An observational study in Patients Presenting Essure Device Attributed Symptoms, sponsored by University Hospital, Montpellier. Completed at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by University Hospital, Montpellier · Observational
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):
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.
Patient with definitive sterilization by Essure®
Exclusion Criteria:
Patients seen in consultation between January 2017 and August 2017, who have already completed the SF-36 questionnaire (pre-operative, M1 and M3), the HAD and ANSM questionnaires (pre-operative and M3)
Patients seen in consultation between August 2017
Behavioral: SF-36 · Behavioral: HAD · Other: ANSM
Evaluation of the quality of life with an auto-questionnaire validated, with 8 dimensions: physical activity ; limitations due to physical condition; physical pain; perceived health; vitality; life and relationship with others; limitations due to physical condition; psychic health as well as the assessment of perceived health compared to a year ago. Evaluation done pre-operatively, at M1 and M3
Also known as: Short Form 36 Health Survey questionnaire
Evaluation of anxiety and depression with a scale validated with 14 items assess between 0 and 3. Evaluation done pre-operatively and at M3.
Also known as: Hospital Anxiety and Depression scale
Additional information requested by the ANSM (french National Agency for Medicines and Health Products Safety) following a materiovigilance report. Evaluation done pre-operatively and at M3.
Also known as: ANSM questionnaire
Improving the quality of life between pre and post-operative at 3 months
The quality of life is measure with Short Form (36) Health Survey Questionnaire
Time frame: 3 months after the surgery
General disorders and anxiety or depression
General disorders and anxiety or depression (by questionnaire HAD)
Time frame: One month before surgery and 3 months after surgery.
Performance of 3D ultrasound
Estimate the performance of preoperative 3D ultrasound to identify a poor implantation of the Essure® found in Preoperatively
Time frame: Preoperatively
Allergy to components
Reaction to metals: Estimate the prevalence of contact allergy to components through skin tests
Time frame: Before removing the sterilization devices (Essure®)
Allergy to components
Reaction to metals: to estimate the prevalence of Nickel release by the Essure® , by the analysis of the surgical parts
Time frame: During surgical removal
Defects in installation or secondary migration
Estimate the prevalence of Essure® deposition or secondary migration defects
Time frame: during surgery
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier