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.
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