Fresh calls for regulatory reform as PiP implants are confirmed as 'substandard'

Government review reveals low-grade silicon implants are twice as likely to rupture

Thousands of women are now being urged to see their GP after an expert group confirmed the PiP breast implants at the centre of the recent scandal are substandard

Confirmation this week from an expert group that the breast implants at the centre of the PiP scandal are substandard and twice as likely to rupture as other brands has led to renewed calls for improvements to the regulatory process in the UK and Europe.

The comments come following the publication of the final report by the NHS Medical Director’s expert group, which has looked into the PiP implants that were found to contain non medical-grade silicon.

We have found that these implants are substandard when compared to other implants and that they are more likely to rupture

Led by Professor Sir Bruce Keogh, the findings reveal that, while the industrial-grade gel used is not of the standard required for medical products, it is not toxic or carcinogenic and would not cause a long-term threat to human health.

However, clinical tests of 240,000 implants of different makes used throughout England did reveal that PiP implants have a higher rupture rate, around two times higher than other brands. It found the rate to be around 6-12% after five years and 15-30% after 10 years, compared to 10-14% after 10 years for other brands.

The study ruled that, although the contents of the silicon are not harmful and the gel has not been shown to contain any toxic substances, the inferior mechanical strength of the implants makes them ‘substandard’. It added that, in cases where the implants have ruptured, it has been found to cause localised reactions in a small proportion of women, resulting in tenderness or swollen lymph glands. However, there is no evidence it causes any significant health conditions.

The expert group is now advising women who have had PiP implants to speak to their surgeon, adding that the NHS will support those who want their implants removed. Sir Bruce is also writing to medical directors to address the issue of private providers refusing to offer treatment.

New surgical devices, and the techniques required to implant them, must be regulated so that they can be safely introduced into our healthcare system, disseminated appropriately and monitored in the long-term

He said: “This has been an incredibly worrying time for women and we have been determined to look thoroughly at all available evidence so we are able to give them the best clinical advice possible.

“Repeated tests on different batches of PiP implants have been carried out in the UK, France and Australia according to international standards. Those tests have shown that the implants are not toxic and therefore we do not believe they are a threat to the long-term health of women.

“We have, however, found that these implants are substandard when compared to other implants and that they are more likely to rupture. We would therefore advise that women who have symptoms of a rupture – for example tenderness, soreness or lumpiness – should speak to their surgeon or GP. I would ask all GPs to refer any patient who has concerns about their PiP implants to a specialist.”

The report is expected to have a massive impact on the NHS as women take up the offer of having their implants removed. So far 7,098 women who had their PiP implants put in privately have been referred to a specialist on the NHS, 4,349 scans have been undertaken, and 490 women have decided to have their implants removed on the NHS.

The PiP breast implant issue brought into sharp focus the need for better regulation and surveillance for all surgical implants

The publication of the report has also led to calls for widespread improvements to the regulatory process for medical implants. This comes after it was revealed the manufacturers of PiP implants, Poly Implant Prothese, were found to have changed the type of silicon they used in their implants from that originally given CE Mark approval.

Speaking this week, Professor Norman Williams, president of The Royal College of Surgeons, said: “The PiP breast implant issue brought into sharp focus the need for better regulation and surveillance for all surgical implants. With the publication of the final report by the expert group, it is time to look to the future to ensure no patient experiences unnecessary harm or distress from substandard surgical implants.

“It is the view of the college that we should, as a minimum, have mandatory databases for all surgical implants and associated techniques that would provide ongoing patient safety data. New surgical devices, and the techniques required to implant them, must be regulated so that they can be safely introduced into our healthcare system, disseminated appropriately and monitored in the long-term.”

The college is now drawing up a set of professional standards for cosmetic surgery and will contribute to the Government’s review of the regulation of the cosmetic surgery industry when it begins.

“We are committed to working with the Government to ensure a robust, open and transparent regulatory system is in place,” said Professor Williams.

Despite rigorous testing showing no long-term danger to human health from the individual chemicals in the gel, the fact remains that PiPs are significantly more likely to rupture and leak and, therefore, cause physical reactions in an unacceptable proportion of the patients

And Fazel Fatah, a consultant plastic surgeon and president of the British Association of Aesthetic Plastic Surgeons (BAAPS), who participated in the expert group, said all women who want their implants removed should be given treatment, regardless of rupture.

He told BBH : “Despite rigorous testing showing no long-term danger to human health from the individual chemicals in the gel, the fact remains that PiPs are significantly more likely to rupture and leak and, therefore, cause physical reactions in an unacceptable proportion of the patients.

“We agree with the report findings that anxiety itself is a form of health risk and thus it is entirely reasonable for women to have the right to opt for removal, regardless of whether there has been rupture. Available data shows that should intact implants be left in the body there is still a 15-30% chance that patients may need removal or replacement surgery at some stage. That ‘silent’ ruptures do not manifest in outward symptoms will in all likelihood not reassure many of those affected, so we welcome the decision that any and all women should be given the option to discuss their individual needs and should be fully supported by their provider whatever their choice, removal or monitoring.”

He also welcomed the report conclusion that all providers who implanted PiPs have a responsibility to pro-actively share with their patients objective and up-to-date information about the risks to their health so they can make fully informed decisions on the removal of their implants.

A statement from the UK medical devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) states: "Updated information suggests that there is no guarantee that PIP silicone gel breast implants manufactured prior to 2001 contained the approved filler. Therefore, all women implanted with PIP silicone gel breast implants should be supported and managed in line with the Department of Health’s recommendations."

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