What is Interceed
If it were not for talking to other women, I could not share with you many important things that have happened to other women, nor how it changes their lives. Yesterday I posted a blog about Seprafilm and the fact there are lawsuits on this product. Then I remembered a young woman I had tried to help about eighteen months ago after she had pelvic pain and struggled to get her records because they told her they couldn’t find them. She contacted me because at that time she wondered if they put mesh in, when she had a C-Section. She is a young mother raising young children and the pain is constant and she has never found out why. I gave her the blog link about Medical Records Law, and she kept pursuing until she did get them because she finally made the hospital tell her where her records were stored. Once she got her operative report, she found out the only thing that was used was Interceed. At that time I could find nothing on this product to help her, so she did make a trip to see Dr. Raz and had the translabial ultrasound done, where it did not show any mesh. He did tell her to have an MRI done and send him the results.
Yesterday I suddenly remembered her and sent her a note to look at her operative report because I remembered they did use something but I could not remember what. This morning I did remember what it was and I began researching about Interceed. Once again there are lawsuits on this one as well. So I searched until I found a really good paper written on these scar tissue barriers and I took some of it to post on this blog. There is a lot more and there are other barrier products, so please read the entire post of which I will give you the link at the end.
“Ninety-three percent of patients who have abdominal surgery will have adhesions,” according to Togas Tulandi, MD, Professor of Obstetrics and Gynecology, The Milton Leong Chair in Reproductive Medicine, McGill University, Montreal. “Adhesions cause infertility, pain, and bowel obstruction,” he explained.
The National Hospital Discharge Survey of hospitalizations between 1998 and 2002 found that out of 281,982 hospitalizations, 51,100 were related to adhesions and adhesions were one of the problems for 227,882 other hospitalizations. Altogether, adhesions were directly or indirectly responsible for 948,000 hospital days, costing $1.18 billion (U.S.).
Another financial consideration is intestinal injury during adhesiolysis. One study found that 52 out of 270 patients had inadvertent injury during adhesiolysis. Risk is related to body mass index and the number of operations. “More injury occurs because of previous abdominal and pelvic surgery,” Dr. Tulandi said.
“There is an association between infertility and adhesions,” he continued. He described research he conducted to test whether removing adhesions would enable women to get pregnant faster. If a patient was not able to achieve pregnancy within one year, Dr. Tulandi would do laparoscopic surgery to remove adhesions. He found that women who had adhesions removed got pregnant faster than those who had adhesions that were not removed.
Pain is another critical aspect of pelvic adhesions. He described an old study that looked at pain in patients who had stage IV adhesions, local adhesions, or adhesions that had been removed. The study found that there was much greater reduction of pain in the group with stage IV adhesions that had been removed.
Small bowel obstruction is another critical aspect of adhesions. “Post-surgical adhesion is the most common cause of bowel obstruction,” Dr. Tulandi said. Within one year following surgery, 1% of patients with adhesions develop bowel obstruction. He explained that gynecologists rarely see patients with bowel obstruction because it can occur years after the initial surgery. When symptoms occur, the patients usually go to the emergency room or to a general surgeon. He added that there is a slightly higher risk of small bowel obstruction in patients who underwent peritoneal closure. “Peritoneal closure is unnecessary and can be harmful,” said Dr. Tulandi.
The most commonly used adhesion prevention method, which is not approved by the FDA, is hydroflotation using crystalloid solutions such as lactated Ringer’s solution or saline. However, “hydroflotation does not work because of the rapid rate of absorption,” explained Dr. diZerega. He listed several studies that have all shown that crystalloids do not prevent adhesions.
There are three devices approved by the FDA for adhesion prevention: the site-specific Interceed® and Seprafilm®, and the broad-covering Intergel®. These devices are FDA-approved for laparotomy use. “There are no approved devices in the United States for adhesion prevention by a laparoscopic instillation,” Dr. diZerega said. Numerous studies have demonstrated the effectiveness of these adhesion prevention devices. More and more physicians, both gynecologists and general surgeons, are utilizing these devices on a routine basis.
Seprafilm® is a site-specific device that is made out of hyaluronic acid and carboxymethylcellulose, and it achieves good results, according to Dr. diZerega. Seprafilm® is very tacky and surgeons must hold the film in its special packaging. The surgeon needs to make sure that the field is dry and easily accessible. Applying Seprafilm® to the posterior pelvis is very challenging. “Studies have provided compelling evidence that Seprafilm® works,” he said.
Interceed® is made of oxidized regenerated cellulose. It is the same material as Surgicel; however, Interceed® lasts longer in the peritoneal cavity. Dr. diZerega reviewed six studies on the efficacy of Interceed®. The results of the studies were fairly consistent and showed that Interceed® is twice as good at preventing adhesions as surgical technique alone. He cited a study by Sawada and colleagues in which patients in a general infertility practice who received Interceed® became pregnant more frequently than the surgical controls (J Repro Med. 2000;45(5):387-9).
Dr. diZerega said that there are two problems with Interceed® that compromise efficacy. First, Interceed® turns black when placed on bleeding tissue because hemoglobin has touched the oxidized cellulose. If a spot of black appears, it is not of concern. However, if the spot enlarges, Interceed® should be removed and better hemostasis established. The second problem is related to the presence of residual irrigation fluid. In the Trendelenburg position, the excess fluid goes into the upper abdomen. Once the patient is out of this position, the excess fluid flows down into the cul-de-sac and washes off the Interceed® (or Seprafilm®). “This is a very major consideration in using this technology,” said Dr. diZerega. He recommended that, when using these site-specific barriers, the patient be placed in reverse Trendelenburg and the fluid in the cul-de-sac removed until there is less than 10 milliliters remaining.
Intergel®, the most recently approved adhesion prevention device, is made of hyaluronic acid, iron, and water. Hyaluronic acid is naturally found in the human body — it fills the eye chamber and is used routinely in ophthalmologic procedures. The hyaluronic acid molecule is absorbed very quickly across the peritoneal membrane. Read more here
There are many abdominal surgeries including keyhole surgeries as well as C-Sections, so if you know someone who has had problems ever since their surgery, please share this blog with them, because they need answers as to why they live in pain. The following is an article written by a surgeon and it has photos of how these barriers are used. I took part of it to explain more but I don’t like to share these phots as I know some people cannot stand the sight of open wounds. So if you have any pelvic pain and had a surgery done, but never felt well since, then please read everything and view how these other surgeries are done. Knowledge is power.
What Is a Laparoscopic Myomectomy?
Laparoscopic surgery is usually performed as out-patient surgery under general anesthesia and has absolutely revolutionized gynecologic surgery because of the short hospital stay and quick recovery. The laparoscope is a slender telescope that is inserted through the navel to view the pelvic and abdominal organs. Two or three small, half-inch incisions are made below the pubic hairline and instruments are passed through these small incisions to perform the surgery. Because the incisions are smaller, patients can enjoy faster recovery times and smaller scars.
Laparoscopic surgery differs from traditional surgery in a few key ways: during laparoscopic surgery, the surgeon is not looking into the abdomen directly through a large incision across the abdomen, but performs the surgery while looking at a large video monitor suspended over the patient’s abdomen. The surgery, and especially the suturing of the uterus that is necessary during a laparoscopic myomectomy, requires a great deal of hand-eye coordination and dexterity, as well as knowledge of pelvic anatomy in order to be successful.
Can Adhesion Barriers Prevent Scar Tissue?
Another new advance in surgery has been the use of special substances, called adhesion barriers, which help prevent the formation of scar tissue after surgery. Small sheets of cloth-like material can be wrapped around the raw areas from surgery and the material prevents nearby tissue such as the intestines from sticking to the surgery sites. After a few weeks, the material dissolves, leaving the newly healed surgery sites fairly free of adhesions. While the barriers are not perfect, they have been shown to help reduce the formation of adhesions. Read about this here
I found a lawsuit for this product
Once again there are statutes of limitation which usually begins at the time you found out what your problem was.
If you want to learn more about Seprafilm read the blog I wrote yesterday
To know more about getting your records, read this one