I'm trying to find out when a medical device was recalled.
This device or thing was used for a scleral buckle. A silicon sponge
like device placed around the eye to attempt to hold a detached
retina in place and prevent it from getting worse. Sort of a rubber
band placed around the eye but surgically implanted. I believe around
1995 it was found to have problems and recalled. The problem with it
was it starts to expand crushing and distorting the eye as it expands,
kind of a bad thing.
The thing/device is called a Miragel sponge. I' beleive it was made by
Mira Inc. but not 100% sure of that.
The questions are:
- when was it recalled, my Dr's records say that it was but unclear as
to excatly when.
- when recalled, by who( the company, FDA, etc.)?
- when the recall was done who were the recall notices sent to, if anyone?
- were their ever any legal actions filed about this. |
Request for Question Clarification by
umiat-ga
on
01 Dec 2005 14:14 PST
Hello, jdbooteg-ga!
I am a bit confused about the references to and relationsip between
the Miragel Sponge and Miragel buckle. I can find virtually nothing
about the sponge, except for the first article, but there is recent
mention of the Miragel Buckle.
Has the Mirgel Buckle "replaced" the Miragel sponge?
=
Perhaps you can tell me if the following references shed any light on
your questions.
* You may have to type the title into your browser since this is a cached version.
"FDA SHUTS DOWN WALTHAM MANUFACTURER." Magazine: Boston Business
Journal, November 17, 1995
http://72.14.203.104/search?q=cache:WtgCppMlhpIJ:mgv.mim.edu.my/Articles/00076/96020092.Htm+FDA+recalls+Miragel+sponges&hl=en
"The federal Food and Drug Administration has shut down Waltham-based
medical equipment maker Mira Inc. after investigators found the
company's manufacturing processes to be "out of control."
"Founded in 1962, Mira was slapped with an injunction in April by the
U.S. Justice Department preventing the company from further production
until it complies with FDA manufacturing standards."
"The company specializes in ophthalmic products: cryogenic probes used
to freeze eye tissue during surgical procedures, diathermy devices and
accessories, silicone eye implants and sponge eye implants. The
company's products include the Mira Ophthalmic Cryo CR4000 system and
Miragel, a silicone sponge eye implant."
"The government charges that Mira ignored repeated warnings from
federal regulators about its manufacturing deficiencies."
..
"Before the company can resume manufacturing, it must undergo FDA inspection."
"In addition, the company is required to hire an expert consultant to
inspect its operations at least five times during the next two years
to ensure that its operation remains in compliance with good
manufacturing practices."
"Good manufacturing practices" are regulations monitored by the FDA to
ensure that medical devices are safe for use and are medically
effective for their intended use."
==
Recent mention of the Miragel Buckle:
"Long-term complications of MIRAgel exoplants in scleral buckling
surgery." Nippon Ganka Gakkai Zasshi. 2003 Feb;107(2):71-5.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12647330&dopt=Abstract
BACKGROUND: Long-term complications of extrusion have been reported in
patients who received MIRAgel buckles for retinal detachment. All
ophthalmologists need to recognize the clinical characteristics of
these severe complications, and how the clinical course of
complication after the use of MIRAgel buckles differs from that of
silicone buckles. METHODS: Case reports and a review of the
literature. RESULTS: Severe deterioration of MIRAgel buckles may occur
when left in place for 5 years or longer, causing adverse symptoms and
occasionally intraocular complications. This deterioration is
associated with changes in the microstructural architecture of the
hydrogel material in the MIRAgel buckles. CONCLUSION: Long-term
follow-up is necessary for patients with MIRAgel buckles, and the
buckles should be removed prophylactically when advisable. When severe
ocular motility disturbances and/or presence of a tumor-like
extraocular mass are observed in patients several years after retinal
detachment surgery, the cause may be a swollen MIRAgel buckle.
==
LATE SWELLING AND REMOVAL OF MIRAGEL BUCKLES: A COMPARISON WITH
SILICONE INDENTATIONS.
Retina. 23(5):641-646, October 2003.
LE ROUIC, JEAN-FRANCOIS MD; BETTEMBOURG, OLIVIER MD; D'HERMIES,
FRANCOIS MD, PHD; AZAN, FREDERIC MD; RENARD, GILLES MD; CHAUVAUD,
DOMINIQUE MD
http://www.retinajournal.com/pt/re/retina/abstract.00006982-200310000-00006.htm;jsessionid=DPt75WQ2waSCIb2MmUqqKktxaCbqSDyM9cUZMWb5mT0XyCrPp8DT!-985028433!-949856144!9001!-1
==
"Long-term complications of silicone and hydrogel explants in retinal
reattachment surgery." Arch Ophthalmol. 1999 Oct;117(10):1449.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10037564&dopt=Abstract
==
As of Dec 19, 2004 :
http://66.102.7.104/search?q=cache:2bGELHRFNg0J:www.retinadoc.com/scripts/retina.pl%3Ffunction%3DGetAnswer%26id%3D682++Miragel+sponge&hl=en
Question: can you tell me if miragel sponge are still used in retina surgery?
Answer: Miragel is still available as a buckling devise in retinal surgery.
Answered By David Watt, M.D.
==
Any input?
umiat
|
Request for Question Clarification by
umiat-ga
on
01 Dec 2005 15:01 PST
Hello, again,
I have found no evidence that the Miragel sponge was actually
recalled. It apears that the company must have "cleaned up their act"
after the temporary closure by the FDA in 1995. I finally located the
Mira Inc. website, and they are still sponge implants for scleral
buckling:
Products - click on Silicone Sponge implants
http://www.mirainc.net/frame_products.htm
Does this help to answer your question? If so, let me know. If not,
what more do you require? I did not find any evidence of lawsuits,
either.
umiat
|
Clarification of Question by
jdbooteg-ga
on
01 Dec 2005 16:15 PST
I believe the scleral buckle is the procedure of putting in the
device(sponge) or other material to hold the retina in place.
I have found the articles you mentioned below before.
In particular the article on FDA shuts down Mira.
However I found there in another Mira that makes scleral buckle
sponges, don't know it it's the same one in a different form or what.
I have that corparations name at home but can't seem to find it today,
I 'm at work. Can't do much more of this at work I'll have to answer
more at home.
I also found a link to Dow chemicals but I don't know what the
association of the matierial they made was the same to what Mira used.
Wish I could give you
the companys name now, it's something like Mira Research but they sell
products for eye surgery.
I'll look more for what I found in a few hours from now.When I get home.
|
Request for Question Clarification by
umiat-ga
on
01 Dec 2005 17:03 PST
Now I am REALLY perplexed! Let me know what you find out when you get home!
|
Clarification of Question by
jdbooteg-ga
on
01 Dec 2005 18:09 PST
I'm not home yet but if you see this what are you really perplexed about now?
Maybe I can answer that to when I get home.
|
Request for Question Clarification by
umiat-ga
on
01 Dec 2005 18:14 PST
I am perplexed that two companies would have the same (or almost the
same) name, make the same product with the same name, and there is
virtually no information about an FDA licensed sponge (called Miragel
sponge) other than what I have found (and the MIRA website shows that
it is still being used). You have stated that the name is the Miragel
sponge, but now you are quite sure it is made by "another" company.
That is confusing in itself. Two products with the same name, made by
companies with a similar name, used for the same procedure, licensed
by the FDA.....??????
I will await your additional information!
|
Clarification of Question by
jdbooteg-ga
on
01 Dec 2005 23:13 PST
Excuse my spelling before and in the future, I was in a bit of a hurry
and no spell checker.
Your comments and response are sort of why I posted the research
question, I was perplexed to. Who made this, do other people know
about this? What the heck is going on? This could make people blind,
or at least suffer a lot.
I've searched the web. FDA website, .gov sites, etc. for the various
information that I can find and for the most part found the same
things you did. I was hoping you or others had access to some premium
databases like Lexus Nexus, or other research sources, etc. that I
can't get to easily.
Not that any premium databases may shed anymore light on the subject
but they might.
Now as to further details.
In the report that I have about what the Dr. took out of me (Miragel
sponge) he said he took out and I quote, "The problem now was the
Miragel has expanded by a factor of least four and the Miragel has
actually been recalled and is no longer used because of this
recongized problem."
Additionally, In the Dr's report which I quoted above and quote here,
this is what he says he put into my eye, on 4/18/89. a "#946 Mira-gel
sponge was used to cover the superior quadrant", ... .etc. goes on for
a page or so. But that was the name and # of the product used.
As to what company that made it? I dont't really know I came across
the same two that you did, so I'm not sure, Mira... Inc something. Who
is who? Who is on 1st :-)
Did they go bankrupt reorganize then come back, I don't know. Again
looking for answers via the post.
Thanks
John
|
Request for Question Clarification by
umiat-ga
on
02 Dec 2005 05:28 PST
Hello, jdbooteg,
Thanks for getting back to me. I am going to leave this question open
in the hopes that another researcher can help to solve this mystery
for you!
umiat
|
Clarification of Question by
jdbooteg-ga
on
05 Dec 2005 22:10 PST
Thanks anyway.
Do you know what kind of odds another researcher may take this up?
and how long will the question stay on the site.
Thanks again
John
|
Clarification of Question by
jdbooteg-ga
on
05 Dec 2005 22:14 PST
Whoops I see, it expires the 31st.
|
Clarification of Question by
jdbooteg-ga
on
17 Dec 2005 20:27 PST
umiat-ga
I ahve other question that might fufill payment.
You did some reasearch on the question of scleral buckles for me and
it was goof unfortunatly you were not able to find the answers to the
questions any better than I was.
However it does not appear that anyone else is interested so I will
pursue the answer myself some other wayy. I do have a plan and some
other resources that I didn't want to use for various reasons.
But as these things go I'm not sure how the google answers things
works exactly. I would consider changing the parameters of the
questions to some questions that you must know because you are doing
it. With those answers I would consider the question answered and the
payment yours.
That is if this is permissable per google researher rules and regs.
The questions are:
- How does one become an approved google researher.
- What rules and regs must one follow.
- Who mightI contact if I ever wanted to do this perhaps in a year or so.
- Typically what's the sucess rate of questions answered,hmm I guess
the question is really how much per hour can one make typically. I
know this is difficult to answer as there are many variables, i.e.
type of question experience, customer, etc. For instance I have 2
degrees in Physics, worked in the oil industry, nedical industry, TV,
military. written embedded software for 30 years, etc... So I could be
comfortable in a few areas but not others.
- Basically what does it take.
Thanks
John
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Request for Question Clarification by
umiat-ga
on
17 Dec 2005 23:14 PST
Hello again, John,
Unfortunately, Google is not hiring researchers at this time. If you
click on the FAQ's at the bottom of this page, and scroll on down, you
can read a bit about the researchers here at GA, including the hiring
process.
"How do I sign up to become a Researcher?
Because of an overwhelming response by qualified candidates, we are
temporarily not accepting additional applications. Please check back
with us again, as we likely will begin accepting applications again in
the near future."
http://www.answers.google.com/answers/faq.html#aboutres
Your background sounds fascinating! It would be a pleasure to have you
as a researcher colleague if GA ever opens the doors to further
applications!
And....no...there is certainly no charge for this small snippet of information.
Just come back and visit again sometime if you think we can help you out!
Sincerely,
umiat
|
Request for Question Clarification by
pafalafa-ga
on
18 Dec 2005 11:36 PST
jdbooteg-ga,
Hope you and umiat don't mind if I inject my two cents worth, here.
I've been looking through the medical literature on Miragel.
Warnngs about the type of expansion/crushing problems you describe go
back to at least 1992, and possibly earlier. It sounds awful.
My question for you is: What do you actually want to know about Miragel, and why?
If you're looking for a recall date, no one can provide it for you if
the product was never recalled.
If you're looking for information about the company the manufactured
Miragel, we may be able to provide that for you, but please let us
know what particular information you want.
If you're looking for a history of problems with Miragel, then medical
articles and FDA records may be your best bet.
Let me know what you need at this point, and I'll see if I can help out.
Thanks,
pafalafa-ga
|
Clarification of Question by
jdbooteg-ga
on
19 Dec 2005 21:00 PST
umiat
Thanks,
Looking at my email my fingers are too big abd the keyboards too old.
I'm getting a new keyboard and spell checker.
John
umiat
|
Clarification of Question by
jdbooteg-ga
on
19 Dec 2005 21:00 PST
umiat
Thanks,
Looking at my email my fingers are too big abd the keyboards too old.
I'm getting a new keyboard and spell checker.
John
|
Clarification of Question by
jdbooteg-ga
on
19 Dec 2005 21:15 PST
pafalafa-ga
You ask the reason.
Two reasons, one I could go blind.
Second there are probably a lot of people out there that don't know what
can go wrong with their eyes. I was never informed by anyone, someone
should get the information out to those who have this in there eyes.
If people knew of this and did nothing it's criminal.
If those who knew about this tried to get the information out then
it's just everyones hard luck but they should still know about it.
I'm going to try. It will take awhile.
If you read the thread you know I have the Dr's record and he thought
it was recalled.
I've already been through the FDA sight.
I've scanned the web for legal notices.
Now it's time for me to get serious.
Thanks anyway
John
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