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12.12.2013
The Food and Drug Administration has approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant.
Doctors sometimes refer to these implants as "Gummy Bear" implants because of their feel and consistency when held outside the body, Lerman said. The studies did not compare safety data of the new Natrelle 410 to that of other implants on the market, the FDA said. The FDA wants more studies, including a 10-year-study to collect information on long-term complications.
Lerman said these types of implants have been available for years in other countries besides the United States. Like other implants, the new Natrelle implants are not considered lifetime devices, according to the FDA. Lerman adds that it's important to get surgery done by an American Board of Plastic Surgery-certified plastic surgeon.


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Vous utilisez un navigateur trop ancien, merci de le mettre à jour afin de pouvoir naviguer sur le site. Twenty percent of women who get implants for augmentation will need to have them removed within 10 years, reports Dr.
The implant is approved for the purpose of breast augmentation in adults 22 and older and in women of all ages who are undergoing a breast reconstruction following cancer.
Side effects are similar to other breast implants, including tightening of the area around the implant, the need for re-operation or removal, an uneven appearance or infection. The pros of the new implant, he said, is they give a more anatomical-looking, natural result and they are less prone to leading to wrinkling and visible edges that other implants may cause. He noted the implant may be especially beneficial for women who survived breast cancer and undergo reconstruction, because it wouldn't have to be fitted under the breast tissue which had been removed.


The longer a woman has them, the more likely she'll develop complications and need more surgery. While a few women have kept their original implants for 20-30 years, "that is not the common experience," she added. The implants contain more cross-linking in the silicone gel than earlier models which makes it more cohesive, which in turn makes the implants firmer. The investigators also observed cracks in some of the implants, which is characteristic of the silicone gel and is unique to this implant.
The downsides, he said, is some women may not like the added firmness, and the implant requires a slightly larger incision.



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