Tuesday, June 09, 2009

Surgical gel gets blame for pain

By RUTH HILL - The Dominion Post

SCARRED: Carla Gardiner had to have a four-hour operation to remove the scar tissue caused by anti-scarring gel during her initial surgery
Related Links'Scarring more painful than original illness'

A surgical spray gel that may have left hundreds of New Zealand women with painful internal scarring and fertility problems has been modified but doctors have not been told why.
Wellington gynaecologist Hanifa Koya, who first raised concerns about Confluent SprayGel in 2005, accuses the manufacturer of evading its responsibility toward "millions of women" worldwide who have been potentially injured by the gel.
The blue gel renamed SprayShield was supposed to prevent scarring during gynaecological surgery, but left some women with their reproductive organs "super-glued" together.
Up to 1200 New Zealand women were treated with the gel between 2004 and 2008.
Mrs Koya has learned that Covidien, which manufactures and distributes the gel, has replaced the suspect dye, methylene blue, with a vegetable dye. "The fact they withdrew it voluntarily suggests they know there was something wrong with it."
She began using the gel in October 2002, but stopped in April 2006 after her rate of repeat keyhole laparoscopies went from under 2 per cent to 10 per cent. Since switching to an alternative product, she has not repeated any laparoscopies, but patients were still returning from four years ago with "sheets of scarring".
She complained to American manufacturer Confluent Surgical and wrote repeatedly to MedSafe the Government's drug safety agency and professional bodies asking for action, but says she was stonewalled.
Medsafe investigated but accepted the manufacturers' assurances that the product was safe and that clinical trials were continuing.
"[But] methylene blue has never been tested on humans and the gel has never been approved for use in the United States," Mrs Koya said.
At the World Congress on Endometriosis in Melbourne last year, Mrs Koya was appalled to meet other specialists who had stopped using the gel because of complications.
ACC has not accepted any claims by victims for treatment injuries. Most of her patients' repeat operations which cost between $6000 and $12,000 have been covered by insurance, and she has waived her own fee for those with partial cover.
"That's a huge cost to the health system, it leads to increased insurance premiums and makes it harder for people to have their claims accepted. Ultimately it's patients who pay the price."
Health Minister Tony Ryall declined to be interviewed, referring comment to Medsafe.
Medsafe group manager Stewart Jessamine said because the gel was classified as a medical device under the Medicines Act rather than a drug, the legislation did not allow Medsafe to assess its safety or efficacy before it entered the market.

"However ... it has been assessed to very high standards by medical device regulatory authorities in Europe and Australia."
Some studies had showed increased rates of complications, including those described by Mrs Koya, he said. "However, there was no evidence that the rate of adverse effects was significantly different from that expected historically."
2001: American-made Confluent SprayGel approved for use in Europe and subsequently Australia and New Zealand but not the United States.
OCTOBER 2002: Wellington gynaecologist Hanifa Koya begins using the gel.
2005: Mrs Koya first notices patients coming for repeat surgery and contacts the company, which tells her the product is being monitored in clinical trials.
APRIL 2006: Mrs Koya stops using the gel because of ongoing concerns. She alerts the College of Obstetricians and Gynaecologists and the Centre for Adverse Reaction Monitoring. Both refer her to Medsafe, the Government's drug-safety body.
FEBRUARY 2007: Mrs Koya complains to Medsafe.
NOVEMBER 2007: After reviewing international literature, Medsafe finds some reports of complications similar to those described by Mrs Koya. It asks the company include "additional precautions" on packaging but says the product is still safe.
DECEMBER 2007: Mrs Koya writes to the college again with her concerns.
JANUARY 2008: The college says Medsafe appears to have investigated the issue thoroughly.
FEBRUARY 2008: An affected patient talks to The Dominion Post and Mrs Koya speaks publicly about her concerns.
APRIL 2008: Mrs Koya writes to Medical Assurance Committee of the college.
JUNE 2008: Pharmaceutical company Covidien Tyco takes over distributing the gel in New Zealand from Intermed Medical.
AUGUST 2008: Mrs Koya writes to the health and disability commissioner, but is told the matter is outside the commission's jurisdiction.
OCTOBER 2008: Covidien relaunches the product as SprayShield Adhesion Barrier, which uses a vegetable dye instead of chemical dye methylene blue. The gel is available in Europe, the Middle East, South Africa, Australia and New Zealand but still not approved for use in the US.

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