Poly Implant (PIP) Breast Implants:
Interim Report of the Expert Group

1. The overriding concern of the group is the safety and compassionate treatment of women with PIP breast implants. In our report we review the available data on the health risks from PIP implants

- concludes that there is no clear evidence at present that patients with a PIP implant are at greater risk of harm than those with other implants, and we therefore agree with the MHRA advice that there is no specific safety concern identified which requires a recommendation of routine removal of PIP implants

- recognises the anxiety of many women who received PIP implants in good faith on the assumption that they were manufactured in accordance with EC standards

- commends and endorses the decision of DH ministers that, where women have received a PIP implant as part of NHS treatment, they will be contacted to inform them that they have a PIP implant and to provide relevant information and advice; and will be offered further procedures subject to clinical need and taking full account of the wishes and concerns of the patient.

- expect private sector providers to take similar action

- the available evidence is subject to considerable uncertainty and therefore we recommend the collection of additional information which will enable the group reach a more informed view.

Q & A's:

Q: I think I have PIP implants - what do I do next?

A: Contact the Private Hospital where the operation was carried out. A telephone hotline exists which will establish whether or not you have these implants.

Q: If I do have PIP implants but have no concerns, and in fact am very pleased with the results, what are my options?

A: You may be offered a free MRI scan by the Private Hospital initially. You then have three options:

1. If you have no symptoms you can choose not to have anything done, as the current Department of Health current guidlenes do not suggest any ill-effects from the implants, and they do not need routine removal.

2. Option two is to attend for a free consultation where the results of the MRI scan will be discussed. If the scan does not show a rupture you can either choose not to have them replaced but to be kept under review with a free scan every two years, or you may wish to to have the implants replaced.

3. Option three is to elect to have your implants replaced in any event.. This clearly will require a further surgical procedure, a fresh scar and the attendant risks of the anaesthetic need to be borne in mind.

Q. What implants will be used to replace the PIP implants and what guarantee will I have?

A: The current choices of implant at our Hospital are either the ALLERGAN 'Natrelle' or the NAGOR 'Impleo' high cohesive gel implants - both carry a Life-time warrantee by the manufacturer against rupture. You may of course choose to have an alternative implant such as a saline filled implant. The relative advantages and disadvantages will be discussed at your consultation.

Q: Is silicone dangerous to health?

A: There is no conclusive proof that medical grade silicone poses any danger to health, and a moratorium on the use of silicone in breast implants in the USA was put in place to review previous use of the implants and their effects, from 1992 to 2006. The results show that there was no evidence of any health issues and the implants were reintrduced under strict controls in 2006. Silicone is used ubiqitously in food products (canning), baby products (teats), medical products (syringes) and many other medical devices and there have been no reports of any adverse effects.

Q: I have heard of silicone 'bleed'- what is this?

A: This is a natural pheneomeon occurring with all implants, whereby a small amount of silicone 'bleeds' though the implant shell and encourages the formation of a layer of thin tissue around the implant called a capsule. This capsule retains the position of the implant and usually prevents the escape of any silicone into the body tissues. If there is a large silicone load as in a rupture of an older implant with liquid silicone, then there may be some escape of this silicone into the body tissues

Q: I thought that silicone implnats had a firm consistency and did not leak?

A: Modern quality silicone implants have a textured surface, a multilayered silicone elastomer shell, and a high cohesive silicone gel filler. The latter has the consistency of a 'turkish delight' and is reputed not to leak at all after rupture. In some cases PIP implants were alleged to have been filled with a substandard silicone mixture, which resorted to fluid after some time.

In my experience to date ruptures have not been as frequent as recent publicity has suggested. Those presenting to my clinic have been relatively rare occurring in only 3% of cases over 10 years (less than the 10% -13% reported in the American literature), and in those cases liquid silicone was only seen in half the number, with the rest still being in a cohesive gel state.

Q: Should I be concerned if silicone is found in the lymph nodes in my armpit?

A: The lymph nodes simply act as a filter to trap any foreign substances in the blood, and this includes silicone if it has found its way into the tissues around the breast. With increasing load of silicone presenting to the lymph node, it accumulates and enlarges. A lymph node only needs removing if it is large and painful, as once the silicone load from the implant has been removed no further silicone should leach into the tissues. Any small or painfree lymph node can be left alone, and may occur after ANY implant, due to the silicone bleed phenomenon..

Q: If a lymph node does need removing what problems may this cause?

A: A small incision will neeed to be made over the node in order to remove it, but the scar is usually well hidden in the armpit crease lines. Only the affected lymph node needs to be removed, and therefore the risk of Lymphoedema (commoner in cancer cases after full Lymph Node dissection where up to 30 nodes may be removed together) is negligible.