Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03623126

Acronym

ESSURE

Enrollment

Registered

2018-08-09

Start date

2018-08-08

Completion date

2018-09-03

Last updated

2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive Device; Complications, Quality of Life

Brief summary

The ESSURE device is a method of permanent contraception, marketed in France since 2005. Multiple side effects have been reported by patients since 2015 and the marketing was stopped in 2017. For several months it was observed an increase in requests for withdrawal of these devices. The principal objective of this study is to evaluate clinical improvement and quality of life after ESSURE removal. This is a multicenter retrospective descriptive study involving the gynecology department of the Croix Rousse Hospital and the gynecology department of the Lyon Sud Hospital over a period of 1 year (1 January 2017-31 December 2017).

Interventions

OTHERQuestionnaire

A questionnaire to evaluate clinical improvement and quality of life after ESSURE removal will be completed by patients at least one month after the procedure.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Women who underwent ESSURE removal due to suspected adverse effects of the device. * Women who agreed to participate in the study

Exclusion criteria

\- Women who underwent ESSURE removal to restore their fertility.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the clinical improvement after the intervention of withdrawal of ESSURE devices	One day at least one month after the procedure	This evaluation will be carried out thanks to a questionnaire. The 4th question retrospectively identifies the symptoms presented by patients. The proposed list of symptoms was established by reviewing the symptoms most often found in the medical records of the patients included. Question 11 evaluates the variation of each symptom after removal of ESSURE devices through an ordinal scale (total disappearance, significant improvement, poor improvement, no improvement, worsening).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026