Surgical gel gets blame for pain

By RUTH HILL - The Dominion Post


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

DaVinci Robot Peels Grape

Adhesion Barrier return on investment

INVESTORS BEWARE!

As IHRT contemplates the desperation of consumers to have adhesion barriers provided in their surgeries and industries willingness to provide them, we are disheartened.
Patients aware of adhesion barriers or indeed adhesions are a slim minority.
Adhesion Barrier Market to Skyrocket to Over $550 Million by 2013PR Newswire (press release), NY - Feb 2, 20092 /PRNewswire/ -- According to Millennium Research Group's (MRG's) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 ...
As we reflect on this headline, one wonders where this number comes from?
IHRT then looks at the source of this press release.
IRONICALLY, Millennium Research Group is based in Waltham, MA, home of Confluent SprayGel and SprayShield !
If an effective adhesion barrier were found and put into use….the number would be enormous!
Here is an example of a guess on what that number might truly be.
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Cesarean Fact Sheet - Childbirth.org
Some facts about cesarean sections from Childbirth.org. ... The latest statistics indicate that 967000 cesareans were performed in the US in 1989. ...www.childbirth.org/section/CSFact.html - 16k - Cached - Similar pages
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Lets say each of these c-sections had and adhesion barrier applied at the cost of $200.00 per procedure. We feel that this would be a very conservative estimate. The cost would be $193,400,000 for just one procedure in which the number of c-section has increased dramatically since this statistic was reported…
Take the history of Spraygel to it’s current incarnation as SprayShield TM.
All IHRT can think to say is, “return on investment”.
Here is an example to see.
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Tuesday, October 28, 2008
Falling apart over Omrix
When I added Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) to my portfolio, tracked by "Globes", I noted that it was a profitable biotechnological company in a most interesting niche - biosurgical sealants for the prevention of hemostasis in surgery - and that it was not an all or nothing company, like Pharmos Corp. (Nasdaq: PARSD), for example, where one failed trial can wipe almost an entire investment.
_____________
The founder of Confluent Surgical knew his product would not pass FDA standards so the product was taken out of clinical trials….
Somehow, with fraudulent information SprayGel got it’s CE mark and was used throughout the world as an anti-adhesion barrier. Those in the United States remained safe.
IHRT was founded by the victims of ongoing study of Spraygel until we realized we were being experimented on and paying for the pleasure. In of all places Germany!
The gig was up and Confluent was sold to Tyco which was then sold to Covidien.
As IHRT continues to watch Covidiens stocks fall we become more concerned about them seeking a quick return on their investment!
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Top of Form
COV (Common Stock)
Exchange
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Change (%)
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http://investor.covidien.com/preview/phoenix.zhtml?c=207592&p=irol-alerts
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It looks like Covidien may have learned to save money by moving it all offshore just as Confluent did.
Is it the old lets see if it works ON THEM and then go to the FDA?
The same scenario is happening again with of all people, Kruschinski and Mettler. In of all places Germany!
http://www.or-live.com/covidien/2457/Pre-clinical%20Data.pdf
Kruschinski D, Homburg S, D’Souza F, Campbell P, Reich H.
Adhesiolysis in severe and reccurent cases of adhesions related
disorder (ARD) - a novel approach utilizing lift (gasless)
laparoscopy and SprayGel™ adhesion barrier. Surg Technol Int.
2006;15:131-9.

Mettler L, Audebert A, Lehmann-Willenbrock E, Schive-Peterhansl
K, Jacobs VR. A randomized, prospective, controlled,
multicenter clinical trial of a sprayable, site-specific adhesion
barrier system in patients undergoing
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Somehow the bogus science in the above studies are being used once again to tout a product and way after the fact are we learning how the bogus studies of SprayGel made thing worse for us for all of us. Victims of this fraud would tell you there are things worse than death....

It is IHRT’s opinion that until there are actually surgeons learned enough to perform an adhesiolysis that needs no barrier, these products are just a panacea…

Skill is what’s needed and compensation for the time it takes to perform a successful adhesiolyis.
Until then we fell everyone’s just kidding themselves and no product can compensate for, quick or ultra conservative surgery.
So think hard and do your research, be careful of patients who claim this is the best or only way.
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...and then you have Karen Steward!!!! Beware!
How many doctors (surgeons) encourage those who are sick to contact his former patients? No doubt, Dr. Kruschinski has raised the bar of excellence when it comes to "treating" a patient. See: Patient List

Thanks Dr. Kruschinski. Our daughter has regained her life due to your brilliance, commitment and compassion for those who suffer from this dread disorder.
http://www.adhesionpain.net/2008/09/five-yearsthank.html

This is what IHRT calls “Harvesting” a dreadful practice that can lead a person to an unwanted intervention.
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Remember that these biomedical companies and surgeons are expecting a return on their investments and patients are a dime a dozen. We must remember always “people are willing to profit from others pain”. Our capitulation to the adhesion barrier craze just seems to make us “a return on investment”

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.

Adhesion Barrier Market to Skyrocket

Time to do more homework. Time to be extra careful.

Adhesion Barrier Market to Skyrocket to Over $550 Million by 2013PR Newswire (press release), NY - Feb 2, 20092 /PRNewswire/ -- According to Millennium Research Group's (MRG's) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 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.

New Principles of Adhesion Prevention Covidien Sprayshield

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 Adhesion

Adhesions Related Disorder News you can use ARDvark Blog

Novel Product for Post Surgical Scar Formation Entering Clinical ...PR Newswire (press release), NY - Jan 21, 2009Adhesions are bands of scar tissue that connect anatomic structures that should not normally be connected. These develop when the body's repair mechanisms ...

Feasibility of laparoscopy for small bowel obstruction7thSpace Interactive (press release), NY - Jan 19, 2009The first cause of laparotomic conversion is a difficult exposition and treatment of band adhesions. The incidence of laparotomic conversions is major in ...

Study Finds MRSA In Midwestern Swine, WorkersThe first study documenting methicillin-resistant Staphylococcus aureus (MRSA) in swine and swine workers in the United States has been published by University of Iowa researchers...[read article]

U.S. Government Finds 40% Of People Currently Receiving Long Term Care Are 18-64; Numbers Continue To Rise

Economic Stimulus Bill Mandates Electronic Health Records For Every Citizen Without Opt Out Or Patient Consent Provisions

Discovery Of A Key Protein Regulator Of Inflammation And Cell Death

Flowering Plants Speed Post-surgery Recovery

Research Finds Genetic Connection Between PTSD, Depression And Anxiety

Irritable Bowel Syndrome Can Have Genetic Causes

Increase In C-Section Deliveries Coincides With Increase In Complications During Birth, Study Finds

Tension Free Vaginal Tape Underneath Bladder Base: Does It Prevent Cystocele Recurrence?

Progress Made In Understanding Causes And Treatment Of Endometriosis

Prescription Opioid Abuse, Addiction Less Common Than Many Believe

FDA Approves Fibromyalgia Drug - Savella(TM) (milnacipran HCl), A Selective Serotonin And Norepinephrine Dual Reuptake Inhibitor

Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC) - Exclusive Report From 2008 Asian IC Guideline Meeting

Pain Treatment Research Reports Often Cannot Be Trusted

Study First To Pinpoint Why Analgesic Drugs May Be Less Potent In Females Than In Males

Common Treatment For Men's Pelvic Pain Proves Ineffective, Queen's-led Study Shows

Symptoms of post-traumatic stress disorder (PTSD)

Following a traumatic event, almost everyone experiences at least some of the symptoms of PTSD. It’s very common to have bad dreams, feel fearful or numb, and find it difficult to stop thinking about what happened. But for most people, these symptoms are short-lived. They may last for several days or even weeks, but they gradually lift.
If you have post-traumatic stress disorder (PTSD), however, the symptoms don’t decrease. You don’t feel a little better each day. In fact, you may start to feel worse. But PTSD doesn’t always develop in the hours or days following a traumatic event, although this is most common. For some people, the symptoms of PTSD take weeks, months, or even years to develop.
The symptoms of post-traumatic stress disorder (PTSD) can arise suddenly, gradually, or come and go over time. Sometimes symptoms appear seemingly out of the blue. At other times, they are triggered by something that reminds you of the original traumatic event, such as a noise, an image, certain words, or a smell. While everyone experiences PTSD differently, there are three main types of symptoms, as listed below.
Re-experiencing the traumatic event
Intrusive, upsetting memories of the event
Flashbacks (acting or feeling like the event is happening again)
Nightmares (either of the event or of other frightening things)
Feelings of intense distress when reminded of the trauma
Intense physical reactions to reminders of the event (e.g. pounding heart, rapid breathing, nausea, muscle tension, sweating)
PTSD symptoms of avoidance and emotional numbing
Avoiding activities, places, thoughts, or feelings that remind you of the trauma
Inability to remember important aspects of the trauma
Loss of interest in activities and life in general
Feeling detached from others and emotionally numb
Sense of a limited future (you don’t expect to live a normal life span, get married, have a career)
PTSD symptoms of increased arousal
Difficulty falling or staying asleep
Irritability or outbursts of anger
Difficulty concentrating
Hypervigilance (on constant “red alert”)
Feeling jumpy and easily startled
Other common symptoms of post-traumatic stress disorder
Anger and irritability
Guilt, shame, or self-blame
Substance abuse
Depression and hopelessness
Suicidal thoughts and feelings
Feeling alienated and alone
Feelings of mistrust and betrayal
Headaches, stomach problems, chest pain
Getting help for post-traumatic stress disorder (PTSD)
If you suspect that you or a loved one has post-traumatic stress disorder (PTSD), it’s important to seek help right away. The sooner PTSD is confronted, the easier it is to overcome. If you’re reluctant to seek help, keep in mind that PTSD is not a sign of weakness, and the only way to overcome it is to confront what happened to you and learn to accept it as a part of your past. This process is much easier with the guidance and support of an experienced therapist or doctor.
It’s only natural to want to avoid painful memories and feelings. But if you try to numb yourself and push your memories away, post-traumatic stress disorder (PTSD) will only get worse. You can’t escape your emotions completely – they emerge under stress or whenever you let down your guard – and trying to do so is exhausting. The avoidance will ultimately harm your relationships, your ability to function, and the quality of your life.
Why Should I Seek Help for PTSD?
Early treatment is better. Symptoms of PTSD may get worse. Dealing with them now might help stop them from getting worse in the future. Finding out more about what treatments work, where to look for help, and what kind of questions to ask can make it easier to get help and lead to better outcomes.
PTSD symptoms can change family life. PTSD symptoms can get in the way of your family life. You may find that you pull away from loved ones, are not able to get along with people, or that you are angry or even violent. Getting help for your PTSD can help improve your family life.
PTSD can be related to other health problems. PTSD symptoms can worsen physical health problems. For example, a few studies have shown a relationship between PTSD and heart trouble. By getting help for your PTSD you could also improve your physical health.
Source: National Center for PTSD