Quality of Life Assessment Before and After Essure Removal

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.

• SF-36 (Behavioral), also known as Short Form 36 Health Survey questionnaire: 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
• HAD (Behavioral), also known as Hospital Anxiety and Depression scale: Evaluation of anxiety and depression with a scale validated with 14 items assess between 0 and 3. Evaluation done pre-operatively and at M3.
• ANSM (Other), also known as ANSM questionnaire: 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.

Primary outcomes

• Improving the quality of life between pre and post-operative at 3 months [3 months after the surgery]: The quality of life is measure with Short Form (36) Health Survey Questionnaire

Secondary outcomes

• General disorders and anxiety or depression [One month before surgery and 3 months after surgery.]: General disorders and anxiety or depression (by questionnaire HAD)
• Performance of 3D ultrasound [Preoperatively]: Estimate the performance of preoperative 3D ultrasound to identify a poor implantation of the Essure® found in Preoperatively
• Allergy to components [Before removing the sterilization devices (Essure®)]: Reaction to metals: Estimate the prevalence of contact allergy to components through skin tests
• Allergy to components [During surgical removal]: Reaction to metals: to estimate the prevalence of Nickel release by the Essure® , by the analysis of the surgical parts
• Defects in installation or secondary migration [during surgery]: Estimate the prevalence of Essure® deposition or secondary migration defects

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* Patients carrying Essure®
* Patients requesting surgical removal of Essure®
* Patients with adverse effect
* Being affiliated or benefiting from a French social security system

Exclusion Criteria:

\- Patients with guardianship or curators

• PATRICE PC CROCHET, PhD, Study director, University Hospital, Montpellier