FDA Approves To Modification Of Conceptus' Sterilization Device

Main Category: Sexual Health / STDs
Also Included In: Women's Health / Gynecology;  Medical Devices / Diagnostics
Article Date: 31 Jul 2007 - 12:00 PDT

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The San Carlos, Calif.-based pharmaceutical company Conceptus on Wednesday announced that it has received FDA approval of an updated version of its nonincisional female sterilization device called Essure, the AP/Forbes reports (AP/Forbes, 7/25). FDA in November 2002 approved Essure, which consists of small metal coils that are implanted in the fallopian tubes, prompting scar tissue to grow and permanently "plug" the tube. Sterilization is not immediate following the procedure, as the scar tissue might need to grow for up to three months before the fallopian tubes are completely blocked. After three months, patients must return for testing to ensure the tubes have been completely blocked.

The agency in 2005 granted Conceptus approval to update Essure's stated effectiveness from three years to five years. The updated packaging for the product states that the device is 99.8% effective at preventing pregnancy up to four years after implantation and 99.74% effective up to five years after implantation (Kaiser Daily Women's Health Policy Report, 7/20/05).

Conceptus' modified product reduces the number of steps a physician is required to perform during a placement procedure, the AP/Forbes reports (AP/Forbes, 7/25). The company also made improvements to the hysteroscopic visualization of the implant and placement markers, according to a Conceptus release. The product's package also includes a new device that lessens distension fluid loss.

"We anticipate these physician-recommended changes will lead to a shorter learning curve for newly trained doctors and allow them to add the Essure procedure to their office practice services," Mark Sieczkarek, president and CEO of Conceptus, said, adding, "We believe this will foster wider physician adoption, giving more women opportunity to select permanent birth control without the need to undergo tubal ligation and the risks associated with surgery" (Conceptus release, 7/25).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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