Coloplast Teams Up with Dr. Arturo Menchaca for a study that will IMPLANT MESH in NEW WOMEN

Hello Warriors;

This post may be more important than any post I’ve ever written.

Coloplast is teaming up with a doctor in Illinois, Dr. Arturo Menchaca of Paris Community Hospital and Family Medical Center for a NEW STUDY that would implant Coloplast’s Restorelle Direct Fix in NEW PATIENTS who suffer from POP. A call has been put out for participation of 900 women WHO HAVE NOT HAD SURGERY FOR REPAIR OF POP yet. The study aims to follow women over a three year period. Some women will receive the Coloplast Restorelle Implant. Others will undergo an organic procedure that does not use mesh.

Dr. Menchaca’s clinic is centrally-located in the Midwest in a small city called Paris, Illinois, about 165 miles south of Chicago and 100 miles from Indianapolis. The city is a small town of about 8,800 residents, according to Wikipedia. Seems like a rather small clinic to play host to such a large-scale study. I wonder how Dr. Menchaca came to be a physician who’s heading up Coloplast’s study.

Dr. Arturo Manchaca of Paris Community Hospital Family Medical Center in Paris, Illinois.

Dr. Arturo Manchaca of Paris Community Hospital Family Medical Center in Paris, Illinois.

I called Dr. Menchaca’s office this morning, and APPARENTLY I AM THE FIRST TO CALL TO INQUIRE ABOUT THE STUDY. A very polite receptionist told me that she wasn’t sure what the process for enrolling patients will be yet, but reassured me that she will speak with Dr. Menchaca and return my call this afternoon. The doctor was in surgery, she said.

The following article in the Terre Haute Tribune Star has been circulating in the mesh community since it was posted online by the newspaper two days ago.

http://www.tribstar.com/features/health/patients-sought-for-national-study-of-mesh-use-in-pelvic/article_c60fc7eb-de02-53bc-a885-fd41d9007ac0.html?mode=jqm

Our community must find a way to intercede and stop this study from happening. If you follow my blog, you already know this information, but it is worth repeating.

PLEASE SHARE THE ARTICLE AND THE FOLLOWING INFORMATION WITH EVERYONE YOU KNOW.

THIS PELVIC MESH IS NOT, “Unlike the many other synthetic mesh products on the market,” as Dr. Menchaca asserts in the article.
– Coloplast’s Restorelle suite of products is made of Polypropylene plastic- exactly the same substance used in most pelvic mesh repair products.
– Dr. Tom Margolis of Bay Area Pelvic Surgery is one of the foremost experts in the study of pelvic mesh and has been quoted numerous times as saying, “Our body’s immune system did not evolve to break down and eliminate plastic.” His contact information here: http://www.bapelvicsurgery.com
– This device is PERMANENT, and if you have adverse reactions to the device, it cannot be safely removed in most instances. Again, Dr. Tom Margolis has been quoted as saying, “Polypropylene mesh can never be 100% removed.”
– The need for “revision surgeries” is common. Revision surgeries usually seek to remove some or all of the mesh when adverse reactions are noted. Women have reported between 1 and 18 follow-up surgeries, which are necessary to decrease pain, reconstruct damaged organs or “revise” the original placement of the mesh in hopes pain will subside. These follow-up “removal” or “revision” surgeries are invasive, require general anesthesia and are offered by only a handful of highly-specialized surgeons who can ATTEMPT removal of mesh that has migrated and/or adhered to other organs, bones or vital arteries.

The FDA ITSELF HAS ISSUED TWO WARNINGS about the safety of this and similar devices.
– 1st FDA Warning: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm
– 2nd FDA Warning: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

PROFOUND, LIFE-ALTERING SYMPTOMS ARE ASSOCIATED WITH IMPLANT OF ALL POLYPROPYLENE VAGINAL MESH IMPLANTS.
– Symptoms include but not limited to: PERMANENT chronic pain; PERMANENT nerve damage; chronic life-threatening infection; chronic UTIs; PERMANENT PAIN with intercourse (dyspareunia); recurrence of prolapse (POP); bladder and bowel incontinence; erosion and/or perforation of mesh through vital organs and tissues including the bladder, urethra, uterus, bowels, sensory and motor function nerves and arteries; Foreign Body Response (an immune system reaction that can cause systemic symptoms such as painful rashes, painful abdominal swelling and fluid retention, expulsion of the mesh through the surface of the skin, the formation of painful scar tissue in the sensitive uro-genital area); loss of mobility including loss of the ability to SIT or STAND for long periods of time and severe pain with movement. Many patients (young and older) are forced to use a cane or walker.

STUDY HAS SOME OBVIOUS DESIGN FLAWS
– This study is calling for HUMAN SUBJECTS to be newly implanted with a permanent device known to be harmful.
– What is the clinical reason for using NEW HUMAN SUBJECTS, when there are already thousands of women implanted with Coloplast’s Restorelle? Why not use these women as control subjects instead of taking on the risk of injuring more women?
– Why not perform a 3-year study on an animal population first? Long-term studies should have been performed on an animal population first and should have been undertaken PRE-MARKET (before mesh was allowed to be sold to the general public) not POST-MARKET (after many innocent people have been harmed by implant).
– Polypropylene mesh has already been proven to be dangerous to humans as a permanent implant by ETHICAL post-market medical studies, published in medical journals. What will happen to patients enrolled in this study at year 4, 5, 6 and beyond?
Squamous Cell Carcinoma:
http://www.ncbi.nlm.nih.gov/pubmed/23604537
Long-term effects from the degradation of polypropylene in vivo:
http://onlinelibrary.wiley.com/doi/10.1002/jbm.b.33502/abstract

THERE ARE ALREADY THOUSANDS OF WOMEN WHO HAVE THIS MESH PRODUCT and are suffering greatly, as evidenced by the fact that more than 100,000 cases are filed in FEDERAL COURT against the manufacturers of polypropylene mesh for repair of POP/SUI, INCLUDING COLOPLAST.
http://www.tmwfoundation.org/the_mdl_mesh_litigation

THE LIVES OF 900 WOMEN AND THEIR FAMILIES ARE AT GREAT RISK IF THIS STUDY IS UNDERTAKEN. ACTIONS YOU CAN TAKE TO LEARN MORE OR HELP PREVENT THIS STUDY FROM MOVING FORWARD:

7 responses

  1. Pingback: “A Doctor A Day” – Douglas Van Drie of Grand Rapids, MI | The Mesh Warrior

  2. Pingback: A Call A Day Keeps This Study Away/Oz Harmanli, MD & Pam Behrens, NP of Baystate Health System/Springfield, MA | The Mesh Warrior

  3. Pingback: A DOCTOR A DAY KEEPS THIS STUDY AWAY/Dr. Ty Erickson & Lisa Boozer, CRC, of Rosemark Women Care Specialists in Idaho | The Mesh Warrior

  4. Reblogged this on The Mesh Warrior and commented:

    IMPORTANT FOLLOW UP TO TODAY’S POST regarding Coloplast and Dr. Arturo Manchaca of Paris Community Hospital, Paris, Illinois. If you have a Coloplast device, and/or you see your doctor in the list below, contact your state Attorney General IMMEDIATELY. It’s best to do so in writing, but if you are too ill, a call will suffice. Tell your State AG that you do not want this study to be conducted in your state on the basis of deceptive trade practices. Your state may already be pursuing civil action (as is Texas), but now is a GREAT time to remind your state’s AG Office of the responsibility they bear to keep the citizens of YOUR STATE safe. See example from the Texas AG filing against #JnJ on a former blog post here: https://themeshwarrior.files.wordpress.com/2014/10/jj-civil-investigative-demand.pdf

    Below is a list of ALL participating recruiting doctors and locations. Please share with your friends and family.

    United States, California
    Sherry Thomas, M.D. Recruiting
    Agoura Hills, California, United States, 91301
    Contact: Shirley Louis 818-991-0988
    Principal Investigator: Sherry Thomas, MD, MPH

    Stanford University Recruiting
    Stanford, California, United States, 94305
    Contact: Kathryn Batham 650-724-7826 kbatham@stanford.edu
    Principal Investigator: Eric R Sokol, MD

    United States, Delaware
    Center for Urogynecology and Pelvic Surgery, Christiana Care Health System Recruiting
    Newark, Delaware, United States, 19713
    Contact: Jennifer Mann, BSN RN CCRC 302-733-3056 jmann@christianacare.org
    Principal Investigator: Babak Vakili, MD, FACOG

    United States, Idaho
    Rosemark Women Care Specialists Recruiting
    Idaho Falls, Idaho, United States, 83404
    Contact: Lisa Boozer, CRC 208-557-2981 lboozer@rosemark.net
    Principal Investigator: Ty Erickson, MD, FACOG
    United States, Massachusetts

    Baystate Health System Recruiting
    Springfield, Massachusetts, United States, 01199
    Contact: Pam Behrens, NP 413-794-7045 pamela.behrens@baystatehealth.org
    Principal Investigator: Oz Harmanli, MD, FACOG

    United States, Michigan
    Female Pelvic Medicine & Urogynecology Institute of MI Recruiting
    Grand Rapids, Michigan, United States, 49503
    Contact: Beth Rogers, RN 616-588-1800 brogers@grwh.org
    Principal Investigator: Douglas Van Drie, MD

    United States, New Jersey
    Cooper University Hospital Recruiting
    Camden, New Jersey, United States, 08103
    Contact: Gunda Simpkins, RN 856-968-7547 simpkins-gunda@cooperhealth.edu
    Principal Investigator: Karolynn Echols, MD, FACOG

    United States, North Carolina
    Novant Health Urogynecology Recruiting
    Charlotte, North Carolina, United States, 28210
    Contact: Christine Mackey 704-574-5157
    Principal Investigator: William Porter, MD
    Novant Health Clinical Research Recruiting
    Winston-Salem, North Carolina, United States, 27103
    Contact: Kim Robinson krrobinson@novanthealth.org
    Principal Investigator: John J Smith, III, MD

    United States, Ohio
    Akron Urogynecology Associates Recruiting
    Akron, Ohio, United States, 44333
    Contact: Connie Cottrell 330-344-7681
    Principal Investigator: Costas Apostolis, MD
    Good Samaritan Hospital Recruiting
    Cincinnati, Ohio, United States, 45220
    Contact: Vivian Ghodsi, RN, CCRC 513-463-4308 vivian_ghodsi@trihealth.com
    Principal Investigator: Steven Kleeman, MD, FACOG

    United States, Pennsylvania
    The Institute for Female Pelvic Medicine and Reconstructive Surgery Recruiting
    Allentown, Pennsylvania, United States, 18103
    Contact: Marcie Taff, RN 610-435-9575 mtaff@fpminstitute.com
    Principal Investigator: Vincent Lucente, MD, MBA

    United States, South Dakota
    Sanford Research Recruiting
    Sioux Falls, South Dakota, United States, 57104
    Contact: Jessica Howard 605-328-1389 jessica.howard@sanfordhealth.org
    Principal Investigator: Kevin Benson, MD, MS
    United States, Tennessee
    Center for Pelvic Health Not yet recruiting
    Franklin, Tennessee, United States, 37067
    Principal Investigator: Barry K Jarnagin, MD

    United States, Texas
    Plano OB/SYN and Urogynecology Not yet recruiting
    Plano, Texas, United States, 75093
    Principal Investigator: J Kyle Mathews, MD, DVM

    United States, Vermont
    Vermont Urogynecology Associates, P.C. Recruiting
    Williston, Vermont, United States, 05495
    Contact: Penny 802-872-7001 ext 7
    Principal Investigator: Anne Viselli, MD

    United States, Virginia
    The Group for Women Recruiting
    Norfolk, Virginia, United States, 23502
    Contact: April Rusch 757-471-3375 tcrrusch@cox.net
    Principal Investigator: Jon Crockford, MD

    United States, Washington
    Integrity Medical Research Recruiting
    Mountlake Terrace, Washington, United States, 98042
    Contact: Sarah Weese sweese@integritymedresearch.com
    Principal Investigator: Karny Jacoby, MD, CPI

    Canada, Ontario
    Kingston General Hospital Recruiting
    Kingston, Ontario, Canada, K7L 2VT
    Contact: Lizy Kodiattu 613-533-6000 ext 79382 kodiattu@queensu.ca
    Principal Investigator: Marie-Andree Harvey, MD

    Canada, Quebec
    Hôpital Maisonneuve-Rosemount Recruiting
    Montreal, Quebec, Canada, H1T 2M4
    Contact: Lise Lauzon 514-252-3400 ext 3996 llauzon.hmr@ssss.gouv.qc.ca
    Principal Investigator: Marie-Claude Lemieux, MD, FRCSC
    CHUS-CRC Recruiting
    Sherbrooke, Quebec, Canada, J1H 5N4
    Contact: Elsie Morneau 819-346-1110 ext 12827 emorneau.chus@ssss.gouv.qc.ca
    Principal Investigator: Le-Mai Tu, MD, FRCSC

    Sponsors and Collaborators
    Coloplast A/S
    Investigators
    Principal Investigator: James Lukban, DO The Pelvic Solutions Center

    Responsible Party: Coloplast A/S
    ClinicalTrials.gov Identifier: NCT02162615 History of Changes
    Other Study ID Numbers: SU014
    Study First Received: June 11, 2014
    Last Updated: May 27, 2015
    Health Authority: United States: Food and Drug Administration
    United States: Institutional Review Board
    Canada: Ethics Review Committee

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