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28.08.2015
WASHINGTON — Federal health officials say the latest data on silicone breast implants show they are relatively safe, despite frequent complications that lead about one in five women to have the implants removed within ten years.
A Food and Drug Administration report issued Wednesday is the agency’s first safety assessment of the implants since regulators returned them to the market in 2006.
The FDA pulled silicone implants off the market in 1992, saying manufacturers had not provided medical data showing their safety and effectiveness. But the agency returned the implants to the market five years ago after most studies failed to find a link between silicone breast implants and those diseases.
The approval came with conditions, including a requirement that the companies complete studies on women who have received the implants.
But industry critics point out that most of the studies are incomplete, and many women have already dropped out.
For example, only 58 percent of women enrolled in a 1,000-patient study of Mentor’s implants are still accounted for after eight years.


The most common side effect remains scar tissue which hardens around the implant, warping the shape of the breast. Based on the company data, FDA says 20 to 40 percent of patients who have implants for cosmetic reasons will need another operation to modify or remove them within eight to 10 years. Quis autem vel eum iure reprehenderit qui in ea voluptate velit esse quam nihil molestiae consequatur, vel illum qui dolorem? If you're dreaming of a curvy figure, but concerned about the risks of breast implants, there's good news!
You can decide which point of entry {Periareolar or Inframamamary) and which position you prefer the set point of the implant {Subglandular or Submuscular} Submusculara is more painful and a bit longer to heal.
At the time, there were worries about a connection to a variety of diseases, including cancer and lupus. Patients and plastic surgeons say the silicone-filled implants look and feel more real than saline versions.


Two larger studies of 40,000 women, conducted by both Allergan and Mentor respectively, have each lost a significant number of patients after just two to three years.
Diana Zuckerman of the National Research Center for Women and Families said most medical journals would not publish the studies cited by FDA because of the missing data. Other problems include implant rupture, wrinkling, and lopsided appearance, according to the report.
For women with implants for breast reconstruction, the number is even higher, at 40 to 70 percent. Please download the latest version of the Google Chrome, Mozilla Firefox, Apple Safari, or Windows Internet Explorer browser.



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Comments »

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28.08.2015 | 12:47:45
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28.08.2015 | 15:46:52