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24
NOV
2015

Silimed: Particles and Polymers – Professor J D Frame, Dr M Olivan

The recent release of censured but commercially sensitive information on particle surface contamination of silicone implants via the Silimed information centre , the MHRA (Medicines and Healthcare Regulatory Agency), the International Association of Aesthetic Plastic Surgeons (ISAPS) and inevitably the press, has led to a catastrophic withdrawal of all Silimed implants from the EU market. The Australian and New Zealand Regulatory Authorities followed suit very rapidly. Interestingly the American Association of Plastic Surgeons (ASPS) have considered the claims of particle contamination as being irrelevant and within acceptable limits caused during the manufacturing process and of no relevance to patient safety. The Brazilian Plastic Surgery Society has made a statement that patients are not at risk but Silimed are working hard to satisfy the Brazilian Regulators before releasing implantable products back onto the market.
Gleaning the evidence and argument for the suspension of all implantable devices made by Silimed has been very difficult and embarrassing for trainer Surgeons that have been advising less experienced Surgeons to use Polyurethane Breast implants for patient safety reasons. It becomes somewhat awkward. In the United Kingdom the BAPRAS initial , but we would suggest premature advice, was to inform and thence potentially panic all implanted patients, including those with calf and chin implants, who continue with perfectly good outcomes over the past 10 years.
Information supplied in small snippets, appears to suggest that all implants made by Silimed may be affected by the presence of non- dangerous surface particles because all the range of implants have been preventively withdrawn, despite EU certification as recently as 2014. There is every reason to believe that all manufactured devices including cardiac pacemakers and urological stents, from whatever supplier, have particles on their surface. Why then should the Polyurethane range of Silimed implants be taken off the market when peer reviewed published evidence demonstrates the clear benefit to patients from having polyurethane implants as opposed to textured or smooth silicone implants (1-5).
Why this event has suddenly and unexpectedly happened gives rise to frequent and varied conspiracy theories. In the mix is the thought that the TUV- SUD ( German CE marking authority) were concerned about previous debacles, such as occurred with the fraudulently manufactured PIP implant .
As of now the particles found are only cotton and silica – big deal! All surgical wounds are impregnated with more cotton from one swab during a bloody operation, than a non- visible particle on an implant- and are cotton swabs banned? The other particle is Silica but Silica has been used in medicine for Centuries and in fact is still used to augment noses and in other reconstructions, for example in the disguise of pectus excavatum , chin augmentation , joint replacement and heart valves. It is the raw ingredient of silicone, so of course it must be present.
This whole situation is unnecessary and alarmist and must be urgently resolved. Denying patients the chance to have implants known to have least risk compared to its alternatives seems wholly inappropriate and dangerous for the long term. We should also try to prevent these knee jerk reactions with publishing of incomplete and alarmist information. The FDA Silicone Moratorium in the USA in 1992 was born out of the media frenzy around silicone implants and autoimmune disease. The media may eventually be judged if reporting heresay detail inaccurately or associating perfectly legal products with banned illegal products without foundation. It can destroy decades spent building an International brand and reputation, together with indeterminable and irretrievable losses to associated business, distributors, professionals and Plastic Surgeons.

References
1. Frame JD, Kamel D, Olivan M, Cintra H. The In Vivo Pericapsular Tissue Response to Modern Polyurethane Breast Implants. Aesthet Plast Surg (2015): 39: 713-723.
2. Frame JD, Connolly C. Framing The Breast. Aesthet Surg J. 2015; 35:106-12.
3. Rupani A, Kamel D, Frame JD. Lymphomas Associated with Breast Implants: A Review of the Literature. Aesthet Surg J. (2015); 35: 533-544.
4. Frame JD. Commentary on: Breast Implants and the Risk of Breast Cancer: A Meta-Analysis on Cohort Studies. Aesthet Surg J. (2015) 35: 63-65.
5. Georgeu G, Frame JD (Jnr), Frame JD. Conical polyurethane implants: an uplifting augmentation. Aesthet Surg J. (2013); 33:1116-28.

Yours Sincerely
Professor James Frame, FRCS(Plast),
Consultant Plastic Surgeon,
President of UK Association of Plastic Surgeons (UKAAPS)
Anglia Ruskin University,
Essex , UK .

Dr Marcelo Olivan, MD, PhD
Consultant Plastic Surgeon
University of Sao Paulo,
Sao Paulo,
Brazil.

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