I found this today on an NZ website...
I had endo when i lived in NZ...but maybe i was lucky that it went undiagnosed and therefore untreated until i moved to Melbourne in 2006.
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.
I was searching on confluent spraygel in Aus & this is the only link that came up in google...
I had a laparoscopy in Wellington Nov 2002, Hanifa Koya was my surgeon & this product was used in my surgery. My problems started immediately following surgery (pain, bloating, etc). Most of the endo she removed was from my bowel & so that is where all my probs are. 6 1/2 years later I am still suffering & quite traumatised. The whole thing was very stressful as I had no symptoms before surgery but have suffered very, very badly ever since, to this day.
I moved to Aus 2004. This recently came up again in NZ media and my mum heard it. I am going to see a doc next week about it & presumably referral to a gynae. Bit scared really, don't know if they will find anything, but with my history I have a strong feeling that they will.
The articles I have found online talk about massive sheets of scarring found internally & repeat surgeries. I am stressed as this might, maybe explain my probs over the past years, but I don't know if I do have scarring, whether they will be able to improve my probs by removing it.
Sorry, I am a newbie here & a bit nervous about the while thing...reassurance appreciated.
i suffer from severe abdo adhesions caused by surgery....mine is all through my abdo....the doctor wont operate because its risky and i will more than likely end up in a worse state than iam now.
the pain is crippling 24/7 and im on morphine for the pain.
Gosh that is dreadful. So far the people in the news who had surgery under the same surgeon as me have gone for surgery to remove sheets of scarring, but nowhere does it mention if it helped them at all.
My pain is not that bad - if things get dire I can eat just plain white rice for 2 or 3 days & it starts to settle down. It is never completely gone, but it can be worse or better.
Thanks for the answer, I was just wondering if there was anyone else out there - all these years I thought it was just me & now it is in the news, in NZ at least.
Hi there, I have just stumbled upon this thread when looking up Hanifa Koya. I had three surgeries with Hanifa, one of which the spray gel was used (all endorsed by my insurance company as being a preventative measure for scaring). Like you I also had extreme pain after the operation and wondered if it was taking a long time to heal - since it became so severe I once again underwent surgery where Hanifa found huge amounts of scarring where she had sprayed the gel spray and many of my internal organs were glued together. She was able to "un-glue" everything and remove most of the scarring and I definately felt better for it afterwards. I have since had a hysterectomy (unrelated) so can not say if it was a lasting result. However was horrified when my family found the same article and learn't that the spray gel had been untested on humans! Hope this helps
No I didn't have gel I dont think Im in the uk but I did speak to my surgical team a few weeks ago and their view hasnt changed. Wont operate due to the risk of leaving me with a stoma again, create more adhesions or kill me. Bit of a hard thing to take but Iv been ill for over 5 years now. How are you? What operations have you had?? xxx
Scarring caused by surgical gel spray
Reply With Quote& so that is where all my probs are. 6 1/2 years later I am still suffering & quite traumatised. The whole thing was very stressful as I had no symptoms before surgery but have suffered very, very badly ever since, to this day.
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