U.S. Food and Drug Administration certified the new silicone gel breast implant for enlargement and rehabilitation of women's breasts.
The agency claimed that «The Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant» can be used for women of 22 years of age and older to change their breast size, and for women of any age for the purpose of breast rehabilitation.
After the approval, Natrelle 410 becomes the fourth silicone gel breast implant to be certified by the FDA.
The implant has more cross-connect ties that link one silicon chain to another compared to other models. However, FDA did not inform whether such innovation has clinical significance.
941 women took part in the research conducted by FDA to support the approval. They wore implants for 7 years. Negative events during the period of the research were mostly the same as those that were found in prior breast implants studies.
The main problems concerned capsular contracture, implant removal, infection, and asymmetry. In one unusual case, Natrelle 410 gel broke apart inside an implant.
According to Jeffrey Shuren, the head of the Center for Devices and Radiological Health in FDA, the results of the research showed «acceptable confidence of safeness and efficiency».
As a part of approval, the FDA obliged the manufacturers must do more long-run tests to determine safeness and effectiveness of the new implant.
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