§ Mr. Gordon PrenticeTo ask the Secretary of State for Health, pursuant to his answer of 24 February,Official Report, column 70, if he will make it his policy to collect information centrally on the number of breast implants which leak. [18409]
§ Mr. HoramThe medical devices directive—Council directive 93/42/EEC concerning medical devices—already requires manufacturers of medical devices, including breast implants, to review systematically any reports of implant failures which might have caused death or serious injury. Under the directive, manufacturers are also required to notify the relevant competent authority—in the United Kingdom, the Medical Devices Agency—of such cases.