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Thread: National Breast Implant Registry coming ...

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    Banned Melonie's Avatar
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    Default National Breast Implant Registry coming ...

    from


    "GAITHERSBURG, Md. -- A federal advisory panel has recommended the creation of a nationwide database to follow women who have had silicone-gel breast implants for at least a decade after they had the surgery.

    The two companies that manufacture silicone implants -- Allergan and Mentor -- are required to follow women who've had their implants for a number of FDA-mandated studies, but enrollment in those follow-up studies has been disappointing, and in some cases the number of women being followed is so small that FDA cannot definitely rule out a connection between implants and a rare disease, such as anaplastic large-cell lymphoma or connective tissue diseases.

    The FDA's General and Plastic Surgery Devices Panel, which wrapped up a two-day meeting Wednesday afternoon, said that current data collection demands are too onerous. Both companies ask women who've received their implants to fill out a 25-plus page questionnaire every year following surgery. Not surprisingly, not many women do that.

    In 2006, the FDA broke a 14-year moratorium on silicone implants by approving two new models, one made by Mentor and one by Allergan. The approval was controversial because critics of silicone implants said there wasn't enough evidence that the implants were safe in the long term.

    To study how the implants held up longer-term, the FDA ordered Mentor and Allergan to perform an array of follow-up studies -- some of which won't end until 2016. The studies involve 80,000 implant recipients -- 40,000 for each of the two brands -- who will be followed for a decade.

    But so far, Allergan has mustered only about a 60% follow-up rate after two years for its studies -- far short of the goal of 93% -- and only one in four patients who received a Mentor implant were followed up after two years.

    Creating a national database that isn't tied to any particular company could help the FDA more easily collect data on how safe and effective breast implants are many years after they're implanted. Having all women who have received breast implants, either for cosmetic or reconstructive purposes, in one place could allow researchers to select samples from the registry to answer questions such as "What percentage of silicone implants leak?" and "How long is the lifespan of a breast implant?""(snip)

    and from

    (snip)"The companies and FDA advisers said patients and their doctors may not have enough incentives to stay in the company-funded studies, especially if they have to fill out a 27-page questionnaire every year, or do expensive medical procedures such as MRIs that test if their implant has ruptured.

    A registry, which would track any patient who has had a breast implant, can provide broader data, making it easier to identify any complications, such as rupturing of the device."(snip)


    I'm not sure what to make of this. On the one hand, establishing a national registry of women who have ( silicone only ? or all types per Reuters ? ) breast implants would indeed provide the US gov't via the FDA the ability to more easily track any correlations to auto-immune disease, implant ruptures, and other health problems. On the other hand, being added to a national registry of women who have ( silicone only ? or all types per Reuters ? ) breast implants would also provide the US gov't via other federal agencies with the ability to more easily track any number of non-health related correlations !!!

    At any rate, anyone considering getting breast implants in the near future may want to consider advancing their timetable to avoid the distinct possibility of being mandatorily entered into this new federal database, with an associated mandatory requirement of having to provide '25 pages worth' ( 27 pages per Reuters ) of personal / health related information to the US gov't every year for the next 10 years !!! It's only logical that some of the information to be collected by the gov't will pertain to whether or not your 'occupation' subjects your breast implants to any unusual 'stress' !!! There's also the potential that annual mandatory testing may be involved, with no guarantees that the associated annual testing costs will be 100% 'free' to the breast implant patient.

    ~
    Last edited by Melonie; 09-03-2011 at 11:34 AM.

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    Default Re: National Breast Implant Registry coming ...

    Yikes.

    I recall back when I got my silicone in 2006, I was enrolled in some sort of study...and I never bothered keeping up with it, just signed the damn papers to get my new boobs. I haven't spoken or heard from my old PS in years, and am currently living in a different country - so I'm surely one of those women Mentor/Allergan hasn't be able to keep tabs on.



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    Default Re: National Breast Implant Registry coming ...

    This is really interesting. I for one would like to have my information studied as I seem to be the ONLY person on the planet that has suffered a late onset (3 months) fluid build up, which when drained, appeared to be milky, with debris in it. I also had the very rare lactation problem (galorectia??) and think i may have gotten plugged milk ducts because of it, which in turn has lead to the fluid build up. No one seems to know if these things are connected, there's nothing on the internet about it, and my surgeon is none the wiser. I have Allergen CUI standard round implants. Perhaps this registry will lead to the increase of information available about rare complications after BA.

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    Banned Melonie's Avatar
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    Default Re: National Breast Implant Registry coming ...

    I think a lot more women would participate in this if their MRIs were paid for, and even more if the implant cost was waived (ie paying for surgeon, anesthetic, and hospital fees but not the implant). I would do it in a heartbeat if there were any financial incentive.
    ^^^ that's essentially the same thing that the doctors are saying about their own unreimbursed 'administrative costs' of attempting to track down implant patients to pursuade them to come in for a check-up so the doctor can fill out updated annual 'voluntary' survey forms under the existing program.

    In the final analysis, breast implants are almost always an 'elective' medical choice. This is the reason that health insurance won't pay towards breast implant procedures. And obviously the manufacture of breast implants needs to be a profitable enterprise if the breast implant companies are to stay in business. Similar situation for plastic surgeon / PS office staff time, hospital MRI machine / staff time etc. Similar situation regarding future (non) appropriation of gov't public health funds towards subsidizing an 'elective' procedure that only benefits 'rich' females. So if additional costs for gov't mandated annual check-ups and gov't paperwork filing wind up being added to the overall breast implant cost equation, it's almost certain that those additional costs will fall on the patient making the 'elective' choice to get the breast implants by one means or another.


    Perhaps this registry will lead to the increase of information available about rare complications after BA.
    This is obviously a logical assumption. But the flip side question is whether or not you, or the 80,000+ girls who also got breast implants this year, would have been willing to pay double the price for your implants ( either up front or over the course of the next 10 years ) in order to support the collection of that increased information ?

    It could happen that the new additional costs get 'front loaded' i.e. paying for 10 years worth of annual checkups and annual gov't paperwork filings gets rolled into the initial price of implants by the manufacturer and rolled into the initial price of implant surgery / post-op care by the plastic surgeon. This would be the only real way for the breast implant companies and plastic surgeons to make sure that their own costs of performing annual checkups and doing annual gov't paperwork filings for implant patients are paid for. But how many girls would still choose to get breast implants if an extra $5,000-$10,000 in 'front loaded' costs was involved on top of the $5,000-$10,000 existing cost of getting breast implants ? This would obviously become a huge problem for the implant companies and for the plastic surgeons if 'front loaded' annual gov't mandated checkup / paperwork filing costs for the next 10 years had to be tacked onto the initial price of the breast implant procedure.

    However, to avoid this scenario of breast implant costs doubling but the number of future breast implant procedures being cut in half, if the new costs aren't 'front loaded' but instead must come $500-$1000 per year for the annual checkups and gov't paperwork filings, how many girls would actually schedule and pay for their annual checkups ? THIS is the real problem with the existing implant manufacturer based study scenario ... and the very low number of actual girls voluntarily scheduling and paying for annual checkups / survey filings is the specific justification being cited by the gov't panel in recommending that a national gov't database and mandatory compliance with annual checkups / paperwork filings be established in the first place.


    I was enrolled in some sort of study...and I never bothered keeping up with it, just signed the damn papers to get my new boobs.
    Again this is the basic problem with the current implant manufacturer based study ... very few girls voluntarily ponied up the $500-$1000 a year for their annual checkups and annual survey filings, very few doctors are going to offer to perform annual checkups for 'free' etc. Zero hospitals are going to offer to perform MRI's 'for free'. So without 'front loading' the 10 years worth of annual study costs and thus greatly reducing the number of breast implants 'sold' at a much higher price ( something which the breast implant manufacturers and the plastic surgeons will strongly oppose !!! ) , how can the gov't otherwise 'force' girls with breast implants to schedule / pay for their annual mandatory checkups allowing their plastic surgeons to file their annual mandatory surveys ?

    A gov't breast implant database tie-in to the IRS along the lines of the new national health care 'penalty' tax for failure to buy health insurance could certainly be a possibility. If the breast implant patient fails to schedule / pay for her next annual breast implant checkup, thus no new entry appears in the gov'ts national breast implant database, will that in turn result in a new $500-$1000 IRS 'penalty' tax being added to that girl's annual tax return ? No mention has been made along this line in the news blurbs, but the precedent now certainly exists for something like this to happen ... i.e. gov't mandated individual expenditures related to health care can be enforced via the IRS.

    There are obviously a ton of unresolved issues involved here ... issues that the gov't panel hasn't considered, since all they actually care about is the complete collection of breast implant study data on every breast implant patient for the next 10 years. They do NOT care about, nor have they considered, the 'unintended consequences' upon breast implant manufacturers, upon plastic surgeons, or upon breast implant patients.

    There's really no point in speculating further about any specific future possibilities given the very limited release of initial information from the gov't panel. However, the fact remains that there is 'no such thing as a free lunch' - thus if the gov't mandates that new annual procedures MUST be performed, one way or another someone is going to have to pay for the new costs associated with those new gov't mandated annual procedures. And the virtually certain payers of those new costs will be the girls 'electing' to get breast implants.

    However, one thing IS known for certain. Girls who decide to get breast implants BEFORE a gov't mandated database and annual checkup / filing requirement get established will be able to avoid having to deal with these possibilities - and the possible additional costs ... which is the main reason that I posted this thread.

    ~
    Last edited by Melonie; 09-04-2011 at 06:02 AM.

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    Default Re: National Breast Implant Registry coming ...

    ^^^ as I said, so far there are no specifics to go on other than the strong probability that new federal mandates will be issued creating the national breast implant database ... which to be of any value must also mandate annual checkups and annual filing of new information by the patients' plastic surgeons. History of the existing implant manufacturer's based program has already proven that annual checkups and annual filings by the plastic surgeons are not going to happen 'voluntarily' ... because the patients don't want to spring for the annual $500-$1000 checkup costs with tests, because the plastic surgeons don't want to 'donate' their own time and their office staffs' time to track down breast implant patients etc. So I have less confidence than you do that the gov't will fail to include some 'enforcement' measure re annual checkups and paperwork filings in their new mandate ... because without some 'enforcement' measure there's no reason to believe that the participation rate is going to be any better than the current 'voluntary' implant manufacturer based study participation rate has been.

    You may be right about a new tax on breast implants to help provide funding. There is already a new 'medical device' tax imposed on implant manufacturers. A new 5% 'cosmetic surgery' tax was also proposed. But neither of these would come close to providing the amount of money necessary to fund 10 years worth of checkups and tests ... which would be in the ballpark of at least 10 * $500 = $5000 ON TOP OF the existing costs of purchasing the implants and covering the plastic surgeon / medical facility fees. Indeed the FDA / gov't does have the authority to impose such a tax which would basically create a dictate that 'any girl wanting to get future breast implants in the USA must also pay up front for 10 years worth of annual checkups / paperwork filings if she wants to get implants at all'.

    There's no way I can see the implant manufacturers and the plastic surgeons 'sitting still' regarding the imposition of a new $5000 tax on every pair of implants 'sold' in the future ... because obviously the 'front loading' of breast implant costs by adding such a tax would drastically reduce the 'affordability' of future breast implants such that some 50% of would-be breast implant patients would simply opt not to get implants in the future. The reduced implant sales volume / plastic surgery volume could in turn force an additional price increase as the implant manufacturers and plastic surgeons attempt to cover their 'fixed costs' from a much smaller number of customers. So the breast implant manufacturers and plastic surgeon's organizations are going to fight any plan that involves 'front loading' an additional $5000+ to the cost of getting breast implants. And this will bring us back to some alternate means of 'enforcing' the requirement that girls with breast implants get / pay for their annual checkups with tests and paperwork filings.

    Again there aren't enough specifics to really know anything yet ... other than the fact that getting implants THIS year would allow girls to avoid whatever additional breast implant costs may be involved NEXT year as the result of a new gov't mandate.

    ~
    Last edited by Melonie; 09-05-2011 at 07:08 AM.

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