Contraceptive Research, Introduction, and Use: Lessons From Norplant, Summary (1998)

In late 1996, the Institute of Medicine’s (IOM) Committee on Contraceptive Research and Development completed a major study of the state of contraceptive science, the need for new contraceptives, and factors helping or hindering response to that need.* As part of its work, the committee reviewed case histories of experience with the development and introduction of new contraceptives, including a brief review of the contraceptive implant, Norplant^®. The committee believed that the Norplant experience echoed critical elements in the history of several other contraceptives and that a detailed analysis of that experience would be particularly instructive. As the first real contraceptive innovation in over two decades and as a long-acting method requiring clinical intervention for application and removal, the method raised an especially wide range of issues that could offer valuable lessons about the barriers and problems to be addressed if other new technologies are to enter the contraceptive marketplace.

Thus, in April 1997, a subcommittee of that original study committee convened a workshop, “Implant Contraceptives: An Illuminating Case Study in Current Dilemmas and Possibilities.”^† This workshop arose from the belief that reviewing the experience with the development and introduction of the contracep

tive implant, Norplant, would be illuminating. As the first real contraceptive innovation in over two decades and as a long-acting method requiring clinical intervention for its application and removal, the method raised a range of issues that could offer valuable lessons about the challenges to be addressed if other new technologies are to enter the contraceptive marketplace, so as to make the entry of those technologies as positive and trouble-free as possible.

The workshop had three objectives:

• to review newly available data on Norplant’s efficacy, safety, and use;

• to extract lessons from diverse aspects of the method’s development, introduction, use, and market experience; and

• to explore approaches to developing and introducing new contraceptives based on learning from the Norplant market experience.

The workshop consisted of these elements: 17 formal presentations; two organized dialogues, one on consumer perspectives, the other on strategies for developing and introducing new contraceptive technologies; and extensive discussion among subcommittee members, presenters, and invited participants on the information presented and its implications. The dialogues were led by panels of individuals with perspectives from women’s health advocacy, reproductive ethics, and the clinic. The subcommittee then met in executive session to analyze the workshop proceedings and develop a list of lessons and points for further consideration or action.

The full report is organized in the following manner: The first section reviews the major points in the workshop presentations and dialogues; the second section summarizes the principal lessons they provided and the areas of action most urgently suggested for the future. In the full report, three appendixes and detailed endnotes follow. Appendix A contains abstracts of the 15 formal presentations in a common format. Appendix B presents background material on the technology and a chronology of its development and market experience. Appendix C provides the workshop agenda and list of participants. The endnotes consist of references made by presenters and other information deemed necessary to support and clarify the text.

The following section presents:

• a data review, consisting of brief summary statements on key points presented at the workshop;

• the subcommittee’s analysis of those lessons learned that it considered most crucial for the future; and

• areas for consideration and action.