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Medical Devices Agency wants to see prospective clinical study of contraceptive device

BMJ 1998; 316 doi: (Published 28 March 1998) Cite this as: BMJ 1998;316:1021
  1. Susanne M Ludgate, Medical director
  1. Medical Devices Agency, Department of Health, London SE1 6TQ

    EDITOR—I wish to correct a factual error in Mayor's news article on the contraceptive device Persona.1 Mayor states that “theMedical Devices Agency was unable to substantiate the reliability [of the device] because Unipath declined to provide data from the trial” conducted before the device was marketed. This is incorrect.

    The reason that the Medical Devices Agency is unable to substantiate or confirm the claimed reliability of Persona is that this claim is based on a retrospective analysis of data, for which software containing a mathematical model derived from those data was used. The agency, supported by a number of experts, believes that only a prospective clinical study of the modified and marketed version of Persona can confidently determine its reliability.


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