Research introduction and use: advancing from Norplant.

An April 1997 workshop convened by the US Institute of Medicine reviewed data on Norplants efficacy safety and use; considered lessons learned from the methods development introduction and market experience; and explored approaches based on these lessons that could improve the environment for contraceptive research and development and facilitate market entry for new contraceptive technologies. A review of clinical experience with Norplant suggested the importance of delivery in a medically controlled environment provider training in insertion and removal techniques intensive client counseling and free choice. Negative mass media coverage and litigation have had an adverse impact on Norplant use patterns. Nine areas were identified for consideration or action: clinical research on hormonal effects market research and regularized interactions with industry a preintroductory phase permitting various assessments in advance of full-scale product introduction mechanisms to ensure informed decision making postmarketing surveillance provider credentialing core guidelines for long-acting contraceptives cost analyses and product liability legislation. Dialogue at the workshop provided evidence of a paradigm shift toward a woman-centered contraceptive research agenda.