Experts writing in the Journal of the Royal Society of Medicine disagree with the conclusion that PIP breast implants do not show any evidence of significant risk to human health. This was the decision reported in June 2012 by the panel appointed to investigate the PIP breast implant scandal chaired by NHS medical director Sir Bruce Keogh.
Disputing this, the authors point to evidence showing that the PIP implants were found to contain a higher proportion of a group of small-sized molecules than the norm, including one referred to as D4, which has been identified as an endocrine disrupting chemical (EDC). In low doses, EDCs are known to cause damage to a developing foetus.
Co-author Andre Menache, Director of consumer protection organisation, Antidote Europe, said: ‘Considering these known risks and the fact that most women receiving breast implants were of reproductive age, we would expect the MHRA and the [UK] Department of Health to fulfil its duty of care and thoroughly investigate these risks as well as provide full information to patients.’
The authors raise a number of other concerns, including that the report bases much of its evidence on animal data rather than readily available human-based methodologies. ‘This is surprising given the current level of knowledge of the human genome,’ says Menache.
‘Furthermore, the report is inconsistent with its reliance upon animal-based data, accepting some results while dismissing others without providing human-based support tests as back up.’
The authors also raise concerns about the make-up of the expert panel, which contained just one toxicologist. ‘A panel appointed to investigate a scandal of this nature is expected to contain more than one toxicologist,’ says Menache.
Menache concludes: ‘Based upon the evidence presented here we feel that the PIP breast implant scare is an example of regulatory and quality control failure that urgently requires addressing.’