As the above suggests, such breast implants were filled with various organic oils. The hope was that, as in the case of saline, organic oils would be absorbed in the case of a leak without setting up an inflammatory reaction, in the case of implant rupture. Safety data lacking, along with reports of local inflammatory effects on rupture, the implant was taken off the UK market. Further information from the British MHRA (Equivalent of FDA, except for the food part), can be studied below.
Trilucent breast implants
These implants were removed from the market in 1999, and in 2000 the Medical Devices Agency (now MHRA) recommended that these implants should be explanted.
The Trilucent™ Care Centre (TCC), which was set up for patients with these implants, closed on December 31 2004. AIE Inc has taken over the functions carried out by the TCC.
A clinical research programme was sponsored by AIE Inc and was carried out by an independent panel of experts to investigate the long-term health effects of Trilucent™ implants. This was completed in 2004. The full report concluded that there is no evidence for local or systemic disease risk once the implants have been removed.
MHRA issued a device alert (MDA/2004/047) in September 2004 to notify interested parties of the conclusions of this study and the closure of the TCC.
Trilucent™ breast implants were available for sale throughout the EU between 1995 and March 1999. They consisted of a silicone elastomer shell with a lipid filler based on soyabean oil. Since they were first marketed in 1995 over 9,000 implants were sold in the UK, and implanted into almost 5,000 women.
As a result of an investigation into reports of inflammation associated with rupture of Trilucent™ breast implants, MDA reviewed the manufacturer’s safety assessment. This revealed serious concerns relating to the long term safety of Trilucent™ breast implants, in particular in relation to the breakdown of the lipid filler. As a result of MDA’s concerns the company voluntarily withdrew the product from the market in March 1999 and MDA issued an Advice Notice AN 1999(01). The withdrawal was a precautionary measure until further information could be gathered about the biological safety and clinical experience with these implants. The advice given at that time was that there was no evidence to suggest that removal of Trilucent™ breast implants was indicated but that women should be advised to seek an immediate consultation if they noticed unusual breast swelling or inflammation associated with their Trilucent™ breast implants.
In AN 1999(01) clinicians were advised not to use MRI (magnetic resonance imaging) on women implanted with Trilucent™ breast implants, because of concerns about heating up of the transponder (a device contained within the implant to provide identification information electronically). In the light of subsequent enquiries on the value of MRI for detecting implant rupture, this advice was modified. Clinicians have since been advised to use MRI with caution on women implanted with Trilucent™ breast implants.
The first results of further analytical studies on the filling material in Trilucent™ breast implants became available in May 2000. MDA convened a group of independent experts (the Trilucent™ Advisory Group) to consider the available scientific evidence. This Group made an assessment of the risk to women with these implants and provided advice to MDA. A statement summarising the Trilucent™ Advisory Group’s conclusions and advice is available, with the minutes of a meeting held on 19 May 2000 . Based on this advice, MDA issued a Hazard Notice (HN 2000(05)).
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 was completed in 2004. The panel 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. This information was the subject of MHRA Medical Device Alert MDA/2004/047.
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, MHRA will issue advice.
Safety information published by MHRA relating to Trilucent™ breast implants:
AN1999(01) – Trilucent breast implants: Voluntary recall
Voluntary recall of Trilucent breast implants
HN 2000(05) – Trilucent™ breast implants: recommendation to remove
Recommendation to explant Trilucent™ breast implants
MDA/2004/047 – Trilucent (soya bean oil filled) breast implants
Conclusions of clinical research programme and closure of TCC