the mesh warrior foundation for the injured · twitter: @themeshwarrior 226 followers increasing...
TRANSCRIPT
WELCOME TO The 1st “EARN & LEARN” LAUNCH PARTY
for
THE MESH WARRIOR FOUNDATION
for the injured
WELCOME
• A TX-based 202/NON-PROFIT in application process for TAX EXEMPT STATUS with active Board of Directors
• A COLLECTION OF VOLUNTEERS, INJURED PATIENTS AND INJURED FAMILY MEMBERS/“WARRIORS”
• AN ORGANIZATION THAT WILL SUPPORT VICTIMS OF FAILED MESH IMPLANTS, AND LATER, OTHER FAILED IMPLANTS
• AN ORGANIZATION OF PATIENT ADVOCATES
WHO WE ARE
• TO EDUCATE
• Those injured by a Transvaginal Mesh Implant who know they are injured
• Those injured who don’t yet know it • Families of the injured • The media and communities at-large • Doctors (yes, doctors) • Policy makers (Legislature & the FDA) • Provide Research & Data: http://meshproblems.weebly.com
MISSION – TO EDUCATE
• TO ADVOCATE
• Within the media by writing patient stories and trying to get published
• By standing out with “Color for a Cause” • Attending trials to support the injured • Seek continuing educational opportunities
concerning patient advocacy • Public Speaking • Making patient voices heard in
Washington – GET MESH OFF THE MARKET!
MISSION – TO ADVOCATE
MISSION – TO BUILD COMMUNITY
• TO BUILD COMMUNITY
• Online & Face-to-Face Support Groups • Seek the injured among us to bring them
to community & support • Provide financial assistance for mental,
emotional & physical needs of the injured • Create programs to visit isolated and
injured patients unable to travel • Find, interview and endorse
compassionate and well-trained experts
• The following slides are example questions using the layouts in the Quiz Show template. View them in slide show to see the answer animations.
VISION • TO EVOLVE
• To apply our Mission Statement to those injured by Transvaginal Mesh Implants
• As funding allows, apply focus to injured
patients who’ve received other defective medical implants/devices
• Always focus on the injury as a FAMILY
INJURY/ILLNESS • Educate at higher & higher levels of
government and media • Address/Change the FDA 510k Process
VISION – TO EVOLVE into a National Patient Advocacy
Organization
TWO CONDITIONS FOR WOMEN:
Stress Urinary Incontinence - Urinary incontinence is the unintentional loss of urine. Stress incontinence is prompted by a physical movement or activity — such as coughing, sneezing, running or heavy lifting — that puts pressure (stress) on your bladder. Stress incontinence is not related to psychological stress. Stress incontinence is also different from urge incontinence, which is the unintentional loss of urine caused by the bladder muscle contracting, usually associated with a sense of urgency. Stress incontinence is much more common in women than men. If you have stress incontinence, you may feel embarrassed, isolate yourself, or limit your work and social life, especially exercise and leisure activities. With treatment, you'll likely be able to manage stress incontinence and improve your overall well-‐being.
Pelvic Organ Prolapse - When the muscles and ligaments supporting a woman's pelvic organs weaken, the pelvic organs can slip out of place (prolapse). Pelvic organ prolapse can worsen over time, and you may need surgery to fix it. There are different types of pelvic organ prolapse. Some women develop pelvic organ prolapse after childbirth, a hysterectomy or menopause. Read more about anterior prolapse (cystocele), posterior prolapse (rectocele), uterine prolapse, and small bowel prolapse (enterocele). *Source: Mayo Clinic
S.U.I. & P.O.P. –TRANSVAGINAL MESH
ONE CONDITION FOR WOMEN and MEN:
HERNIA REPAIR - A hiatal hernia occurs when part of your stomach pushes upward through your diaphragm. Your diaphragm normally has a small opening (hiatus) through which your food tube (esophagus) passes on its way to connect to your stomach. The stomach can push up through this opening and cause a hiatal hernia. In most cases, a small hiatal hernia doesn't cause problems, and you may never know you have a hiatal hernia unless your doctor discovers it when checking for another condition. But a large hiatal hernia can allow food and acid to back up into your esophagus, leading to heartburn. Self-‐care measures or medications can usually relieve these symptoms, although a very large hiatal hernia sometimes requires surgery. OTHER COMMON TYPES OF HERNIA: FEMORAL, UMBILICAL, INGUINAL *Source: Mayo Clinic
HERNIA REPAIR
MESH IS POLYPROPYLENE
PLASTIC
NOT inert in our bodies
THE PROBLEM WITH MESH FOR REPAIR OF SUI, POP and/or HERNIA
• The following slides are example questions using the layouts in the Quiz Show template. View them in slide show to see the answer animations.
THE PROBLEM with TVM or Hernia Mesh
• Patients’ “Informed Consent” – The process by which a doctor explains the use of the device, its risks and benefits is inadequate.
• The Procedure – Transvaginal placement
creates higher likelihood of infection which cannot be addressed with antibiotics.
• Marketing from manufacturers is for doctors (IFU)
and NOT patients, taking advantage of a patient’s trusting relationship with his/her doctor.
• Doctors are often not informed of FDA warnings
and/or do not keep up with the newest research
THE PROBLEM WITH MESH FOR REPAIR OF SUI, POP and/or HERNIA
• The following slides are example questions using the layouts in the Quiz Show template. View them in slide show to see the answer animations.
THE PROBLEM with TVM or Hernia Mesh
• The risk for “Serious Adverse Events” is much higher than the medically accepted rates – some experts say as high as 15% of patients will have profound, serious, life-altering “adverse reactions.”
• The Procedure – Transvaginal placement creates a
high likelihood of serious infection, which cannot be treated with antibiotics.
• Marketing from manufacturers is for doctors (IFU)
and NOT patients, taking advantage of a patient’s trusting relationship with his/her doctor.
• Doctors often not informed of FDA warnings and/
or do not keep up with the new research
THE PROBLEM WITH POLYPROPYLENE PLASTIC MESH FOR REPAIR OF SUI, POP
and/or HERNIA
• The following slides are example questions using the layouts in the Quiz Show template. View them in slide show to see the answer animations.
• Use of PP Plastic Mesh causes more serious symptoms than disclosed which are often permanent
• Dyspareunia (Painful Intercourse) • Erosion of mesh through the vaginal wall or other tissues • “Hispareunia” - injury to spouse/partner, pain & infection • Adhesion to surrounding organs including the bladder,
bowel, urethra, vagina, intestines, arteries • Leg/groin pain • Degradation of the mesh, releasing particulate matters • Fraying, roping & migration of the mesh • Hardening of the mesh • Development of painful scar tissue • Voiding dysfunction • Bleeding • Permanent nerve damage, causing motor or sensory
dysfunction
THE PROBLEM WITH POLYPROPYLENE PLASTIC MESH FOR REPAIR OF SUI, POP
and/or HERNIA
• The following slides are example questions using the layouts in the Quiz Show template. View them in slide show to see the answer animations.
• Use of PP Plastic Mesh showing signs Foreign Body Response (FBR)/Autoimmune Response in the General Population
• Skin rashes • Rare blood disorders/clotting disorders & bruising • Lupus • Cancers • Constant flu-like symptoms/low grade fever • Respiratory, cardiovascular disease/failure • Severe abdominal pain, bloating, swelling • Trouble concentrating • Trouble breathing • Muscle atrophy, weakness and pain • Chronic Fatigue • Fibromyalgia • Rheumatoid Arthritis • Unexplained back and leg pain • Painful fluid retention (pregnant belly) • Weight gain, not attributable to diet
THE PROBLEM WITH POLYPROPYLENE PLASTIC MESH FOR REPAIR OF SUI, POP
and/or HERNIA
COMMUNITY PROGRESS The FDA
PROGRESS WITHIN MEDICINE AND GOVERNMENT:
FDA WARNING: April 29, 2014 http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm395192.htm
FDA PROPOSED ORDER: MAY 2, 2012 RECLASSIFICATION FROM MED TO HIGH RISK https://www.federalregister.gov/articles/2014/05/01/2014-09907/reclassification-of-surgical-mesh-for-transvaginal-pelvic-organ-prolapse-repair-and-surgical
FDA PROPOSED ORDER: MAY 2, 2012 PRE-MARKET FDA APPROVAL OF MESH https://www.federalregister.gov/articles/2014/05/01/2014-09909/effective-date-of-requirement-for-premarket-approval-for-surgical-mesh-for-transvaginal-pelvic-organ
FDA WARNING: July 13, 2011 http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
FOUNDATION PROGRESS
PROGRESS via a robust Social Media Presence:
FACEBOOK: The Mesh Warrior 556 Followers increasing daily TWITTER: @themeshwarrior 226 Followers increasing daily BLOG: www.themeshwarrior.com 636 Followers increasing daily
Media Coverage is INCREASING!
PHILADELPHIA’S COURT RADIO – October 2013 THE DALLAS OBSERVER MAY 1, 2014 – PRINT & ONLINE FEATURE STORY THE U.K.’s DAILY RECORD SUNDAY EDITION, APRIL 13, 2014 THE ADVOCATE – DALLAS/LAKEWOOD JUNE FEATURE STORY
FOUNDATION PROGRESS Local, National & International Media
FOUNDATION PROGRESS Local, National & International Media
WFAA-ABC/Channel 8 News in Dallas
BATISE v. ETHICON & TMW FOUNDATION
April 24, 2014/Janet St. James
FOLLOW-‐UP STORY: April 29, 2014/Janet St. James
SIMPLY TO HELP Our Grandmothers,
Mothers, Sisters, Aunts.
Our Grandfathers,
Fathers and Brothers.
Matriarchs &
Patriarchs can no longer lead families
because of this injury!
WHY DOES OUR COMMUNITY NEED THIS FOUNDATION?
PROGRESS THROUGH OUR MISSION STATEMENT, provided proper funding: EDUCATE: - Billboard Campaign with the “Silent No More” Photo - Create Speaking Opportunities across the U.S. ADVOCATE: Make Progress with the FDA/510k Process BUILD COMMUNITY: -Find those injured who are still in isolation and keep our current community up-to-date with progress, research, friendship. -Hire one administrative employee to help with scheduling, community questions and managing a HELPLINE.
WHAT’S NEXT | WAYS TO HELP | NEEDS | PLANS FOR 2014
Ways to Help THE MESH WARRIOR FOUNDATION
PLEASE DONATE & Follow Us on Social Media!
PayPal Account: www.paypal.com
(search for “[email protected]”)
By Mail/Money Order or Check to: TMW Foundation
3100 Main St. #234 Dallas, TX 75226
Tonight:
Consider a donation of more than $25.
Thank you to our hosts! If you’ve been pleased with your service,
please tip generously!
THE MESH WARRIOR FOUNDATION
for the injured
THANK YOU FOR COMING!
“SILENT NO MORE”