I never use PIP implant made by a French company.
Twelve years ago when I was studying with my teacher, Professor Mutuz Habal, in Tampa, Florida, I met a sale representative selling PIP implants. Without a known reason, my instinct told me something was not right about the product from this company. I felt this kind of implant that is composed of shell and content must only be from company you can trust. The shell is prone to break and the content is ready to leak at any time. This company was too new, I told myself.Around 5 years later in Bangkok, I met another sale representative who tried to introduce the PIP implant, but this time from a newly established local distributor.I told her I could not use this product because it was too new without enough scientific data for its safety.
It was a different story for other plastic surgeons. The product was sold at almost 50% cheaper than Mentor and McGhan which are the two most famous in the world market. It was very well welcomed by many surgeons, including my colleaques and those hospitals which advertise a lot to get cosmetic patients.
Now in 2011 and 2012, PIP implant has become very famous in the international media but not for its success. The product is banned in several countries, especially in Europe since April 2010. The French government alerted everyone and recommended immediate implant removal.
I would like to share with everyone the latest annoucement on Feb 1, 2012 from the European side called Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR).
It is conclusive that many of the PIP implants are made of industrial grade silicone of lower quality than medical grade silicone. Chance of gel leakage is much higher than other brands. To date, few studies aimed at evaluating the toxicity of the contents of PIP silicone breast implants have been conducted. However, an in vivo test for irritancy was positive. This indicates the potential for inducing local irritancy (which may manifest as sore and/or enlarged local lymph nodes or sensation in the breast) when the silicone gel is released from the implant.
It is important to note that clinical breast examinations alone have little sensitivity for detecting implant rupture. If there are clinical signs of adverse effects, then a diagnostic work-up is mandatory.
There are cases reported suggesting that PIP silicone breast implants may have a higher failure rate in the first few years after implantation compared with those from other breast implant manufacturers. There are also a few case reports that ruptured PIP silicone breast implants may be associated with a higher incidence of swollen and painful lymph nodes in the axilla, the groin, the neck and the mediastinum.Further work is still necessary to establish with greater certainty the health risks, if any, that may be associated with PIP silicone breast implants.
Now I am reassured that my policy is right. I have been very conservative with drugs, medical products and implants. I will not consider to use any products used in human for less than 10 years in my patients.
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