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 “themeshwarrior@gmail.com”)

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”