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The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published the final version of its updated opinion - external site on the safety of PIP silicone gel filled breast implants.
The opinion remains consistent with the TGA's position on PIP implants.
The TGA published key points from the preliminary draft of SCENIHR's opinion on 30 October 2013. The text below has been updated to reflect the final version.
The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published an updated opinion - external site on the safety of PIP silicone gel filled breast implants.
In the update, the SCENIHR states:
- There is currently no convincing medical, toxicological or other data to justify removal of intact PIP implants. Implant removal in the absence of malfunction may be considered for women who are experiencing significant anxiety because they have a PIP breast implant. However, the decision to remove an intact PIP implant for this reason should be based on an individual assessment of the woman's condition by her surgeon or other treating physician after consultation.
- PIP silicone gel filled breast implants are reported to have a higher prevalence and incidence of implant ruptures than other silicone breast implants, and that ruptures also tend to occur earlier in the implant life than is the case with other implants. These reports indicate that the shell/patch or the manufacturing process for a number of batches of PIP implants was of inferior quality, which may be a reflection of variations in the manufacturing process. The risk of implant rupture increases with implantation time. Quantifying the actual increase in failure rate is problematic because the failure rates of non-PIP implants are not well documented.
- The purpose of this opinion is to update the previous SCENIHR opinion on PIP breast implants in February 2012. In the previous opinion the effects of both released polymeric and unpolymerised silones in general were considered. Since then several cyclic siloxanes (known as D4, D5 and D6) have been identified in PIP devices at higher concentrations than in other silicone breast implants. This has led to investigations into the possible toxicological consequences of their release from damaged PIP implants. It has become apparent that these chemicals are commonly present in the bodies of women even without breast implants. This is a consequence of the widespread use of siloxanes in many domestic products. Cyclic siloxanes D4, D5 and D6 are non-toxic and not irritant in standard tests.
- In some cases implant gel-bleed or rupture has been associated with an inflammatory reaction either locally or in regional lymph nodes. In other cases, ruptures were free of symptoms. Neither implant rupture, nor local inflammation, has been found to be associated with breast cancer or anaplastic large cell lymphoma. While there are differences in rupture rates there is no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured silicone breast implant from another manufacturer.
- In the case of implant rupture, explantation is strongly advised. Because of the widespread concern of undetected ruptures, there is a need for women with PIP breast implants to seek regular clinical examinations and, where deemed appropriate, individual counselling and imaging with ultrasonography or MRI.
The TGA has conducted a detailed investigation into PIP silicone gel breast implants. This investigation included extensive research, laboratory testing and collaboration with international regulators. Details of the TGA's investigations and advice regarding PIP implants can be found at: Poly Implant Prothese (PIP) breast implants. Since the last update on 11 February 2013, the TGA has received a further 54 reports of confirmed ruptures and 1 report of unconfirmed ruptures. A breakdown of all reports received is below.
| Reporter | Confirmed ruptures1 | Unconfirmed ruptures2 |
|---|---|---|
| Surgeons | 386 | 13 |
| Patients | 120 | 12 |
| Supplier | 24 | - |
| All reporters | 530 | 25 |
1 The TGA categorises ruptures as 'confirmed' if there is sufficient information to uniquely identify:
- the patient
- the implant used
- that an X-Ray or other diagnostic image showed that the device was ruptured; or the implant was found to be ruptured when it was removed.
2 The TGA has sought further information but as yet has not received sufficient information to uniquely identify the rupture.
The SCENIHR report is a comprehensive survey of investigations carried out around the globe on PIP breast implants. The SCENIHR report recommendations for women with PIP silicone gel breast implants agree with those made by the TGA, and the report does not identify any matter that requires further investigation by the TGA. However, the TGA will continue to monitor the situation regarding PIP silicone breast implants and will take any action deemed necessary to ensure Australian women receive the most up to date advice.
