Patients requiring corrective surgery or who were deemed “untreatable” because of the damage caused by fillers were seen by 41% of those surveyed and surgeons voted the top reason for filler complications being “unqualified practitioners administering fillers incorrectly”.
Filler complication rates double in three years
Renewed calls from aesthetic bodies for regulation and reclassification.
When news of the Poly Implant Prothèse (PIP) scandal broke last year, a spotlight targeted the aesthetic industry. Both media and government were overrun with calls for tighter regulation and enquiries delved into surgical and non-surgical practices. One review in particular, carried out by NHS medical director Sir Bruce Keogh, has been deemed the ‘ideal platform’ to highlight failures within the system, particularly concerning the safety of dermal fillers.
A recent survey carried out by the British Association of Aesthetic Plastic Surgeons (BAAPS) shows that cases with filler complications seen by the association’s surgeons have doubled in the last three years. The same survey released in 2009 showed only 23% of members were seeing problems with permanent fillers; the 2012 equivalent has seen these figures rise to 49%.
In a 2012 paper published in Opthalmic Plastic & Reconstructive Surgery, surgeons at the University Hospital Coventry and Warwickshire NHS Trust reported serious migration of a permanent dermal filler in the forehead, 10 years after treatment. The female patient complained of a bluish swelling around the left brow, temple and glabella, which appeared on an MRI to be a vascular malformation.
But after further investigation, it was revealed she had received a permanent polyalkylimide filler in the glabella 10 years previously. Following surgical intervention, the gel and granulomas were removed and the patient made a good recovery. But the authors emphasised that while this is a rare occurrence, a detailed patient history is vital.
Around 69% of surgeons polled have seen problems stemming from temporary fillers—of these, 57% saw one to three patients with complications, while 12% saw between 4–6. Over a quarter of surgeons reported between one to three of these cases in the last year required surgery to correct the damage.
Commenting on the findings, BAAPS president Mr Rajiv Grover says that while many surgeons do not provide filler treatment, they are increasingly dealing with the consequences of botched procedures.
Filler treatment is currently unregulated and can be administered by anyone upon completion of a short training course. “The growing popularity of these non-surgical treatments has clearly led to complacency regarding how they are performed and by whom,” says Mr Grover. “As shocking as these figures may appear to the public, none of us in the profession are actually shocked by the results of this survey. What I would find surprising is if anyone was still able to maintain, in good conscience, that fillers should not be reclassified as medicines,” he says.
Almost all BAAPS members responded that fillers should be treated as a medicine when undergoing approval, as it is by the US Food and Drug Administration (FDA). They are currently classed as a medical device, which receives a CE mark—indicating that while the product meets the requirements of EU legislation, it does not have to undergo scientific tests.
In response to the PIP implant scandal, Sir Bruce Keogh launched an enquiry into cosmetic procedures earlier this year, which will take into account regulation and safety of products used in cosmetic procedures, as well as regulation of those who carry out procedures. In August, the review group called for evidence from the profession and public, and the review process ended in October. Conclusions are set to be published by March 2013.
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