Contraceptive Research, Introduction, and Use

Lessons From Norplant

Author: Rosenfield, Allan; Harrison, Polly F.
Publisher: National Academies Press
ISBN: 9780309059855
eISBN Pdf: 9780309591539
eISBN Epub: 9780309174428
Place of publication: United States
Year of digital publication: 1998
Month: March
Pages: 129
Language: English

Caption

As the first real contraceptive innovation in over 20 years, and as a long-acting method requiring clinical intervention for application and removal, the implantable contraceptive Norplant has raised a wide range of issues that could offer valuable lessons about the problems to be addressed if other new contraceptive technologies are to enter the marketplace. In April 1997 an Institute of Medicine workshop on implant contraceptives reviewed newly available data on Norplant's efficacy, safety, and use; identified lessons to be learned about the method's development, introduction, use, and market experience; and explored approaches to developing and introducing new contraceptives based on those lessons. This resulting book contains an examination of Norplant's efficacy and safety, its user populations, training for insertion and removal, consumer perspectives (quality of care, informed decisionmaking, and consumer involvement), and new approaches to contraceptive development and introduction. An appendix contains summaries of 17 workshop presentations.

Contraceptive Research, Introduction, and Use
Copyright
Acknowledgments
Contents
1 Introduction
2 Workshop Report
- EFFICACY AND SAFETY
  - Efficacy
  - Safety
    - Major Health-Related Events
    - Significant Health-Related Problems
    - Silicone Biocompatibility
    - Progestin Effects on Vaginal HIV Transmission
- WHO USES NORPLANT AND HOW
  - User Populations
  - Method Continuation and Discontinuation
  - Side Effects as Factors
  - User Satisfaction
  - Barriers to Discontinuation
    - Cost and Cost-Effectiveness
    - Effects of Media Coverage and Litigation on Norplant Use
- INSERTION AND REMOVAL: EXPERIENCE AND IMPLICATIONS
  - Technical Aspects
  - Case Experiences
  - Rates of Complicated Removals
  - Implications
- CONSUMER PERSPECTIVES
  - Communication and Quality of Care
    - Quality of Care
  - Informed Decision-Making
    - Importance
    - Content
    - Special Challenges
    - Potential for Abuse
  - Consumer Involvement
- NEW APPROACHES
  - Reproductive Health Technologies Project's "Boom and Bust Initiative"
  - The WHO Strategic Approach to Contraceptive Introduction
  - A ''Government Standards Defense"
3 Workshop Summary and Analysis
- DATA REVIEW
  - Efficacy
  - Safety
  - User Profiles
  - Side Effects
  - Continuation and Discontinuation
  - User Satisfaction
  - Postmarketing Surveillance
  - Cost-Effectiveness
- LESSONS LEARNED
- NEXT STEPS: AREAS FOR CONSIDERATION AND ACTION
  - Areas for Strengthening or Expansion
    - 1. Clinical Research
    - 2. Market Research
    - 3. "Pre-introduction"
    - 4. Informed Decision-Making
    - 5. Postmarketing Surveillance
  - Areas for New Initiative
    - 6. Credentialing
    - 7. Core Guidelines for Long-Acting Contraceptives
    - 8. Costs
    - 9. Product Liability
- FINAL COMMENT
- ENDNOTES
Appendixes
- A Presentation Summaries
  - Presentation 1
  - Background
  - Methodology
  - Findings
    - Age and Educational Levels
      - Major Health-Related Events
      - Significant Health-Related Problems
      - Continuation and Removals
      - Efficacy
  - Conclusions
  - Presentation 2
  - Background
  - Methodology
  - Findings
    - Pregnancy and Continuation Rates
      - Reasons for Discontinuation
      - Removal Difficulties
      - Mortality and Hospitalization
  - Conclusions
  - Presentation 3
  - Background
  - Methodology
  - Findings
  - Conclusions
  - Presentation 4
  - Background
  - Findings
    - Composition
      - Inflammatory Wound Healing Reaction and Blood Protein Absorption
  - Conclusions
  - Presentation 5
  - Background
  - Methodology
  - Findings
  - Conclusions
  - Presentation 6
  - Background and Methodology
  - Findings
  - Conclusions
  - Presentation 7
  - Background
  - Findings
  - Conclusions
  - Presentation 8
  - Background
  - Methodology
  - Findings and Conclusions
    - Sample Characteristics
      - Continuation and Discontinuation
      - Media Effects
      - Norplant and Coercion
  - Presentation 9
  - Background
  - Methodology
  - Findings
    - Sample Characteristics
      - Continuation and Discontinuation
      - The Question of Coercion
      - Postdiscontinuation Experience
  - Conclusions
  - Presentation 10
  - Background
  - Methodology
  - Findings
  - Conclusions
  - Presentation 11
  - Background
  - Removal Techniques
    - Standard Technique
      - Pop-Out Technique
      - U Technique
  - Removal Difficulties and Training
  - Conclusions
  - Presentation 12
  - Background
  - Methodology
  - Findings
  - Conclusions
  - Presentation 13
  - Background
  - Methodology
  - Findings
  - Conclusions
  - Presentation 14
  - Background
  - Findings
    - Choice
      - Removal on Demand
      - Tracking Capacity
  - Conclusions
  - Presentation 15
  - Background
  - Discussion
    - The Role of the FDA
      - The Potential Role of a Federal Standards Defense
  - ENDNOTES
- B Norplant: Historical Background
  - THE TECHNOLOGY
  - HISTORY
  - ENDNOTES
- C Workshop Agenda
  - Implant Contraceptives: An Illuminating Case Study in Current Dilemmas and Possibilities 7-8 April 1997
    - NATIONAL ACADEMY OF SCIENCES INSTITUTE OF MEDICINE
    - WORKSHOP
    - PARTICIPANTS