Washington, 9 mar ( EFE).- The Administration of drugs and foods of USA ( FDA, in English) today approved the third silicone gel for implants breast manufactured in the United States.UU., to increase the breastfeeding females age of 22 years and to rebuild the fabric at any age.
As condition for approval, the manufacturer will have to do after this approval studies that assessed security long term effectiveness and risks of the results in rare diseases.
“Data on these and other implants approved continue to demonstrate a reasonable assurance of safety and efficiency”, said William Maisel, Deputy director for Science at the Center for devices and radiological health FDA.
“Is important to remember that you breast implants are not devices of life.” “Women should fully understand the risks associated with implants breast before considering the increase or reconstruction surgery and recognize that long-term follow-up is essential”, assured Maisel.
The FDA based its authorisation to Sientra on three years of trials in 1,788 patients.
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The FDA is committed to working with the manufacturers of breast implants to collect useful data subsequent to the marketing to gather information on the long-term safety and effectiveness”, has insisted Maisel. EFE
