Other breast implants

Information for women considering breast implants
The Department of Health has taken action to ensure women considering breast implants have appropriate advice. Every medical intervention carries some risk. It is because such risks exist that women need to have accurate and complete information prior to deciding to have surgery. The risks associated with silicone gel breast implants have been investigated on three occasions by independent expert groups working on behalf of the Department of Health. The latest of these, the Independent Review Group, concluded that the risks were no greater than for other implants, such as hip joints. MHRA is not aware of any evidence suggesting that saline used to fill saline breast implants presents any hazards.  The Department of Health published a booklet in September 2000 (revised April 2002) that summarised the key issues and suggested questions that women could ask to help them make an informed choice about surgery. The MHRA updated this booklet (148Kb) and produced it in a new format (November 2005).

Local complications and known risks
Complications, such as capsular contraction or loss of sensitivity, have long been known to be associated with breast implantation, although good information on the incidence of such problems is lacking. The possibility of these complications should be fully explained to patients by their surgeon before surgery. There is also a possibility of rupture of the implant, which will normally necessitate reoperation. It should not be assumed that breast implants will last indefinitely. The technique of 'closed capsulotomy' which has been used to relieve capsular contracture, is known to increase the chance of rupture and is not recommended by manufacturers.

Saline-filled breast implants
Saline-filled breast implants consist of a silicone elastomer shell, which is filled with saline solution (salt water).

There are no restrictions on the sale or use of CE-marked saline-filled breast implants in the UK.

Polyurethane-coated breast implants
Polyurethane-coated silicone gel breast implants are now available for implantation in the UK.

These implants consist of a silicone elastomer shell filled with silicone gel.  The shell is coated with a polyurethane foam which breaks down over time.  Polyurethane-coated breast implants were removed from the UK market in 1991, following concerns about the possible carcinogenic risk from the polyurethane breakdown product.  The Committee on Carcinogenicity1  concluded that carcinogenic risk from these implants is small and unquantifiable.  In April 2005, the manufacturer of one type of polyurethane-coated breast implant reintroduced them to the UK.  The manufacturer claims that the incidence of capsular contracture is lower than with other types of breast implant, and that the movement or rotation is less.  In April 2005, MHRA issued a letter to the plastic surgery professional bodies to bring this issue to their attention and to inform them of the risks and claimed benefits.

MHRA’s letter (35Kb), the accompanying patient information sheet (21Kb), a review of the polyurethane breakdown product (287Kb) carried out by MHRA in 2001 and the paper (84Kb) presented to the Committee on the Safety of Devices (CSD) in November 2003 are available to view,  as are the minutes from the November 2003 CSD meeting (34Kb).

1 The Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment (COC) provides expert advice to the Chief Medical Officer and UK Government Departments.

Titanium-coated breast implants
These implants are made from a silicone gel filler with a titanium coated silicone elastomer shell, not titanium mesh.  Titanium coated mesh is a different material used in some other surgical applications.

Titanium-coated breast implants are not CE marked and are not available in Europe.