Hanifa B. Koya FRCOG, FRANZCOG
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."
Thank you Dr Koya for saving us!