Posted on 07/29/2005 9:56:46 AM PDT by wagglebee
WASHINGTON (Reuters) - Silicone gel-filled breast implants won conditional approval to return to the broad U.S. market after a 13-year ban when health officials on Thursday backed a version made by Mentor Corp.
The U.S. Food and Drug Administration said the device maker must satisfy a number of conditions before it receives final approval to sell the implants. FDA officials said they were legally prohibited from making the conditions public.
Mentor said the conditions were "generally consistent" with recommendations from an FDA advisory panel earlier this year.
In April, the expert panelists voted 7-2 to recommend approval of Mentor's silicone implants, but called for the company to monitor some women for rupture over 10 years as well as educate patients and doctors.
The FDA said its decision "does not mean that the device is approved for marketing in the United States at this time."
Critics of the implants, banned for most women since 1992 amid allegations that leaking silicone caused disabling, long-term illnesses, were hopeful the FDA would require more safety information before making a final decision.
"FDA can still do the right thing," Sybil Goldrich, head of the patient group the Command Trust Network.
The U.S. Senate health committee is investigating the FDA's handling of the decision, citing complaints about a conflict of interest among some FDA advisers. Other critics called for the FDA to delay a final decision pending the probe's conclusion.
Studies have failed to find a connection between silicone implants and chronic diseases. Researchers have linked the devices to pain and other local complications, and manufacturers admit the implants can break and require replacement.
Only U.S. women who need reconstruction surgery after breast cancer, have a physical deformity, or need a replacement after other implants ruptured have had access to silicone implants as part of special clinical studies.
Many women and plastic surgeons say silicone implants, which are available in Europe, look and feel more natural than saline-filled ones.
"I think women, with their physicians, can make informed decisions," said Betsy Mullen of the Women's Information Network Against Breast Cancer.
Ping!
Unfortunate phraseology.
With a lot of first-hand experiences!
"There has never been an established link between silicone breast implants and any adverse health problems. The trial lawyers saw a way to make money and created a mass hysteria."
_____________________________________________________________
Any woman who came down with a nasty, crippling, chronic disease and just happened to have implants was encouraged to assume the implants were the cause. Subsequent epidemiological studies proved they were no sicker as a group than the rest of the population.
Just like Agent Orange. Even the Operation "Ranch Hand" aircrews who got routinely soaked in the stuff while spraying it proved to be no worse off after several decades than their generational cohort (save for a slightly increased mortality due to years of hard-partying).
The trial lawyers don't find a problem and sue, they find a corporation (or group of corporations) with buge cash reserves and figure out a way to target one of the companies products. The lawyers become incredibly wealthy while the "victims" generally get nothing.
once again...freepers never fail me.
ha ha
I'll have to show that to hubby; he might be more supportive when I spend a lot of time on FR looking at things that interest ME, LOL!
you better be carefull - he might take over your account...
;-)
LOL
Implants? Who needs implants? LOL
I got my first feel of a fake one last week and I thought it was horrible. Real, no matter the size, is much better.
Fredric David Anderson says it's OK.....Thats me yeeehaw
So, do the new regulations contain any wiggle room for further improved designs?
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