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.
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.
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:
Long-term effects from the degradation of polypropylene in vivo:
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.
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:
Call/email the FDA and report your own adverse reaction to mesh or that of a loved one:
Call/email the doctor who is heading up the study and implore him not to proceed.
Dr. Arturo Menchaca – Contact Info: http://pariscommunityhospital.com/sites/www/findadoc/View.aspx?id=101
CONTACT ME VIA MY PUBLIC FACEBOOK PAGE if you have ANY Coloplast implant for POP.