Re-post: Report complications/failures directly to the FDA!!!
Post Date: 4/29/11 11:19 pm
I wonder how many surgeons are reporting their band failures to the FDA, which regulates the use of these devices? Let’s see – why would they do that? They’re getting paid by you (and “incentives" by the manufacturers)
* to implant them,
* to fill them,
* to unfill them,
* to resituate them when they slip,
* to reposition the ports when they flip,
* to replace the ports when they fail,
* to explant them when they fail, leak, tear, disintegrate, erode into your stomach, destroy your esophagus, induce scar tissue or adhesions, etc.
* And then to replace them and start all over again!
Why would they want to tell the FDA about the earning power of their cash cows?
But you, the consumer, have the right to report the problems directly to the FDA! Here’s where you do it: https://www.accessdata.fda.gov/scripts/medwatch/
They want you to use specific codes, selected from a HUGE list of arcane descriptions (http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/Even tProblemCodes/ucm134761.htm). Here are a few suggested ones you might find helpful:
Device Operational Issue - LEVEL 1 - Issue associated with any deviations from specifications relating to device operations (e.g. deployment, connection, electrical, computer software, infusion/flow, output, protective measure, and incompatibility issues).
Device Operates Differently than Expected C62955; FDA 2913 - Issue associated with any deviations from expected performance while operating and using the device.
Therapy delivered to incorrect body area C62858; FDA 1508 - Issue associated with the device causing unintended therapeutic action to an area of the body other than the intended area.
Calibration Issue C63028; FDA 2890 - Issue associated with the operation of the device, related to its accuracy, and associated with the calibration of the device
Connection Issue C62952; FDA 2900 - Issue associated with linking of device and/or device components and/or the functional units set up to provide means for a transfer of liquid, gas, electricity or data.
Blocked Connection C63288; FDA 2888 - Issue associated with linking of device and/or device components whereby their functional units set up to provide means for a transfer of fluid, gas, or data is prevented or impeded.
Filling Problem C63144; FDA 1233 - Issue associated with the method or amount of time associated with the delivery of a fluid. Time to delivery or amount of delivered entity may be affected.
- Inability to Auto-fill C63106; FDA 1044
- Overfill C62884; FDA 2404
- Short Fill C62841; FDA 1575
- Volume Accuracy Issue C62805; FDA 1675
Inflation Issue C63076; FDA 1310 - Issue associated with the inability of a device and/or device components to expand or enlarge with the intended inflation agent (e.g. saline or air)
Occlusion within Device C62896; FDA 1423 - Issue associated with an obstruction or blockage within any of the device components (e.g. tube, opening, pipe) that results in a restriction of flow.
Human Factors Issue - LEVEL 1 - Issue associated with the interaction and interfacing between devices and users in terms of users' abilities, expectations, and limitations with work environments and system design.
Instruction for Use Issue C63072; FDA 1318 - Issue associated with the accuracy and appropriateness of any written, printed, graphic or audio/visual matter that is supplied with a medical device or its containers, wrappers; with any matter that accompanies a medical device including instructions related to identification, technical description and use of the medical device provided by the device manufacturer.
· Inadequate instructions for healthcare professional C63087; FDA 1319 - Issue associated with inaccuracies in any written, printed, or graphic matter that is affixed to a medical device or its containers, wrappers; with any matter that accompanies a medical device including verbal instructions related to identification, technical description and use of the medical device provided by the device manufacturers.
· Inadequate instructions for non-healthcare professional C63267; FDA 2956 - Issue associated with users being unclear and not able to follow any written, printed, or graphic matter that is affixed to a medical device or its containers, wrappers; with any matter that accompanies a medical device including verbal instructions related to identification, technical description and use of the medical device provided by the device manufactures that vary from the standard of medical care in a given environment.
Improper or Incorrect Procedure or Method C62862; FDA 2017 - Issue associated with the use of the device in terms of nonconforming to that device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers.
Physical Property Issue - LEVEL 1 - Issue associated with any deviations from specifications relating to device physical properties in terms of material integrity, mechanical, manufacturing/shipping, communication/transmission, optical, temperature, chemical, and electronic issues.
Device Ingredient or Reagent Issue C62982; FDA 2910
· Biocompatibility Issue C63294; FDA 2886
Material Integrity Issue C62968; FDA 2978 - Issue associated with any deviations from device documented performance specifications relating to the limited durability of all material used to construct the device.
Degraded C62970; FDA 1153 - Issue associated with a deleterious change in the chemical structure, physical properties, or appearance in the materials that are used in device construction.
Naturally Worn C62906; FDA 2988 - Issue associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Material Rupture C62965; FDA 1546 - Issue associated with the bursting or tearing apart of a material.
Mechanical Issue C62961; FDA 1384 - Issues associated with any deviations from device documented performance specifications relating to mechanical defects, including moving parts or subassemblies, etc.
Dislodged or Dislocated C62950; FDA 2923 - Issue associated with mechanical force that displaces device and/or device components from an intended location.
· Slippage of Device or Device Component C62840; FDA 1584
Leak C63058; FDA 1354 - Issue associated with the escape of a liquid or gas from the vessel or container in which it is housed.
· Fluid Leak C63137; FDA 1250
Positioning IssueC63034; FDA 3009 - Issue associated with the forward movement of the device and/or device components to an intended location.
· Difficult to Position C63230; FDA 1467 - Issue associated with the use of the device in terms of user experiencing difficulty to put device and/or device components in place, even if the operation is being performed according to labeled instructions for use.
· Difficult to Remove C63228; FDA 1528 - Issue associated with the use of the device in terms of user experiencing difficulty to take out or get rid of a device and/or device components, even if the operation is being performed according to labeled instructions for use.
· Entrapment of Device or Device Component C63210; FDA 1212 - Issue associated with the device and/or device accessories caught within patient vasculature or tissue.
· Failure to Advance C63198; FDA 2524 - Issue associated with failure to move the device or its components to an intended location
· Malposition of Device C63043; FDA 2616 - Issue associated with device being positioned in a location other than intended or specified.
Unintended Movement C62814; FDA 3026 - Issue associated with an undesired movement of device, which may be related to device malfunction, misdiagnosis, or mistreatment.
Migration of Device or Device Component C62917; FDA 1395 - Issue associated with an undesired movement of device and/or device components, related to its movement away from or dislodging from a source.All of them.
Its required by the FDA and licensing boards.
Nothing wrong with this info being provided to the folks, but that kind of talk is ridiculous.
People, there are a few bad doctors out there, but the overwhelming majority (I would say over 99%) are law abiding, rule following Guys and Gals that want what is best for the people they serve.
Yes, amazingly enough, they are interested in making a living, paying their student loans off, and saving for retirement. But guess what ....the best way to be successful in medicine is to do the right thing.
To suggest that there is some huge conspiracy where the surgeon gets rich off of kickbacks at the expense of the patient is paranoia. It doesn't happen, or if it has, it would be a very, very isolated thing.
highest weight : 428 Banded 11/3/2011 surgery weight : 386
All of them.
Its required by the FDA and licensing boards.
Nothing wrong with this info being provided to the folks, but that kind of talk is ridiculous.
People, there are a few bad doctors out there, but the overwhelming majority (I would say over 99%) are law abiding, rule following Guys and Gals that want what is best for the people they serve.
Yes, amazingly enough, they are interested in making a living, paying their student loans off, and saving for retirement. But guess what ....the best way to be successful in medicine is to do the right thing.
To suggest that there is some huge conspiracy where the surgeon gets rich off of kickbacks at the expense of the patient is paranoia. It doesn't happen, or if it has, it would be a very, very isolated thing.
~People, there are a few bad doctors out there, but the overwhelming majority (I would say over 99%) are law abiding, rule following Guys and Gals that want what is best for the people they serve.~
I think that *most* do have the best interest of the patient in mind. And that is why so many surgeons now are refusing to put in Lap-Bands and Realize Bands. That is why most surgeons that still do bands are taking out more bands than they are putting in.
I don't know why you think that the band doesn't have these problems. I know you have only had your band a short amount of time, and you love it. Hell everyone loves their band initially.......till they find out it doesn't work......or it breaks. I can guarantee you that in just a few years you will have a completely different opinion of the band! Just read on the revision forum and you will see how prevelent band problems are.
Now band complications ar greatly UNDER-REPORTED! One look at the Lap-Band or Revision forum will tell you that!
And lwts say for arguments sake that there are a few Drs. that are not concerned about thier patient, only about their revenue. 10% shall we say. Do you realize how many unnecessary band surgeries that would be?! Do you realize just how many unreported band failures that would be?
Why would you have a problem with me posting this articles urgeing ppl to report their band problems?!
on 12/3/11 12:02 am - Califreakinfornia , CA
All of them.
Its required by the FDA and licensing boards.
Nothing wrong with this info being provided to the folks, but that kind of talk is ridiculous.
People, there are a few bad doctors out there, but the overwhelming majority (I would say over 99%) are law abiding, rule following Guys and Gals that want what is best for the people they serve.
Yes, amazingly enough, they are interested in making a living, paying their student loans off, and saving for retirement. But guess what ....the best way to be successful in medicine is to do the right thing.
To suggest that there is some huge conspiracy where the surgeon gets rich off of kickbacks at the expense of the patient is paranoia. It doesn't happen, or if it has, it would be a very, very isolated thing.
I was banded twice with both of those bands being removed by two separate surgeons and neither one of those surgeons reported these adverse events to the FDA or had they returned the bands back to Allergan for "analysis" as :recommended" by Allergan to its Lap Band surgeons.
on 12/3/11 12:35 am - Califreakinfornia , CA
I am currently unaware of anyone who has successfully requested and received and " Explant " kit. I'm on a mission to find someone who successfully completes this process.
To report an adverse event/device problem or to request an explant return kit: Health Devices: Phone: 1-800-624-4261 option 3 Fax: 866-221-3206 Email: [email protected]
I am currently unaware of anyone who has successfully requested and received and " Explant " kit. I'm on a mission to find someone who successfully completes this process.
To report an adverse event/device problem or to request an explant return kit: Health Devices: Phone: 1-800-624-4261 option 3 Fax: 866-221-3206 Email: [email protected]
Yeah I "strongly suspect" that them wanting the band returned to them is just their way of "getting rid of the evidence"!
Now as far as the "Explant" kit, I was totally unaware of that! Thanks for mentioning!
10% is ridiculous assumption.
And (you say this a lot, but it isn't true) you cannot guarantee me or anyone that we will dislike our band in a few years.
I don't deny issues with the band, nor do I say that you and the others shouldn't air your grievances about your issues with the band. Nor am I saying that somehow I am exempt from long term issues with my band.
I'm saying that to say that all bands go bad or that even 10% of surgeons are shysters is hyperbole born in your hatred of YOUR band.
nothing else.
Carry on with your rid-the-world-of-bands mission, but don't be so surprised when someone actually calls you on inaccurate statements.
highest weight : 428 Banded 11/3/2011 surgery weight : 386
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