Confluent SprayGel used in Endometriosis surgery causes excruciating internal scarring

Scarring caused by surgical gel spray
Women are being hurt by a surgical treatment
LANE NICHOLS – The Dominion Post | Monday, 11 February 2008

A surgical gel – containing a drug untested on humans – has caused excruciating internal scarring in dozens of women that could lead to infertility, claims a leading gynaecologist.

Many of the endometriosis patients have already forked out thousands of dollars for repeat surgery. Some are now pursuing compensation from ACC.

Endometriosis is a condition where abnormal growths develop in pelvic organs, causing inflammatory reactions leading to scarring and pain. It affects millions of women worldwide.

Though some gynaecologists have stopped using the anti-scarring gel because of concerns about its safety and effectiveness, others still use the treatment, Wellington specialist Hanifa Koya said.

Medsafe, the Government agency that approves medicines, has told the American manufacturer to add additional precautions to the instruction pamphlet. But it maintains the product is safe, and refuses to ban its sale without conclusive evidence of harm – even though the gel is considered high risk under proposed legislation.

Dr Koya – who first raised concerns in December 2005 – was disillusioned at the response of health agencies, which she claimed had let Confluent SprayGel be used internally on thousands of Kiwi women since about 2002 without adequate clinical testing or ongoing monitoring of its effects.

She had spoken out because of concern for her patients and to highlight the need for immediate law changes to protect people.

“Confluent SprayGel is a product sprayed inside human beings and contains a section 29 drug (methylene blue) which has not been tested on human beings, and this product was allowed to be used … [with] no quality assurance in terms of monitoring,” she wrote to Medsafe in December.

“It’s quite amazing – we’re using it inside human beings,” she told The Dominion Post. “I would have expected … that they would have said, `Let’s put this product on hold or start asking some questions’, but that didn’t happen.”

Dr Koya began using the gel in October 2002, but stopped in April 2006 after her rate of repeat laparoscopies – keyhole operations – jumped from less than 2 per cent to around 10 per cent.

Women who would usually have made swift recoveries developed severe pain or discomfort after their initial operations. Dozens of the many hundred women she treated with the gel needed repeat surgery to remove scarring – which could cause infertility – even though their endometriosis had not returned. “It’s only where I’ve sprayed the SprayGel. It’s like sheets of scarring which I’ve never seen in my practice.”

Dr Koya said she had not repeated any laparoscopies since using an alternative product.

She complained to American manufacturer Confluent Surgical and has written repeatedly to MedSafe and the Health Ministry asking them to investigate, but felt her concerns had been ignored.

New Zealand distributor Covidien Tyco did not return calls.

Medsafe interim manager Stewart Jessamine said SprayGel was classed as a device under the Medicines Act, not a medicine. No clinical assessment was required before its sale, though manufacturers had to ensure the device was safe. Medical practitioners had the ultimate responsibility for its use on patients.

After a review, it it concluded the gel was safe “when used as intended”.

There had been no other complaints and there were no plans to restrict its supply, it said.

DESIGNED TO HELP HEALING

What is Confluent SprayGel?

• Marketed as a synthetic, absorbable barrier to prevent tissue sticking together and forming scarring after abdominal pelvic surgery.
• A gel-based product containing methylene blue – a dye substance which is added to make it visible.
• Medsafe says methylene blue is already used widely in humans but is not approved for general supply as a medicine.
• The gel is in clinical trials in the United States but not approved for sale there.
• Approved for use in Australia and Europe.
• Sprayed on internal tissue. Usually absorbed within a week then excreted.
• Distributed in New Zealand till last month by Intermed Medical but now by Covidien Tyco.