Hello Bill,
Thank you for asking quite a challenging question.
Although hemoclips are widely used in operating rooms around the
world, there is surprisingly little formal research on either their
effectiveness or on potential problems that might occur from their
use.
In fact, I can say only one thing with a fair degree of certainty in
responding to your question, and that is: Yes, hemoclips are
generally intended to remain in the patient permanently.
Beyond that, however, things get a bit murky. The available
information suggests that:
--hemoclips are considered to be relatively safe by the medical
community
--hemoclips are known to dislodge, but are not considered
less-reliable than other means of closure
--there have apparently been no cases of complications caused by the
dislodging of a hemoclip (other than the re-bleeding that can occur),
as evidenced by both medical and legal literature
--there have been few follow-up studies to conclusively demonstrate
the long-term safety of hemoclips
I will review the available information in more detail below. But I
would like to say up front that if anything in this answer is unclear
-- or if you simply need additional information -- please let me know
by posting a Request for Clarification, and I will be happy to assist
you further.
And a reminder, if I may...I am an expert researcher, but not an
expert in medicine or law. Please do not base any medical or legal
decisions solely on the information I'm providing you here...it's
always best to consult with the professionals in the relevant fields.
pafalafa-ga
-------------------
Hemoclips are made by Weck Closure Systems
http://www.weckclosure.com/products/7_1_5_1.html
who proudly note that "...the Hemoclip clip has been the most popular
clip system in operating rooms around the world".
Notwithstanding their popularity, however, there is not a great deal
of readily-available information on the hemoclip. Here are a list of
some of the searches I conducted at Google:
www.google.com
and at a medical literature search site, PubMed:
http://www.ncbi.nlm.nih.gov/PubMed/
in the course of completing my research:
--------------------------------------------------
SEARCH..............................# OF RESULTS
Google:
hemoclip gallbladder........................13
hemoclip malpractice.........................5
hemoclip (dislodge OR dislodging)............5
PubMed:
hemoclip OR hemoclips......................122
gallbladder.............................25,820
-------------------------------------------------------
As you can see, the information base is rather sparse, especially when
compared to a mainstream medial topic such as "gallbladder".
Nonetheless, there are certainly some documents that shed light on
your question.
=================
My first set of searches focused on medical malpractice cases
involving hemoclips. Only two cases of any substance were found, both
arising out of claims that the surgeon left a hemoclip in place on the
patient's ureter, causing subsequent damage (i.e, the ureter should
not have been permanently closed). There was no indication in the
available records that a dislodged hemoclip was ever a factor in a
malpractice suit.
---------------------------
http://www.bkslegal.com/html/newsletters/lawnotes/FirstQuarter2001.html
In Patel v. Barker...the plaintiff claimed that the defendant surgeon
sutured the colon inadequately, causing it to leak into the abdominal
cavity, and also that the surgeon left a hemoclip on the ureter.
---------------------------
http://webboard.sdbar.org/opinions/1998/May/1998_048.htm
Marjorie Beckel (Marjorie) suffered the loss of use of a kidney in
1994. She alleges it occurred because, in 1979, Dr. Bernard Gerber had
negligently placed a metal hemoclip in her body cutting off the blood
flow to her ureter. Marjorie and her husband (collectively referred to
as Beckels) brought suit against Dr. Gerber and St. Luke's Midland
Regional Medical Center in Aberdeen, South Dakota (Hospital).
[I include language, below, regarding the permanent nature of the
hemoclips]
...Dr. Gerber stated in his affidavit that the hemoclips were intended
to remain permanently in Marjorie's body...There is no question that
the clips were intentionally placed in Marjorie with the intention
that they remain there permanently
==================
I also reviewed the medical literature that is available to me
on-line, in order to gauge the experience of the medical community
regarding dislodging of hemoclips, and any problems that may result.
As I already mentioned, the literature is sparse regarding hemoclips
in general, and sparser, still, regarding dislodging problems.
------------------------------
A recent (2003) study acknowledges the sparseness of information
outright:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12612510&dopt=Abstract
TITLE: A prospective, randomized trial of endoscopic hemoclip
placement and distilled water injection for treatment of high-risk
bleeding ulcers
Although endoscopic hemoclip therapy is widely used in the treatment
of GI bleeding, there are few prospective trials that assess its
efficacy...
CONCLUSION: Endoscopic hemoclip placement is a safe and effective
hemostatic method that is superior to distilled water injection for
treatment of bleeding peptic ulcer.
-------------------
Another study makes note of the spontaneous dislodging of hemoclips,
but with no apparent problems:
www.cpmc.org/advanced/endoscopy/ physician/endo_hemoclip.pdf
TITLE: Endoscopic Hemoclip Treatment for Gastrointestinal Bleeding
Clips were observed to dislodge spontaneously with reepithelization
of the ulcer base. This occurred 1-3 weeks after placement. The clips
were
passed in the feces without any complication.
[NOTE: Figures 1 and 4 in this study offer good illustrations of the
hemoclip, itself]
-------------------
There is a good overview article of endoclips (the generic category to
which hemoclips belong) from 1999 at this link:
http://www.cpmc.org/advanced/endoscopy/physician/endoclip.pdf
TITLE: Endoclip: closing the surgical gap
[The author notes the permanent nature of the clips}
For hemostasis, the clip is used to grasp, compress, and ligate a
bleeding vessel. The hemostatic effect is immediate and should be
permanent if the
vessel is properly ligated...
[Towards the end of the article, safety and dislodging are briefly
discussed]
What about the safety of endoclips? No serious complications have been
reported. The potential for significant tissue injury is small, as
clips have been found to grasp only the mucosal and submucosal
layers...For hemostatic indications, clips have been observed to
dislodge spontaneously 1 to 3 weeks after placement with
re-epithelization of the lesion. There have been isolated reports of
clips remaining in situ up to 26 months after deployment when used for
marking. There has been no evidence of clip-induced tissue injury or
impairment of healing. Concerns that clips could impact (e.g., at the
ileocecal valve) and perforate have not been validated.
-------------------
Another GI tract review of hemoclip use can be found here:
http://www.wjgnet.com/1007-9327/6/53.htm
TITLE: Endoscopic hemoclip treatment for bleeding peptic ulcer
...Clips dislodge spontaneously and pass through the gastrointestinal
tract safely within 3 weeks. The damage to surrounding tissue was
reported to be limited. In the present study, follow-up endoscopy
showed no obvious clip-related tissue injury or impairment of ulcer
healing. Our findings confirm that no obvious complications resulted
from clip placement.
-----------------
And finally, this article again notes spontaneous dislodging,
particulary in difficult-to-clip situations, but also concludes that
hemoclips result in a smaller overall rate of rebleeding than other
some other established techniques:
http://www.wjgnet.com/1007-9327/6/42.htm
Endoscopic treatment of non-variceal gastrointestinal bleeding:
hemoclips and other hemostatic techniques
...Rebleeding after hemoclip treatment occurred in three cases
secondary to dislodging of clips associated with difficult to approach
location when applying the clips in two patients and use of
anticoagulants in the other. Hemoclip treatment reduced the rates of
rebleeding to 15% in the spurting group and 4% in the oozing group.
==============
I hope the information here provides the perspective you were looking
for regarding the type and extent of literature on hemoclips and
dislodging.
Although your question title specifically mentions the gallbladder, I
did not restrict myself in my searches to literature or cases that
only involved hemoclips and the gallbladder, for there was very little
available information that fit this description.
At the risk of repeating myself, please consult appropriate medical or
legal professionals for more in-depth information in this area.
And again, feel free to ask for clarification or elaboration on any of
the information I've provided here.
All the best.
pafalafa-ga |
