Pharmabiz
 

New sterilization method approved by the FDA

New YorkTuesday, November 12, 2002, 08:00 Hrs  [IST]

The U.S. Food and Drug Administration (FDA) has approved the first nonsurgical method of sterilization for women in the United States. The product had already been approved for sale in Europe, Canada, and Australia. This new device, called Essure, is a small implant that is inserted into the fallopian tubes of women seeking permanent contraception. In a country like the U.S., it can be safely inserted at a doctor's office or outpatient clinical setting. It does not require abdominal surgery or general anesthesia, thus significantly reducing the risks of major complications. "This is exciting news," said Amy E. Pollack, President of EngenderHealth. "While the availability of any new method of contraception is an advance, the approval of the Essure device reflects an important step in the search for an effective and safe alternative to traditional surgical sterilization for women." In her testimony before the FDA, Pollack emphasized that "the recognizable risks of surgical sterilization and the side effects of the available temporary methods underscore the importance of the need for a transcervical option like Essure." Today, surgical sterilization is the most widely used form of contraception in the U.S. and worldwide. Reliance on male and female sterilization has grown significantly since 1980. More than 180 million women in the world have chosen sterilization for family planning, including an estimated 700,000 American women.

 
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