The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform

Fabio Ghezzi - One of the best experts on this subject based on the ideXlab platform.

Maurizio Serati - One of the best experts on this subject based on the ideXlab platform.

Klaas Heinemann - One of the best experts on this subject based on the ideXlab platform.

  • Real world data on Nexplanon® procedure-related events: final results from the Nexplanon Observational Risk Assessment study (NORA).
    Contraception, 2019
    Co-Authors: Suzanne Reed, Thai Do Minh, Jens A. Lange, Carol Koro, Michelle C. Fox, Klaas Heinemann
    Abstract:

    Abstract Objectives We conducted this study to characterize the frequency of insertion-, localization- and removal-related events and their clinically significant consequences among Nexplanon® (etonogestrel radiopaque contraceptive implant) users in the United States during standard clinical practice. Study design The Nexplanon Observational Risk Assessment (NORA) study was a large, prospective cohort study conducted in the United States. A total of 428 Health Care Professionals (HCPs) who had completed the Nexplanon clinical training program recruited women who were newly prescribed Nexplanon. We collected data on insertion-, localization- and removal-related events experienced during routine clinical practice via questionnaires completed by patients and HCPs. Recruitment began in December 2011 and follow-up ended in October 2017. Data analysis characterized the frequency of procedure-related events. Results We collected data on 7364 insertion procedures. The incidence of incorrect insertion (i.e., initially unrecognized non-insertion, partial insertion or deep insertion) was 12.6 per 1000 insertions (95% CI, 10.2–15.5). Pins and needles/numbness in the arm/hand/fingers was the most common patient-reported event. We obtained data on 5159 removal procedures, of which all were successful but one (due to the location of the implant in deep muscle tissue). No implants were localized outside the arm. The most common challenge reported by HCPs during implant removal was encasement of the implant within fibrotic tissue. Conclusions Events associated with the insertion, localization and removal of the Nexplanon contraceptive implant were rare and their clinical consequences were generally not suggestive of serious injury. Implications This study is the largest prospective evaluation of events associated with insertion and removal of Nexplanon during routine clinical practice. It demonstrates that complications associated with insertion and removal of Nexplanon are rare when performed by trained clinicians.

  • Nexplanon Procedure-Related Events: Final Results From the Nexplanon Observational Risk Assessment Study (NORA) [9G]
    Obstetrics & Gynecology, 2018
    Co-Authors: Suzanne Reed, Carol Koro, Klaas Heinemann, Carolyn Westhoff
    Abstract:

    INTRODUCTION:To characterize the frequency of insertion- and removal-related events among Nexplanon users in the US during standard clinical practice.METHODS:This large, prospective, non-interventional cohort study followed 7,369 new users of Nexplanon recruited by US health care professionals (HCPs

Suzanne Reed - One of the best experts on this subject based on the ideXlab platform.

  • Real world data on Nexplanon® procedure-related events: final results from the Nexplanon Observational Risk Assessment study (NORA).
    Contraception, 2019
    Co-Authors: Suzanne Reed, Thai Do Minh, Jens A. Lange, Carol Koro, Michelle C. Fox, Klaas Heinemann
    Abstract:

    Abstract Objectives We conducted this study to characterize the frequency of insertion-, localization- and removal-related events and their clinically significant consequences among Nexplanon® (etonogestrel radiopaque contraceptive implant) users in the United States during standard clinical practice. Study design The Nexplanon Observational Risk Assessment (NORA) study was a large, prospective cohort study conducted in the United States. A total of 428 Health Care Professionals (HCPs) who had completed the Nexplanon clinical training program recruited women who were newly prescribed Nexplanon. We collected data on insertion-, localization- and removal-related events experienced during routine clinical practice via questionnaires completed by patients and HCPs. Recruitment began in December 2011 and follow-up ended in October 2017. Data analysis characterized the frequency of procedure-related events. Results We collected data on 7364 insertion procedures. The incidence of incorrect insertion (i.e., initially unrecognized non-insertion, partial insertion or deep insertion) was 12.6 per 1000 insertions (95% CI, 10.2–15.5). Pins and needles/numbness in the arm/hand/fingers was the most common patient-reported event. We obtained data on 5159 removal procedures, of which all were successful but one (due to the location of the implant in deep muscle tissue). No implants were localized outside the arm. The most common challenge reported by HCPs during implant removal was encasement of the implant within fibrotic tissue. Conclusions Events associated with the insertion, localization and removal of the Nexplanon contraceptive implant were rare and their clinical consequences were generally not suggestive of serious injury. Implications This study is the largest prospective evaluation of events associated with insertion and removal of Nexplanon during routine clinical practice. It demonstrates that complications associated with insertion and removal of Nexplanon are rare when performed by trained clinicians.

  • Nexplanon Procedure-Related Events: Final Results From the Nexplanon Observational Risk Assessment Study (NORA) [9G]
    Obstetrics & Gynecology, 2018
    Co-Authors: Suzanne Reed, Carol Koro, Klaas Heinemann, Carolyn Westhoff
    Abstract:

    INTRODUCTION:To characterize the frequency of insertion- and removal-related events among Nexplanon users in the US during standard clinical practice.METHODS:This large, prospective, non-interventional cohort study followed 7,369 new users of Nexplanon recruited by US health care professionals (HCPs

Sanjeev Kumar - One of the best experts on this subject based on the ideXlab platform.