A government review into the PIP breast implants scandal has highlighted that many “serious lessons must be learned”.
The PIP scandal involved low-grade silicone not intended for medical use being used in around 300,000 breast implants, and has triggered a government review into the cosmetic surgery industry as a whole.
In February, the British Association of Aesthetic Plastic Surgeons (Baaps) called for a complete ban on all cosmetic surgery advertising, in light of the incident; and during last month’s BBC debate on the issue consultant plastic surgeon Kevin Hancock described the cosmetic surgery industry as “almost unregulated”.
Now the government review, led by health minister Lord Howe, has established much must be learned from this scandal. In addition to the scandal itself, the review investigated the role of the Department of Health and UK regulator the MHRA.
Among the issues investigated was how well informed of the risks were the women affected.
Although the report pointed out that the fact these silicone breast implants, manufactured by French company Poly Implant Prothese (PIP), were made from industrial-grade rather than medical-grade silicon is indicative of fraud, which is something regulation on its own would struggle to prevent, more could have been done.
The report highlighted that a “higher level of proactive public communication could have been helpful” and that there should have been greater interaction with the women who’d had these implants.
In the report, Lord Howe commented that there is insufficient evidence the Department of Health or the MHRA majorly failed in their roles. However he does state that “serious lessons must be learned from this scandal”.
“The MHRA needs to look at how it gathers evidence so it is able to identify problems early. It needs to better analyse reports about higher risk medical devices. And it needs to improve the way it communicates with the public.”
Between 2003 and 2010, the MHRA sent more than 20 letters to PIP with concerns about the implants – and looking back, “this body of evidence could be seen as suggestive of a problematic manufacturer”. It was only in 2010 that PIP’s implants were banned.
The report emphasised the need for regulators in EU countries to work together more effectively to help early detection of issues and ensure the relevant measures to protect patients can then be taken.
The President of Baaps, Fazel Fatah, said: “Poor post-marketing surveillance of medical devices lies at the root of the PIP crisis. At the BAAPS we feel there needs to be significantly more stringent monitoring of all medical devices including breast implants and all cosmetic injectables, via compulsory, regular reporting of adverse effects and mystery shopping which are all part of our regulation proposals.”
Lord Howe’s review is one of two set up by the Department of Health in January, with the second being led by the NHS Medical Director Professor Sir Bruce Keogh. This review will focus on whether the cosmetic surgery industry needs tighter regulation.
Back in January, Professor Keogh confirmed there was insufficient evidence to advocate the routine removal of PIP implants. However, in the UK any woman affected who had the implants fitted on the NHS can have them removed and replaced for free.
In Wales, the NHS will also replace those of private patients, while in England and Scotland the NHS will remove the implants of private patients but not replace them.
Have you or anyone you know been affected by the PIP breast implants scandal?
[Source: BBC]
