New Soya Bean Oil Breast Implant Recommendation

The Ministry of Health is recommending women with Trilucent breast implants discuss with their plastic surgeons having them removed, following new information on possible side effects.

The recommendation follows a risk assessment by Britain's Medical Devices Agency on the potential health side effects. There is a risk that if the contents of the implant leaked and broke down they would form toxic substances harmful to unborn or breastfed babies. The implants are filled with soya bean oil.

Chief Advisor of Safety and Regulation Dr Bob Boyd said the Ministry contacted the four surgeons who implanted this type of prosthesis in New Zealand from 1997 until they were withdrawn from the market in March 1999. Thirty-seven women in New Zealand are believed to have the Trilucent implants, which are filled with soya bean oil.

The Ministry today forwarded the four plastic surgeons the British report and recommended that they contact as many of the women as they could and inform them of the new information.

"We believe this new information is significant enough that women should discuss it and their options with the doctors," Dr Boyd said.

"However it is also important to stress that this recommendation is precautionary because although there have been reports of breast swelling and discomfort in women with this type of implant, there has been no clinical evidence of any serious health problem."

Dr Boyd said while women had the implants in place they should take precautions against becoming pregnant and should not breastfeed.

The Ministry will contact surgeons in a fortnight to follow up on what actions they have taken. In the meantime it is encouraging the Australian based company acting as the product's agent, Collagen Aesthetics Australia, to establish a freephone number for inquiries, Dr Boyd said.

Background Information

Soya bean oil breast implants were performed in New Zealand from 1997 to March 1999, when Australian company Collagen Aesthetics Australia voluntarily withdrew the product following consultation with the Ministry. This followed Britain's Medical Devices Agency raising concerns as to their long term safety. At that time there was no information to support the removal of existing implants.

The agency then carried out further toxicological testing which suggested genotoxic products may be created if the implant ruptured and the soya bean oil broke down in the body. The broken down substance could harm newborn babies or infants being breastfed.

The conclusions in the latest British risk assessment were; there was evidence to suggest that the concentration of breakdown products from the implants was much higher than the concentration normally found in the body there was an explicit risk from the potential release of genotoxic products as a result of the ongoing diffusion of filler thorugh the implant shell and possible rupture to the shell although there was insufficient data to establish an increased risk of cancer or reproductive toxicity, these possible risks could not be excluded all women with these implants should be informed that removal of the implants is recommended because of these risks there was not data on whether or not is it safe to implant other breast implants subsequent to the removal of Trilucent implants

The Ministry will be informed if any further information becomes available from the British agency, and will pass this to surgeons for their patients' information.

For further information please contact; Sue McCabe, Media Advisor, 04 496 2067 or 025 495 989 Internet Address; http://www.moh.govt.nz/media.html

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