Originally published July 1 2011
FDA now admits breast implants only last 10 years and have to be removed in all women
by J. D. Heyes
(NaturalNews) Reversing earlier statements that breast implants are completely safe and never have to be replaced, the Food and Drug Administration now says many women who have implants must have them removed or replaced within a decade.
According to the agency, new research data from a long-term study found that the implants should be examined every 10 years because they were at risk of rupturing, and that some are linked to a rare form of cancer.
"The key point is that breast implants are not lifetime devices," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, told Reuters. "The longer you have the implant, the more likely you are to have complications."
The agency says there were some 400,000 breast enhancement or reconstruction surgeries in the U.S. alone last year, making it the number one cosmetic surgery procedure in the country. Breast implant and augmentation surgery is followed in popularity by nose reshaping, eyelid surgery, liposuction and abdominoplasty (tummy tucks).
The FDA banned silicone gel-filled implants in 1992 after some women complained they leaked and caused some chronic illnesses. The health regulatory agency approved silicone implants made by Allergen and Johnson & Johnson's Mentor division for use again in November 2006.
Then, the agency said it approved the silicone-filled implants only "after rigorous scientific review" that the agency said took years.
"FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products," Daniel Schultz, M.D., director of the agency's Center for Devices and Radiological Health. The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions."
Now, however, the agency is singing a different tune.
Implants "are not lifetime devices," adding that "the more likely she is to experience complications," with one in five women who have implants "will need them removed within 10 years of implantation."
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