ARD, CAPPS, Adhesions and Adhesion Related Disorder , Internal Scar Tissue, Hope for those who suffer from Adhesions

Tuesday, February 12, 2008

Spraygel in question

~Former Endogyn Human Experiments ~ here is more to worry about.

Surley the great Kruschinski knows something she does not....when you realize that L. Mettlers "clinical studies" with Spraygel were NOT acceptable in Australia as submitted by her, and that the ONLY other person doing susposed "studies" on the Spraygel was Kru, and his "studies" were UNAUTHORIZED!! Those bogus "studies" were for his monetary gain alone and certainly were not acceptable for use to identify pros and cons of the Spraygel!

It comes down to NO ONE doing any studies on the Spraygel to know it's hazards!

Think YOU were not an experiment if you had surgery with Kruschinski?? Think again!

Or maybe he'll join the spraygel excuse movement. Blaming ineffective adhesiolysis surgery on spraygel rather than the surgeon.

I know I was a spraygel experiment as I had 6 kits instilled in my first surgery w Kru. It is not reccomended to use more than 1 1/2 kits as per manf. information......and he knew that!

Kru and Mettler with all thier spaygel experience should have seen this coming as they are the biggest (former) docs associated with spaygel. (oppps a Freudian slip or perhaps a new nickname)

Makes ya wonder! Did he or didn't he. We will never know I suspose.

Hey what about those of us who it says on their operative reports:

Reaction to spraygel?
Is that why this pic looks like someone poured acid in my guts?


Scarring caused by surgical gel spray
Surgical treatment hurts women but is allowed to continueBy LANE NICHOLS - The Dominion Post Monday, 11 February 2008ANDREW GORRIE/ Dominion PostANGRY AND AMAZED: Hanifa Koya has stopped using SprayGel after her patients required further surgery to remove scars. She says the product should be put on hold till surgeons and patients can be assured of its safety. Related Links•
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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.http://www.stuff.co.nz/stuff/4395993a11.html'I shouldn't have to pay for it'The Dominion

Post, New Zealand - 21 hours agoTwo years after she had invasive surgery to treat her endometriosis, Anastasia Spallas-Blades has had to go back to have painful scarring caused by a ...Expert: Surgical gel has injured womenUnited Press International - 14 hours agoKoya said these women now suffer from endometriosis, a medical condition in which abnormal growths appear in a woman's pelvic organs. ...Gynaecologist calls for ban on surgical gel

Radio New Zealand, New Zealand - 9 hours agoA Wellington gynaecologist is calling for a ban on a gel used in operations to treat endometriosis. Hanifa Koya, a surgeon at Wellington's Wakefield ...IHRT.....the jury is out here. We will wait for science and not accusation before we give up hope on Spraygel. As we all were told....Spraygel is only as effective as the surgeon using it.The blue coloring in question is used to run the bowel and bladder all the time.

Maybe they were using too many kits ( like some surgeons we know) Science please.

1 comment:

hbkgyn said...

TO ANSWER YOUR QUESTION:
I refer to the recent article on Spray Gel(Dom Post 11/2) featuring my comments since which I have received numerous calls from patients as to why they were not informed. I would like to inform all patients that I had addressed my concerns regarding Spray Gel through appropriate authorities with no resolution. The last letters were written in early Feb 08. I still had lots of unanswered questions which I was still pursuing and therefore could not write to inform all patients at that stage. It was as a result of some patients presenting with recurrent pains that I began to take the responsibility on myself to inform them of my concerns. Following this one patient took her story to the media and I had to support her by answering the questions.
Please feel free to phone my rooms on 04-3818134 weekdays or on 04-3885080 between 2 and 5pm on Sundays.