Release date: 2013-02-28
Last week, a new silicone breast implant made by Allergan was approved by the FDA.
The US Food and Drug Administration (FDA) said it approved the Ai Lili 410 implant in Ailigen to increase the size of breasts of women aged 22 and over and to repair breast tissue in women of any age. The silica gel in the Naqili 410 implant is more stable than the silicone in the previous Nai Lili implant product.
The FDA requires Allergan to conduct a series of studies to evaluate the long-term safety of the product after it has been approved. The company must track about 3,500 women who use the product for a five-year period and conduct a 10-year study of more than 2,000 women who use the product.
The FDA's approval of the product is based on 941 trial data from women using the product. Common complications of this product are similar to those found in previous breast implants, including the tightness of tissue surrounding the implant, secondary surgery, implant removal, and infection.
Source: vCount:
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