Breast implants to be reclassified to highest risk category for medical devices

[Guest guest]

I received this from a silent sister . . . Notice the

date is almost three years ago. Does anyone know what

is coming of the " Independent Review " breast implants

must undergo? - Rogene

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Health Minister Lord Warner welcomes new safety

measures for breast implants

Published:

Friday 25 July 2003

Reference number:

2003/0277

Breast implants to be reclassified to highest risk

category for medical devices

New safety measures for breast implants were welcomed

today by Health Minister, Lord Warner. From 1

September 2003, breast implants will be reclassified

to the highest risk category for medical devices,

following concerns about the safety of some breast

implants in Europe and America.

All breast implants sold in Europe will have to pass

stringent safety checks, similar to those already

carried out in the U.K. Manufacturers will have to

have their design dossiers examined and clinical data

verified by a designated independent body - in the UK

the independent body will be appointed by the

Medicines and Healthcare products Regulatory Agency

(Devices).

Lord Warner said:

" These new measures will boost public confidence in

the safety of breast implants. The UK has been leading

the way in pushing for new regulation in this area and

today's announcement will ensure that implants

manufactured throughout Europe are subject to the same

stringent checks currently in place in the UK. "

The new regulations follow guidelines issued by the

European Commission in November 2001- and requested by

the UK - which sought to address concerns about

patient information, tracking and surveillance and

quality control and assurance of breast implants. The

recommendation that there should be a reclassification

of breast implants from a medium to a high risk

category has finally been achieved by this directive

following extensive lobbying by the UK.

Dr s, Head of the Devices Sector of MHRA

(Devices) said:

" I welcome the move to tighten safety checks on breast

implants. We have pushed strongly for these changes.

It will ensure that all breast implants sold

throughout Europe meet the same high standards of

quality and safety. "

Notes to editor

The recommendation that there should be

reclassification of breast implants from a medium risk

to a high risk category has been achieved by the

European Directive 2003/12/EC, which will be

transposed into UK regulations by extending Consumer

Protection legislation.

The Medical Devices Directive contains classification

rules the manufacturer must use when deciding in what

class its device belongs. There are four classes,

Class I for low risk, Class IIa and ClassIIb for

moderate risk and Class III for high-risk devices.

Breast implants will be reclassified as Class III. For

moderate and high-risk devices the manufacturer must

employ an independent conformity assessment body

(Notified Body) to review and validate aspects of both

the manufacturing and design process. The Notified

Body is designated and monitored by its Competent

Authority, which in the U.K, is MHRA.

The new Directive will take effect from 1 September

2003. For devices placed on the market before that

date manufacturers have until 1 March 2004 to comply.

In the UK, the Department of Health has been reviewing

the safety of silicone gel breast implants since 1991

and, in 1997, established an Independent Review Group

to look into their safety and use, in response to

concerns expressed by women. In 1998 this Group

reported that silicone gel breast implants posed no

greater risk than any other type of implant, but that

information given to women considering implantation

was often inadequate. The Department of Health

therefore produced an information booklet for women

considering breast implants. Subsequent safety reviews

by the Medical Devices Agency (now part of MHRA) led

to the removal from the UK market of breast implants

filled with soya bean oil or hydrogels. Only silicone

gel and saline filled breast implants are currently

available in the UK

The National Breast Implant Registry was set up in

1993 and collects data from private and public sector

hospitals on breast implant usage. Registration is

voluntary and requires patient consent. In 2001, over

13,400 patients (nearly 24,000 breast implants) were

registered. The most common reason reported for

primary surgery was cosmetic augmentation (77% of

total). Replacement operations accounted for 17%.

For media enquiries only please contact Vicky Wyatt at

the Department of Health Media Centre on 020 7210

5656.

Contact

Press officer

Phone

Media Centre

020 7210 5221

Fax

Media Centre

020 7210 5433

Address

Media Centre, Department of Health

Richmond House, 79 Whitehall

London

SW1A 2NL