Breast Implant Safety

by Dr. Adam Rubinstein on January 3, 2012

Recently there has been news of issues with breast implants in France. The French government has gotten involved by launching an investigation regarding problems with a particular type of silicone breast implant. These implants, manufactured by a company called Poly Implant Prothese (PIP), are now suspected of having higher than usual rupture rates. Most recently it has been learned that the silicone gel used to fill the implants was not medical grade. The former CEO of PIP has admitted that “non-standard” silicone was used in the manufacturing of PIP implants.

In October the French equivalent of the FDA shut down PIP for producing substandard implants. Since then thousands of women in France have filed complaints against the now defunct company. It is estimated that over 300,000 women worldwide have undergone breast augmentation using PIP implants. French authorities have recommended that women with PIP implants have them removed as a precaution. This has sparked responses from countries around the world ranging from recommendations that women with PIP implants be checked regularly to government sponsored programs to remove the implants at no cost to the patients.

It is important to remember that  the FDA monitors breast implants very carefully in the United States. There is perhaps no other medical device in the world that is more carefully watched than breast implants. In fact, in the year 2000 the FDA warned French authorities that the manufacturing process of PIP implants failed to meet US standards in at least eleven different ways. The US report went as far as describing the PIP implants as “adulterated”.

Breast implants used in the United States remain very safe and reliable. PIP implants have never been approved for use in the US. There should be no cause for concern about breast implants in general, though PIP implants definitely seem to be problematic. If you or someone you know has PIP implants you might want to consider having them exchanged for breast implants that are approved for use in the US. Both Allergan and Mentor brand implants are approved and are safe options. If you had breast augmentation performed in the United States you almost certainly have one of these two brands of implants and do not need to be concerned about the news coming from France.

Here is a link to a recent article about this issue:

http://www.reuters.com/article/2011/12/27/us-breast-implants-lawyer-idUSTRE7BQ0XN20111227

 

 

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