Herald on Sunday editorial: We can make surgery safer

5:30 AM Sunday Oct 7, 2012

Surgical mesh does not sound like something anybody would want in their body - and they may be right. The problems we reported last Sunday and follow up today suggest it is time medical authorities reviewed its use.

The mesh, inserted to strengthen tissue against hernia and the like, has been the subject of 600 ACC claims since 2008, and 389 have been accepted, costing the scheme $3.1 million in remedial treatment and compensation.

This country is not alone. In the United States thousands of patients have suffered severe pain, excessive bleeding or infections when the mesh has perforated organs. Some have died.

If it works as it should - and in most cases it probably does - the mesh is placed on weakened tissue which then grows through it and over it. But too often the mesh has not worked properly, possibly because it has been implanted incorrectly or it has bunched or shrunk. And its removal is obviously not straightforward if tissue has already formed around it.

Since mesh is used in abdominal and pelvic organs, the complications can be not just excruciatingly painful but socially debilitating. Incontinence is a common consequence.

Surgeons are divided on its use. A gynaecologist, who told us he repairs at least one mesh-related operation each week, nevertheless supports its continued use in the repair of severe or recurring tissue weakness.

He said, "It is a difficult operation to do and best done by people who have undergone training and have done a reasonable number of them." He estimated about 10 doctors in this country were trained to use it and said there were strict guidelines on who could use it.

But another gynaecologist was against it, questioning the adequacy of the research behind its development and the stringency of the regulations around its use. The number of failures we have found surely warrants a review. It may be a population of New Zealand's size is not giving some of the authorised surgeons a sufficient number or operations to maintain their proficiency. That would not be an unusual problem.

But the complaints in the United States suggest the problem is much deeper. Medical products such as mesh are not subject to as rigorous a testing regime as drugs. This sort of experience argues they should be.

New Zealand's equipment regulating agency, Medsafe, should be looking more closely at the 389 cases ACC has accepted as injuries caused by implants. Medsafe's investigations so far have led it to conclude mesh is not harmful when implanted correctly.

In that case, the Medical Council and the Royal College of Obstetricians and Gynaecologists should be no less concerned that so many implants are having to be reversed. The Health and Disability Commissioner, too, ought to be taking a harder look at complaints that are not being upheld.

If none of these agencies are inclined to act of their own accord, Health Minister Tony Ryall should set up an inquiry under his powers. It should not be too hard to review all the cases that have come to light and find some characteristics in common.

At the very least, patients offered this surgery should be made more aware of its risk and its failure rate than they say they were. Consent forms are meaningless unless the patient is properly informed, which may be hard for surgeons to do if Medsafe is right, that they are the problem, not the product.

Mesh is not a new product. Doubtless it is performing well for thousands of Kiwis. But 390 successful claims since 2008 is an average of 100 injured patients a year. Surgery should be safer than this.

- Herald on Sunday