Breast implants manufactured by PIP should be removed as a preventative measure (recommendation) - Swedish Medical Products Agency

Breast implants manufactured by PIP should be removed as a preventative measure (recommendation)

The Medical Products Agency and the National Board of Health and Welfare change the previous recommendation regarding silicone breast implants manufactured by Poly Implant Prothèse (PIP) as a result of the changed state of knowledge.

The Medical Products Agency and the National Board of Health and Welfare recommend:

  • Clinics that have implanted PIP implants should contact the women concerned to inform them about the state of knowledge and about the risks of keeping the PIP implants in relation to the risks of undergoing an operation to remove the PIP implants.
     
  • Clinics that have implanted PIP implants should remove them. This should be done as a preventative measure even in cases where there are no indications of problems. In individual cases, there may, with reference to the patient's current health situation, be medical reasons to refrain from removing the PIP implants.
     
  • Clinics that have implanted PIP implants should make any women who choose not to have their PIP implants removed aware of the signs of rupture or of the symptoms of inflammation in the breast area, and, if these occur, it is recommended that they consult a doctor and also that they have the PIP implants removed. The signs of rupture or inflammation could be changes in the shape of the breast, lumps, pain, swelling, swollen lymph nodes etc. in or around the breast and armpit.
     

Justification

According to the earlier recommendations (01/11/2010), the risk of replacing a PIP implant was judged, in most cases, to be greater than the risk of keeping an implant that was not causing problems.

These changes to the recommendations are based on an analysis of the new studies of PIP implants which have been conducted in Sweden and abroad. PIP implants have been shown to have a coating which has poor durability. This increases the risk of rupture when compared with other brands of silicone breast implant. Therefore, the risk is large that many women will, sooner or later, require removal of their PIP implants.

The Medical Product Agency's investigation has shown that there are two types of PIP implant, manufactured from different types of silicone. One type of silicone contains a substance octamethylcyclotetrasiloxane (D4) which is irritant to tissues. This is present in such quantity that it may constitute a risk of serious inflammation in surrounding tissues.

In a small group of women, in which removed PIP implants belonged to the type with a higher D4 content, there were signs of tissue inflammation in about one third of cases. Signs of tissue inflammation have also been observed in connection with non-ruptured PIP implants, which were removed without the women having displayed any outward signs of inflammation or other symptoms.

Silicone may leak from the breast implant because of either rupture or by passing through the coating. This can lead to silicone accumulating in, for example, the lymph nodes. The examination of a number of removed PIP implants with large ruptures shows that the silicone gel within the coating has changed its character and sticks together less well, which may further increase the risk that the silicone disperse in the tissues. A clinical investigation, MRI scan or ultrasound scan cannot definitively exclude ruptured breast implant. A leak of D4 from the PIP implant into the surrounding tissues cannot be excluded as the cause of local inflammation. The possible long-term effects of chronic inflammation caused by silicone containing D4 cannot be determined, as there is a lack of knowledge. The group of women who have PIP implants are relatively young and may be expected to carry their breast implants for a very long time. The recommendations are based on the precautionary principle.

It is not possible to know with certainty which PIP implants contain one or the other type of silicone, as the manufacturer lacked a satisfactory traceability system. Therefore, the recommendations apply to all women with PIP implants.

The doctor responsible will, in each case, need to weigh up the risks associated with the PIP implants, described above, with the risks of an operation. This general assessment is based on the intervention involving a short operation, under local anaesthetic when removing an intact PIP implant, or under general anaesthetic when removing a ruptured PIP implant or replacing one with a new breast implant, in those women who have been judged to belong to a low risk group (ASA 1-2, a classification of health for the assessment of the general anaesthetic risk). As a result, the risks of removing PIP implants are judged to be very limited. Furthermore, the assessment takes into account that there is a tangible risk that many women will, within the foreseeable future, be required to undergo an operation as a result of the poor quality of the coating on the PIP implants that leads to ruptures. An operation that takes place following a rupture is more complicated and time-consuming, involving greater risks. Thus, there is no benefit in waiting until a PIP implant has ruptured before removing it. The exception is those women who, for various reasons, have developed conditions which increase the risk of an operative intervention.

In summary, a controlled, preventative removal of PIP implants involves a lower risk than removing them once they have ruptured or after inflammation and/or swollen lymph nodes have developed.

Impact assessment

A total of about 4000 women have received PIP implants in Sweden. There is no information about how many of them have, so far, had the PIP implants removed.

 


 

 
 

References

 Compilation of reports from aesthetic plastic surgery clinics

 Chemical analyses performed at MPA

 Toxicological evaluation PIP-implants

 Technical report 

ANSM reports

 Les prothèses mammaires implantables PIP - État des lieux (april 2013) 

 Situation update of the controls regarding the Poly Implant Prothèse company performed by the health authorities (oktober 2012)

 Situation update on checking procedures performed by the health authorities on the Poly Implant Prothèse Company (oktober 2012) (This link is not available)

   
 

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