Gynecare Inter Gel Solution
Okay I am seriously angry about what is and has happened to the women of the world because it seems women are the target sex because drug manufacturers can make vast sums of money from their bodies. The sad thing is most of these products are used without a woman’s knowledge because barriers do not need to be disclosed before surgery takes place. I am sure there are many, many women who don’t have a clue why they suffer after a surgery, because women rarely ask for an operative report after the surgery is over. I am trying so hard to warn women so that they can go to the HOSPITAL where they had the surgery (not doctor’s office) and purchase their operative report before time runs out. Hospitals only need to keep records for up to five years before they are moved to storage. So please collect your operative report from any surgery and store it with your important papers.
For years awful things have happened to women and this blog is to show you how much confusion there is about a product EVEN NOW years later. You should also know that a product can be used for many years before there is a red flag and the FDA takes notice, so the more you report your bad reaction, the sooner this will happen. You may think you need verification of what you believe could be the cause of your illness, but you don’t. Get the operative report and write down your symptoms and report to the FDA or any government if you live in another country.
I came across this product warning because I have been researching scar formation barriers that are on the market now and I was trying to find out more about scar tissue and what you can do to help yourself. When I came across an FDA report written in 2003 and then found an approval. This is that report and make note of the fact that it was used in many countries.
Urgent Global Market Withdrawal: GYNECARE INTERGEL Adhesion Prevention Solution Voluntarily Withdrawn from the Market by GYNECARE Worldwide
April 16, 2003
GYNECARE Worldwide, a division of Ethicon Inc. of Somerville, New Jersey, notified FDA that they are voluntarily withdrawing “GYNECARE INTERGEL Adhesion Prevention Solution” from the global market and are urging customers to immediately stop using this device. This product has been distributed in the following countries; Austria, Canada, Egypt, England, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Portugal, Republic of Singapore, Saudi Arabia, Scotland, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and the United States.
This product is intended to be used in open, conservative gynecological surgery as an adjunct to good surgical technique to reduce post-surgical adhesions. GYNECARE is conducting this voluntary withdrawal to complete an assessment of information obtained during post-marketing experience with the device, including adverse events associated with off-label use in laparoscopy and non-conservative surgical procedures such as hysterectomy.
Post-market reports include late-onset post-operative pain and repeat surgeries following the onset of pain, non-infectious foreign body reactions, and tissue adherence. In some patients a residual material was observed during the repeat surgery. Post-operative pain could be suggestive of other serious complications and physicians should be aware of this in managing patients in the post-operative period.
GYNECARE is withdrawing the device from the market to conduct a full and thorough assessment of technical issues, surgical techniques and circumstances associated with the post-market events. From the launch of this device in 1998 to February 2003, the overall complaint rate worldwide is low.
GYNECARE is requesting all GYNECARE INTERGEL product and samples be returned to GYNECARE. Questions about returning these products can be answered by GYNECARE sales representatives or the Customer Hotline at 1-800-551-7683. Further information can be found at: http://www.fda.gov/medwatch/safety/2003/Intergel.pdf
FDA is also investigating to determine the nature of the problem and will update this webpage as information becomes available.
So now you may wonder what this product is and why it was used and here is what I found.
What is it and when is it used? GYNECARE INTERGEL® is a thick liquid (gel) made of sodium hyaluronate and iron. It is used during gynecological surgery to separate and protect tissues as they heal, preventing adhesions. The gel is supplied in a sterile, single-use bottle.
How does it work? After surgical procedures are finished, but before the abdominal cavity is closed, the inner tissues are coated with GYNECARE INTERGEL®. The gel lubricates the tissue surfaces and keeps them from sticking together (adhering) while they heal. After about a week, the tissues absorb the gel and it is passed out of the body.
What will it accomplish? GYNECARE INTERGEL® will reduce the chance that a woman will develop adhesions following surgery. Adhesions are a common complication of surgery on the female reproductive organs (ovaries, uterus, or fallopian tubes). They are bands of scar tissue that sometimes form during healing. Adhesions connect organs or tissues that should normally be separate. This can cause pelvic pain, bowel obstruction, or infertility. Once adhesions form, they can only be removed with surgery.
When should it not be used? GYNECARE INTERGEL® should not be used in patients who:
- have pelvic or abdominal infections
- are pregnant
- are undergoing laparoscopic surgery
FDA Patient Safety News: Show #16, June 2003
Urgent Market Withdrawal of GYNECARE INTERGEL Solution
Now for an alert about a product that’s been voluntarily withdrawn from the market. The product is the GYNECARE INTERGEL Adhesion Prevention Solution, and It’s used to reduce post-surgical adhesions in patients undergoing open, conservative gynecologic surgery. Adverse event reports associated with this solution have included late-onset post-operative pain and repeat surgeries following the onset of pain, non-infectious foreign body reactions, and tissue adherence. In some patients, a residual material was observed during the repeat surgery.
GYNECARE Worldwide, a division of Ethicon, Inc. is urging customers to immediately stop using the INTERGEL Adhesion Barrier Solution, and return all remaining product and samples to the company.
GYNECARE is taking this action while it completes an assessment of the experience with the device. Part of the assessment will include adverse events associated with off-label use, for example in laparoscopy and non-conservative surgical procedures such as hysterectomy.
I found this on a lawsuit page dated 2007
Intergel is made from sodium hyaluronate and iron, and was developed to help the healing process and prevent adhesions by separating and protecting tissues after gynaecological surgery. It was originally approved by the FDA only for open gynaecological procedures. Intergel was specifically NOT approved for laparoscopic surgeries or hysterectomies, as data presented a higher rate of infection when used in this fashion. Still, Intergel was often used off-label for hysterectomies, and laparoscopic procedures.
Post-operative issues arising from use of Intergel include pelvic pain, internal scarring, infertility, allergic reactions, tissue adherence and issues with the bowel. Some patients have reported requiring repeat surgery to correct problems allegedly brought about by the use of Intergel.
Examples of procedures for which Intergel has been prescribed include surgery for the removal of fibroids, and treatment for endometriosis. Following use of Gynecare Intergel, patients have reported symptoms ranging from abdominal pain to shortness of breath.
One case, cited in the 2004 communiqué to Lifecore from the CDRH, identified a patient with such advanced adhesive disease that the left side of her pelvis appeared frozen.
So what now you may wonder. Well this would have been a class action lawsuit product and you can find out if they are still taking cases, because often a product will have a fund for continuing cases. This is a lawyer’s link I found.
Now you would think that was the end of that product but then I came across an article saying the FDA had approved in again in 2007. I wondered what the heck was going on, so I kept digging and found this article.
Even though Gynecare Intergel Solution was being marketed successfully outside of the U.S. since 1998, the manufacturer had a tougher time convincing the FDA as to the merits of its product. There was concern over the potential for infection, and even suggestions that the product might prove unsafe for use by women.
“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation,” the Agency’s own mission statement begins.
“The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”
And that should have been the end of that.
But it wasn’t, by virtue of an appeals process, which allows a manufacturer to have a second go at the FDA. Not unlike the appeals process in courts of law, there is the provision which grants the right to dig in ones heals and say, “I don’t agree with that.” Such is the benefit of democracy.
In the end, Gynecare Intergel was approved in November 2001 through an appeals commission. The product was re-evaluated and approved as being ‘reasonably safe’ in the agency’s view.
One has to wonder, which part of the FDA Mission Statement supports the phrase, ‘reasonably safe’?
As it turned out, patients began experiencing the very adverse effects the FDA evaluation team was worried about in the first place – a situation complicated by a plethora of off-label product use for procedures not approved by the FDA. To be fair, the FDA has no control over off-label use. The latter is the sole jurisdiction of the doctor, who may in turn base an opinion on misinformation, or make a decision under influence of savvy marketing.
However, it can hardly be a surprise for a product described as ‘reasonably safe’ to be recalled. Either a product is safe, or it isn’t. If there are side effects that are mitigated by the overall value of the drug for which it was prescribed, then it’s a judgement call based on the lesser of two evils.
Compare that to, “…well, we think this could kill you. But go ahead and try it, first. We think it’s reasonably safe.”
In recent days the FDA has allowed limited distribution of Zelnorm, a drug that it referred to as unsafe three short months ago.
And on July 30th a federal drug advisory committee that included FDA officials gave a virtual pardon to the drug Avandia. The latter was the subject of scandalous headlines this past May after a study published in the New England Journal of Medicine linked the diabetes drug to an increased risk of cardiovascular complications.
It should be noted that the FDA, once funded entirely by taxpayers and beholden to no one, is now partially funded by pharmaceutical companies.
Perhaps the FDA mission statement, and that of any publicly funded agency entrusted with a nation’s health and well-being, should include some wording that suggests it knows which side of its bread is buttered.
Seventy recorded adverse affects were received by the FDA concerning Gynecare Intergel Adhesion Prevention Solution, including 48 injuries and three deaths.
It wouldn’t be too much to suggest that pharmaceutical companies appear accustomed to the inside of a courtroom, when a medical product or device is accused of inuring, or killing someone.
It’s a wonder more people aren’t, in fact, attempting to sue the FDA. This is where I found this article
So now what? Now I am wondering how many women who have undergone surgeries over the past few years have undergone many symptoms that no doctor accepts as a problem. So I hunted more and found a forum and this is one ladies report of this product dated 2004.
well lets see we can start by saying the doctor went in and had already done a laproscopy he then went in and removed my ovary and used the intergel before he closed me up in december of 2002. then I wasnt feeling any better when I got released from the hospital and I ended up calling him one night and he told me to come to fort hamilton hospital in hamilton, ohio.
When I got there they did a cbc and the doctor came in and said I had an infection my white bliood count was 22,000. So they admiitted me again then he went in and removed my apendix but thats not what the problem was.
It was the intergel, I then developed a square blood clot and it was so pain full and the doctor said it was one of the rare side effects from the gel. I had three surgeries after the intergel was used and becase of it I ended up with a full blown hysterrectomy and I was thrown into menopause at 30 I turned 30 on January 28th of 2003. I have been seing a pain doctor for over a year I have had to have two colonoscopies and sent to a uroligist to try to figure out what all my pain was from.
Once again the gel is and has been my problem it has caused alot of uneccasery surgeries and taken alot from my life I was back at the doctor yesterday and we talked about the intergel thats why I decided to do some research and I have spent about 11 hours so far searching things and this gel. so yes the gell that was turned down by the fda 11 times should have never been used.
also my doctor didnt tell me he used it untill my 4th surgery. then when he trieg to contact the company no one wold get ack with him because he had all these questions about me and the gel and no one would get back with him for weeks I spent alot of time in the hospital and I was told yesterday he is going to do surgery AGAIN because I am still having pain from that gel. At this time my youngest child was getting ready to turn 1 in febuary. I wasnt able to lift her for almost a year with out being in so much pain.
My other two which are now 14 and 12 suffered because I couldnt drive them to soccer so they dropped out and I couldnt and still cant do any straining or anything using my stomache muscles or sleep on my stomache. Not sure of the exact dates of all my surgeries but know end of 2002 and begining of 2003. ow that the pain I suffer everyday is the worst pain I have ever had I live with pain on a scale of 8 atleast daily. I do knAlso my husband has his own company and had to stay home with the children during all this time I spent in the hospital and our sex life it not good. It hurts for me to have sex.
why at 31 almost 32 should my body be like im 70. Have a bestfriend that had endometriosis and the doctor may have used the same gel we dont know so we both want to find out about her also. but I know it was used on me. This is the link
Johnson & Johnson (Ethicon) are now in lawsuits concerning mesh implants, but all these big pharmaceutical companies are doing the same thing. From everything I have read, the cure is often far worse than leaving things alone, but of course they can’t make money unless they have their products sitting in surgeries so that big bucks can be charged on your surgery bill when they are used. It is time to change this. Ask many questions before you have any surgery. Do not expect these products will be disclosed and you have to sign a release before anything is used. That is not the case. Once you feel better after any surgery, go to the hospital and get your operative report. Time to stand up to what is going on and report your symptoms to the FDA.