Surgical device that can spread cancer recalled

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By Nonee Walsh

A surgical device which can spread cancer in women having fibroid surgery or hysterectomies is being recalled by the manufacturer.

Johnson & Johnson is asking surgeons and hospitals around the world to return devices used for keyhole surgery which removes growths or women’s reproductive organs.

In April the company suspended sales of laparoscopic power morcellators, which have spinning blades to cut up tissue, when the US Food and Drugs Administration issued a safety warning.

The Royal Australian College of Obstetricians and Gynaecologists says the device is used in some circumstances in Australia but is less commonly used than in the US.

Spokesman Dr Martin Ritossa says women should always be checked for cancers before surgery.

“The concern is when the mechanical morcellators are used that the very little pieces that are cut up could spread throughout the abdomen,” he said

“So if there is a cancer, there is a small risk that it might be spread. And that’s why it is very important that women are screened prior to the surgery to make sure that there is no cancer present.”

The FDA said the devices posed a risk of spreading unsuspected cancerous tissue into the abdomen and pelvis. It rated that risk as one in about 350 women undergoing surgery.

About 30,000 women have a hysterectomy in Australia every year.

Australia’s Therapeutic Goods Administration (TGA) published the American alert this week.

“Health professionals are strongly advised to consider whether to use alternative treatment methods … where definitive exclusion of malignant change cannot be made,” it said.

The TGA continues to investigate, while Johnson & Johnson has asked surgeons and hospitals around the world to return the device.

Dr Ritossa says there are other similar products on the market which can be used after a patient is carefully screened.

“The concerns have been raised out of one or two cases in the US, and to some extent the company response was a bit of a knee-jerk reaction; other companies have not made the same response.

“But I do think the organisations are giving careful thought to the processes and what is appropriate for the future.”

In the US, law firms are considering morcellator lawsuits as medical technology moves on.

New instruments include the use of a bag to safely enclose the damaged tissue the surgeon is cutting up for removal.