LAPBANDERS: The FDA wants to hear from YOU!!
What this means is that under the current procedures, not only are device manufacturers and surgeons who implant them NOT required to report failures, medical misadventures and deaths - or "advere events" in their lingo - there really isn't any way to report such things effectively even if you want to! I have heard from a revision surgeon about the frustration he encountered when trying to report f'ed up bands he removed from patients whose own band surgeons had abandoned them.
Well, to NOBODY'S surprise, the device manufacturers are mounting an aggressive defense of the status quo, disparaging the IOM's report (the IOM, by the way, is a part of the National Academy of Sciences). And the FDA is also trying to marginalized them - but, as required by their regulations, they are forced to solicit public comment on the report.
I urge all LapBanders and former LBs who have had "adverse events" with their bands to provide their comments as members of the injured public to the FDA about the need for post-marketing surveillance of problems with the bands, so that data can be collected and warnings can be issued, and recalls be made if/when it becomes clear that these devices (or specific versions of them) are DANGEROUS. Please feel free to repost this wherever it might be helpful.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc m265908.htm
FDA NEWS RELEASE
For Immediate Release: July 29, 2011
Media Inquiries: Karen Riley, 301-796-4674, [email protected]
Consumer Inquiries: 888-INFO-FDA
FDA to seek public comment on IOM recommendations
Agency continues to improve device review process
The FDA today announced that it will open a public docket [I have no idea what this means - I could not see where THIS document leads the public to a place to send their comments] to begin receiving public comments on the Institute of Medicine’s (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices.
The FDA commissioned the report in September 2009. While none of the IOM’s recommendations are binding, the FDA is planning a public meeting in the coming weeks to discuss recommendations made in the report, titled “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years."
“We appreciate the IOM’s report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today," said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them."
“FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs," Shuren said.
In order for a manufacturer to begin marketing a device subject to 510(k) review, FDA must “clear" a premarket notification (510(k)) demonstrating that the new or modified product is substantially equivalent to another legally marketed “predicate" device.
Some of the IOM’s recommendations, such as the recommendation to design a new regulatory framework for Class II (moderate risk) devices, may require congressional actions. However, the FDA plans to continue its review of the report and to solicit input from stakeholders regarding the recommendations in the report involving existing FDA authorities. [in other words, they don't want to have to do what the report that they commissioned TOLD them needs to be done]
“Many of the IOM findings parallel changes already underway at the FDA to improve how we regulate devices. These actions, plus a sufficiently funded device review program, will contribute to a stronger program," said Shuren. “Any major modifications made to the agency’s premarket review programs should be based on sound science and through thoughtful and transparent discussion," he added.
In September 2009, in response to concerns raised by various stakeholders, the FDA undertook an assessment of its 510(k) program to determine what, if any, changes should be made to improve the program and update it so that it adequately addresses the level of current device complexity and today’s marketplace.
To that end, the FDA committed to an aggressive action plan designed to improve predictability, consistency, and transparency under the existing statutory framework, not only to the 510(k) process but to our device review programs in general.
For example, FDA has already:
• issued a draft guidance clarifying when manufacturer changes to a 510(k)-cleared device already on the market warrant a new 510(k) submission
• taken several steps under its “515 Program Initiative" to address all outstanding “preamendment" Class III device types subject to 510(k) review. The CDRH website includes up-to-date information on the status of each of the 25 remaining device types and the agency plans to complete this process by the end of 2012.
Still to come:
• draft guidance to strengthen and streamline the “de novo classification" path to market for novel low and moderate risk devices that are not substantially equivalent to an existing device
• draft “510(k) Paradigm" guidance clarifying certain aspects of FDA’s 510(k) substantial equivalence review
• issue a proposed rule on Unique Device Identifiers this fall. The IOM noted that UDI would be a meaningful change to the agency’s postmarket capability.
Should I contact them and let them know that I'm doing just fine?
Your pre-post narrative sounds like and advertisement for a law firm. Call 1-800-BAD-DRUG.
Judging by the lack of responses you have here, I would say I am not the only one who feels this way about your inflamitory post, but I'd rather not get into a snippy surgery wars battle with you or any other DS'er.
Unless you have a specific concern or issue with your LAP-BAND then this isn't the place for you to be posting.
The device that has brought this issue to the attention of the FDA, IOM and the press relates to meshes implanted mostly in older women to address pelvic floor problems. They have a RIDICULOUS complication rate, documented in the scientific literature - yet the FDA has NO authority to do anything about it. They have NO authority to require post-marketing surveillance, nor to go searching the scientific literature looking for the AMPLE documentation of the problems that the mesh is causing. Do you not see the relevance to gastric band issues, which are exacerbated by the fact that band surgeons have a vested interest in NOT reporting that there is anything wrong with the bands they implanted? You all are cash cows to the surgeons.
Putting risks and complications into fine print in an "informed consent" release that doesn't accurately portray the scale and scope of the risks, and which can't provide accurate numbers because there is no post-marketing surveillance or any sort of comprehensive data collection mechanism, and therefore is hardly providing informed consent.
This is precisely a place to be posting this information - if you don't have anything to say to the FDA, please feel free to ignore this. If you are someone who wants the FDA to know that you want the band surgeons and manufacturers to have an affirmative obligation to report adverse events to a centralized regulatory authority, even if YOU are not CURRENTLY having problems, let them know that.
Nope, as I explained below, I am neither a former bandster (I figured out very quickly after starting my research on WLS back in 2002 that I would rather have had NO surgery than the band), nor was I bringing up the DS as a better alternative (although now that YOU mention it, yes, it is!), nor am I trying to get legal work - I'm not that kind of lawyer. Just trying to help fix a system that's broken, because on the DS board, and from DS surgeons, I'm seeing a LOT of bandsters in agony trying to get revisions.
on 7/30/11 12:35 pm - Califreakinfornia , CA
This post is very informative and helpful and I really do not see this as a band bashing post. You don't have to do anything with the information if you don't want to, but I will have it saved for anybody that feels that they may in the future benefit from it.
I was in the process of trying to figure out whom to contact for him, when I noticed that serendipitously, MSNBC reported on Tuesday that the report was coming out from the National Academy of Sciences' Institute of Medicine (IOM), a report COMMISSIONED by the FDA about their abbreviated approval process for medical devices (510(k), for devices for which there is an earlier version already on the market, which is about 90% of them), and that the report was SCATHING about the lack of oversight, and in particular lack of postmarketing surveillance - a means for mandatory reporting of problems ("adverse events") encountered with devices after they are installed. There is currently NO postmarketing reporting requirement for these medical devices, including the bands.
The IOM is recommending that the FDA scrap the entire 510(k) process and start over with new legislation, including more testing before new devices are approved, but most importantly, requiring postmarketing surveillance and adverse event reporting - in other words, making it MANDATORY that the medical device manufacturers and surgeons report adverse events to the FDA so they can keep track of the problems and identify problem devices sooner, as well as order warnings and recalls in a timely fashion to protect patients from bad devices.
Although I am an attorney, I am not the kind of attorney who does litigation. I do patent law, and the law firm I am a partner in doesn't do this kind of law either. I'm just publicizing it as a favor to the surgeon who contacted me, and in fact, whether you like it or not, to all of you. This is a situation that is very very WRONG, and allows the band manufacturers and surgeons - who have financial conflicts of interest with their patients - to avoid accountability for the problems they see. This issue is not specific to bands - it is about all medical devices that currently fall under the 510(k) regulations, but with all the advertising for bands going on, it is particularly impactful on band patients. You should be interested in having FDA oversight of the bands (as well as any other medical devices) that are implanted in you.
And by the way, for those of you who have had problems with your band, and have been shamed out of your surgeon's office and told that it is YOUR fault, don't you think it would be nice if the surgeon had an OBLIGATION to report your problem to the FDA? Maybe THEY would be able to see the trends of bands and/or surgeons who were the problem, and not the patients?
on 7/30/11 10:47 pm - Rockville, MD
I've seen how people live with the Lap Band my sister and a few friends currently have a band. I've seen how the band is supposed to be used and I've seen a few friends not use it correctly. Based on reviewing the Lap Band website they have several contradiction's and warnings on how to use their product the Lap Band.
From my research many surgeons many deviate from the manufacturers recommendations. Also they have many contradiction's if patients have pre existing illness, etc. that may interfere with the success or effectiveness of the band. Hence every patient is not an ideal candidate for the Lap Band. Also they warn about allowing patients to eat solids before 6 weeks versus keeping the patient on soft and mushy food until 6 weeks post op and first fill adjustments after 6 weeks post-op. Based on my research this could be causing some of these complications since surgeons create their own protocol in how they treat patients and administer aftercare.
If these surgeons and patients are not following safety guidelines and fill protocols I doubt nothing can be done about trying to remove the Lap Band from the market, since it seems to be a very safe and effective tool for those who are good candidates and follow proper guidelines and receive adequate aftercare. Also there will always be a market for patients that don't want malabsorptive procedures or to have their stomachs removed, the Lap Band seems be a safe alternative for these patients if they follow proper guidelines.
I am sure there can be faulty devices that are implanted into patients, this is also indicated on the Lap Band website as well, and if the band is proven to be defective Allergen mentions that they will pay for any type of defect that causes problems for the patient, i.e. port, tubing or other issues.
From my research things such as band slippage, damaged or stretched esophagus are from the lap band being tighten too frequently or too tightly. I've seen first hand how serious and painful a very tight band can be from my sister accidentally getting her band adjusted too tight but she went back to her surgeon to get a little taken out before more serious harm was done. But I can surely see her experiencing horrible complications if she was not willing or could not get to her surgeon to remove saline, all is well with her now, but if she experienced a complication due to her band being filled too tightly I don't see how Allergen would be responsible for this. Thanks again for you insight on the subject.
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