Bayer HealthCare announced that a recent Food and Drug Administration (FDA) Advisory Committee met to review and discuss data regarding the benefits and risks associated with use of the Essure medical device for hysteroscopic sterilization. The Advisory Committee meeting was convened due to a dramatic increase in the number of adverse events submitted to the FDA in relation to the Essure device.
The Advisory Committee evaluated currently available scientific and clinical data and discussed a number of considerations including patient education and counseling, training and certification of physicians, post-procedural patient management, and clinical research. The Committee determined that because rates of adverse events cannot be determined by Medical Device Reporting (MDR) data, it is not possible to assess whether the numbers of reports represent a true increase in rates of particular known or expected events or if they represent an increase in the reporting of adverse events or increase in the number of devices in clinical use.
Bayer emphasized that physicians should counsel their patients on the risks of Essure, the permanency of the procedure, the importance of the three-month confirmation test to verify that the inserts can be relied upon to prevent pregnancy, and the need to use an alternate contraceptive method until a satisfactory Essure confirmation test is documented.
Essure inserts are permanently placed into a woman’s fallopian tubes and work with the body to form a natural barrier against sperm reaching the eggs. The inserts do not contain hormones.
For more information call (877) ESSURE1 or visit Essure.com.