The Dominion Post
Last updated 05:00 08/06/2009
NATALIE SLADE/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.
Carla Gardiner, 35, had surgery in 2005 for severe endometriosis, a condition in which abnormal growths develop in pelvic organs, causing inflammation, scarring and pain.
"It [the endometriosis] was so bad I would be on the floor in the foetal position howling with period pain. I needed codeine just to get through the day."
About a week after the operation, she developed an infection and spent a week in Wellington Hospital hooked up to a drip.
In fact, Ms Gardiner had probably suffered chemical peritonitis her internal organs had become inflamed by Confluent SprayGel, which was supposed to prevent scarring.
She recovered, and initially, the surgery seemed to have worked. But when she began getting bad period pain and intermittent bleeding a couple of years later, she went back to her specialist, Hanifa Koya.
It was then that she learned her problem could have been caused by the gel.
She had repeat surgery in March last year a four-hour operation to remove scar tissue.
Both operations have cost her insurance company about $30,000. Her insurance premiums have skyrocketed in recent years, but since the endometriosis diagnosis, no other company will agree to cover her.
Belinda Colley, 32, has had three operations since 2004: the first for endometriosis and two more to remove scarring caused by anti-scarring gel.
All her operations were covered by insurance, but she is angry she had to go through so much "unnecessary pain".
"It astounds me that they have never admitted liability when it's patently obvious their product was faulty.
"The scarring was worse than the endometriosis. Hanifa said it was like a spider-web ... everything was stuck together."
Newtown artist Mika Still, 34, had surgery for severe endometriosis in Wellington Hospital in 2004 after a referral from her private specialist.
"For the first couple of months after the operation, I was in very bad pain ... but I thought that was to be expected with major surgery.
"But then I started to feel something wasn't right. I had this dull ache all the time."
In 2007, she consulted Mrs Koya. Surgery revealed there was no endometriosis but her fallopian tubes were "super-glued" to her pelvic wall with multiple layers of scar tissue.
"That explained the pain."
Ms Still did not blame surgeons for using the gel because they thought they were doing the right thing.
"But it makes me angry that no-one was monitoring it ... it goes against medical ethics, firstly do no harm."
http://www.stuff.co.nz/national/health/2480461/Scarring-more-painful-than-original-illness
Tuesday, June 09, 2009
Surgical gel gets blame for pain
By RUTH HILL - The Dominion Post
Last updated 06:44 08/06/2009
NATALIE SLADE/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."
TIMELINE
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.
http://www.stuff.co.nz/national/health/2480461/Scarring-more-painful-than-original-illness
Last updated 06:44 08/06/2009
NATALIE SLADE/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."
TIMELINE
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.
http://www.stuff.co.nz/national/health/2480461/Scarring-more-painful-than-original-illness
Tuesday, May 05, 2009
Saturday, February 14, 2009
No health insurance? Get help here
From Cnn
Click below for full story
http://www.cnn.com/2009/HEALTH/02/12/ep.health.insurance.help/index.html
Negotiating with doctors and hospitals is just one thing you have to learn how to do when your insurance disappears, says Steve Luptak, executive director of an assistance group called Healthcare Advocacy. "I've had so many people who've just been laid off coming to me for help because they've lost their insurance. They're so stressed, they're so depressed, they feel like it's the end of the world," he says. "But there are things you can do. It's not a futile situation," he says. Watch for more tips for the uninsured »
If you want to try to get new, affordable insurance, or find programs that offer you financial help for doctor's visits, prescription drugs and more, follow these steps:
Step 1: Get good advice
When you get laid off and lose your health insurance, you may need someone in your corner. Several places specialize in helping people find new, affordable insurance and free care:
Healthcare Advocacy
Patient Advocate Foundation
Patient Services Incorporated
Step 2: Search for affordable insurance
With advice from experts at the groups above, begin your search for affordable insurance. Start with COBRA, which means you continue with your employer's insurance, except now you're paying the entire premium on your own. You can learn about COBRA at the Department of Labor's Web site.
If you can't afford to go on COBRA, you're in good company; a recent study by the Commonwealth Fund found that only nine percent of people who are offered COBRA actually use it. Sometimes it's less expensive to buy your own insurance policy rather than going on COBRA. You can compare prices at ehealthinsurance.com.
Step 3: Get your child on SCHIP
Even if you have too much money to qualify for Medicaid, your children may qualify for SCHIP, the State Children's Health Insurance Program. Here's a state-by-state directory of SCHIP programs.
There are other government programs, too. Your entire family may qualify for insurance from a state high-risk pool if you live in a state that has one.
If you think you might quality for Medicaid, see this state-by-state Medicaid directory.
Step 4: Get help with prescription drugs
If you can't afford health insurance -- or if your insurance doesn't include good prescription drug benefits -- look for $4 generic drugs at many major supermarkets and drug stores. Also, your state may offer a discount drug program (after you click, scroll down to see Table 2). You can also check these private groups that offer prescription assistance.
HealthWell Foundation
FamilyWize discount drug card
Needy Meds
Rx Assist
Rx Hope
Chronic Disease Fund
Partnership for Prescription Assistance
The Access Project
Step 5: Find financial assistance for your particular disease
Many diseases have specific foundations that offer financial assistance.
Heart Disease: Heart Support of America
Kidney Disease: American Kidney Fund
HIV/AIDS: The Access Project
Hepatitis: The Access Project
Cancer: see this Empowered Patient for a list of services
Alpha-1 Antitrypsin Deficiency, Chronic Granulomatous Disorder, Huntington's Disease, Idiopathic Pulmonary Fibrosis, and Pulmonary Arterial Hypertension: Caring Voice Coalition
Other rare diseases: National Organization for Rare Diseases
Vision Care: EyeCare America and Vision USA
Step 6: Find free clinics
Federally funded health centers offer free care in both urban and rural areas. Put in your address here and find one near you.
Click below for full story
http://www.cnn.com/2009/HEALTH/02/12/ep.health.insurance.help/index.html
Negotiating with doctors and hospitals is just one thing you have to learn how to do when your insurance disappears, says Steve Luptak, executive director of an assistance group called Healthcare Advocacy. "I've had so many people who've just been laid off coming to me for help because they've lost their insurance. They're so stressed, they're so depressed, they feel like it's the end of the world," he says. "But there are things you can do. It's not a futile situation," he says. Watch for more tips for the uninsured »
If you want to try to get new, affordable insurance, or find programs that offer you financial help for doctor's visits, prescription drugs and more, follow these steps:
Step 1: Get good advice
When you get laid off and lose your health insurance, you may need someone in your corner. Several places specialize in helping people find new, affordable insurance and free care:
Healthcare Advocacy
Patient Advocate Foundation
Patient Services Incorporated
Step 2: Search for affordable insurance
With advice from experts at the groups above, begin your search for affordable insurance. Start with COBRA, which means you continue with your employer's insurance, except now you're paying the entire premium on your own. You can learn about COBRA at the Department of Labor's Web site.
If you can't afford to go on COBRA, you're in good company; a recent study by the Commonwealth Fund found that only nine percent of people who are offered COBRA actually use it. Sometimes it's less expensive to buy your own insurance policy rather than going on COBRA. You can compare prices at ehealthinsurance.com.
Step 3: Get your child on SCHIP
Even if you have too much money to qualify for Medicaid, your children may qualify for SCHIP, the State Children's Health Insurance Program. Here's a state-by-state directory of SCHIP programs.
There are other government programs, too. Your entire family may qualify for insurance from a state high-risk pool if you live in a state that has one.
If you think you might quality for Medicaid, see this state-by-state Medicaid directory.
Step 4: Get help with prescription drugs
If you can't afford health insurance -- or if your insurance doesn't include good prescription drug benefits -- look for $4 generic drugs at many major supermarkets and drug stores. Also, your state may offer a discount drug program (after you click, scroll down to see Table 2). You can also check these private groups that offer prescription assistance.
HealthWell Foundation
FamilyWize discount drug card
Needy Meds
Rx Assist
Rx Hope
Chronic Disease Fund
Partnership for Prescription Assistance
The Access Project
Step 5: Find financial assistance for your particular disease
Many diseases have specific foundations that offer financial assistance.
Heart Disease: Heart Support of America
Kidney Disease: American Kidney Fund
HIV/AIDS: The Access Project
Hepatitis: The Access Project
Cancer: see this Empowered Patient for a list of services
Alpha-1 Antitrypsin Deficiency, Chronic Granulomatous Disorder, Huntington's Disease, Idiopathic Pulmonary Fibrosis, and Pulmonary Arterial Hypertension: Caring Voice Coalition
Other rare diseases: National Organization for Rare Diseases
Vision Care: EyeCare America and Vision USA
Step 6: Find free clinics
Federally funded health centers offer free care in both urban and rural areas. Put in your address here and find one near you.
Wednesday, February 04, 2009
Hysterectomy death case back in court
http://www.theherald.co.za/herald/news/n24_03022009.htm
Hysterectomy death case back in court
Lynn Shaw HERALD REPORTER
AN expert in the field of pathology was still in the witness stand when the trial of two PE doctors, accused of negligently causing the death of hysterectomy patient Ilse Malherbe, resumed in the Port Elizabeth High Court yesterday.
The case started again after a two-month adjournment.
The St George‘s Hospital doctors on trial are GP anaesthetist Mike Botha and specialist gynaecologist Marcus van Heerden.
Malherbe underwent a routine hysterectomy at the hospital in 2004 and died a few hours later.
She was the wife of radiologist Daan Malherbe.
When the case resumed Prof Jan Botha was under cross-examination by senior state advocate Johan Bezuidenhout.
Defence advocate Graham van der Spuy will re-examine Botha when the case continues today.
Hysterectomy death case back in court
Lynn Shaw HERALD REPORTER
AN expert in the field of pathology was still in the witness stand when the trial of two PE doctors, accused of negligently causing the death of hysterectomy patient Ilse Malherbe, resumed in the Port Elizabeth High Court yesterday.
The case started again after a two-month adjournment.
The St George‘s Hospital doctors on trial are GP anaesthetist Mike Botha and specialist gynaecologist Marcus van Heerden.
Malherbe underwent a routine hysterectomy at the hospital in 2004 and died a few hours later.
She was the wife of radiologist Daan Malherbe.
When the case resumed Prof Jan Botha was under cross-examination by senior state advocate Johan Bezuidenhout.
Defence advocate Graham van der Spuy will re-examine Botha when the case continues today.
Wednesday, January 28, 2009
New Principles of Adhesion Prevention Covidien Sprayshield
New Principles of Adhesion Prevention Covidien Sprayshield
Principles in the Prevention of Adhesions
An informative powerpoint presentation about the state of adhesion patients, adhesion prevention and hopes for the future.
It is easy to register to view this presentation. Minimum personal information.
It does contain graphic surgical images.
Please use this link to register from the ISGE ( www.isge.org )
http://www.surgipeer.com/sprayshield/
This is the direct link but we are unsure it will work without registration:
http://www.ja-online.com/design/covidien_articulate_interface/SS/player.html
Principles in the Prevention of Adhesions
An informative powerpoint presentation about the state of adhesion patients, adhesion prevention and hopes for the future.
It is easy to register to view this presentation. Minimum personal information.
It does contain graphic surgical images.
Please use this link to register from the ISGE ( www.isge.org )
http://www.surgipeer.com/sprayshield/
This is the direct link but we are unsure it will work without registration:
http://www.ja-online.com/design/covidien_articulate_interface/SS/player.html
Saturday, January 24, 2009
Endometriosis EndoTimes Blog
Having babies after being diagnosed with endometriosisExaminer.com - Jan 22, 2009I knew it wasn’t going to be good news because when I woke up from the surgery my doctor came in and told me that I had stage 5 endometriosis and one of the ...
lity problems and endometriosisguardian.co.uk, UK - Jan 21, 2009Doctors don't know exactly how endometriosis can reduce your chances of getting pregnant. But there are some theories. To read more about the causes and ...Surgery for endometriosis guardian.co.ukHow do doctors diagnose endometriosis? guardian.co.ukWhat's the evidence for surgery to remove endometriosis? guardian.co.ukguardian.co.uk - guardian.co.ukall 12 news articles »
Endometriosis linked to embryo defectsUnited Press International - Jan 20, 200920 (UPI) -- A US researcher links endometriosis to abnormalities resulting from defects in the early embryo. Endometriosis is a disease that can cause pain ...
What is endometriosis?guardian.co.uk, UK - Jan 21, 2009If you have endometriosis, small pieces of the lining of your womb stick to other parts of your body, such as your ovaries or your bladder. ...What are the symptoms of endometriosis? guardian.co.ukWhat will happen to me? guardian.co.ukQuestions to ask your doctor guardian.co.ukall 4 news articles »
What treatments work for endometriosis?guardian.co.uk, UK - Jan 21, 2009If you have endometriosis, the tissue that normally lines your womb grows in other places outside the womb such as your ovaries and part of your bowel. ...Hormone treatments for endometriosis guardian.co.ukHormone treatments before surgery guardian.co.ukTypes of hormone treatment guardian.co.ukguardian.co.uk - guardian.co.ukall 10 news articles »
Who's at risk of endometriosis?guardian.co.uk, UK - Jan 21, 2009Reproductive history and endometriosis among premenopausal women. Obstetrics and Gynecology. 2004; 104: 965-974. Sangi-Haghpeykar H, Poindexter AN 3rd. ...
Progress made in understanding causes and treatment of endometriosisHindu, India - Jan 17, 2009CHICAGO: Endometriosis is a poorly understood chronic disease characterized by infertility and chronic pelvic pain during intercourse. ...
A life with endometriosisHealth24.com, South Africa - Jan 19, 2009After numerous visits to a range of specialists, I was diagnosed with endometriosis. I was immensely relieved to finally attach a medical name to the beast ...
lity problems and endometriosisguardian.co.uk, UK - Jan 21, 2009Doctors don't know exactly how endometriosis can reduce your chances of getting pregnant. But there are some theories. To read more about the causes and ...Surgery for endometriosis guardian.co.ukHow do doctors diagnose endometriosis? guardian.co.ukWhat's the evidence for surgery to remove endometriosis? guardian.co.ukguardian.co.uk - guardian.co.ukall 12 news articles »
Endometriosis linked to embryo defectsUnited Press International - Jan 20, 200920 (UPI) -- A US researcher links endometriosis to abnormalities resulting from defects in the early embryo. Endometriosis is a disease that can cause pain ...
What is endometriosis?guardian.co.uk, UK - Jan 21, 2009If you have endometriosis, small pieces of the lining of your womb stick to other parts of your body, such as your ovaries or your bladder. ...What are the symptoms of endometriosis? guardian.co.ukWhat will happen to me? guardian.co.ukQuestions to ask your doctor guardian.co.ukall 4 news articles »
What treatments work for endometriosis?guardian.co.uk, UK - Jan 21, 2009If you have endometriosis, the tissue that normally lines your womb grows in other places outside the womb such as your ovaries and part of your bowel. ...Hormone treatments for endometriosis guardian.co.ukHormone treatments before surgery guardian.co.ukTypes of hormone treatment guardian.co.ukguardian.co.uk - guardian.co.ukall 10 news articles »
Who's at risk of endometriosis?guardian.co.uk, UK - Jan 21, 2009Reproductive history and endometriosis among premenopausal women. Obstetrics and Gynecology. 2004; 104: 965-974. Sangi-Haghpeykar H, Poindexter AN 3rd. ...
Progress made in understanding causes and treatment of endometriosisHindu, India - Jan 17, 2009CHICAGO: Endometriosis is a poorly understood chronic disease characterized by infertility and chronic pelvic pain during intercourse. ...
A life with endometriosisHealth24.com, South Africa - Jan 19, 2009After numerous visits to a range of specialists, I was diagnosed with endometriosis. I was immensely relieved to finally attach a medical name to the beast ...
Subscribe to:
Posts (Atom)