According to a release from the UK’s MHRA, its Swedish equivalent has adopted the position that PI implants should be removed as a precautionary measure. The MHRA has issued its own statement reasserting its position that this is not necessary in all cases.
Background
Sweden’s Medical Products Agency and the National Board of Health and Welfare in Sweden have published a report recommending the removal of PIP breast implants from patients as a precautionary measure. In response the Department for Health has issued its own statement as follows:
“Our independent expert group – chaired by the NHS Medical Director Professor Sir Bruce Keogh – looked in detail at worldwide toxicological studies last year and found that the silicone contained in PIP breast implants does not pose a long-term risk to human health.
“The UK experts looked at siloxanes – silicone derivatives which are widely used in consumer products such as hair and skin products – and were satisfied that, at the very small concentrations found in PIP implants, these compounds pose no significant risk to health.
“The UK regulator, the MHRA, keeps all evidence under review and will speak to the Swedish health authorities to explore the basis for their advice.
“In the meantime, the advice from our experts still stands – anyone who is concerned or has side effects such as soreness, lumpiness or anxiety, should speak to their surgeon or GP. We expect private clinics to care for their patients but, if they refuse, the NHS will look after them.”
The Swedish agency’s guidance can be found here.
What’s sure to happen now is that this will stoke up pressure from UK implantee groups for the government to review its position. In the absence of any new information that’s unlikely to happen.
Source: MHRA
published: June 5, 2013 in: Alerts/Adverse Events, Plastic/Reconstructive