Medicines for PIP breast implants

What it is

PIP breast implants are a specific type of breast implant that was made by a French company, Poly Implant Prothèse (PIP). These implants became the subject of a health concern and were withdrawn after it was discovered that the company had, fraudulently, used a non-medical-grade (industrial) silicone filler in the implants instead of the approved medical-grade material, without approval. This led to concerns because PIP implants were found to be more likely to rupture (split) or leak than other approved implants. The main issues identified were: a higher-than-expected rate of rupture; and, when they ruptured, the leaking of the unapproved silicone into the surrounding tissue, which could cause local problems such as inflammation, lumps, swelling, or pain, and could spread to nearby lymph nodes. Investigations were carried out into whether the silicone posed a wider health risk (such as toxicity or cancer), and the overall conclusion of expert reviews was that, while the implants were more prone to rupture and this was clearly unacceptable, there was no evidence that the silicone itself caused a significant toxic effect or a link to cancer — so the main concern relates to the higher rupture rate and the local effects of rupture, rather than a proven serious health danger from the silicone. Following the discovery, guidance was issued for people who had received PIP implants, including advice on how to find out if they had PIP implants, on being monitored, and on the options regarding removal (with or without replacement) — and provisions were made regarding removal in certain circumstances. People who have or think they may have PIP implants are advised to seek information and, where relevant, assessment, and to be aware of signs of a possible rupture. The key messages are that PIP implants used unapproved industrial silicone and were more prone to rupture, that expert reviews did not find evidence of a serious toxic or cancer risk from the silicone, and that affected people are advised on checks, monitoring, and options including removal.

How it is treated

The approach for people with (or possibly with) PIP breast implants involves finding out whether they have PIP implants, being monitored and assessed, being aware of signs of rupture, and considering the options regarding removal, guided by medical advice. A first step for anyone concerned is to find out whether they actually have PIP implants — this can be done by contacting the clinic, hospital, or surgeon where the implants were placed, or seeking advice through the appropriate channels, to check the type of implant used; records and guidance help with this. For those who do have PIP implants, the guidance (following the expert reviews) has generally been that routine removal is not automatically necessary for everyone purely as a precaution, given the lack of evidence of a serious toxic or cancer risk from the silicone, but that people should be able to be assessed, monitored, and informed about their options, and that removal is appropriate in certain circumstances (such as if there are signs or evidence of rupture, or if the person, after being informed, wishes to have them removed and this is agreed as appropriate). Being aware of the signs of a possible rupture is important — such as a change in the shape or feel of the breast, new lumps or swelling, pain, tenderness, or redness — and seeking assessment if these occur. Assessment may include examination and imaging (such as ultrasound or MRI) to check the implants, particularly if rupture is suspected. Where an implant has ruptured, or where removal is decided upon, the options (removal, with or without replacement) are discussed and arranged, and provisions were made regarding this in certain situations (for example, arrangements for removal for those who had them on the NHS, and guidance for private patients). Support and clear information help people make informed decisions. The reassuring context is that expert reviews concluded there was no evidence that the PIP silicone caused a significant toxic effect or a cancer link, so the main issue is the higher rupture rate and the local effects of rupture, rather than a proven serious systemic danger — while the use of unapproved material was clearly unacceptable, and affected people are supported with information, monitoring, and options. The key messages are that people with or possibly with PIP implants should find out their implant type, be aware of the signs of rupture and seek assessment if these occur, and be informed about monitoring and their options including removal — with the reassurance that no serious toxic or cancer risk from the silicone was found.