US warns against womb surgery tool – why is it still in use here?

Doctors have said a method used to remove fibroids in the womb by keyhole surgery, may be putting women’s lives at risk.

Already the Food and Drug Administration in the United States has issued a warning against using a tool called a power morcellator, which shreds the fibroids, making them easier to remove from the womb. And one manufacturer has withdrawn its morcellator from the market after a study claimed that one in every 350 women who has fibroids removed by this method, has a hidden cancer called a sarcoma.

In England, the National Institute for Health and Care Excellence (Nice) has told Channel 4 News that it will be reviewing its guidance in the new year.

Sarcoma’s are rare cancers and those that grow in the lining of the uterus can be masked by the fibroids. It is believed that if a morcellator is used, it causes cells from that sarcoma to spread, leading to secondary cancers.

The problem is a disagreement in the medical profession about the level of risk.  Professor Ian Judson, a consultant medical oncologist and expert in sarcomas at the Royal Marsden Hospital in London, said the evidence appeared to show an increased risk in women over the age of 50.

He also said research now showed that if a morcellator had been used, the average time it took to recur appeared to be faster and the risk of death increased.

“We need more data,” Professor Judson told Channel 4 News.  “In the meantime, until we can reach agreement I think there should be a moratorium on their use.”

Debate over data

There are those who disagree. The British and European societies of gynecological endoscopy acknowledge the concerns over power morcellation.  However, they say, the data is poor and the risk of a fibroid being a sarcoma is very rare.

Thomas Ind, consultant gynecological surgeon, said that they believed the risk was one in 1,300 – not the one in 350 that the FDA has claimed.

“What one has to be concerned about is that one doesn’t over react and withdraw the instrument from women who will benefit from it,” Mr Ind said.  “So the first thing we have to consider is what the incidence – or likelihood is. Women who have fibroids removed for fertility, the incidence is very low, certainly under the age of 40 it is extremely rare.”

He said minimally-invasive surgery for a condition that can be painful and lead to infertility, must be weighed up against the rarity of sarcomas.

However, the charity, Sarcoma UK, is also calling for morcellators to be withdrawn until a consensus can be reached.

Older women

In the meantime, doctors are in agreement that women should be advised that there may be a risk and that if they are older, then it would be safer not to use the tool.

Prof Judson said there also needed to be greater awareness of the symptoms of sarcoma: sudden growth of the fibroid, pain and post-menopausal bleeding.

One of the manufacturers of a power morcellator, just sent this statement.

“While our devices have always carried a warning about the potential spread of cancerous tissue, as new information and questions have begun to arise, there has been growing uncertainty about the potential risk of the procedure,” said Matthew Johnson, communications director at Ethicon. “Because there is no consensus in the medical community about the rate of this relatively rare form of cancer that may be spread after morcellation, we elected to suspend sales and then to voluntarily withdraw our devices from the marketplace.”

For more information, visit the Sarcoma charity website.

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