|January 2011 · Vol. 23, No. 1
Bridging the Use of Adiana®
from Clinical Trials
to Community Practice
James B. Presthus, MD
EASE Trial Investigator
Physician and Head of Clinical Research, Minnesota Gynecology & Surgery, Edina, Minnesota
DISCLOSURES AND ACKNOWLEDGEMENTS
Dr. James B. Presthus is a paid consultant for Hologic, Inc., and an active speaker, preceptor, and investigator. He is also a consultant and investigator with stock ownership for Interlace Medical, and a consultant and speaker for American Medical Systems and Olympus/Gyrus/ACMI.
Industry support for this study was provided by Hologic, Inc., Malborough, MA. Editorial support was sponsored by Hologic, Inc., and provided by Ed Shifflett, PhD, and Amanda McGeary, MS, at AlphaBioCom.
The contraceptive needs of women change as they progress through life. Nearly all sexually active women (98%) aged 15 to 44 years have used at least one form of contraception.1 In women aged 35 to 44 years, female sterilization is the most common form of contraception, and the second most common choice of contraception in those aged 15 to 44 years.1
With the approval of transcervical sterilization, permanent female sterilization is now less invasive. In 2009, the US Food and Drug Administration approved Adiana® Permanent Contraception (Hologic™, Inc., Marlborough, Mass.), a female sterilization procedure that involves surgical implantation of a polymer matrix into the fallopian tubes.2 The EASE (Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy) pivotal trial demonstrated safety and efficacy of Adiana in 645 women aged 18 to 45 years. The 3-year pregnancy prevention rate was 98.4%.2
During its first year of use, approximately 5,000 Adiana procedures have been performed. A community-based survey was conducted to evaluate US physicians’ experiences with Adiana. Results of the survey are presented in “Results of a Community-based Survey Evaluating Pregnancy Prevention with Adiana Permanent Contraception.”
The option to perform the Adiana procedure in the office offers several benefits to both patient and physician. Performance of the Adiana procedure in two different settings is reported in “The Adiana Procedure in the Office Setting Compared With the Operating Room.”
Considering the age (35 to 44 years) of many women who choose permanent sterilization to prevent pregnancy, it is likely that many patients will need to undergo subsequent gynecologic interventions. Safety data from the EASE trial are evaluated in “Intrauterine Procedures in Women Who Have Previously Undergone Adiana Permanent Contraception.”
The aforementioned Adiana data provide insight into 1) real-world use of the procedure and 2) its compatibility in the office and with subsequent gynecologic procedures. Data presented here are encouraging, and show how the Adiana procedure can be easily integrated into clinical practice.
1. Chandra A, Martinez G, Mosher W, Abma J, Jones J. Fertility, family planning, and reproductive health of U.S. women: Data from the 2002 National Survey of Family Growth. National Center for Health Statistics. Vital Health Stat. 2005;23(25):1–160.
2. Adiana Permanent Contraception Instructions for Use. Marlborough, MA: Hologic, Inc.; 2009.
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