§ Tim LoughtonTo ask the Secretary of State for Health (1) if he will make a statement on the use of(a) bovine derivative substitutes, (b) hydroxyapatites and (c) coraline derivative substitutes in hip revisions, with special reference to efficacy, duration of use and cost; [127540]
(2) if he will make a statement on his recommendations to the NHS on the use of porous hydroxyapatites for use in hip revisions. [127541]
§ Mr. HuttonAll these materials are used as artificial bone substitute implants. They have a variety of uses, but in hip replacements they can be used in granular form and moulded in a paste with the patient's blood which is then used to fill the space left if a patient has lost their natural bone (a process which can occur in a failing hip replacement).
These products are regulated in line with the Medical Devices Regulations 2002 (SE2002 No. 618). Under these regulations, the manufacturer is required to place the CE marking on the medical device—unless it is part of a clinical investigation approved by the Medicines and Healthcare products Regulatory Agency (MHRA) or a custom made device—indicating that the medical device meets the essential requirements for safety and design in Annex 1 of Council Directive 93/42/EEC. For the medical devices specified, the manufacturer's declaration will be audited by an independent Notified Body. Any product bearing the CE marking may be placed on the United Kingdom market.
The Department of Health and the MHRA do not collect information on efficacy and costs of these products. Duration of use is a matter for the individual manufacturer of the product.