§ Ann ClwydTo ask the Secretary of State for Health what advice and information his Department makes available to women considering breast implants. [125464]
§ Mr. DenhamWe will shortly be publishing an information leaflet for women considering having breast implants.
§ Ann ClwydTo ask the Secretary of State for Health what recent report he has received of adverse incidents relating to silicone gel implants; and what further action he has taken as a result. [125473]
§ Mr. DenhamIn the 12 months prior to 31 May 2000, the Medical Devices Agency (MDA) received 19 reports of adverse incidents involving silicone gel breast implants. MDA have not identified any trends which suggest there is a problem with the performance of any particular model of silicone gel breast implant. MDA continues to record and review all reports of problems with silicone gel breast implants received via the Adverse Incident Centre. This information is regularly reviewed by the Independent Review Group.
§ Ann ClwydTo ask the Secretary of State for Health what evidence he has recently received that silicone gel breast implants are causing illness. [125463]
§ Mr. DenhamThe Department has received no new evidence recently that silicone gel breast implants are causing illness. The Independent Review Group on silicone gel breast implants continues to meet twice a year to monitor emerging scientific data on this subject. In March 2000, the Group confirmed that there was no need to revise the conclusions reached in 1998.
§ Ann ClwydTo ask the Secretary of State for Health what action has been taken by his Department through the Advertising Standards Authority implant procedure, stating the possible health and safety implications of breast implants. [125470]
§ Mr. DenhamOur response to the Health Committee's Fifth Report on the regulation of private and other independent healthcare (Command 4540) made it clear that the powers given in the 1988 Control of Misleading Advertisements Regulations are adequate to control 479W advertising. We were however concerned to ensure that the information patients receive in the independent sector is of an acceptable standard.
We are addressing this in two ways. We will soon be publishing a Department of Health information leaflet for women considering breast implants. In addition, the Care Standards Bill, as drafted, will allow us to introduce regulations covering standards of information given to patients in the independent sector.
§ Ann ClwydTo ask the Secretary of State for Health if information on the Breast Implants Register is made available to recipients of implants in(a) NHS and (b) private hospitals. [125467]
§ Mr. DenhamThe National Breast Implant Registry produces an annual report which is available, upon request, to recipients of breast implants, regardless of whether they received their implants in a National Health Service or a private hospital.
§ Ann ClwydTo ask the Secretary of State for Health if he will introduce legislation to make registration of breast implants compulsory. [125466]
§ Mr. DenhamWe support the collection and provision of as much information as possible and the Medical Devices Agency has increased funding of the National Breast Implant Registry to improve compliance monitoring. Any legislation would however be coercive and would invalidate the individual's consent to surgery.
§ Ann ClwydTo ask the Secretary of State for Health what progress has been made on the European Commission's investigation into silicone breast implants. [125474]
§ Mr. DenhamIt is understood that the European Commission currently plans to review breast implants taking account of the options presented in the draft report from the Scientific Technological Options Assessment Committee (STOA) of the European Parliament. The Commission intends to give a report to STOA in November 2000. It is further understood that the investigations will involve action in three areas
Reviewing the requirements for conformity assessment of implantable breast prostheses;Addressing the provision of information to patients for these products;Possible revision of the published standards for manufacturers of breast implants.
§ Ann ClwydTo ask the Secretary of State for Health how many breast implants have been registered through the National Breast Implant Registry since 1997; and what estimate he has made of the number not registered. [125469]
§ Mr. DenhamThe total number of breast implants registered on the National Breast Implant Registry (NBIR) in each complete calendar year since 1997 is as follows:
480W
Year Number of implants registered 1997 14,800 1998 16,161 1999 18,173 Based upon compliance studies carried out by the NBIR, it is estimated that this represents about 60–70 per cent. of the breast implants used in the United Kingdom.
§ Ann ClwydTo ask the Secretary of State for Health how recipients of breast implants and doctors are informed of the reporting facility of the Adverse Incident Centre within the Medical Devices Agency. [125462]
§ Mr. DenhamAt the beginning of each year, the Medical Devices Agency (MDA) writes to chief executives of trusts, health authorities and primary care trusts reminding them of their obligation to report adverse incidents involving medical devices, including breast implants, to the Adverse Incident Centre. MDA also encourages trusts to appoint MDA liaison officers, whose role is to co-ordinate adverse incident reporting and the dissemination of safety information about medical devices within the trust.
As the adverse incident reporting system is focused upon healthcare professionals and medical device manufacturers, MDA does not systematically inform recipients of breast implants of the system. Information on the system is however publicly available via the MDA worldwide website.