Update on PIP implants

Cate Swannell
Med J Aust
Published online: 18 November 2013

The Therapeutic Goods Administration (TGA) says it will “continue to monitor the situation” following the release of the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) updated opinion on the safety of PIP [poly implant prothese] silicone gel-filled breast implants.

Points from the update include:

• there is currently no convincing medical, toxicological or other data to justify removal of intact PIP implants as a precautionary approach;

• PIP implants are reported to have a higher prevalence and incidence of ruptures than other silicone breast implants, and these also tend to occur earlier in the implant life;

• several cyclic siloxanes (known as D4, D5 and D6) have been identified in PIP devices at higher concentrations than in other silicone breast implants; . . . these chemicals are commonly present in women even without breast implants, as a consequence of their widespread use 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. Neither implant rupture, nor local inflammation, has been found to be associated with breast cancer or anaplastic large cell lymphoma;

• in the case of implant rupture, explantation is strongly advised . . . and there is a need for women with PIP breast implants to seek regular clinical examinations.

The TGA released a statement saying it had conducted a detailed investigation into PIP 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”, it said.

“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.”

  • Cate Swannell



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