this will also help change laws the way courts also will not allow truth , the whole truth in courts in America. HOW LONG WOULD IT TAKE FOR EVERY STATE LEADERS TO ALSO INVESTIGATE TO GET TO THE BOTTOM OF TRUTH, THE EXPENSIVE VACATIONS AND MORE THAT DOCTORS GOT TO PUSH BLADDER MESH SLINGS, FOR $$$$$$$. NOT CARING WHAT HAPPENED TO AMERICANS? I am not against medical at all, we need medical for sure, but to many also are not honest and truthful and cover up truth. THOSE TRULY THAT CARE , AS IT HAS BEEN SAID ARE SO HARD TO FIND. AND IT COMES WITH THOSE THAT WHISTLE BLOWED ON WHAT VETERANS HOSPITAL COVER UP, THOSE THAT TELL THE TRUTH, was called names and harassed by those that covered it up what was going on. Thank you to those that care, and tell the truth, Was glad to read , dr. raz. words that cat scans does not detect mesh, I HAVE GONE THROUGH MANY, now I CAN SAY NO MORE, DO ULTRA SOUND TO DETECT THE MESH, NO MORE LIES, CONS PLAY MIND GAMES AND LIE, NOT GOOD PEOPLE. RICH OR POOR, This needs to be stopped and judges need to be the ones to stop it, IF THEY ARE NOT INVOLVED, AND OWE FAVORS TO ANYONE.

        example: true story, 1 attorney known to win cases above all, was also known as the most crooked , lying attorney’s, close to judges and power for favors, cover up and lies, perjury, as guilty walked out of court rooms laughing. THIS ATTORNEY IS NOT 1 OF AMERICA’S BEST, IF HE CONSPIRES , CORRUPTS COURTS WITH JUDGES JUST LIKE HIM. NEVER SHOULD THESE BE KNOWN AS AMERICA’S BEST. their crimes in courts against americans should never be tolerated, prison and losing license is where they should be. SURE HE WINS CASES , BUT HE DIDN’T WIN THE CASES ON TRUTH. HE CONSPIRED , CORRUPTED , OBSTRUCTED COURT ROOMS, ALLOWED PERJURY, BUT SO DID THE JUDGES FOR FAVORS. THE SAME WITH THOSE MESH COMPANIES THAT HAD TRUTH COVERED UP AND THOSE THAT LIED FOR THEM FOR $$$$$$. THE MESH CONSUMES OUR LIVES GOING FROM 1 DOCTOR TO ANOTHER , being lied to, and treated cruel, because of mesh. costly, having to pay others now for work we did before mesh as it took us down our bodies fighting what mesh is made of and more pain, cutting through inside to protrude out, bleeding, infections, still learning, reading dr raz, saying cat scan does not detect, ultra sound only, draining ins. this cost should go to the companies and doctors that lied and more. THIS IS NOT OUR FAULT! WOULD RATHER NOT SPEND MY LIFE IN DOCTOR’S OFFICE AND SURGERY AND LIES. PAIN AND SUFFERING. LIKE THOSE THAT GOT RICH OFF MESH IMPLANTS.i want to feel like those women my age, not a 90 year old woman.

  4. Suzanne McClain says:

    Thank you, Ms. St. James for pursuing the injustices done to us by mesh, and asking for Attorney Generals to lead an investigation that would hold manufacturers accountable for this atrocity. I hope Eric Holder from Mississippi will jump aboard and fight for his constituents, of which I am one. I will be pushing that issue after my next surgery!

    Thank you too, Aaron L. Horton for standing out on that limb on our behalf, you are a trooper, and I love you for it! And, of course, if Jane Akre had not listened to my (our) stories in the beginning, (2009) I know we wouldn’t be anywhere near as close as we are to blowing the lid right off this powder keg! Many of us are doing vast amounts of research in different areas, and my hats off to all of you. Many deserve recognition for the work they have done, and please forgive me if I am leaving anyone out on this, (and I know I am) but I must include Nonie, Jaye, and Teresa & David in my accolades. Let’s keep up the fight ladies and gents!

  5. Suzanne McClain says:

    Below is my letter to the FDA regarding reclassification of meshes. Feel free to use information from it, but please, get your letter to them quick. The deadline is July 30 to have our collective voices heard. Here is the link to post, or there is an address where letters can be mailed: http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0297-0001

    Though I am grateful that the FDA is finally initiating a review regarding the reclassification of permanent surgical mesh implants for Pelvic Organ Prolapse (POP) from Class II devices to Class III devices, I am also disturbed by a number of things regarding surgical mesh that I feel need to also be addressed. My questions, and justifications for these questions are as follows:

    • What took so long to get this review underway?

     In September 2011 the FDA’s Obstetrics and Gynecology Devices Panel recommended requiring premarket approval, which would include clinical trials of surgical mesh products for transvaginal POP repair

     To date, the FDA continues to leave these products on the market despite the recommendation made by their device panel over 2.5 years ago.

     Had you followed their recommendation in a timely manner, thousands of women could have been spared complications of having this “cheese grater” put in their bodies to grate away their tissues and cause immeasurable pain. This was an act of gross negligence on the part of the FDA!

    • Why did the FDA allow subsequent devices to be cleared under the 510K process, (as late as 2013) when one or more of the predicate devices used to gain clearance (either directly or indirectly) could be tied straight back to the ProteGen Sling, a recalled device?

     The first was the IN-SLING, manufactured by Influence Inc., and cleared by the FDA on September 19, 1997. The approval number is K972651. Within their submission documents, Influence Inc., under the subheading “Performance Standards” clearly stated “No performance standards applicable to surgical mesh have been established by the FDA” yet the FDA approved this device and has subsequently cleared many more surgical mesh devices over the last decade. If, as this document states, no performance standards had been established, neither this device or its predecessor the ProteGen Sling should have received FDA clearance.

     On August 12, 1996, Boston Scientific submitted documents to the FDA under the 510K clearance process for their new device, the ProteGen Sling. As the predicate for this new device, Boston Scientific used a device that had been approved under the Pre-Market Approval process, Ethicon’s Mersilene Mesh, approval #K851086. On November 15, 1996, Boston Scientific was cleared to proceed to market with the ProteGen Sling, under clearance number K963226. Just two years and two months after receiving 510K clearance, Boston Scientific on January 22, 1999 submitted a letter to the FDA initiating a recall of this product. The reason as stated in the FDA’s enforcement report of March 17, 1999 stated “Use of the ProteGen in the treatment of female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”

     I can prove at least 60 devices used the ProteGen Sling either directly or indirectly as their predicate device to obtain 510K clearance after this device was pulled from the market, and after Boston Scientific specifically stated that their device “does not appear to function as intended.”

    • Why does your review not include mesh devices for Stress Urinary Incontinence (SUI)?

     There are thousands of women all over the world who have sustained serious, life altering injuries from these products, and I know hundreds if not thousands of them have filed adverse event reports with the FDA regarding the type of mesh used for SUI. There is no possible way that you don’t know of these people, or of the problems with these products!

     Below is the response I received from MedWatch, a division of the FDA on July 29, 2008. In this correspondence it clearly states “One or two well-documented case reports may provide an early signal of unexpected problems and lead to additional evaluation.” This evidently was a joke, as there have been thousands of reports, and I am fairly certain more than one or two of them were well documented, as was mine.

     ————– Forwarded Message: ————–

    From: medwatchcomments@cder.fda.gov

    To: editwrtr@bellsouth.net

    Subject: Thank you for your submission

    Date: Tue, 29 Jul 2008 10:03:13 +0000

    Dear Reporter:

    Thank you for submitting your report to MedWatch, The FDA Safety Information and

    Adverse Event Reporting Program.

    This acknowledgement confirms that your report was received. Reports are added to a postmarketing safety database with similar reports and reviewed by the FDA’s postmarketing safety staff. Voluntary reports are essential for ensuring the continued safety of FDA-regulated products. One or two well-documented case reports may provide an early signal of unexpected problems and lead to additional evaluation. This may result in FDA regulatory actions

    that improve the safety of the products used in patient care each day.

    You might be contacted by an FDA staff member if additional information on your

    report

    is needed.

    Again, thank you for taking the time to submit your report.

    Sincerely yours,

    MedWatch

     The FDA sure dropped the ball on this!

    • Why does your review not include mesh devices for Hernias?

     There are thousands of men and women worldwide who remain unrepresented, and these people have also suffered greatly and sustained life altering injuries due to hernia mesh implants.

     I know many who have filed adverse event reports with the FDA, so there is no possible way that you don’t also know of these people, or of the problems with these products!

    • Why, when there are tens of thousands of people already injured, are you even considering reclassification that would result in clinical trials?

     The pharmaceutical companies already have the results of their clinical trials. They allowed us to be used as their guinea pigs, and these injured parties should be considered their “clinical trials.” These “trails” in many if not most cases, were performed without our informed consent, and they have failed miserably!

     Reclassifying these devices, as opposed to removing them from the market is setting up thousands more to suffer potential injuries. At what point do you look in the mirror and say, “THIS, is my fault. I allowed this travesty to continue?”

     Even ONE more injured party is TOO Many!

    • Why have these obviously defective products, (all of them) not already been removed from the market?

     This question stands on its own. It is up to you to go beyond even what your advisory panel has recommended, and pull this garbage off the market! Your actions thus far have been unconscionable

    With all due respect,

    Suzanne McClain

  6. Suzanne McClain says:

    One more thing we really need to voice our concerns about with the FDA is their proposed “Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair.” The deadline has long passed for reclassification or clinical trials. We need to tell them in no uncertain terms, ‘we were the Uninformed Clinical Trials and they failed miserably.’ We don’t want a date for reclassification, we want all surgical mesh off the market!

    Here is the link to this FDA proposal: http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0298-0001

  7. Suzanne McClain says:

    Sandy,

    All transvaginal mesh devices were put on the market without clinical trials! They were approved under the FDA’s 510K process, which allows a device to be cleared for market based on a substantially equivalent device that is already on the market. The problem with this is that the first device was cleared based on a different kind of mesh entirely, and though this mesh was approved under the Pre-Market Approval Process, it was a device that was used in a different part of the body, and in no way could be considered significantly equivalent.

    The first was the ProteGen Sling. On August 12, 1996, Boston Scientific submitted documents to the FDA under the 510K clearance process for their new device, the ProteGen Sling. As the predicate for this new device, Boston Scientific used a device that had been approved under the Pre-Market Approval process, Ethicon’s Mersilene Mesh, approval #K851086. On November 15, 1996, Boston Scientific was cleared to proceed to market with the ProteGen Sling, under clearance number K963226. Just two years and two months after receiving 510K clearance, Boston Scientific on January 22, 1999 submitted a letter to the FDA initiating a recall of this product. The reason as stated in the FDA’s enforcement report of March 17, 1999 stated “Use of the ProteGen in the treatment of female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”

    Next came the IN-SLING, manufactured by Influence Inc., and cleared by the FDA on September 19, 1997. The approval number is K972651. Within their submission documents, Influence Inc., under the subheading “Performance Standards” clearly stated “No performance standards applicable to surgical mesh have been established by the FDA” yet the FDA approved this device and has subsequently cleared many more surgical mesh devices over the last decade. If, as this document states, no performance standards had been established, neither this device or its predecessor the ProteGen Sling should have received FDA clearance.

    (These are included above, and were put in the wrong chronological order) Darn. I wish I could make the correction!

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