Twenty Spanish women with soya oil breast implants are to sue the UK based manufacturer, AEI, and its Barcelona based importer, Colagen Biomédica, after being advised that they should have the prostheses removed.
The women will sue the companies through the Spanish Association of Victims of Health Errors (Avinesa), which is providing them with legal aid. Maria Antonia Moral, the association's president, said that the company's offer to pay for the surgical removal of the implants did not go far enough and that patients should be compensated. The Spanish Ministry of Health and the Spanish Society of Plastic Surgeons (SECPRE) jointly issued a protocol governing the removal the Trilucent implants.
The authorities have decided that women who have had local complications such as swelling or redness and those who want to get pregnant must have priority over the rest. Dr César Casado, the president of SECPRE, said that women who have the implants will be recalled to the centre that carried out the original surgery. SECPRE has also confirmed that AEI, based in Caversham, will pay for the costs of the removal procedure.
Trilucent breast implants were designed to make mammographic explorations more reliable as soya bean oil is translucent. The implants, first licensed in 1995 in Germany, have since become widely used throughout Europe. Over 9000 have been implanted into almost 5000 women in the United Kingdom since 1995. In Spain over 1800 prostheses have been implanted into 916 women. An estimated 11 000 women in the European Union have received Trilucent implants.
Medical specialists first became aware of possible problems when women complained of breast swelling. In March 1999 the UK Medical Devices Agency and LipoMatrix/Collagen Aesthetics—former suppliers of Trilucent—voluntarily withdrew the implant from use. The decision to withdraw it was taken after 74 adverse events, including 22 cases of local swelling, were reported to the Medical Devices Agency. Such swelling, usually associated with implant rupture, is “believed to resolve once the ruptured implant has been removed,” said the agency, but “on the precautionary principle we consider that no more of these particular devices should be implanted.”
The UK Department of Health said that the decision had been taken because “not enough is currently known about the long term safety and rate of breakdown of the soya bean oil in the filling and its possible effects on the body,” but that women who have had this type of implant need take no immediate action “unless they experience unusual symptoms.”
In May 2000 the Medical Devices Agency convened an advisory group (consisting of toxicologists, plastic surgeons, and a lay representative) to consider new safety data on Trilucent implants.
It considered the available evidence, assessed the likely risks to patients, and reported to the agency. The agency issued a hazard notice on 6 June informing all UK hospitals that all women with Trilucent breast implants should be identified and advised to consider having their Trilucent breast implants removed. The notice was also sent to other European healthcare regulatory bodies.
The advisory group concluded that there was an explicit risk from the potential release of genotoxic products (alde-hydes) as a result of the ongoing “bleed” and the possible rupture. Although there was insufficient evidence to establish an increased risk of cancer or reproductive toxicity, these possible risks could not be excluded. The group advised that all women with these implants should be informed that removal of Trilucent breast implants was recommended.