New Recommendations for French PIP Implants

The founder of Poly Implant Prothese (PIP) was arrested in France on January 26th. His company has been accused of filling more than 400,000 breast implants with industrial grade silicone. Industrial grade silicone is not produced for use in the human body and could potentially lead to health and implant related problems in the future. Use of this type of silicone instead of medical grade silicone, allowed this company to produce lower quality implants for a much lower price. This concept reminds me of my last blog titled “Lo Barato Sale Caro.” Unfortunately, these implants were not only used in France. Many of these implants were exported to other countries in Europe including England and Germany and more than half of the implants were sent to South America. They were subsequently used in women in Argentina, Colombia and Brazil. There is no evidence that any of these implants were ever used in the United States because they were never FDA approved.

Here is where the story gets complicated. If you assume that up to 400,000 women in 65 countries have these implants in their bodies, the question is, “What do we do now?” Should all of these implants be removed as suggested by the medical authorities in France? Or is there no evidence on which to base a recommendation for routine removal as stated by health authorities in England? In case these questions aren’t complicated enough, there is still the question of who would pay for the removal of more than 400,000 breast implants. Both France and Colombia have offered to pay for the removal if surgery is recommended by a plastic surgeon. Other countries are still undecided. It is important to understand, however, that even if a country is willing to pay for the removal of the PIP implants, they are not going to pay for new high quality implants.

So where does that leave you if you have breast implants? If your surgery was performed in the United States by a plastic surgeon certified by the American Board of Plastic Surgery, then you have little to worry about. If your surgery was performed outside of the United States in the last 12 years, then I have a few suggestions.

1. Obtain the documentation that states what type of implants you have in your body. In the United States all implants have serial numbers and all patients are given cards with the manufacturers implant information on them. If you don’t have this information, call your plastic surgeon and get it.

2. If it turns out you have PIP implants, it is time to meet with a board certified plastic surgeon. By discussing the details of your individual case, you will have the opportunity to make an informed decision on how to proceed. Your options will be to keep the implants you have, exchange the implants for FDA approved implants or remove the implants all together.

If you have additional questions about this or would like to discuss this in more detail you can always call my office to schedule a consultation.

For more information:

http://www.bbc.co.uk/news/health-16391522

http://www.bbc.co.uk/news/health-16395244

http://www.bbc.co.uk/news/world-europe-16736385

Written by Dr. Morin
Monday, January 30th, 2012