The Medical Products Agency and the National Board of Health and Welfare in Sweden published updated recommendations regarding silicone breast implants manufactured by Poly Implant Prothèse (PIP).
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.
- 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.
- 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.
- The groups of women who have PIP implants are relatively young and may be expected to carry their breast implants for a very long time.
- It is also not possible, with any certainty, to identify which type of silicone is in any woman's PIP implants.
Based on these findings, the Medical Products Agency and the National Board of Health and Welfare will recommend the followings based on the precautionary principle:
- 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.
For more information, please refer to the website of the Medical Products Agency, Sweden:
http://www.lakemedelsverket.se/english/All-news/NYHETER-2013/PIP-implants-should-be-removed-for-preventative-reasons/
Posted on 05 Jun 2013