More from Dr Koya Mesh Failure & MESH TRAINING and REGULATION

More from Dr Koya Mesh Failure & MESH TRAINING  and REGULATION

Hanifa B. Koya FRCOG, FRANZCOG
Gynaecologist
Wakefield Specialist Medical Centre
Wellington, New Zealand
21 March 2013
MESH    TRAINING  and REGULATION
"It has been estimated that 50% of women by the age of 50 years will have some degree of pelvic
organ  prolapse  (POP)  and  at  least  10%  by  the  age  of  80  will require  surgery.  The  vaginal
prolapse  is  classified as anterior, posterior  and  apical (vaginal  vault).  POP has always been
considered a difficult problem to manage and in a significant percentage of patients the prolapse
surgery has a tendency to fail.
The surgeons invariably felt that the failure was  due  to the poor quality of the patient’s tissues
and therefore looked for a substitute for conventional vaginal repair.  A synthetic mesh therefore
seemed  the  ideal  material  to  use.  There  are  many  different  types of meshes used  in POP
surgery  (biological,  absorbable  synthetic,  non­absorbable  and  composite).  Nearly  all  of  the
meshes  used  for  POP  repairs  are  non­absorbable  synthetic  i.e.  lightweight  monofilament
polypropylene.  Ideal  mesh  properties  for  POP  surgery  should  result  in  minimal  infection,
minimal inflammatory reaction and avoidance of excessive fibrosis."

"If the Medical Profession and the Regulatory Board were ‘in control’, we would not be seeing so
much  unhappiness  and  Class  Action.  The  patients  are  generally  suspicious  of  Industries
wanting to  sell their products, but  want to trust the Doctors  and  the Regulators.  One  cannot
regulate  everything  and  credentialing  retains  a  certain  degree  of  trust.  A  further  report  was
released by  the FDA in 2011 which said that “there were an enormous number of serious,
unique complications with use of vaginal mesh and that these cases were just the tip of
a looming iceberg.”

. " I wrote to Medsafe for three years regarding another product (Spray Gel) and really got nowhere. Medsafe  informed  me that they did not have  all the  jurisdiction and  because we did not have
FDA, they could only take limited action."

Dr Hanifa Koya was the doctor who was instrumental in stopping Confluent's adhesion barrier Spray Gel after realizing it was actually causing more adhesions as she re-operated on patients who had Spray Gel ( now SparyShield ) instilled 
Thank you Dr Koya for saving us!

Please read the rest of this important PDF file

file:///C:/Users/grayce/Downloads/DrHanifaKoyaNewZealandGynecologistSpeaksoutagainstVaginalMesh.pdf