Breast implants

We have produced a printable summary (381Kb) of the information on these web pages concerning breast implants.

Types of breast implants
Breast implants can contain different filler materials inside a silicone elastomer shell. Only two types of breast implant filler are currently in use in the UK:

• silicone gel
• saline.

The shell can be either smooth or textured. Some are covered with a polyurethane foam coating.

Implants that are not available in the UK are:

• hydrogel-filled implants
• soya bean oil-filled (Trilucent™) implants
• implants with a titanium coating.

Information about breast implants
In 2001, the Department of Health published a booklet giving useful information for women who are considering breast implantation. This booklet was updated by the MHRA in November 2005

• Information for women considering breast implants booklet

Other notices or reports relevant to the safety of breast implants have been produced by the MHRA, the Department of Health and Independent Advisory Groups:

• list of safety information publications

Adverse events
If safety concerns arise with any breast implants, the MHRA will investigate and issue advice to the health service if necessary.

Patients or members of the public can report problems with breast implants directly to us.

• Report an incident

Health professionals who wish to report adverse events to us should not the following relevant guidance and links:

• Guidance on incident reporting in general (MDA/2007/001)
• Printable poster: breast implants - key reportable adverse events
• Report an incident

Manufacturers of breast implants should be aware of the following document:

• Guidance on the medical devices vigilance system for  CE marked breast implants (updated August 2006)

The UK Breast Implant Registry
The UK Breast Implant Registry (UKBIR, formerly the National Breast Implant Registry) has been funded by the MHRA since 1993. It was set up, at Salisbury District Hospital, to form a basis for future research projects into aspects of breast implant surgery or possible breast implant morbidity. Further to the outcome of a pilot study (14Kb) (carried out by an independent research group funded by the Department of Health), the MHRA's funding of the UKBIR is no longer available. Recent annual reports are accessible here:

• UKBIR Annual Report 2003 (2322Kb)
• UKBIR Annual Report 2004 (1153Kb)
• UKBIR Annual Report 2005 (389Kb)

Patients requesting information about the devices which they have been implanted with, should seek this information from the implanting surgeon or centre.

MHRA contacts (e-mails)
Clinical: Susanne Ludgate
Technical: Crina Cacou
Adverse Incident Reports: AIC