Information for women considering polyurethane-coated breast implants…What are polyurethane-coated breast implants?
Micro-Polyurethane Surfaced (MPS) mammary implants, manufactured by Polytech
Silimed Europe GmbH, consist of a silicone elastomer shell, filled with silicone gel.
This design is similar to other silicone gel breast implants, except that the shell is
coated with a polyurethane foam, intended to reduce the rate of capsular contracture.
What is capsular contracture?
Fibrous tissue forms around any implant as part of the body’s response to the implant material. The formation of a fibrous capsule around a breast implant is thus a normal reaction. In some women, however, the fibrous capsule can contract and ‘squeeze’ the implant resulting in an altered appearance and consistency of the breast, and is sometimes associated with pain. This is known as capsular contracture. The amount of contracture varies from person to person and cannot be predicted before implantation. An additional operation to remove the fibrous capsule, and possibly the implant, is sometimes necessary.
What are the advantages of polyurethane-coated breast implants?
The manufacturer claims that the incidence of capsular contracture is lower for MPS implants than for other silicone breast implants with smooth or textured shells. The texture of the foam coating is believed to disrupt the organisation of the cells that form the fibrous capsule, thus making the capsule less likely to contract. They also claim that movement or rotation of the implant is less likely due to better adhesion to the underlying tissue.
What are the risks associated with polyurethane-coated breast implants?
Following implantation, the polyurethane foam coating breaks down over several years. After this time, it is thought that the protective effect against capsular contracture may be lost or diminished. One of the chemicals that is released into the surrounding tissue during the breakdown of the coating is known to cause cancer in animal experiments. The risk of developing cancer in humans due to the presence of these implants is small and unquantifiable.
How do I decide whether to have polyurethane-coated breast implants?
Many factors need to be taken into account when deciding which type of implant is most suitable for a particular person, and the relative importance of these factors varies with individual circumstances. Your plastic surgeon will be able to discuss the options available to you and the advantages and drawbacks of each, so that, between you, you can reach a decision on which type of breast implant would be the most appropriate for you.
This information sheet has been produced by the Devices Division of the Medicines and Healthcare products Regulatory Agency (MHRA), which was formerly the Medical Devices Agency (MDA). MHRA is an executive agency of the UK Department of Health whose role is to protect and promote public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely.