So Pandora’s box was finally opened. The eventual worldwide recall of French Polyimplant Prothese (PIP) silicone breast implants puts a final exclamation mark behind what everybody knows but hates to admit – cheap is bad, to be cheap you have to cut corners to cut costs and cutting corners – such as using industrial instead of medical grade silicone (besides other substandard manufacturing practices such as inferior easily ruptured shells) – costs in the end. An estimated 300000 women were implanted PIP silicone implants, mainly in countries with low level of medical care and deficient in plastic surgery training and acumen, such as Venezuela, Belgium, Poland, Czecheslovakia etc. It doesn’t stop in third world and quasi third world countries. UK surgeons allegedly succumbed about 40000 times to the same error, French surgeons around 30000 times and Australians, Austrians and Germans line up right behind to match the price of their competitors down the road or across the border.
Like a knee jerk reaction comes the desire to blame somebody after the company PIP is not any longer available to take the fall having gone to bankruptcy heaven months ago. What I am going to say now will not be popular, like any truth. No single entity is to blame, it is everybody’s and thus nobody’s fault.
Regulatory oversight according to European Community standards over the manufacturing of a high risk medical device failed miserably. Nobody noticed for years that this crap did not conform any longer to the CE specifications and European Medical Device Directive ? Give me a break. Want to sue somebody over PIP implants – these are the people to start with wanting the company itself as a primary culprit. Without the CE label the device could not have been used legally in the European Community and close to 100000 women would likely have been spared the fate to agonize over the decision what to do now.
Blame the surgeons – always popular, and at least in this case partially correct. Any surgeon naive enough to make him or herself believe there is no difference between an implant costing around 200 USD per pair and one costing around 1500 USD/pair should voluntarily stop practicing because this degree of stupidity might affect all decisions he or she makes. But according to the CE label the 200 USD/pair joke was at least harmless, as this is what the CE label essentially means. It signifies safety, not much more, particularly does not imply any effectiveness. So in the mind of the naive a safe device was used, no less.
Now very unpopular – the consumer may have some responsibility for his/her decisions. You get what you pay for, literally, that is the essence of consumerism. Cosmetic surgery is a luxury good and it has the price tag of a luxury good. Anything cheaper means corners have to be cut. Properly trained plastic surgeon, experienced, certified by a reputable specialty board (no, not the one in Santa Somewhere), with enough training, experience and judgment to know the difference between a good and a cheap implant, high end implants and equipment, respected hospital, first class anesthesiologist – all are on the same level as German luxury cars. And those don’t come at a price of some bamboo cart held together by dried spit, just ask your local dealer. So no, the consumer was not cheated, consumers did what they do best, consume based on the number on the price tag of the good they desire, short sighted to what that number actually means. Consumers, who do not look beyond that number, will always get what they pay for, particularly in cosmetic surgery.
So what now – after all PIP implants may result in health related problems ?
If there is any clinical evidence of device failure, explantation or exchange are the only two options, like for any ruptured silicone implant regardless of the manufacturer. In my opinion explantation is aesthetically unfavorable, but the desire of the client should certainly take precedence. Without clinical evidence of device failure a more difficult situation arises. The options are watchful waiting, watchful waiting with imaging surveillance to screen for silent rupture (as mandated by the FDA for Allergan/Mentor silicone implants in the US) or prophylactic exchange/explantation of any and all PIP silicone breast implants. The speculation of French health authorities that breast cancer risk in women with PIP implants may be increased contradicts all biologic knowledge about silicone, is not substantiated by their data at the present moment and may not be a valid argument for prophylactic exchange/explantation at this time.
When data is lacking, opinion is abundant – so here are my five cents: a woman having PIP implants obviously has a substandard device implanted, which will likely have to be exchanged or explanted at some time, even in the absence of clinically evident rupture at present. If the personal health related concerns of the woman are high enough I would advise exchange of implants for a high end device such as Polytech, Silimed, Mentor or Allergan. Explantation alone should be performed if the client is clear about the aesthetic consequences and absolutely does not desire implants any more.