Food and Drug Administration (FDA) will work to revise the labeling for the safety of silicone breast implants after reviewing some data from long-term studies, which show that breast implants linked to a rare type of cancer.
“The key is not a breast implant device that can last a lifetime,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, as reported by FoxNews.
According Shuren, the longer people use the implants in her breasts, the more likely complications.
Data of the American Society of Plastic Surgeons show there are nearly 400,000 breast augmentation or reconstruction procedures in the United States in 2010. That includes silicone implants and saline implants.
Studies show 70 percent of all women who received reconstructive surgery and 40 percent of them do use silicone augmentation procedure, requiring another operation within eight to 10 years later.
The FDA first approved the silicone gel used as material for breast implants in 2006, namely to Allergan and Mentor’s Natrelle Worldwide’s MemoryGel. Since then, manufacturers and institutions have conducted a study to review the security of post-surgery.
The FDA says the most common complication is the hardening of the breast around the implant, additional surgery and implant rupture or deflation.
Other local complications like implant wrinkling, asymmetry, scarring, pain and infection at the incision site.
The study also found a small correlation between the implant and anaplastic large-cell lymphoma (AlCl), which is a form of cancer that affects about 3,000 Americans a year.
“If there is a genuine relationship between cancer and implants, it’s very very rare,” says Shuren.
But the FDA said that women who use implants should always monitor her breasts for the rest of their lives to ensure no problems are caused by the implants.
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