One of the biggest news in the plastic surgery community in the past months has been the association of silicone breast implants with a rare form of cancer in France. The company named Poly Implant Prothesis manufactures the PIP implants. These implants were filled with industrial grade silicone instead of medical grade silicone among other additives that are routinely use to make mattresses.
This composition has resulted in a higher rate of rupture implants as well as inflammatory breast reaction once the implant rupture. Now, different European institutions are currently evaluating the association with breast cancer and their results will be most likely published this year.
Although the association of breast cancer might be dismissed in the future, this situation has brought many questions related to the regulatory system in Europe and South America. This scandal exposes Europe’s weak regulation system – one that allowed PIP to operate for longer than it could have under a more rigorous regimen. Many patients seek to have a plastic surgery in other countries for various reasons. This can expose the patient to devices and products that have not had a strict regulatory regimen to make sure that these are safe to use. For example, the French medical device regulatory authority (AFSSAPS) released the results of their testing on September 29, 2010 and have confirmed there was a higher rate of rupture in PIP breast implants. Now, this was a year or more before the news became public. In their report, AFSSAPS has confirmed that the gel within the PIP implants is not the same as it is described in the manufacturer’s design guide. It was also determined that the gel does not reach the level of quality required before a silicone gel can be used in breast implants and that the gel can lead to inflammatory reactions in some women because of the irritant character of this gel secondary to additives that should have not been used.
Now, these silicone implants are very different from the FDA approved implants in the USA.
Dr. Cortés recently was interviewed by Revista Hispana and was able to discuss the current news related to the PIP implants. You can read about this interview in the following link: http://issuu.com/revistahispana/docs/revistahispana-febrero2012/1