The intrauterine contraceptive device, "Multiload Cu 250": a regulatory problem.

Reports to the control agencies in Sweden and Australia of fractures of the intrauterine contraceptive device. Multiload Cu 250, led to a review of the safety of this device in these countries. The review revealed that fractures of the device had occurred in 15 other countries but in these countries only 5% of reports had been directed to the relevant national control authorities. The remainder either had been reported to the sponsor or had appeared in the published literature. An additional problem identified was one of thread rupture with the resultant difficulty in removal and the need for surgical intervention. It is apparent that the sponsor of the device was aware of the problems for some time since it made several significant changes to the device marketed in Sweden. These changes were made in 1983, without informing the Swedish agency and without its approval. These were 1622 Multiload Cu 250 devices returned to the Swedish agency for examination from 1988 to 1989. An analysis of 1516 of them found that the overall incidence of device fracture was 1:405 and of broken threads, 1:8. However, evidence suggests that the modifications conducted in 1983 and 1984 resulted in a device with very much less chance of fracture and/or ruptured threads on removal. Stress testing of 106 used devices suggested that the risk of fracture may increase with the length of time left in utero. Regulatory action in both Sweden and Australia involved changes in the information provided to physicians and patients. In Sweden, the additional step of withdrawing all earlier devices suspected of being associated with fracture and/or ruptured threads was taken.(ABSTRACT TRUNCATED AT 250 WORDS)