Hologic’s Adiana Pregnancy Prevention Device Effectiveness Unclear, FDA Advisory Panel Says

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Hologic’s Adiana Pregnancy Prevention Device Effectiveness Unclear, FDA Advisory Panel Says

December 18th, 2007 amy

Per a recent Reuters article, a U.S. expert advisory panel has expressed concerns about the effectiveness of an experimental sterilization device made by Hologic. The panel called the company’s data inconclusive. The device, called Adiana, uses a catheter to implant a silicone device in the Fallopian tubes to prevent pregnancy.

“There is some difficulty with a risk-benefit analysis because of a concern about the benefit, and the effectiveness of this technology,”
said the panel’s acting chairwoman, Marcelle Cedars of the University of California.

While the FDA advisory panel said the device is generally safe, a majority of panel members had doubts about whether the company’s stated “success rate” in preventing pregnancies can be generalized to the population, because of problems with the study’s design.

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