Patients Presenting Essure Device Attributed Symptoms Clinical Trial
Official title:
Quality of Life Assessment of Women Undergoing Laparoscopic Removal of Essure System : a Before-and-after Study
To evaluate quality of life before and after laparoscopic removal of the Essure® system. Women who complain about symptoms attributed to the Essure® device are expected to have an improved quality of life postoperatively.
Tubal sterilization is a widely used method of contraception. The hysteroscopic sterilization
method (Essure®; Bayer, Germany) was approved in 2007 in France. Increasing patients reports
of complications, such as bleeding pain, allergies, fatigue or articular pain have raised
concerns about the safety device. Women suffering of alleged complications of the Essure®
device ask for surgical removal. But, only few studies have assessed Essure® removal in terms
of quality of life. This observational study contains two parts will be conducted at two
academic tertiary care center (Montpellier - Marseille):
- a prospective part having received a favorable opinion from a Committee for the
Protection of Persons,
- and a retrospective part having received a favorable opinion from the Institutional
Review Board (IRB), local ethics committee
Patients: Women requesting surgical management for removal of Essure® for alleged adverse
effects.
Assessment tools :
Quality of life with the Short Form 36 (SF-36) Health Survey questionnaire (pre-operatively
and at 1 and 3 months) Hospital Anxiety and Depression (HAD) scale (pre-operatively and 3
months)
Preoperative imaging, procedure characteristics, including the Essure® removal method,
operative findings, perioperative complications, histopathologic report, and length of
hospital stay will be collected.
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