l

The content of this website is intended for healthcare professionals only

UK plastic surgeons renew call for universal PIP implant removal

Call follows decision in Sweden to act, in wake of new analysis

Caroline White

Friday, 07 June 2013

UK plastic surgeons have renewed their calls for the removal of all PIP breast implants as a preventive measure in the wake of Sweden’s announcement that it intended to act, following the emergence of potentially new safety concerns.

The Swedish Medical Products Agency and the National Board of Health and Welfare have recommended the removal of all PIP breast implants based on a "changed state of knowledge", resulting from an analysis of the chemical content of surgically removed implants rather than off-the-shelf ones.

Their document states: "The examination of a number of removed PIP implants with large ruptures shows that the silicone gel within the coating has changed its character," prompting the British Association of Aesthetic Plastic Surgeons to demand a similar analysis to take place in the UK as a matter of urgency. 

BAAPS, which represents most NHS plastic surgeons in private practice, claims the findings finally address some of the previously unexplained symptoms seen in patients with PIP implants.

“We have long been warning that a major loophole in safety regarding these defective implants relates to the lack of ‘in vivo’ testing of PIPs (that is, analysis performed on those that have been removed from the human body),” comments consultant plastic surgeon and BAAPS President, Rajiv Grover.

The Swedish analysis shows that when inside the body, the silicone doesn’t stick together as well, allowing it to disperse more easily, he explained.

“It is known that there is a subgroup of PIP implants in which the concentration of an irritant compound (known as D4) is higher than in others, but there is no way of knowing which ones are affected. This is why the Swedish government has made the decision to remove all PIPs as a preventative measure,” he said.

“The combination of higher concentrations of D4 and the changes in the silicone which happen when the implant is within the body, finally explain the issues that surgeons and patients have been seeing and experiencing around the country,” he added.

“We urge the government, who we know have collected in vivo specimens, to perform similar analyses, as a matter of urgency,” he said.

In response, the Department of Health said in a statement said that its independent expert review, chaired by NHS Medical Director, Professor Sir Bruce Keogh had been comprehensive and had found no evidence the PIP implants posed 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,” it said.

But it added that the devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) would speak to the Swedish health authorities to explore the basis for their latest 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 statement concluded.

Registered in England and Wales. Reg No. 2530185. c/o Wilmington plc, 5th Floor, 10 Whitechapel High Street, London E1 8QS. Reg No. 30158470