Post by abornich on Feb 11, 2008 10:43:52 GMT -5
Hi everyone. I know this is just an article, but I thought I'd post it here in case any doctor uses this stuff here in the U.S. I have no idea if mine did during my first lap. Here is the article:
Scarring caused by surgical gel spray
Surgical treatment hurts women but is allowed to continue
© Fairfax New Zealand Limited
By LANE NICHOLS - The Dominion Post | Monday, 11 February 2008
Email a Friend | Printable View | Have Your Say
[photo] ANGRY AND AMAZED: Dr. 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.
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.
Scarring caused by surgical gel spray
Surgical treatment hurts women but is allowed to continue
© Fairfax New Zealand Limited
By LANE NICHOLS - The Dominion Post | Monday, 11 February 2008
Email a Friend | Printable View | Have Your Say
[photo] ANGRY AND AMAZED: Dr. 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.
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.