Patients Presenting Essure Device Attributed Symptoms
Conditions
Keywords
adverse effects, Salpingectomy, Essure® device ablation, Cornual resection
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSF-36
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
BEHAVIORALHAD
Evaluation of anxiety and depression with a scale validated with 14 items assess between 0 and 3. Evaluation done pre-operatively and at M3.
OTHERANSM
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.
Sponsors
La Conception Hospital - Marseille - France
Public Assistance - Marseille Hospitals
Aix Marseille Université
University Hospital, Montpellier
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Defects in installation or secondary migration | during surgery | Estimate the prevalence of Essure® deposition or secondary migration defects |
Countries
France
Outcome results
None listed