Please Advise on Eurosilicone Breast Implants, Are the Safe?

Question

Please advise on the safety and integrity of these particular ones. Also which ones do you consider the Rolls Royce of breast implants? Thanks

David Shafer, MD, FACS · Answer

If you have PIP implants, then they should be removed.  You may want to check with your insurance company to see if they will cover the removal procedure.  For some patients, they are covering the removal but not replacement with new implants.  In this case, it would be your responsibility.  These implants were manufactured in France and were never FDA approved but were implanted in women outside of USA.  Eurosilicone breast implants are approved in Europe but not in the USA.  In the USA, Mentor and Allergan implants are FDA approved and very safe.  

	 

	Good Luck.

Thangavel Ayyappan, MBBS, MS, MCh, DNB · Answer

i have been using them whenever patients wanted and also whenever  Allergan Silicone implants where unavailable ,especially since last 2 years  Allergan Silicone implants are not available in INDIA for reasons not known to me,when i contacted the sales person he told me that it was stopped due to lack of volumes.so it is not unsafe but it is not US FDA Approved

Erez Sternberg, MD · Answer

Eurosilicone implants are manufactured in France and sold throughout much of the world EXCEPT the United States. These implants are not approved by the FDA in the U.S and are therefore not placed during breast augmentation here. The company has been in operation for a number of years and claims to follow all recommended manufacturing standards for their products. I just removed a pair of EuroSilicone Saline implants from a patient of mine that had the implants put in while in German over 16 years ago. She had no problems with them, except that one just recently deflated. I removed these saline implants and replaced them with Allergan Silicone implants instead. The old implants looked good, but were slightly more firm than saline implants that I am used to seeing. They were also textured surface implants. She was very happy with her implants until they ruptured.

Jon F. Harrell, DO, FACS · Answer

Eurosilicone implants are manufactured in France and sold throughout much of the world EXCEPT the United States. These implants are not approved by the FDA in the U.S and are therefore not placed during breast augmentation here. The company has been in operation for a number of years and claims to follow all recommended manufacturing standards for their products. I just removed a pair of EuroSilicone Saline implants from a patient of mine that had the implants put in while in German over 16 years ago. She had no problems with them, except that one just recently deflated. I removed these saline implants and replaced them with Allergan Silicone implants instead. The old implants looked good, but were slightly more firm than saline implants that I am used to seeing. They were also textured surface implants. She was very happy with her implants until they ruptured.

Steven Schuster, MD, FACS · Answer

Dear Betty, the euro silicone does not seem to be the problem so I would not be concerned. Those implants are not FDA approved in the USA so I am not that familiar with them. If you have any concerns by all means contact your plastic surgeon. Remember that implants don,t last forever and should be exchanged every 10-15 years at the most (FDA recommends 10). Good luck and try not to worry, dr. Schuster in Boca Raton

Adam Hamawy, MD · Answer

Eurosilicone  is a a French breast implant manufacturer that is not related to Poly Implants Prothese (PIP).

	The current safety warnings are about the PIP implants and anyone with these implants in place should have them removed.  There are no such warnings about Eurosilicone.

	Implants produced by Eurosilicone, are CE marked, Class III medical devices and meet all standards specific to breast implants in Europe.  However, they are not FDA approved for implantation in the United States.  The only breast implants Currently approved in the US are made by Allergan and Mentor.

Please Advise on Eurosilicone Breast Implants, Are the Safe?

Answers (6)

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