| December 2007
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Interview with
ARD Patient & Dr. Wiseman in "The
Union Leader",
newspaper, New Hampshire USA, December 24, 2007 edition.
Read the latest press on Adhesions & ARD from one
of our members & ARD patient, Christine Damon and Dr.
David Wiseman, PhD, MRPharmS, Founder, International
Adhesions Society.
For woman with adhesion disorder, only pain ahead
By GRETA CUYLER
Union Leader Correspondent
Monday, Dec. 24, 2007
EPSOM – Christine Damon has always been in pain.
As a teenager, she sought medical treatment for abdominal
pain, back pain and vomiting.
Doctors dismissed it as a "woman problem" and
didn't take her seriously until a doctor finally
diagnosed her with endrometriosis, a chronic disease
in which
the tissue lining the uterus begins growing in other
parts of the body. In her early 20s, Damon underwent her first surgery
to remove the tissue.
She's now 44 and has had 14 surgeries because the
adhesions keep growing back. Damon
suffers from Adhesion Related Disorder, in which
internal scars -- caused by trauma - bind
organs and
tissues not normally connected. Ninety to 100 percent of surgery patients develop
adhesions, said David Wiseman, who conducts research
on ARD.
continued.......Click
here.
Do Men Get
Adhesions? an informative look by David Wiseman
PhD, MRPharmS, Founder, International Adhesions
Society
It is a common myth that only women are prone to adhesions.
While it is certainly true
that women have more “internal
parts” that require surgery, which inevitably
leads to adhesions, men are not excluded from the problem
of adhesions. A
simple look at the national statistics collected from
hospital discharges (ICD9 codes) from the most recent data available (2001-2005)
reveals the following:
- Over 50,000 men were discharged from hospital in
2005 with a diagnosis of
peritoneal adhesions (568.0), accounting for
28% of such diagnoses,
compared with 72% for women.
- Over 37,000 men were discharged in 2005 with
a diagnosis that included the
specific diagnosis of intestinal adhesions
with (ie causing)
bowel obstruction (560.81).
This number accounts for 38% of cases, compared with
62% for women.
- Men also accounted for 37% of discharges
with a principal diagnosis (as opposed
to an incidental diagnosis) was intestinal
adhesions with obstruction
(560.81). Their length of stay was slightly
higher than
that of women in 3 of the five
years studied and their hospital charges
exceeded those
of women in every year by as much as $2500.
- Over 2000 men and women died every year with
a diagnosis of intestinal adhesions
with obstruction, representing about 3% of the
total discharges with
that diagnosis. The contribution of males to
this death rate was
in every year slightly
higher than that of women in proportion to
their discharges,
by 10-15% in the years 2002-2005, and about
2% in 2001.
You can read more of this report by clicking
here or visiting the Men's section on our website or the
Downloads page.
IAS
announces world's first comprehensive "Adhesions-CAPPS
Clinic" The IAS is proud to announce its role in the opening
of the world's first center for the integrated diagnosis
and treatment of Adhesion Related Disorder (ARD) at
Florida Hospital, Celebration Health, Celebration,
FL. The founders of this clinic include our long time
friend, Dr. Jay Redan, and the IAS’ very own,
Dr. David Wiseman.
Although we have dreamed about this clinic since the
beginning of the IAS in 1996, the idea began to take
root about four years ago when Dr. Redan invited Dr.
Wiseman to make a presentation to Celebration Hospital’s
management about establishing a center for Adhesion
Related Disorder.
Dr. Wiseman recounts:
“As a result of the research done through the
IAS web site we realized that the problems of the ARD
patient extend well beyond those of adhesions. An ARD
patient will have some or all of a number of issues
including chronic pelvic and abdominal pain, bowel
and bladder disturbances as well as spiritual and psychological
imbalances.
There was no one place for long-suffering ARD patients
to turn that could tackle these issues in a coordinated
manner. Dr. Redan arranged for me to present a proposal
to Celebration’s management that would change
all of that. What impressed me was the forward-thinking
way that Celebration Health conducted every aspect
of the patient experience, from the location to the
décor of the radiology department to the scent
wafting through the air conditioning system. This hospital’s
approach may be close to Walt Disney World, but it
was no ‘Mickey Mouse’ Since that initial
presentation, I have been working closely with Drs.
Redan, McCarus and a whole project team that has brought
us to this launch.”
But there was a problem in the way the world thinks
about this condition. As a result of Dr. Wiseman’s
work it became apparent that adhesions and ARD are
part of a wider set of overlapping and coalescing conditions
including endometriosis, pelvic pain, Interstitial
Cystitis (IC), Irritable bowel syndrome (IBS) and even
fibromyalgia.
It was just not good enough to think just about adhesions,
or just about chronic abdominal pain, or even bowel
or bladder problems. We needed to think about it all.
Together. And so was born the term "COMPLEX ABDOMINAL
AND PELVIC PAIN SYNDROME (CAPPS)" defined as:
“a syndrome, of non-malignant origin consisting
of a complex of symptoms of the abdomen or pelvis that
includes pain, bowel or bladder dysfunction, of at
least 6 months duration.”
Attempting to treat these individual symptoms or conditions
as separate entities for the most part is an exercise
in frustration. Although they may start out as separate
conditions, they end up as essentially one condition
- CAPPS.
Now we understand the disease we can get to work to
prevent it and to treat it using the multi-disciplinary,
integrated and holistic approach that the CAPPS Center
is all about.
The Florida Hospital Center for CAPPS (www.adhesionscenter.com)
consists of: Dr. Jay Redan (General, laparoscopic surgeon),
Dr. Steve McCarus (Gynecologic Surgeon), Dr. Kathy
Jones (Urogynecologist), Dr. David Wiseman (Consultant,
Scientific Advisor) backed by a team that will ultimately
include care coordinators, specialist nurses, physical
therapists, nutritionists, psychologists, social workers,
exercise physiologists, psycho-spiritual counselors,
pain management specialists and neurologists.
As a separate endeavor, the IAS will establish a sister
organization, the:
International Society for Complex Abdomino-Pelvic & Pain
Syndrome (ISCAPPS) www.iscapps.org
Please visit the new CAPPS center at: www.adhesionscenter.com
PAX
Conference to be held in Belgium, September 2006
Learn more about the PAX
Society conference being
held in Belgium 27-29 September. This conference highlights:
Adhesion Formation, Tumor Implantation & Mesh Biology.
Visit the website by clicking the link above or review
the conference brochure (pdf).
Tyco
International Signs Agreement to Acquire Confluent
Surgical
Press
Release (full version)
TYCO INTERNATIONAL SIGNS
AGREEMENT TO ACQUIRE CONFLUENT SURGICAL
PEMBROKE, Bermuda – July 18, 2006 – Tyco
International Ltd. (NYSE: TYC, BSX: TYC) today announced
that U.S. Surgical, a subsidiary of Tyco’s Healthcare
segment, entered into a definitive agreement to acquire
Confluent Surgical, Inc., a leading developer and supplier
of polymer-based technology used in sprayable surgical
sealants and anti-adhesion products. The transaction
is priced at $245 million. The Boards of Tyco International
and Confluent Surgical have approved the transaction,
which is expected to close by the end of August. Tyco
expects to incur a charge in its fiscal fourth quarter
to write off in-process research and development.
Confluent Surgical, located in Waltham, Mass., markets
a neurosurgical sealant that was the first product
to receive Food & Drug Administration (FDA) approval
for use in cranial dural repair. This sealant, along
with several other products in the company’s
pipeline, is intended to improve patient outcomes by
reducing leaks or adhesions across various surgical
specialties. Over the next six years, the biosurgery
market—which is estimated at $900 million—is
expected to double in size. This acquisition helps
position Tyco Healthcare and U.S. Surgical to compete
effectively in that growing market.
continued here: Press
Release
Participate in
our most sophisticated Adhesions Survey yet!
Click
here to
participate in our latest & most sophisticated adhesions
survey yet!
You have been very kind in the past to respond to
one of our International Adhesions Society (IAS) surveys.
As a result YOU have helped advance the medical understanding
of Adhesions Related Disorder (ARD). As a result of
your prior participation we are now developing specific
medical programs for adhesions patients like you. The
results of our surveys have now been submitted to a
major medical conference for presentation. THANK YOU!!
But there is more to do. We have more questions that
we need to answer in order to make more progress in
the treatment of Adhesions and Related Disorders.
This survey will open a new browser window.
State of Massachusetts
Resolution for Endometriosis.
Click here to review
the latest Resolution for Endometriosis, with mention
of adhesions & the IAS.
Thanks to Dawn (from MA) for her efforts!
Recent IAS Survey Results
Over the past 24 months,we have conducted patient surveys
regarding 'Informed Consent' and "Adhesions &
Bowel Obstruction (pelvic & abdominal only).
Click here to review
the results!
Thanks to everyone who participated.
Angiotech Gets Positive
Results in Study of Adhibit Spray Gel to Prevent Adhesions.
Wednesday September 28, 11:06 am ET
Angiotech Gets Positive Results in Study of Adhibit
Spray Gel to Prevent Adhesions
NEW YORK (AP) -- Angiotech Pharmaceuticals Inc. said
Wednesday it received positive results from a clinical
study conducted to evaluate how safe and effective its
Adhibit Adhesion Prevention Gel is in reducing scarring
after uterine surgery.
Adhibit is a spray gel applied during surgery that binds
directly to the tissue and creates a temporary barrier,
preventing contact and adhesions from forming between
tissue surfaces.
The company said the number of patients who suffered
from adhesions in the control group was double that
of the group receiving Adhibit -- 65 percent versus
33.3 percent. Safety data also indicated fewer adverse
events occurring with the Adhibit group than the control
group.
The study was conducted at six sites in Germany, Canada
and Curacao. Patients who were scheduled to undergo
myomectomy surgery were randomized to either receive
Adhibit or be part of a control group. Patients then
returned 8 to 10 weeks later for a second-look procedure
and were evaluated for both extent and tenacity of adhesions.
Uterine fibroids are benign tumors of muscle and connective
tissue that develop within, or are attached to, the
uterus. Fibroids are the most common pelvic tumor and
they may be present in as much as 70 percent of women,
for which surgery is a common treatment.
"One of the major challenges to date has been
to deliver an effective adhesion barrier through a laparoscope,
a technique that requires only a very small scar as
compared to the traditional and more disfiguring technique
of open surgery," said Rui L. Avelar, senior vice
president of medical affairs for Angiotech. "Adhibit
is a sprayable and versatile adhesion barrier that can
serve as a useful tool in women's health-care and gynecological
surgery."
Adhesions occur when normally separate tissues scar
together following surgery or tissue damage. Angiotech
said the incidence of adhesions is remarkably high,
particularly among patients with a history of multiple
surgeries and women with previous gynecologic surgeries.
Adhesions can be life threatening and can make follow-up
surgeries hazardous, and are also a leading cause of
female infertility and bowel obstruction.
Currently approved in Europe to prevent or reduce post-surgical
adhesions in pediatric patients undergoing cardiac surgery,
Adhibit is a synthetic, self-polymerizing liquid hydrogel
that is safely metabolized by the body in less than
30 days.
Adhibit is sold and marketed by Baxter Healthcare Corp.,
who also has an option to license Adhibit in the U.S.,
but it is currently not approved for sale in the United
States.
"Crazy Glue",
an article in the New York Daily News regarding adhesions
on 28 June 2005.
New York Daily
News
Crazy Glue
By RANIT MISHORI, M.D.
Tuesday, June 28th, 2005
[Click
here for full version]
On most days, Maria de los Reyes, a Port Authority
lawyer, feels the pain. "It's like someone's hand
is in my guts, squeezing them to death," she says.
It's been like this for 13 years now, ever since she
had a hysterectomy, which went smoothly. But then a
complication set in, one of the most common but least
talked about side effects of surgery for millions
of American men and women — something doctors call
"adhesions."
Getting an adhesion is like having a not-so-elastic
band suddenly materialize inside your body cavity
and connecting internal organs that are not normally
connected — like loops of intestines, with your
uterus at one end and a bend in the fallopian tubes
at the other, or joining your intestines and the walls
of the abdomen.
The growth can play havoc with your organs, causing
excruciating pain and, when the small intestine is involved,
bowel blockage and obstruction. Says David Wiseman,
a researcher and doctor of pharmacology from Dallas,
an expert on adhesions: "It's like taking
a ball of string that you let the cat play with, and
get it all knotted up and tangled, and then you pour
glue on it and let the glue stay."
Common in men, more so in women
Like hardened glue, adhesions are tough and inflexible,
which is why doctors liken them to scar tissue.
Physically resembling plastic wrap, and composed
of a tissue called fibrin, they can create a range of
different problems. Studies show adhesions can account
for up to 74% of small bowel obstructions, up to 20%
of female infertility cases, and between 20% and
50% of chronic pelvic pain cases.
What's remarkable is how high the risk is for getting
adhesions in the first place. They can develop after
any surgery — former President Bill Clinton
developed a pleural adhesion that required a separate
surgery after his bypass operation. Data show they develop
in at least 55% of patients who undergo surgery. The
number is as high as 90% for certain types of surgeries,
like hysterectomies and C-sections, which is why the
majority of patients suffering from adhesions are women.
The truth is that adhesions, first recognized when
surgery entered mainstream medicine in the early 1800s,
are still not well understood. The best guess is that
they result from a kind of overreaction by the body.
Dr. Soumitra Eachempati, assistant professor of surgery
at Weill Medical College in Manhattan, says: "After
any type of tissue injury, your body would have an inflammatory
response. The more vigorous the response, the more
likely the adhesions would form."
Some people, he says, are more unlucky than others
and have "an exceptionally vigorous response."
They're the ones who get severe adhesions and may suffer
from chronic pelvic or abdominal pain.
De los Reyes is one such patient. Like many who
suffer from adhesions, her difficulties with the
condition began as she recovered from a hysterectomy
her doctor recommended in response to fibroids
growing in her uterus. Pain (resulting from multiple
episodes of bowel obstruction) was the main
symptom — pain she says she can never
get away from for long, even 13 years later. "It
is basically a day- to-day thing to see what I can do
to alleviate — at least to some extent — the
discomfort."
In addition to having had multiple surgeries for bowel
obstruction and what doctors called "adhesiolysis"
— cutting of adhesions — she has tried a lot
of things to ease the pain, including prayer and meditation.
She has even — and she says this seriously —
tried jumping up and down on a trampoline. Sometimes
these measures have helped, but only temporarily. "I'll
get relief for a little while," she says, "but
sooner or later I wind up having problems again."
Suffering from a lack of belief
Some 35% of all patients who undergo abdominal or pelvic
surgery end up back in the hospital because of this
recurring pain, with the usual result that they require
surgery to remove the adhesions.
It's not just pain that's at issue. Certain adhesions
can act to tangle up a woman's fallopian tubes
and ovaries, causing infertility.
Others can cause obstructions in the bowel. In these
cases the only solution is to "go back in"
and try to cut the adhesion or even cut out the
affected part of the organ. "If you liken
your intestines to a long garden hose," explains
Eachempati, "then there's a part that's kinked,
and we'd try to find that part and cut away the scar
tissue that is compressing it."
But even that's not a sure thing. As de los Reyes has
learned, adhesions can be cut, but like bad weeds, they
can spring up again. She has undergone 14 surgeries
to deal with her adhesions.
"It's a tremendous emotional toll," she sighs,
then mentions the part of the experience that really
gets to her: "You start to doubt yourself."
It's a doubt that comes from having been told, too many
times, by too many doctors that "there can't possibly
be anything wrong with you."
Indeed, the medical system seems to be in a certain
amount of denial about the problem of adhesions. Despite
their frequency, few surgeons ever bring them up as
a risk factor in pre-surgery discussions with patients.
Afterward, once the pain begins, many patients encounter
scorn and disbelief from the medical system.
Wiseman is one of the sympathetic ones. President
of Dallas-based Synechion, Inc., a consulting company
that handles the science and business of adhesion prevention,
he also runs a resource Web site, www.adhesions.org.
He's heard the lament from patients over and over again,
he says. "'No one believes me…everyone says
it's in my head… everyone thinks I'm making it
up," he says, reciting a long list of patient complaints
when they bring up their post-surgery suffering.
Sometimes, he says, all the patient needs is someone
to speak to her nicely and say "'Listen, you do
have adhesions, you're not making this up, it's not
in your head.'"
That's the "good" news. Here's the bad news
Wiseman has delivered again and again: "There's
not much we can do about it, but let's plan your life."
A more comprehensive approach is what Wiseman and Dr.
Jay Redan, a surgeon who is an expert on adhesion diagnosis
and treatment, believe that patients need.
"No one's really looking at the whole picture,"
says Wiseman. In the fall, the two hope to launch
what they say is the world's first comprehensive integrated
clinic for patients with adhesions, chronic pelvic pain
and related problems. The center, housed at Florida
Hospital Celebration (Fla.) Health in Celebration, will
feature a multidisciplinary team of surgeons, gynecologists,
nutritionists and urologists, among others. This has
come out of the realization that patients such as de
los Reyes need more than just pain management or repeated
operations.
The medical world keeps waiting for the breakthrough
that will prevent adhesions from forming in the first
place. Laparoscopic surgery, which allows surgeons to
make tiny incisions, has not proved to be that advance.
In fact, research shows adhesions are just as likely
to form after keyhole surgery as conventional surgery.
Some companies are trying to develop what are called
barrier agents, such as Seprafilm, a kind of plastic
sheeting put in place during surgery to keep the various
loops of small intestine from coming into contact with
other organs and each other. It has been available in
Europe for some time and approved by the FDA in 2002.
Wrapping up a better solution
Other researchers are working on gels and solutions,
such as Adhibit and Adept, that insulate body parts
against physical contact with one another. Like the
barrier agents, these products have reduced the severity
of adhesions without eliminating them. Also available
in Europe, their use in the U.S. is pending the results
of clinical trials.
There's also evidence that a surgeon's actual
technique may matter. Studies show the risk of adhesions
may be reduced when surgeons handle tissue carefully,
use powder-free gloves, dissect gently, control
bleeding, prevent infection, and keep tissues moist,
among other measures.
Finally, there is much interest lately in the use of
Cox-2 inhibitors (such as Celebrex), the anti-inflammatory
drug recalled not long ago for its adverse side effects.
A recent study showed a "dramatic" reduction
in adhesions in mice treated with Cox-2 inhibitors.
According to a press release, investigators Dr. Mark
Puder and Dr. Arin Greene from Boston's Children's Hospital
are preparing to set up a clinical trial of Celebrex
in adult surgical patients.
Until more is learned and new products become
available, de los Reyes hopes more people become aware
of the issues surrounding surgery and adhesions.
She teamed with some of her doctors and has been talking
to others in her situation.
"Helping other people… really makes a difference.
It distracts me from myself," she says. "If
I can tell my story and help somebody, at least I am
not going through this agony for nothing."
Adhesion Related Disorder
(ARD) - Recognized by United States Congress.
The Committee on Appropriations for the House of Representatives
has recognized the significance of ARD and has encouraged
the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) division of NIH to investigate
this disease and to support research into its causes
and treatments.
Specifically their report regarding FY2006 (p78) states:
“Adhesion related disorder.--This little known
condition commonly leads to abnormal attachments between
the organs inside the abdomen. The adhesions generally
are composed of scar tissue resulting from previous
operations. Very little is known about why adhesions
form more aggressively in some people. Diagnosis of
the disease is typically difficult, and surgical correction
is often unsuccessful. The Committee encourages NIDDK
to investigate this disease, supporting research to
find treatments and understand causation and to communicate
these findings to broaden knowledge of the disease in
the medical community.”
The report, dated September 7th 2004 may
be viewed here.
Although the report does not earmark any funds for
this research, it represents an important milestone
in our campaign of awareness and research into ARD,
a term first used by the IAS.
It represents the tireless efforts of many IAS volunteers
who have written to their legislators, newspapers and
TV stations about ARD and its devastating consequences.
As part of the budgetary process, all government agencies
that may be affected by recommendations made by the
Committee on Appropriations are required to respond
regarding the action that they will be taking. Accordingly,
in their Congressional Justification 2006, stated
“Future plans for NIDDK research on IBD and other
adhesion-related disorders will include the continued
pursuit of new drug therapies, the development of surrogate
markers of disease, the maximization of research investment
in animal models of disease, and the establishment of
a repository that will collect and make available to
investigators various types of human samples including
blood, biopsied tissue, genetic material, and datasets.”
This response (dated 2/11/05) may
be viewed here.
We spoke today with NIDDK-NIH about our ideas regarding
possible avenues for ARD research. They were very helpful
in providing us with information that would help us
pursue these avenues with NIH-NIDDK backing.
President Clinton to Undergo
Medical Procedure on 08 March 2005.
Statement From The Office of President Bill Clinton
From: www.clintonfoundation.org
President Bill Clinton will be undergoing a medical
procedure this week to remove fluid and scar tissue
from his left chest cavity. The procedure, which is
a recognized, occasional consequence of open-heart surgery,
will take place Thursday at NewYork- Presbyterian Hospital/Columbia
University Medical Center and he will remain in the
hospital for three to ten days.
The procedure is known as a decortication, and will
require general anesthesia. The scar tissue developed
as a result of fluid and inflammation causing compression
and collapse of the lower lobe of the left lung. The
surgery will be done either through a small incision
or with a video-assisted thoracoscope inserted between
ribs. The fluid buildup and lung collapse has caused
the President some discomfort in recent weeks, but he
has otherwise been in very good condition, recently
passed a stress test and is walking up to four miles
a day near his home in Chappaqua, NY.
The risk of the procedure is low, and once fully recovered,
President Clinton is expected to resume his work without
limitations.
Celebrex Prevents Adhesions
After Surgery in Mice
Feb 4th 2005: The recent finding that Celebrex may
help to reduce adhesions after surgery is a significant
finding for several reasons. Although the study reported
by Dr. Mark Puder and his colleagues at Children's Hospital
in Boston was performed in mice there are several reasons
for hope.
Principally, for the first time we have data that shows
that an approved drug is active orally against adhesions.
This provides important leads for future research. There
is a long way to go before this drug should be used
routinely in humans - there are a number of safety concerns
not only related to surgery itself but also related
to the ongoing controversy over the use of COX2 inhibitors,
of which Celebrex is a type.
This landmark study was published in the online version
of the
prestigious journal "Annals of Surgery" .
Dr. David Wiseman, founder of the International Adhesions
Society, had been invited along with two surgeons, to
review the manuscript as part of the peer review process
and was able to make some significant contributions
regarding the presentation and analysis of the data
obtained in the study. Somewhat unusually Dr. Wiseman
was acknowledged in the paper, as "a reviewer."
"I sent the paper back about two or three times
for revision because I wanted to make sure that there
was nothing ambiguous about this landmark paper. I'm
glad I was able to do my part to heighten the awareness
about ARD and to offer hope to all of its victims."
Click
here for more information.
Newscast: Treating Painful
Adhesions after Surgery
Watch the local ABC-affiliate in the San Francisco
Bay area of California (USA) for a segment on "Treating
Painful Adhesions after Surgery". The IAS also
has a link from this page!
View
the video
Read
the summary
Government Recognition Project
Underway for Adhesions & ARD
Want to help get recognition for Adhesions and ARD?
Then visit our Government Recognition page for more
about how you can help get recognition in your state!
Adhesions Resolution Signed in
Massachusetts.
Read the latest Adhesions resolution passed for the
Massachusetts!
Adhesions Resolution Signed in
Minnesota.
Read the latest Adhesions resolution passed for the
State of Minnesota!
Thanks to Helen for all the effort and hard work to
make this happen.
To view a readable text version, click
here
Seprafilm® Efficacy
Data Presented
Press Release Source: Genzyme Corporation
Seprafilm® Efficacy Data Presented at Surgical
Meeting Shown to Reduce Incidences of Adhesive Small
Bowel Obstruction Following Colorectal Surgery
Tuesday May 11, 10:34 am ET
CAMBRIDGE, Mass., May 11 /PRNewswire-FirstCall/ -- Genzyme
Corporation (Nasdaq: GENZ - News) today announced clinical
data were reported that show Seprafilm® Adhesion
Barrier to be effective in reducing the incidence of
adhesive small bowel obstruction following colorectal
surgery. The data were presented at the annual meeting
of the American Society of Colon and Rectal Surgeons
in Dallas and come from a five-year study involving
nearly 1,800 patients.
ADVERTISEMENT
Seprafilm is a temporary, physical adhesion barrier
for abdominal and pelvic adhesion prevention. Patients
in this randomized, controlled, multi- center, international
trial underwent one of several colorectal procedures,
with the majority undergoing colon resection for inflammatory
bowel disease. It is one of the largest clinical studies
of its kind.
In the treatment group, Seprafilm was placed throughout
the abdomen and pelvis with the intention to reduce
the incidence of adhesive small bowel obstruction. The
control group did not receive any anti-adhesion barrier.
The incidence of bowel obstruction of any cause between
the treatment and control groups did not differ. Such
results were not unexpected because an obstruction can
be caused by several factors, including bowel stenosis
and strictures, anastomotic complications, and cancer
-- conditions which would be unaffected by the placement
of an adhesion barrier.
However, detailed analysis indicated that Seprafilm
reduced the relative risk of a first adhesive small
bowel obstruction by 47 percent (1.8% vs. 3.4%, treatment
vs. control, respectively, p<0.05) in colorectal
surgery patients where the outcome was verified by direct
visualization. The study showed this led to fewer repeat
operations for adhesive small bowel obstruction in the
treatment group. There was no difference in the overall
rate of adverse events between groups.
In earlier Seprafilm studies involving 342 patients,
Seprafilm was proven to prevent adhesion formation following
both abdominal and pelvic surgery. However, it was previously
unknown if a reduction in adhesion formation would lead
to a reduction in the occurrence of adhesive small bowel
obstruction. These results suggest that Seprafilm successfully
reduces the incidence of these events in patients undergoing
colorectal surgery, leading to fewer repeat operations.
"These results are very encouraging and confirm
that Seprafilm is safe to use for preventing adhesions
in colorectal surgery patients," stated Lena Holmdahl,
M.D., Ph.D., senior medical director, Genzyme Corporation.
"We believe the data will demonstrate the link
between adhesion reduction and clinical benefit that
had been missing until now."
"These data confirm that prevention of adhesions
with Seprafilm results in improved clinical outcomes,
specifically a clinically significant reduction in the
incidence of adhesive small bowel obstruction,"
said David E. Beck, M.D. of the Ochsner Clinic and a
lead investigator in the trial. "We are encouraged
by the results and are seeing increased use of Seprafilm
in our institution as a result of our experience during
this trial."
Questions regarding these data should be directed to
Genzyme Medical Information at 1-800-745-4447.
About Seprafilm
Seprafilm Adhesion Barrier is indicated for the reduction
of post-surgical adhesions in patients undergoing abdominal
or pelvic laparotomy. Seprafilm currently is not labeled
for use in preventing small bowel obstruction in colorectal
surgeries.
Seprafilm is one of a series of hyaluronic acid-based
products developed by Genzyme. The company's leadership
in biomaterials is built on nearly two decades of pioneering
work in the application of hyaluronic acid (HA) to medical
and surgical uses. HA also is the basis of Synvisc®
(hylan G-F 20) and the Hylaform® (hylan B gel) product
lines. Genzyme is working to extend these products through
significant development efforts and to explore areas
where HA may have a medical advantage.
The most common adverse events in Seprafilm clinical
trials, which were not different from untreated controls,
include ileus, anastomotic leak, and abdominal abscess.
Seprafilm should not be wrapped around an anastomosis,
as such usage may result in increased anastomotic leak
related events. Seprafilm has not been studied prospectively
in pregnancies, in the presence of frank infections,
or in malignancies.
About Genzyme Corporation
Genzyme Corporation is a global biotechnology company
dedicated to making a major positive impact on the lives
of people with serious diseases. The company's broad
product portfolio is focused on rare genetic disorders,
renal disease, osteoarthritis and immune-mediated diseases,
and includes an industry-leading array of diagnostic
products and services, and sophisticated biomaterials.
Genzyme's commitment to innovation continues today with
research into novel approaches to cancer, heart disease,
and other areas of unmet medical need. More than 6,300
Genzyme employees in offices around the globe serve
patients in over 80 countries.
This press release contains forward-looking statements,
including the statements regarding the future prospects
for Seprafilm and Genzyme's efforts to expand its portfolio
of HA-based products to other applications through additional
development work. These statements are subject to risks
and uncertainties that could cause actual results to
differ materially from those projected in these forward-looking
statements. These risks and uncertainties include, among
others, the uncertainties associated with conducting
future clinical trials; the regulatory approval process
for new products; competitive product development; the
requirement for substantial funding to conduct additional
research and development work relating to HA-based products;
market acceptance of new products; the ability to obtain
and maintain patent or other proprietary intellectual
property protection and the actual impact of those patents
and rights; and the risks and uncertainties described
in reports filed by Genzyme with the Securities and
Exchange Commission under the Securities Exchange Act
of 1934, as amended, including without limitation the
information under the heading "Factors Affecting
Future Operating Results" in the Management's Discussion
and Analysis of Financial Condition and Results of Operations
section of the Genzyme Annual Report on Form 10-Q for
the quarter ending March 31, 2004. Genzyme cautions
investors not to place undue reliance on the forward-looking
statements contained in this press release. These statements
speak only as of the date of this press release, and
Genzyme undertakes no obligation to update or revise
the statements.
Genzyme®, Seprafilm®, Hylaform® and Synvisc®
are registered trademarks of Genzyme Corporation. All
rights reserved.
Genzyme's press releases and other company information
are available at www.genzyme.com and by calling Genzyme's
investor information line at 1-800- 905-4369 within
the United States or 1-703-797-1866 outside the United
States.
Media Contact: Investor Contact:
Maria Foley Kristen Galfetti
(617) 768-6690 (617) 768-6563
Adhesions recognized at the NIH
Follow this link to
read what the NIH and National Digestive Diseases
Information Clearinghouse (NDDIC) have to say about
Adhesions!
ARD & ARD-Related Deaths
News Release
Learn more about ARD
& Adhesion Related Deaths in the news release
provided by Dr. Wiseman of the IAS.
IAS Supports HONcode Initiatives
The IAS has received official notification that our
application has been accepted by the Health on the Net
Foundation (HON) and that our website complies with
the major HONcode principles.
The HONcode initiative is dedicated to improving the
quality of medical & health information on the internet.
As a qualifying member, the IAS can now proudly display
the HONcode seal on our website.
This seal means,
- that the IAS has submitted a formal application
for membership and after a detailed review process,
has been accepted.
- that Adhesions.org maintains constant compliance
with the HONcode requirements.
- that the IAS is committed to observing the HONcode
principles.
Learn more about the HONcode
Foundation or read the HONcode
of Conduct Principles.
To Top
Patient Survey Results Now
Available
Groundbreaking patient research by the IAS presented
at the PAX Congres in Amsterdam on 12 April.
In December 2002, the IAS sent out requests for participation
in our Informed Consent and Bowel Obstruction surveys.
These surveys represented groundbreaking research into
the area of adhesions and further our efforts to create
awareness for Adhesions and ARD.
Your information was compiled between December 2002
- March 2003 and the results submitted in abstract form
for acceptance at the PAX
Congres in Amsterdam earlier this month.
Our research has revealed a number of important findings
that we hope will advance the treatment and prevention
of ARD. Read the full results.
The highlights are:
- ARD patients have a bowel obstruction on average
once a year.
- 85% ARD patients suffer from chronic pain. Pain
medication often makes their bowel problems worse.
- 48% of patients are unable to work, and 46% of
these could not obtain benefits.
- 32% of those who tried physical or massage therapy
reported a benefit.
With regard to the information given to patients prior
to surgery:
- Information about adhesions was given to patients
in 54% of adhesiolysis procedures, but in only 10%
of other abdominal or pelvic procedures
- In procedures not involving cutting of adhesions,
patients were told of adhesion barriers in only 6%
of cases
A big THANK YOU to everyone who participated in the
surveys! A special thanks to Dr. Lena Holmdahl and Bev
Doucette for helping with the presentations.
If you have not participated yet in these surveys,
they are still available at our Campaigns
and Projects section.
To Top
INTERGEL Withdrawn from
Market by Company
GYNECARE Voluntarily Suspends Marketing and Sales
of Anti-Adhesion Product Pending Evaluation of Postmarketing
Events
Gynecare (division
of Johnson & Johnson) have voluntarily withdrawn
the anti-adhesion product - INTERGEL - from the market
pending an investigation into the circumstances surrounding
some adverse events including post-operative pain and
inflammatory reaction. There were also two deaths where
the product had been used after the accidental puncture
of the bowel. The relationship between the product and
these events is not certain, but the company are investigating
it.
WHAT TO DO IF YOU THINK YOU HAVE
HAD SIMILAR REACTIONS
The IAS has been contacted by a number
of patients who have asked us what to do if they believe
they have had a reaction to Intergel. Gynecare (a division
of Johnson & Johnson - the marketers of the product)
have kindly provided us with the following announcement:
"If you have had Intergel used during a surgical
procedure and have any questions about it or believe
you have had a reaction to it, you may contact Gynecare
directly by dialing 877-384-4266, option 1. This number
will connect you with a Registered Nurse who is trained
to respond to your call."
You may also contact your own doctor who will make
a report to the company, since this information will
be useful to them in determining the cause. (If you
do contact the company, let your doctor know this so
that s/he can inform the company). You can let
us know too if you wish.
For more information you can read the following press
releases (PDF), as well as a copy of the
letter sent to doctors (PDF) and the FDA
Safety Alert.
To Top
IAS Conference
Tapes
So you could not make it to Detroit for the IAS
Inaugural meeting on March 12, 2001? Don't worry because
now you can order a set of tapes containing
the following lectures:
- Dr. Michael Diamond - "The Significance of
Adhesions"
- Dr. Lena Holmdahl - "Advances in the Understanding
of Adhesions"
- Dr. David Wiseman -"International Adhesions
Society: Patient Perspectives, Why Adhesions Form
and Challenges Ahead."
As well as the following additional lectures:
- Dr. David Wiseman - "The Use of Crystalloid
(Salt) Solutions for Adhesion Prevention
- Dr. David Wiseman - "TEN (and more) WAYS
YOUR DOCTOR CAN HELP TO REDUCE or ALLEVIATE ADHESIONS"
Click here to purchase your
set or one for a friend today!
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