‘Blanket’ mesh ban concerns doctors
Kiwi doctors have condemned Medsafe’s move to restrict surgical mesh in gynaecological operations, citing potential implications for women with urinary incontinence (UI).
Gynaecologist Dr Hanifa Koya said New Zealand ‘‘cannot have a knee-jerk reaction, or blanket rule, and remove all the meshes’’.
‘‘Australia has not removed the incontinence slings, and we should not either,’’ she said.
‘‘The Therapeutic Goods Administration had already undertaken a robust process to confirm the benefits and risks, and that is why Australia did not withdraw the [mid-urethral] incontinence slings. ‘‘
Koya has worked on more than 75 complex cases requiring pelvic mesh removal since 2005, and has been advising against mesh surgery for years.
She supported a ban on mesh for pelvic organ prolapse, but believed mesh slings were still appropriate to implant in women with UI when carried out by competent surgeons.
‘‘A device itself is not the only problem, but rather the regulation, training, oversight and competence of surgeons,’’ Koya said.
The alternatives to UI slings in New Zealand – the Rectus Sheath Sling and Burch Colposuspension – also posed significant risks to health, she said.
Koya said Medsafe’s decision had also robbed women of an important choice. ‘‘The retropubic vaginal sling should remain a choice for women.’’
Urologists, urogynaecologists and gynaecologists needed to be approached by Medsafe for a robust discussion about the use of mesh products for UI treatment, Koya said.
‘‘These specialists have been doing these procedures for many, many years and can provide evidence.’’
Associate Minister of Health Julie Anne Genter said Medsafe reviewed what Australia’s committee decided, and ‘‘agreed that surgical mesh is not suitable to be used for transvaginal surgery, regardless of the surgical competence of the clinician’’.
‘‘We have asked the companies to prove surgical mesh is safe, which if they can prove, then there is a chance that surgical mesh could still be used,’’ she said.
‘‘Hundreds of women have suffered and this Government is committed to ensuring that complaints from patients are taken seriously.’’
Genter said Medsafe had worked closely with the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and other sector groups on the issue. ‘‘I gladly welcome changes to restrict usage,’’ she said.
But urologist Dr Giovanni Losco, a Urological Society of Australia and New Zealand (USANZ) spokesman for female urology, said he expected Medsafe would amend their decision.
‘‘The intention by Medsafe was to replicate the decision by Australia, but my understanding is that they intend to clarify that it wasn’t their intention to ban quite so widely.’’
USANZ was supportive of the ban on transvaginal mesh for prolapse repair, Losco said, ‘‘but transvaginal mesh for incontinence has benefited hundreds of thousands of women around the world’’.
Genter said no amendments were being made, and that Medsafe would not be making another announcement.
Koya believed Medsafe’s response was ‘‘the typical ad hoc reaction which could adversely affect patient care’’.
‘‘Is Medsafe trying to save face and score points with women and the Mesh Down Under group? I sincerely hope this reaction from Medsafe is not just to show that they care, or that they listened to the women’s demands, because they did not listen.’’
The RANZCOG would not comment when approached by The Press.
"A device itself is not the only problem, but rather the regulation, training, oversight and competence of surgeons."
Gynaecologist Dr Hanifa Koya