As of March 2012, a great deal of controversy has been unroofed regarding the PIP implant and implant scandal. Back in June 2000, American medical regulators had posted warning letters on the internet instructing the French authorities to highly consider removing the French PIP implants off the market. Interestingly, the FDA in America had found that the products manufactured by Poly Implant Prosthesis (PIP) had been “adulterated.” They found that substandard silicone implants with industrial strength silicone were made by PIP, and hundreds of thousands of women were implanted with these implants since 2000. The French government in December 2001 advised 30,000 women to have those implants removed. They warned of the unusually high rupture rate with these PIP implants. They highlighted that there may have been alleged fraud with the PIP implants that were maintained on the market due to paying off “inspectors.” Most importantly, the regulation of the implants were found to have many flaws in itself, which allowed the PIP implants to operate for longer than they should have. All devices manufactured by PIP were actually prevented from entering the United States on June 22, 2000 by the FDA. This is associated with the inadequate testing and compliance of this implant manufacturer. In Europe, the CE mark or the CO and Formite Europeenee is their patenting mark which allows these implants to be produced and used in the public. Interestingly, a study found by Stanford University in 2010 showed that it takes approximately 54 months for high risk devices to get through FDA to the market, with just a couple of months to get through the European market. Subsequently, in 2009, the AFSSAPS has set for an overhaul of the PIP case which had the power to take the medical device off the market completely.
The two main problems of the PIP implants included a very thin shell, which allowed for increased risk of rupture of these silicone implants, as well as the use of industrial strength rather than medical grade silicone. The PIP implants were sold on the basis that they were highly cohesive silicone, but they were actually very thin, loose, viscus gel of industrial strength only. They also have been found to have porous smooth coatings which allowed for early leakage, and therefore, PIP implant patients were subject to early exposure of the unauthorized industrial strength silicone gel. According to the UK, the tests on the PIP implants were only with respect to genotoxicity and cytotoxicity rather than the implant shell integrity over time. Recently, the government has said there is no evidence to recommend routine removal of PIP breast implants, and will pay for certain patients who have had the procedures on the NHS to have them removed. As of January 6, 2012, 40,000 women in the UK have had the implants. They may have them withdrawn in France because of fear that they would rupture and leak its silicone throughout the body. France, Germany, Czech Republic, and Belgium have all advised their patients who have been fitted with them to have them removed. However, the UK government, reviewed and ordered by the House Secretary, concluded that there was no greater risk of harm from the PIP implants than silicone leak from any of the other manufacturers.
Signs of PIP breast implant ruptures have included pain, tenderness, redness, deflation of the breast, change in shape or malposition of the breast, lumpiness, selling and increased sensitivity to the breast. The specific silicone implants from Poly Implant Prothesis (PIP) were started to be manufactured in 2001. These implants did not find their way to the United States due to FDA blockage in the United States.