TUESDAY, Nov. 5, 2002 (HealthDayNews) --
A small metallic implant placed into the fallopian tubes of women who want to be permanently sterilized has been approved by the U.S. Food and Drug Administration.
The product, called Essure by San Diego manufacturer Conceptus Inc., is the first nonsurgical form of sterilization for women. The device, which can be implanted in a gynecologist's office, is inserted into each of the two fallopian tubes. Scar tissue subsequently forms around each device, preventing fertilization of the woman's egg by sperm. The procedure is irreversible.
For the first three months after implantation, a woman must continue to use her existing form of birth control. After 90 days, she undergoes a special X-ray to ensure that the devices are properly placed within the fallopian tubes.
The FDA says it based its approval on two clinical trials conducted by the manufacturer involving more than 700 women. No serious side effects were reported from either study, though not every woman can be implanted successfully, the agency says.
The FDA says given the product's potential to help couples who want an alternate method of sterilization, it expedited the approval process. As a condition of approval, Conceptus will be required to follow all women from the two clinical studies for at least five more years to evaluate the device's long-term effectiveness.
Here is the FDA Talk Paper describing the approval. For more about female sterilization, visit EngenderHealth.
