Trilucent (soya bean oil filled) breast implants 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

Previously identified risk from Trilucent breast implants; actions following conclusion of research and update of HN2000(05).The Medical Devices Agency (now part of the Medicines and Healthcare products Regulatory Agency, MHRA) issued two notices about this devices:An Advisory Notice about the voluntary recall of (AN1999(01)This was in response to the Agency identifying concerns about the long-term safety, particularly in relation to the breakdown of the filler material.A Hazard Notice advising that removal of Trilucent breast implants is recommended (HN2000(05)This advice was issued because the preliminary results of toxicological testing indicated that the breakdown products of the soya bean oil filler material were potentially genotoxic.Approximately 4,500 women were implanted with Trilucent breast implants in the UK. As of July 2004, over 3,700 women in the UK have had their Trilucent breast implants removed.In 2000, a programme of research was initiated to investigate any potential risks to women implanted with Trilucent breast implants. This programme was directed, on behalf of AEI Inc, by a panel of independent experts. The programme has recently been completed. The results and conclusions of the research are summarised in Annex 1. A more detailed report of the research programme is available on the Trilucent website (http://www.trilucentinfo.com/) and full details of investigations and results will be published in peer reviewed journals in due course.The independent experts concluded that:the recommendation that Trilucent breast implants should be removed remains appropriate because exposure of local tissue to toxic compounds has been confirmed
there is no evidence for local or systemic disease risk once the implants have been removed
no further studies are needed to assess the potential risk of Trilucent breast implants.The results of the recently completed research programme suggest that there is no significant systemic risk from Trilucent breast implants, whether they are left in place or removed. Therefore, there is no significant risk to the fetus or children of implanted women and there is no evidence to suggest that breastfeeding should be avoided.Although the research programme has been completed, MHRA continues to record and investigate reports of adverse events associated with Trilucent breast implants. If further problems are identified, the MHRA will issue advice.
The independent panel of experts concluded that:the risk of breast implant rupture is low but the shell of Trilucent breast implants may deteriorate more quickly than that of other types of breast implant and the risk of rupture increases with length of time implanted
the filler material undergoes degradation leading to the production of genotoxic breakdown products
there is no evidence of any adverse health effects arising from genotoxic breakdown products
breakdown products were found to bind to DNA in the periprosthetic capsule, confirming exposure of local tissue to genotoxic compounds. However, exposure of mammary tissue or the rest of the body to breakdown products is unlikely and there is no evidence for systemic exposure
any breakdown products would be rapidly metabolised and removed from the body, thus eliminating the risk once the implants have been removed.In summary, the research programme confirmed that women with implants in place can be exposed to genotoxic breakdown products arising from the filler material. However, such exposure is localised to the periprosthetic capsule. There is minimal risk of exposure of breast tissue, other parts of the body, a fetus or breast-fed baby, to genotoxic compounds arising from the filler material.On the bases of these conclusions, it is clear that the recommendation that Trilucent breast implants should be removed remains appropriate. However, there is no significant systemic risk to women who were implanted with Trilucent breast implants, or to their children.