Awaiting FDA approval....BD
An advisory panel to the Food and Drug Administration recommended on Thursday the approval of a new method for sterilizing women that would give them another option to tubal ligation.
The device, called Adiana, is made by Hologic Inc. of Bedford, Mass. The company markets the product as a low-risk procedure that can be performed in the doctor's office. Overall, about 700,000 women in the U.S. elect to have their tubes tied each year, which typically occurs in a hospital operating room.
FDA documents showed that the procedure was not foolproof. During a clinical trial, 570 women were told they could rely on Adiana for contraception. Company officials said they had not yet set a price for the procedure. It will be up to the FDA to determine when Adiana will be made available to the public.
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